Peripheral Vascular Stents

Number: 0785

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

Policy

Scope of Policy

This Clinical Policy Bulletin addresses peripheral vascular stents.

For medical necessity criteria for peripheral vascular stents, see eviCore Healthcare Peripheral Vascular Intervention Clinical Guidelines.

Note: eviCore guidelines undergo a formal review annually; however, eviCore reserves the right to change and update the guidelines without prior notice. Draft guidelines are posted 90 days prior to implementation. Additional clinical guidelines may be developed as needed or may be withdrawn from use.

Medical Necessity

Aetna considers the following interventions medically necessary:
1. Peripheral artery stenting by means of Food and Drug Administration-approved stentsFootnote1* in any of the following situations:
  1. Primary or salvage therapy for popliteal artery aneurysm when all of the following criteria are met:
    1. Aneurysm is symptomatic (e.g., painful, pulsatile or associated with clinical evidence of distal emboli) or equal to or greater than 2.0 cm in size on imaging (even if asymptomatic); and
    2. Documentation supports that the member has high peri-operative surgical risk; and
    3. Acceptable anatomy for stenting is documented and it is specifically shown by imaging that there is at least 15 mm of normal artery proximal AND distal to the aneurysm;
  2. Primary therapy for common iliac artery stenosis and occlusion;
  3. Primary therapy for external iliac artery stenosis and occlusion;
  4. Primary therapy for chronic mesenteric ischemia;
  5. Primary therapy for individuals with symptomatic posterior cerebral or cerebellar ischemia caused by subclavian artery stenosis (subclavian steal syndrome) who are at high-risk of surgical complications;
  6. Primary therapy for individuals with symptomatic extremity ischemia caused by subclavian artery stenosis (used in cases for stenting of the subclavian artery following percutaneous transluminal angioplasty);
  7. Salvage therapy for brachiocephalic arteries: subclavian steal syndrome, upper extremity claudication, ischemic rest pain of the arm and hand, non-healing tissue ulceration, and focal gangrene;
  8. Salvage therapy for common and external iliac arteries for a sub-optimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis greater than 50 %, or flow-limiting dissection);
  9. Salvage therapy for femoral, popliteal, and tibial arteries for a sub-optimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis greater than 50 %, or flow-limiting dissection);
2. The Zilver PTX Drug-Eluting Peripheral Stent for the primary treatment of femoro-popliteal artery disease;
3. The Gore Viabahn PTFE-coated endoprosthesis for improving blood flow in persons with symptomatic peripheral arterial disease in superficial femoral artery and iliac artery lesions;
4. Gore Viabahn stent for the treatment of failing stenotic or thrombosed hemodialysis grafts;
5. Gore Viabahn VBX stent for the treatment of celiac artery aneurysm with dissection, functionally limiting claudication and hemodynamically significant aorto-iliac or femoro-popliteal occlusive disease with inadequate response to conventional therapies, and symptomatic chronic mesenteric ischemia after exclusion of other possible causes for the member's chronic abdominal pain and unintended weight loss;
6. The Gore Tigris Vascular Stent for the primary treatment of superficial femoral artery and proximal popliteal artery diseases;
7. The Eluvia Drug-Eluting Vascular Stent System for the primary treatment of superficial femoral artery and proximal popliteal artery diseases;
8. The LifeStream balloon-expandable covered stent for the primary treatment of iliac artery stenosis;
9. Peripheral venous stents for the following indications (not an all-inclusive list):
  1. Hemodialysis access graft/fistula: stenosis, restenosis, and occlusion; recurrent cephalic arch stenosis (salvage therapy);
  2. May-Thurner syndrome (e.g., the VENOVO venous stent system) Note: The VENOVO venous stent system was recalled on January 13, 2021;
  3. Superior vena cava: superior vena cava syndrome, post radiation venous stenosis, and congenital stenosis.
10. Balloon angioplasty and stenting for the treatment of ilio-caval venous occlusion;
11. Renal artery stenting for stenosis due to atherosclerotic disease when any following criteria is met:
  1. Unilateral renal artery stenosis (RAS) in a member who is intolerant to optimal medical therapy, including a clinically significant rise in serum creatinine after initiation of a renin-angiotensin system inhibitor, or failure of optimal medical therapy to control the blood pressure; or
  2. Hemodynamically significant bilateral RAS (more than 75 % of both arteries); or
  3. Progressive kidney function impairment that is thought to be a result of the stenosis, or progressive kidney function impairment that is thought be a consequence of bilateral renovascular disease or unilateral stenosis affecting a solitary functioning kidney; or
  4. Recurrent flash pulmonary edema and/or refractory heart failure due to RAS; or
  5. Unexplained progressive renal insufficiency, especially if proteinuria is absent.
  Footnote1* All drug-eluting arterial stents and polytetrafluoroethylene (PTFE)-covered arterial stents, other than the Gore Viabahn PTFE-coated stent, the Atium Medical iCast stent, and the Zilver PTX-Drug-Eluting stent, are considered experimental, investigational, or unproven for treatment of peripheral vascular diseases because its effectiveness for this indication has not been established.
Experimental, Investigational, or Unproven

Aetna considers the following interventions experimental, investigational, or unproven because the effectiveness of these approaches has not been established:
1. Peripheral artery stenting in any of the following situations (not an all-inclusive list) for these indications:
  1. Celiac artery stenting in the treatment of celiac artery compression syndrome
  2. Primary therapy for tibial artery stenosis and occlusion
  3. Primary therapy for infra-popliteal lesion
  4. Primary or salvage therapy for atherosclerotic reno-vascular disease (e.g., ischemic nephropathy)
  5. Primary or salvage therapy for aorto-iliac arterial lesion
  6. Renal artery stenting for stenosis due to fibromuscular dysplasia;
2. Peripheral venous stents for the treatment of recurrent phlebitis;
3. Biodegradable stents (i.e. bio-absorbable and bio-resorbable) for the treatment of peripheral arterial disease
4. The Eluvia Drug-Eluting Vascular Stent System for the treatment of iliac artery stenosis;
5. Hybrid foot vein arterialization for the treatment of critical limb ischemia (CLI);
6. The LimFlow Stent Graft System for the treatment of CLI.
Related Policies

Table:
CPT Codes / HCPCS Codes / ICD-10 Codes
Code	Code Description
*Peripheral Artery Stenting*:
CPT codes covered if selection criteria are met:
37236	Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery
37237	each additional artery (List separately in addition to code for primary procedure)
Other CPT codes related to the CPB:
37221	Revascularization, endovascular, open or percutaneous, iliac artery, unilateral, initial vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
+37223	with transluminal stent placement(s), includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)
37226	Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
37227	Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed
HCPCS codes covered if selection criteria are met:
C1874	Stent, coated/covered, with delivery system [not covered for Atrium Medical iCast]
C1875	Stent, coated / covered, without delivery system
C1876	Stent, non-coated/non-covered, with delivery system [for femoropopliteal artery disease]
C1877	Stent, non-coated/non-covered, without delivery system [for femoropopliteal artery disease]
ICD-10 codes covered if selection criteria are met:
G45.8	Other transient cerebral ischemic attacks and related syndromes
I70.1	Atherosclerosis of renal artery [not covered for stenosis due to fibromuscular dysplasia]
I72.4	Aneurysm of artery of lower extremity [popliteal artery aneurysm]
I96	Gangrene, not elsewhere classified
K55.9	Vascular disorder of intestine, unspecified [chronic mesenteric ischemia]
ICD-10 codes not covered for indications listed in the CPB:
I73.00 - I73.9	Other peripheral vascular disease
I77.1	Stricture of artery [tibial]
I77.4	Celiac artery compression syndrome
N28.0	Ischemia and infarction of kidney. [ischemic nephropathy]
*Eluvia Drug-Eluting Vascular Stent System, Gore Viabahn PTFE-coated Endoprosthesis, Gore Tigris Vascular Stent, LifeStream balloon-expandable covered stent, iCast stent, Gore Viabahn VBX stent*:
HCPCS codes covered if selection criteria are met:
C1874	Stent, coated/covered, with delivery system [not covered for other polytetrafluoroethylene (PTFE)-covered stents] [Eluvia Drug-Eluting Stent not covered for iliac artery stenosis]
ICD-10 codes covered if selection criteria are met:
I70.201 - I70.203	Unspecified atherosclerosis of native arteries of extremities, leg
I70.211 - I70.213	Atherosclerosis of native arteries of extremities with intermittent claudication, leg
I70.291 - I70.293	Other atherosclerosis of native arteries of extremities, leg
I70.92	Chronic total occlusion of artery of the extremities
I72.8	Aneurysm of other specified arteries [celiac artery pseudoaneurysm]
I73.00 - I73.9	Other peripheral vascular disease
I74.09	Other arterial embolism and thrombosis of abdominal aorta [aorto-iliac occlusive disease]
I74.3	Embolism and thrombosis of arteries of the lower extremities
I74.5	Embolism and thrombosis of iliac artery
K55.1	Chronic vascular disorders of intestine [chronic mesenteric ischemia]
T82.858A - T82.858S	Stenosis of other vascular prosthetic devices, implants and grafts [hemodialysis grafts]
T82.868A - T82.868S	Thrombosis due to vascular prosthetic devices, implants and grafts [hemodialysis grafts]
*Peripheral Venous Stents*:
CPT codes covered if selection criteria are met:
0505T	Endovenous femoral-popliteal arterial revascularization, with transcatheter placement of intravascular stent graft(s) and closure by any method, including percutaneous or open vascular access, ultrasound guidance for vascular access when performed, all catheterization(s) and intraprocedural roadmapping and imaging guidance necessary to complete the intervention, all associated radiological supervision and interpretation, when performed, with crossing of the occlusive lesion in an extraluminal fashion
37238	Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein
37239	each additional vein (List separately in addition to code for primary procedure)
CPT codes not covered for indications listed in the CPB:
Hybrid foot vein arterialization – no specific code
0620T	Endovascular venous arterialization, tibial or peroneal vein, with transcatheter placement of intravascular stent graft(s) and closure by any method, including percutaneous or open vascular access, ultrasound guidance for vascular access when performed, all catheterization(s) and intraprocedural roadmapping and imaging guidance necessary to complete the intervention, all associated radiological supervision and interpretation, when performed [LimFlow Stent Graft System/Procedure]
Other CPT codes related to the CPB:
37226	Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
37227	Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed
HCPCS codes covered if selection criteria are met:
C1876	Stent, noncoated/noncovered, with delivery system
C1877	Stent, noncoated/noncovered, without delivery system
C2617	Stent, noncoronary, temporary, without delivery system
C2625	Stent, noncoronary, temporary, with delivery system
ICD-10 codes covered if selection criteria are met:
I87.1	Compression of vein [recurrent cephalic arch stenosis]
T82.858A - T82.858S	Stenosis of other vascular prosthetic devices, implants and grafts, [hemodialysis access graft/fistula: stenosis and restenosis]
T82.898A – T82.898S	Other specified complication of vascular prosthetic devices, implants and grafts [hemodialysis access graft/fistula: occlusion]
ICD-10 codes not covered for indications listed in the CPB:
I80.00 - I80.9	Phlebitis and thrombophlebitis
M62.251 – M62.279	Nontraumatic ischemic infarction of muscle, thigh, lower leg, ankle, and foot [critical limb ischemia]
Biodegradable stents - no specific code:
*Balloon angioplasty and stenting for the treatment of ilio-caval venous occlusion*:
CPT codes covered if selection criteria are met:
37238	Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein
37239	each additional vein (List separately in addition to code for primary procedure)
37248	Transluminal balloon angioplasty (except dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; initial vein
37249	each additional vein (List separately in addition to code for primary procedure)
Other HCPCS codes related to the CPB:
C1874	Stent, coated/covered, with delivery system
C1876	Stent, non-coated/non-covered, with delivery system
C1877	Stent, non-coated/non-covered, without delivery system
C2617	Stent, non-coronary, temporary, without delivery system
C2623	Catheter, transluminal angioplasty, drug-coated, non-laser
C2625	Stent, non-coronary, temporary, with delivery system
ICD-10 codes covered if selection criteria are met:
I87.0	Compression of vein [Ilio-caval venous occlusion (ICVO)]
*Renal Artery Stenting for the treatment of stenosis due to atherosclerotic disease*:
CPT codes covered if selection criteria are met:
37236	Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery
37237	each additional artery (List separately in addition to code for primary procedure)
Other HCPCS codes related to the CPB:
C1874	Stent, coated/covered, with delivery system
C1876	Stent, non-coated/non-covered, with delivery system
C1877	Stent, non-coated/non-covered, without delivery system
C2617	Stent, non-coronary, temporary, without delivery system
C2623	Catheter, transluminal angioplasty, drug-coated, non-laser
C2625	Stent, non-coronary, temporary, with delivery system
ICD-10 codes covered if selection criteria are met:
I70.1	Atherosclerosis of renal artery

Background

Peripheral vascular disease (PVD) stems from restriction of blood flow in vessels that lead to the extremities (i.e., arms and legs) as well as internal organs (e.g., kidney and stomach). There are 2 types of PVD:

functional, and
organic.

Functional PVD does not involve defects in the structure of the blood vessels; is usually transient and related to spasm of the vessels (e.g., Raynaud's disease). It can be triggered by smoking, cold temperatures, emotional stress, or working with vibrating machinery. Organic PVD is caused by inflammation and tissue damage in the blood vessels (e.g., peripheral artery disease [PAD]). It is caused by fatty build-ups in arteries that block normal circulation; and is more common than functional PVD.

Peripheral artery disease affects 3 major arterial segments:

aorto-iliac arteries,
femoro-popliteal (FP) arteries, and
infra-popliteal (primarily tibial) arteries.

The disease is usually classified based on claudication, rest pain, or degree of tissue loss due to chronic ischemia. Peripheral artery disease is an important cause of morbidity that affects up to 10 million people in the United States. Physicians can identify patients who are at risk for the disease with a questionnaire and the ankle brachial index (ABI). The ABI can be attained by measuring the blood pressure (BP) at the brachial artery and at the posterior tibialis artery by means of sonography. The ankle systolic BP is divided by the brachial BP, both measured in the supine position. Normally, the ratio is more than 1; in severe disease, it is less than 0.5. More than 70 % of patients diagnosed with the disease remain stable or improve with conservative management. Those who do not improve may undergo contrast angiography or magnetic resonance angiography, which may be used in planning for surgery or percutaneous intervention. In particular, patients with critical limb ischemia (CLI) should undergo interventions for re-vascularization. Re-vascularization methods have entailed surgical as well as endovascular approaches. Surgical bypass, atherectomy, and endarterectomy have been used to restore peripheral circulation. However, the invasiveness and complications of surgical interventions have resulted in the development of endovascular procedures. Percutaneous transluminal angioplasty (PTA) and/or stenting have been employed as primary and salvage therapy for PAD (De Sanctis, 2001; Ouriel, 2001; Balk et al, 2008; AHA, 2009).

There are 2 basic types of stents:

balloon-expandable (BE), and
self-expandable (SE).

The former uses an angioplasty balloon to expand and set the stent within the arterial segment (e.g., the Palmaz stent); although it has been supplanted by the next generation of SE stents for arterial occlusive lesions. Self-expanding stents may have benefits in longer occlusive lesions as primary therapy, especially in the FP segment, where PTA and BE stents may be associated with higher rates of re-stenosis and failure. The SE stent depends on the unique properties of a memory metal (e.g., nitinol) or alternatively the weave of the stent, to assume a pre-configured shape within the vessel lumen. The Wallstent, an example of the latter, is composed of elgaloy, a variant of stainless steel, and the radial force induced by the weave density determines expansion. The SE stent may be post-dilated to ensure strut apposition to the arterial wall. The patency rates of SE stents appear to be superior to BE stents (Balk et al, 2008).

New materials have been added to conventional stents in an attempt to improve their effectiveness. The standard stent (whether BE or SE) is bare-metal, with no added materials. Covered stents use a synthetic fabric, such as polytetrafluoroethylene (PTFE), which covers the metal component of the stent and acts as an exoskeleton. However, animal studies did not support the proposed advantage of the covered stent that it lowers the incidence of neointimal hyperplasia, which can hasten re-stenosis. While the incidence of neointimal hyperplasia was reduced in the mid-portion of the graft, it was comparable to that of controls at the proximal and distal ends of the covered stent. One major advantage of a stent graft is that a longer infra-inguinal lesion can be treated. In theory, the synthetic fabric of the covered stent excludes the atherosclerotic plaque from the lumen. In addition, the combination of the nitinol exoskeleton and the fabric cover yields a flexible, but structurally stable device, which is particularly advantageous in the femoro-popliteal segment (Balk et al, 2008).

Drug-eluting stents (DES) that usually contain sirolimus (rapamycin) have been used "off-label" for patients with PVD. Other treated stents have been developed such as the Carbostent, which has a thin coating of carbon designed to reduce its interaction with platelets. "Off-label" use of stents is problematic because the device does not follow the conventional Food and Drug Administration (FDA) approval process. Randomized controlled trials (RCTs) are underway, one that compares PTA alone to PTA and a biliary stent in the superficial femoral and proximal popliteal arteries; another RCT has been performed, which examines a bare nitinol biliary stent in the same anatomical segment. Neither of these trials has yet been published in peer-reviewed journals (Balk et al, 2008). The National Institute for Health and Clinical Excellence's guideline on "Lower limb peripheral arterial disease: Diagnosis and management" (2012) recommended the use of bare metal stents where stenting is indicated for intermittent claudication because of a lack of evidence of superior clinical outcomes with DES.

There is no consensus on the diagnosis or treatment of renal artery stenosis (RAS). The consequences of renal ischemia are hypertension, neuroendocrine activation, and renal insufficiency, which can result in acceleration of atherosclerosis, further renal dysfunction, myocardial infarction (MI), heart failure, stroke, and death. Whether re-vascularization improves clinical outcomes when compared with optimal medical therapy is unclear.

There is insufficient evidence of the effectiveness of stenting over percutaneous transluminal angioplasty (PTA) for renal artery stenosis. An assessment prepared for the Agency for Healthcare Research and Quality (2007) concluded that "[o]verall, there is insufficient evidence to determine whether angioplasty with stenting is better treatment for [atherosclerotic renal artery stenosis] than aggressive medical therapy alone." The report also concluded that there is no difference in the long-term kidney function of people who have angioplasty compared with people who have medical therapy alone." The report also noted that there is insufficient evidence to determine whether angioplasty reduces the number of antihypertensive medications required after the procedure, and there is no research about how angioplasty and medical therapy compare in treating people who have acutely decompensating hemodynamic and kidney function.

The American Heart Association (AHA)'s symposium on atherosclerotic peripheral vascular disease – intervention for renal artery disease (Rocha-Singh et al, 2008) stated that the treatment of atherosclerotic renal artery disease is evolving and remains controversial. Renal artery stenting is widely available and frequently used to treat patients with renal artery stenosis and poorly controlled hypertension and/or renal insufficiency. However, it is still unclear if percutaneous re-vascularization adds incremental value to optimal medical therapy to prevent the adverse consequence of renal artery disease. Accordingly, the AHA recommended that physicians enroll hypertensive patients with atherosclerotic RAS into the CORAL trial to acquire outcomes and selection data.

More recently published systematic evidence reviews (e.g., Kumbhani et al, 2011) have found no significant differences in clinical outcomes in persons with renal artery stenosis managed with stenting and persons managed medically. Ongoing clinical trials such as the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial will ultimately help to determine the best strategies to limit the morbidity and mortality associated with renal artery stenosis.

Cooper and colleagues (2006) stated that the Cardiovascular Outcomes in Renal Atherosclerotic Lesions Trial (CORAL) is a randomized clinical study contrasting optimal medical therapy alone to stenting with optimal medical therapy for patients with atherosclerotic RAS on a composite cardiovascular and renal endpoint: cardiovascular or renal death, MI, hospitalization for congestive heart failure, stroke, doubling of serum creatinine, and need for renal replacement therapy. The secondary endpoints evaluate the effectiveness of re-vascularization in important subgroups of patients and with respect to all-cause mortality, kidney function, renal artery patency, microvascular renal function, and BP control.

Tuttle and colleagues (1998) reported their 5-year experience with the intra-vascular stent for the treatment of ostial RAS. A total of 129 patients (63 men and 66 women) and 148 arteries were included in this study. The mean age of the patients was 71 +/- 10 years; 98 % were hypertensive and 57 % had renal dysfunction. Angiographical characteristics of RAS were unilateral in 78 %, bilateral in 15 %, and single kidney in 7 %. The technical success rates were 98 % for stent versus 11 % for percutaneous renal angioplasty (PTRA) in the ostial location. The stent re-stenosis rate (angiographical) was 14 % at 8 +/- 5 months. Systolic and diastolic BPs were as follows: baseline, 158 +/- 3 and 84 +/- 2 mm Hg; 6 months, 149 +/- 3 and 81 +/- 2 mm Hg; 12 months, 149 +/- 3 and 79 +/- 2 mm Hg; and 24 months, 135 +/- 3 and 79 +/- 2 mm Hg. Follow-up values were significantly lower than baseline (p < 0.05). The number of medications for hypertension initially decreased from 2.2 +/- 0.1 at baseline to 1.6 +/- 0.1 and 1.8 +/- 0.1 at 1 and 3 months, respectively (p < 0.05). By 6 months, however, the number of medications had increased and was not significantly different from before stent placement. Renal function was stable in the group as a whole: Cockroft-Gault creatinine clearance (C-G CrCl) at baseline was 40 +/- 2 ml/min; at 6 months, 36 +/- 3 ml/min; at 12 months, 39 +/- 3 ml/min; and at 24 months, 39 +/- 4 ml/min. When stratified by degree of renal function, values were similarly stable. Patients with a baseline serum creatinine level of 2 mg/dL or less had C-G CrCl values as follows: baseline, 53 +/- 3 mg/dL; 6 months, 43 +/- 4 mg/dL; 12 months, 46 +/- 4 mg/dL; and 24 months, 52 +/- 5 mg/dL. Those with a baseline serum creatinine level greater than 2 mg/dL had C-G CrCl values as follows: baseline, 26 +/- 2 mg/dL; 6 months, 31 +/- 4 mg/dL; 12 months, 32 +/- 6 mg/dL; and 24 months, 23 +/- 3 mg/dL. Of 8 patients who were dialysis-dependent, 4 (50 %) recovered renal function with a mean serum creatinine level of 2.3 +/- 0.5 mg/dL at 15 +/- 6 months (range of 9 to 24 months). The authors concluded that stent placement for the treatment of atherosclerotic ostial RAS has a high success rate and a low rate of re-stenosis. Control of hypertension improves in most patients. Renal function stabilizes or improves in the majority of patients, even those with severe renal failure. The authors reported that these favorable outcomes are maintained long-term.

In a prospective non-randomized trial, Zahringer et al (2007) evaluated the patency of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in the treatment of atherosclerotic RAS. A total of 105 consecutive symptomatic patients (53 men; mean age of 65.7 years) with RAS were treated with either a bare-metal (n = 52) or a drug-eluting (n = 53) low-profile Palmaz-Genesis peripheral stent at 11 centers. The primary endpoint was the angiographical result at 6 months measured with quantitative vessel analysis by an independent core laboratory. Secondary endpoints were technical and procedural success, clinical patency [no target lesion re-vascularization (TLR)], BP and anti-hypertensive drug use, worsening of renal function, and no major adverse events at 1, 6, 12, and 24 months. At 6 months, the overall in-stent diameter stenosis for BMS was 23.9 % +/- 22.9 % versus 18.7 % +/- 15.6 % for SES (p = 0.39). The binary re-stenosis rate was 6.7 % for SES versus 14.6 % for the BMS (p = 0.30). After 6 months and 1 year, TLR rate was 7.7 % and 11.5 %, respectively, in the BMS group versus 1.9 % at both time points in the SES group (p = 0.21). This rate remained stable up to the 2-year follow-up; but did not reach statistical significance due to the small sample. Even as early as 6 months, both types of stents significantly improved BP and reduced anti-hypertensive medication compared to baseline (p < 0.01). After 6 months, renal function worsened in 4.6 % of the BMS patients and in 6.9 % of the SES group. The rate of major adverse events was 23.7 % for the BMS group and 26.8 % for the SES at 2 years (p = 0.80). The authors concluded that the angiographical outcome at 6 months did not show a significant difference between BMS and SES. Renal artery stenting with both stents significantly improved BP. They stated that future studies with a larger patient population and longer angiographical follow-up are needed to determine if there is a significant benefit of DES in treating ostial RAS.

Corriere et al (2008) retrospectively examined peri-procedural morbidity and early functional responses to primary renal artery angioplasty and stenting (RA-PTAS) for patients with atherosclerotic reno-vascular disease (RVD). Consecutive patients undergoing primary RA-PTAS for hemodynamically significant atherosclerotic RVD with hypertension and/or ischemic nephropathy were identified from a prospectively maintained registry. Hypertension responses were determined based on pre- and post-intervention BP measurements and medication requirements. Estimated glomerular filtration rate (eGFR) was used to determine renal function responses. Both hypertension and renal function responses were assessed at least 3 weeks after RA-PTAS. Stepwise multi-variable regression analysis was used to examine associations between BP and renal function responses to RA-PTAS and select clinical variables. A total of 110 primary RA-PTAS were performed on 99 patients with atherosclerotic RVD with a mean angiographical diameter-reducing stenosis of 79.2 +/- 12.9 %. All patients had hypertension (mean of 3.4 +/- 1.3 anti-hypertensive agents). Mean pre-intervention eGFR was 49.9 +/- 22.7 ml/min/1.73 m(2), and 74 patients had a pre-intervention eGFR of less than 60 ml/min/1.73 m(2). The technical success rate for RA-PTAS was 94.5 %. The peri-procedural complication rate was 5.5 %; there were no peri-procedural deaths. Statistically significant decreases in mean systolic BP (161.3 +/- 25.2 mm Hg versus 148.5 +/- 25.2 mm Hg post-intervention, p < 0.0001), diastolic BP (78.6 +/- 13.3 mm Hg versus 72.5 +/- 13.5 mm Hg post-intervention, p < 0.0001), and number of anti-hypertensive agents (3.3 +/- 1.2 versus 3.1+/- 1.3 post-intervention, p = 0.009) were observed. Assessed categorically, hypertension response to RA-PTAS was cured in 1.1 %, improved in 20.5 %, and unchanged in 78.4 %. Categorical eGFR response to RA-PTAS was improved in 27.7 %, unchanged in 65.1 %, and worsened in 7.2 %. Multi-variable stepwise regression analysis revealed associations between pre- and post-intervention systolic BP (p < 0.0001), diastolic BP (p < 0.0001), and eGFR (p < 0.0001), as well as a trend toward improved diastolic BP response among patients managed with staged bilateral intervention (p = 0.0589). The authors concluded that primary RA-PTAS for atherosclerotic RVD was associated with low peri-procedural morbidity and mortality but only modest early improvements in BP and renal function. They stated that results from ongoing prospective trials are needed to assess the long-term outcomes associated with RA-PTAS and clarify its role in the management of atherosclerotic RVD.

The American Heart Association (AHA)'s symposium on atherosclerotic peripheral vascular disease – intervention for renal artery disease (Rocha-Singh et al, 2008) had the following statements:

The treatment of atherosclerotic renal artery disease is evolving and remains controversial.
Renal artery stenting is widely available and frequently used to treat patients with RAS and poorly controlled hypertension and/or renal insufficiency. However, it is still unclear if percutaneous re-vascularization adds incremental value to optimal medical therapy to prevent the adverse consequence of renal artery disease. Accordingly, the AHA recommended that physicians enroll hypertensive patients with atherosclerotic RAS into the CORAL trial to acquire outcomes and selection data.
In patients with declining renal function due to ischemic nephropathy, when obstructive renal artery disease affects the entire renal mass, renal artery stenting can be expected to either improve or stabilize renal function in the majority of patients and reduce the risk of developing volume overload; however, this potential benefit must be weighed against the potential risk of worsening renal function due to procedure-related atheroembolization or contrast-induced nephropathy, other adverse events, and renal in-stent re-stenosis (ISR). Thus, additional research in this area is needed.
Newer technologies have been applied to treatment of renal ISR, but none has been shown to be superior in limited case-series reports. Use of a PTFE-covered BE stent (iCast Covered Stent, Atrium Medical Corp, Hudson, NH; or Graft Master Stent, Abbott Vascular Devices, Santa Clara, CA) is another potential method to treat renal ISR, although neither device is approved for this indication, nor is there evidence to support their use.
Drug-eluting stents reduce ISR at 12 months in coronary arteries. The efficacy of a sirolimus DES in the renal circulation has been studied in a small feasibility study, the GREAT trial (Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment), in which 6-month follow-up data demonstrated a decrease in renal ISR from 14 % in the BMS group to 6.7 % in the DES cohort on the basis of follow-up angiography.
New technology, devices, and medications are promising, but no data support their routine use for the treatment of renal ISR, and further investigation is recommended.

In a randomized clinical trial, Bax and colleagues (2009) examined the safety and effectiveness of stent placement in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function. Randomization was centralized and computer- generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment. A total of 140 patients with creatinine clearance less than 80 ml/min per 1.73 m(2) and ARAS of 50 % or greater were included in this study. Stent placement and medical treatment (n = 64) or medical treatment only (n = 76). Medical treatment consisted of anti-hypertensive treatment, a statin, and aspirin. The primary end point was a 20 % or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality. Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16 %) in the stent placement group and 16 patients (22 %) in the medication group reached the primary end point (hazard ratio [HR], 0.73 [95 % confidence interval [CI]: 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3 %), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points. Many patients were falsely identified as having RAS greater than 50 % by non-invasive imaging and did not ultimately require stenting. The authors concluded that stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.

In a randomized, unblinded trial, the ASTRAL Investigators (Wheatley et al, 2009) examined if percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease. A total of 806 patients with atherosclerotic renovascular disease were randomly assigned either to undergo re-vascularization (angioplasty either alone or with stenting) in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months. During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was -0.07x10(-3) liters per micromole per year in the re-vascularization group, as compared with -0.13x10(-3) liters per micromole per year in the medical-therapy group, a difference favoring re-vascularization of 0.06x10(-3) liters per micromole per year (95 % CI: -0.002 to 0.13; p = 0.06). Over the same time, the mean serum creatinine level was 1.6 micromol per liter (95 % CI: -8.4 to 5.2 [0.02 mg per deciliter; 95 % CI: -0.10 to 0.06]) lower in the re-vascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the re-vascularization group than in the medical-therapy group. The 2 study groups had similar rates of renal events (HR in the re-vascularization group, 0.97; 95 % CI: 0.67 to 1.40; p = 0.88), major cardiovascular events (HR, 0.94; 95 % CI: 0.75 to 1.19; p = 0.61), and death (HR, 0.90; 95 % CI: 0.69 to 1.18; p = 0.46). Serious complications associated with re-vascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs. The authors concluded that they found substantial risks but no evidence of a worthwhile clinical benefit from re-vascularization in patients with atherosclerotic renovascular disease.

Rabbia and Pini (2010) stated that atherosclerotic renovascular disease is an increasingly recognized cause of severe hypertension and declining kidney function. Patients with atherosclerotic renovascular disease have been demonstrated to have an increased risk of adverse cardiovascular events. In the past 20 years, renal artery re-vascularization for treatment of ARAS has gained great increase via percutaneous techniques. However the effectiveness of contemporary re-vascularization therapies in the treatment of RAS is unproven and controversial. The indication for renal artery stenting is widely questioned due to a not yet proven benefit of renal re-vascularization compared to best medical therapy. Many authors question the effectiveness of percutaneous renal re-vascularization on clinical outcome parameters, such as preservation of renal function and BP control. None of the so far published RCTs could prove a beneficial outcome of RAS re-vascularization compared with medical management.

Peixoto et al (2010) noted that the management of ARAS is controversial. Although it may appear intuitive that restoring normal blood flow to the kidney(s) is the treatment of choice, there are no data showing an obvious advantage of interventional therapy compared with medical therapy. The authors discussed the most recent advances in the treatment of ARAS with a focus on RCTs comparing medical treatment with angioplasty/stenting, especially in patients with underlying renal dysfunction. The available data are still of limited quality but provide support against indiscriminate use of interventions, as these treatments appear no better than best medical treatment that focuses on BP control, use of blockers of the renin-angiotensin system, and aggressive cardiovascular risk management.

Steichen et al (2010) systematically reviewed the controlled studies on primary stenting for ARAS. Studies were included if they compared the outcome of stenting with other treatments, or the outcome associated with different stent characteristics or stenting methods. Stenting is preferred over angioplasty alone and over surgery when re-vascularization is indicated for ostial ARAS, except in cases of co-existent aortic disease indicating surgery. Randomized controlled trials showed no significant benefit and substantial risk of renal artery stenting over medication alone in patients with ARAS without a compelling indication. Improvements in the procedure, such as with distal embolic protection devices and coated stents, are not associated with better clinical outcomes after stent placement for ARAS. The authors concluded that recent evidence shows that impaired renal function associated with ARAS is more stable over time than previously observed. Optimal medical treatment should be the preferred option for most patients with ARAS. Only low-level evidence supports compelling indications for re-vascularization in ARAS, including rapidly progressive hypertension or renal failure and flash pulmonary edema.

Simon (2010) stated that percutaneous intervention has become very popular for treating ARAS, as the use of stents has boosted the rate of technical success and as more cases are being discovered incidentally during angiography of the coronary or other arteries. Yet, RCTs indicate that the procedure does little in terms of controlling BP and may actually harm as many patients as it helps in terms of renal function. Needed are better ways to predict which patients will benefit and better ways to prevent adverse effects such as atheroembolism.

Guidelines on management of peripheral artery disease from the American College of Cardiology (Hirsch et al, 2006), discussed in greater detail below, conclude that primary stent placement is not recommended in the femoral, popliteal, or tibial arteries. In addition, the guidelines state that the effectiveness of stents for the treatment of femoral-popliteal arterial lesions (except to salvage suboptimal results from balloon dilation) is not well established, and the effectiveness of uncoated/uncovered stents for the treatment of infra-popliteal lesions (except to salvage a suboptimal result from balloon dilation) is not well-established.

A Cochrane systematic evidence review of angioplasty versus stenting for superficial femoral artery lesions found most randomized clinical trials meeting inclusion criteria reporting patency rates and ankle-brachial pressure index, with only one trial reporting on quality of life (Twine et al, 2009). The Cochrane review found a small but statistically significant improvement in primary angiographic and duplex patency at 6 months in patients treated with PTA plus stent over lesions treated with PTA alone. However, primary angiographic patency was non-significant at 1 year. A similar but lesser effect was seen for ankle brachial pressure index (ABPI). The review reported a small improvement in treadmill walking distance in patients with PTA plus stent insertion at 6 months and 1 year, but not at 2 years. The Cochrane review found only 1 trial reporting quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval.

The Agency for Healthcare Research and Quality's technology assessment of "invasive interventions for lower extremity peripheral artery disease" and systematic review of "studies comparing stent placement to other interventions" (Balk et al, 2008) reached the following conclusions:

The cited aorto-iliac surgery studies did not describe the pre-operative anatomy and no clinically relevant outcomes were reported. The majority of the studies cited for endovascular treatment of the aorto-iliac segment did have anatomical descriptions of the studied patients; however, none used the Trans-Atlantic Society Consensus (TASC) classification;
There is a dearth of trials of patients with either aorto-iliac or infra-popliteal disease. The newer nitinol stents were used by only 3 of the trials (plus 1 RCT of stent versus bypass and 2 RCTs comparing different stents). The predominant primary outcome of the trials remain patency (variously defined), which has not been adequately demonstrated to be an excellent predictor of clinical outcomes. True clinical outcomes have frequently been inadequately or incompletely reported and analyzed.

Regarding studies comparing stents to PTA, the AHRQ assessment found "Individual studies did find statistically significantly better clinical outcomes with one intervention or the other, but overall, the trials and other comparative studies failed to provide adequate data to show that any one intervention is superior for any outcome over any other intervention in any group of patients. However, for the most part, the data can not be said to convincingly show that stent and PTA (or the other comparisons) are equivalent. The studies are clinically too heterogenous and both individually and collectively too small to accurately estimate relative differences in clinical event rates. The AHRQ assessment stated: "There is a dearth of trials of patients with either aorto-iliac or infra-popliteal disease …. The primary outcome of the trials remains patency (variously defined), which has not been adequately shown to be an excellent predictor of clinical outcomes." The assessment found that clinical studies have frequently focused on patency rates, a surrogate endpoint of unclear clinical significance. The assessment stated: "To be able to assess the true relative value of stent placement compared to PTA, it is important that future trials analyze more clearly defined questions, use greater methodological rigor, and use appropriate clinical outcomes. This includes clearly defining what the population being analyzed is (by diseased artery, lesion morphology, and clinical severity), and what the intervention and comparator is (preferably analyzing stent to PTA, with minimal crossover, since high rates of secondary stenting make the study results difficult to interpret). The primary outcomes should be important clinical outcomes, not surrogate outcomes, such as patency (or even ABI)."

Mewissen (2004) assessed the safety and effectiveness of SE shape memory alloy recoverable technology (SMART) nitinol stents in patients with CLI demonstrating type B or type C TASC lesions in the FP arterial segment. A total of 137 lower limbs in 122 patients with CLI, secondary to TASC A (n = 12) or TASC B/C (n = 125) lesions in the FP artery were treated with the Cordis SMART SE nitinol stents. The hemodynamic primary stent patency was calculated by life-table methods from the time of intervention, uninterrupted by hemodynamic stent failure. The mean lesion length was 12.2 cm (range of 4 cm to 28 cm). The technical success was 98 %. Within the follow-up period (mean of 302 days), 24 limbs were diagnosed with hemodynamic stent failure. The hemodynamic primary stent patency rates were 92 %, 76 %, 66 %, and 60 % at 6, 12, 18, and 24 months, respectively. These data provided objective evidence that endovascular treatment of FP TASC A, B and C lesions using SE nitinol SMART stents in patients with CLI provides favorable safety and durability outcomes.

The Cordis Randomized Iliac Stent Project-US (CRISP-US) trial assessed the performance of the SMART nitinol SE stent and the stainless steel Wallstent for treating iliac artery disease after sub-optimal PTA (Ponec et al, 2004). This multi-center, prospective, randomized trial comprised 203 patients with CLI who received either the SMART stent (n = 102) or the Wallstent (n = 101) after sub-optimal PTA. The primary endpoint was a composite of 9-month re-stenosis, 30-day death, and 9-month target vessel re-vascularization (TVR). Functional, clinical, and hemodynamic assessments were made at hospital discharge and at 1, 6, 9, and 12 months. The 9-month composite endpoint rate was equivalent for the SMART stent and the Wallstent (6.9 % versus 5.9 %), with low rates of re-stenosis (3.5 % versus 2.7 %), death (2.0 % versus 0.0 %), and re-vascularization (2.0 % versus 4.0 %) in the 2 groups. Primary patency at 12 months was 94.7 % and 91.1 % with the SMART stent and the Wallstent, respectively. Functional and hemodynamic improvements were also comparable between the groups. The acute procedural success rate was higher in the SMART stent group (98.2 % versus 87.5 %; p = 0.002). The frequency of major adverse events was similar at 1 year (4.9 % versus 5.9 %). The authors concluded that the performance of the SMART stent was equivalent to that of the Wallstent for treating iliac artery stenosis. The design characteristics of the SMART stent may contribute to greater procedural success and more accurate stent deployment.

In a double-blind, randomized, prospective trial, Duda and associates (2002) evaluated the effectiveness of the SMART nitinol SE stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery (SFA) obstructions. A total of 36 patients were recruited for this study. All patients had CLI and femoral artery occlusions (57 %) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guide-wire passage across the lesion; 18 patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary endpoint of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6 % in the SES group versus 30.9 % in the uncoated stent group (p = 0.294). The in-stent mean lumen diameter was significantly larger in the SES group (4.95 mm versus 4.31 mm in the uncoated stent group; p = 0.047). No serious adverse events (prolonged hospitalization or death) were reported. The authors concluded that the use of sirolimus-eluting SMART stents for SFA occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

In a follow-up study, Duda et al (2005) expanded the treatable population and limited the lesion lengths so that all lesions could be covered by no more than 2 stents. A total of 57 patients (29 in the SES group and 28 in the BMS group) with CLI and SFA occlusions (66.7 %) or stenoses (average lesion length of 81.5 +/- 41.2 mm). Stent implantation followed standard interventional techniques. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. Both stent types were effective in re-vascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 +/- 0.69 mm and 4.76 +/- 0.54 mm for SES and BMS groups, respectively; p = 0.31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the SES, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 +/- 0.64 mm and 0.68 +/- 0.97 mm for the SES group and the BMS group, respectively (p = 0.20). The binary re-stenosis rates, with a cut-off value of 50 % at 6 months, were 0 % in the SES group and 7.7 % in the BMS group (p = 0.49). Clinical outcomes matched angiographical outcomes with improvements in ABI and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. The authors concluded that although there is a trend for greater efficacy in the SES group, there were no statistically significant differences in any of the variables.

Schillinger et al (2006) examined if primary implantation of a SE nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by PTA with optional secondary stenting. These investigators randomly assigned 104 patients who had severe claudication or CLI due to stenosis or occlusion of the SFA to undergo primary stent implantation (n = 51) or angioplasty (n = 53). Re-stenosis and clinical outcomes were assessed at 6 and 12 months. The mean (+/- SD) length of the treated segment was 132 +/- 71 mm in the stent group and 127 +/- 55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 %) in the angioplasty group, in most cases because of a sub-optimal result after angioplasty. At 6 months, the rate of re-stenosis on angiography was 24 % in the stent group and 43 % in the angioplasty group (p = 0.05); at 12 months the rates of re-stenosis on duplex ultrasonography were 37 % and 63 %, respectively (p = 0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group. The authors concluded that in the intermediate-term, treatment of SFA disease by primary implantation of a SE nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting.

Kickuth et al (2007) assessed the primary success and short-term patency associated with a new 4-F sheath-compatible SE nitinol stent after failed conventional angioplasty of distal popliteal and infra-popliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic CLI. A total of 35 patients with Rutherford category 3 to 5 disease (CLI, n = 16; LLC, n = 19) underwent PTA and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, as well as digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated. A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibio-peroneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82 %. The mean resting ABI at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12 to 24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (p < 0.001 for both). The sustained clinical improvement rate was 80 % at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100 %. The rate of major complications was 17 %. The authors concluded that infra-popliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.

Zeller et al (2008) examined the impact of nitinol stenting of SFA lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST). A total of 6 study sites enrolled 110 symptomatic patients (75 men; mean age of 68 +/- 9 years). These patients had a single de novo greater than 70 % SFA lesion that is less than 10 cm long, and they were treated with the SE nitinol Conformexx stent. The primary study endpoint was binary re-stenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were TLR, ABI, mean Rutherford category, greater than 1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received ("on treatment" analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study. Technical success was achieved in 106 (96 %) patients; at 1 year, the primary endpoint of ultrasound-assessed binary re-stenosis was reached in 14 (23.3 %) of 60 patients (95 % CI: 13.4 % to 36 %). This re-stenosis rate was lower versus the historical BA (38.6 %, p = 0.057) or Luminexx 3 stent controls (31.7 %, p = 0.284) from FAST. The clinically driven TLR was 7.4 % (7 of 94 clinically controlled patients), which was also lower compared to 18.3 % (p = 0.098) and 14.9 % (p = 0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75 +/- 0.79 to 0.94 +/- 1.38 (p < 0.0001); 85.1 % were improved by at least 1 Rutherford category. The ABI increased from 0.62 +/- 0.15 to 0.85 +/- 0.20 (p < 0.0001). The authors concluded that this study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was under-powered to prove superiority of the Conformexx nitinol stent design compared to historical balloon angioplasty only or Luminexx 3 stent groups.

It should be noted that Medtronic Inc. (Minneapolis, MN), under an investigational device exemption, is sponsoring a clinical trial of its Complete SE stent for the treatment of PAD in the SFA. The SFA study is a prospective, multi-center, single-arm trial that planned to enroll 178 subjects at up to 30 sites globally.

In a meta-analysis, Mwipatayi et al (2008) reviewed the currently available literature and compared the short-term and long-term results of primary stenting and angioplasty of FP occlusive disease. All studies that reported data on the long-term results after balloon dilatation or stent implantation were included if at least 1-year primary patency or re-stenosis rate was presented; the study follow-up was at least 1 year and the number of subjects at the start of study was at least 20 patients. In the meta-analysis, there were a total of 934 patients: 452 patients underwent BA (273 patients were male) and 482 patients underwent stenting (297 patients were male). Primary patency at 1-year and post-operative ABI post-intervention was used to evaluate the pooled odds ratio (OR) of all studies. The pooled OR of all studies estimate for the 12-month patency rates was 0.989 (95 % CI: 0.623 to 1.570, p = 0.962) showing no difference in outcome between the 2 groups (SE 0.269 % to 1.025 %). The pooled OR estimate for the post-operative ABI was 0.869 (95 % CI: 0.557 to 1.357, p = 0.561) showing a slight advantage in favor of the BA group; but the "p" value was not statistically significant (SE 0.282 % to 1.326 %). The 1-year primary patency rates following BA ranged from 45 % to 84.2 % and at 2 years it varied from 25 % to 77.2 %. In the stent implantation group, the 1-year primary patency rates varied from 63 % to 90 %, and 2-year primary patency ranged from 46 % to 87 %. Heterogeneity was seen among studies, and publication bias could not be excluded. The authors concluded that the results of this meta-analysis suggested that stent placement in the FP occlusive disease does not increase the patency rate when compared with BA alone at 1 year.

Kasapis and colleagues (2009) performed a meta-analysis of RCTs comparing routine stenting (ST) with PTA for symptomatic superficial femoral-popliteal artery (SFPA) disease. A total of 10 trials were pooled randomizing patients to ST (n = 724 limbs) or PTA with provisional stenting (n = 718 limbs) with a follow-up period of 9 to 24 months. The mean lesion length was similar in the two groups (45.8 mm in the ST group and 43.3 mm in the PTA group). These researchers calculated the summary risk ratios (RRs) for immediate technical failure, re-stenosis, and TVR using random-effects models. The immediate technical failure was higher in the PTA group than in the ST group (17.1 % versus 5.9 %, respectively, RR = 0.28, 95 % CI: 0.15 to 0.54, p < 0.001), with 10.3 % of the PTA patients undergoing stenting because of sub-optimal result. There was a trend for lower re-stenosis in the ST group (37.6 % in ST versus 45.3 % in PTA, RR = 0.85, 95 % CI: 0.69 to 1.06, p = 0.146), but no difference in the need for TVR (20 % in ST versus 20.2 % in PTA, RR = 0.98, 95 % CI: 0.78 to 1.23, p = 0.89). In an analysis restricted to nitinol stents, there was a trend towards reduction in TVR (RR = 0.79, 95 % CI: 0.59 to 1.06, p = 0.12). The authors concluded that despite the higher immediate success, routine stenting was not associated with a significant reduction in the rate of re-stenosis or TVR. These findings do not support use of routine stenting as the primary endovascular treatment for short SFPA lesions.

Saxon and colleagues (2008) compared the safety and effectiveness of the Viabahn endoprosthesis with that of PTA alone in the treatment of symptomatic PAD affecting the SFA. From 1998 to 1999, patients with symptomatic SFA PAD were enrolled in a prospective, multi-center randomized study and underwent either PTA alone (n = 100) or PTA followed by stent-graft placement (expanded PTFE [ePTFE]/nitinol self-expanding stent-graft) (n = 97) for stenoses or occlusions of the SFA that were 13-cm long or shorter. At baseline, there were no significant differences between the PTA and stent-graft treatment groups, including CLI status and treated lesion length. The stent-graft group had a significantly higher technical success rate (95 % versus 66 %, p < 0.0001) and 1-year primary vessel patency rate at duplex ultrasonography (65 % versus 40 %, p = 0.0003). A patency benefit was seen for lesions at least 3-cm long. At 12 months, CLI status was 15 % further improved for the stent-graft group (p = 0.003). There were no significant differences between treatment groups with regard to the occurrence of early or late major adverse events. The authors concluded that in this multi-center study, the patency, technical success, and clinical status results obtained with stent-grafts were superior to those obtained with PTA alone. Drawbacks of this study included the lack of an uncovered stent arm that precluded direct comparisons with nitinol stents, the frequency of minor puncture site hematomas (not requiring therapy) was higher in the stent graft group, and short follow-up period. Also, the study was stopped with a smaller patient population than was originally planned, which may have limited the power of the study and resulted in a failure to detect significant differences that may have been present. The authors noted that studies with longer follow-up are needed to define more clearly the durability of stent graft re-vascularization in patients with CLI. Additionally, more RCTs comparing stent graft and new bioactive stent grafts with other endovascular techniques or with bypass surgery are needed.

Kougias et al (2009) performed a retrospective cohort study of consecutive patients with symptomatic SFA occlusions (greater than 15 cm) who underwent subintimal endovascular intervention, either covered stent (CS) or balloon-only subintimal angioplasty (SIA), in a single institution. Primary patency was the primary outcome. Secondary outcomes included complication rates, freedom from re-intervention, and limb salvage rates. Patency was ascertained with follow-up duplex or clinically. These investigators evaluated 57 patients in the SIA group and 31 patients in the CS group. At 1 year the SFA primary patency for the SIA and CS groups was 28 % versus 75 % (p < 0.001), whereas the primary assisted patency was 37 % versus 84 % (p < 0.001), respectively. Need for bypass was 13 % versus 0 % (p = 0.05) in the SIA and CS groups, respectively. The authors concluded that placement of a covered stent improves patency after subintimal intervention for long SFA occlusion. Drawbacks of this study included its retrospective nature, small sample size, and short follow-up period. Also, not all the patients had confirmed patency with imaging studies. The authors noted that primary placement of a covered stent is a promising endovascular modality in the treatment of SFA occlusive disease, and more long-term data are needed to ensure durability.

Kawamura et al (2009) compared patency rates following nitinol stenting in subjects with SFA lesions compared to a historical group of subjects with SFA lesions who received stainless steel stents in preceding years. As the study did not compare stenting with PTA alone, no conclusions can be reached about the value of PTA plus stenting versus PTA in this study. Although the study suggested that nitinol stent implantation improves primary patency after PTA compared with stainless steel stenting, the lack of randomization and use of non-contemporaneous comparison groups introduces the risk of bias. In addition, the study did not report on clinical outcomes.

McQuade and associates (2010) compared the treatment of SFA occlusive disease percutaneously with an ePTFE/nitinol self-expanding stent graft (stent graft) versus surgical femoral to above-knee popliteal artery bypass with synthetic graft material. A total of 100 limbs in 86 patients with SFA occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. Trans-Atlantic InterSociety Consensus (TASC II) A (n = 18), B (n = 56), C (n = 11), and D (n = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups:

a percutaneous treatment group (group A; n = 50) with angioplasty and placement of one or more stent grafts, or
a surgical treatment group (group B; n = 50) with a femoral to above-knee popliteal artery bypass using synthetic conduit (Dacron or ePTFE).

Patients were followed for 48 months. Follow-up evaluation included clinical assessment, physical examination, ABI, and color flow duplex sonography at 3, 6, 9, 12, 18, 24, 36, and 48 months. Mean total lesion length of the treated arterial segment in the stent graft group was 25.6 cm (SD = 15 cm). The stent graft group demonstrated a primary patency of 72 %, 63 %, 63 %, and 59 % with a secondary patency of 83 %, 74 %, 74 %, and 74 % at 12, 24, 36, and 48 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 76 %, 63 %, 63 %, and 58 % with a secondary patency of 86 %, 76 %, 76 %, and 71 % at 12, 24, 36, and 48 months, respectively. No statistical difference was found between the 2 groups with respect to primary (p = 0.807) or secondary (p = 0.891) patency. The authors concluded that management of SFA occlusive disease with percutaneous stent grafts exhibits similar primary patency at 4-year (48 month) follow-up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. The authors concluded that this treatment method may offer an alternative to treatment of the SFA segment for re-vascularization when prosthetic bypass is being considered or when autologous conduit is unavailable. Drawbacks of this study included a small total patient cohort, a single center experience, and that only 64 % (32 to 50 limbs) in the stent graft group and 52 % (26 of 50 limbs) in the surgery group are available for analysis at 4 years. Also, there were a variety of anti-thrombotic medications – almost all (93 %) of the stent graft group were on combination anti-platelet therapy with aspirin and plavix whereas only about 50 % of the surgery group were on this combination regimen. Furthermore, the patients enrolled in this clinical trial had relatively mild lesions (more than 70 % were TASC II A and B lesions with mostly intermittent claudication). It is unclear if the stent graft approach is effective in the more severe lesions.

Lenti et al (2007) reported the findings of a prospective multi-center registry designed to evaluate the safety, effectiveness, and patency of the aSpire SE PTFE-covered stent (Vascular Architects Inc, San Jose, CA) in patients with FP occlusive disease. The aSpire Registry included 150 patients (166 limbs) enrolled in 16 centers during a 28-month period for medium/long (greater than 3 cm) occlusion (n = 115) or stenosis (n = 51) of the SFA (n = 51) or of the proximal popliteal (n = 115) arteries. Procedures were performed for intermittent claudication in 92, for rest pain in 33, and for limb savage in 41. The mean length of arterial segment covered was 107.35 +/- 73.7 mm. Indications for treatment included 44 type B1, 57 type B2, 47 type C1, and 18 type D lesions according to the TASC classification. Clinical and ultrasound evaluations were performed at discharge and at 1, 6, 12 months, and yearly thereafter. Mean follow-up was 13 months (range of 1 to 36). Primary endpoints were immediate technical success (vessel re-canalization with residual stenosis less than or equal to 30 %) and stent patency. Initial technical success was obtained in 162 (97.6 %) of 166 procedures. More than one stent was applied in 48 procedures, for a total of 214 stents. No peri-procedural deaths occurred. Procedure-related complications occurred in 22 of 166 procedures, including 6 peripheral embolizations, 7 thromboses, 2 hemorrhages requiring revision, 1 vessel rupture, and 6 vessel dissections. Life-table estimates of primary patency at 12, 24, and 36 months were 64 %, 59 %, and 59 %, respectively. A total of 32 re-interventions were performed during follow-up, resulting in secondary patency rates at 12, 24, and 36 months of 74.2 %, 67 %, and 67 %, respectively. Amputation was required in 6 of 41 patients treated for limb salvage. At multi-variate analysis, CLI was the only significant predictor of late failure. The authors concluded that endovascular treatment of SFA occlusive lesions provided interesting results. Length of lesion and clinical symptoms influence negatively the patency. The PTFE-covered stent showed good mid-term results, but a number of re-interventions were necessary to obtain an optimal secondary patency. Risk of patency failure was related to CLI as an indication for the procedure. These researchers stated that technological and pharmacological improvement and longer follow-up are needed to define the indications for the aSpire PTFE-covered stent.

Dearing et al (2009) reported on the results of peripheral angioplasty and stenting by a single surgeon of primary stenting of the SFA and popliteal artery. Limitations of this study include the lack of a comparison group and the reporting only of patency rates and not clinical outcomes. Dosluoglu et al (2009) compared percutaneous balloon angioplasty and stenting versus above knee femoral popliteal bypass with PTFE for TASC C and D lesions and reported better primary and primary assisted patency with PTA and stenting than with surgical reconstruction. Limitations of this study included its retrospective nature and its reporting solely of patency rates.

The American College of Cardiology/American Heart Association's guidelines for the management of patients with PAD (lower extremity, renal, mesenteric, and abdominal aortic) had the following statements (Hirsch et al, 2005):

Stenting is effective as primary therapy for common iliac artery stenosis and occlusions
Stenting is effective as primary therapy for external iliac artery stenoses and occlusions
Provisional stent placement is indicated for use in the iliac arteries as salvage therapy for a sub-optimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis greater than 50 %, or flow-limiting dissection)
Stents can be useful in the femoral, popliteal, and tibial arteries as salvage therapy for a sub-optimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis greater than 50 %, or flow-limiting dissection)
Primary stent placement is not recommended in the femoral, popliteal, or tibial arteries
The effectiveness of stents for the treatment of femoral-popliteal arterial lesions (except to salvage a suboptimal result from balloon dilation) is not well-established
The effectiveness of uncoated/uncovered stents for the treatment of infra-popliteal lesions (except to salvage a suboptimal result from balloon dilation) is not well-established.

The American Heart Association (AHA)'s symposium on atherosclerotic peripheral vascular disease – lower-extremity re-vascularization (Gray et al, 2008) had the following statements:

Re-stenosis after endovascular therapy for infra-inguinal PAD remains a major obstacle to widespread adoption of DES as primary treatment of symptomatic PAD. With the dramatic improvement in re-stenosis rates realized in large-scale prospective, multi-center RCT in coronary artery disease using DES compared with BMS, it seems intuitive that similar technology would result in clinical as well as anatomical benefits in infra-inguinal PAD. Unfortunately, data evaluating such therapy are limited.
There is an ongoing clinical trial in the United States, the Zilver-PTX trial (Cook, Inc., Bloomington, IN) in which paclitaxel, which has been shown to dramatically reduce coronary artery ISR, has been placed on the surface of nitinol SE stents, although without a top coat. This randomized, prospective, multi-center trial comparing a DES with a BMS has completed its feasibility phase and is now enrolling patients in the pivotal segment of the trial.
Two treatment strategies have shown efficacy for coronary ISR (DES and vascular brachytherapy), however, there is no consensus for the treatment of SFA ISR.
Further studies with DES for SFA re-stenosis are warranted.
Anecdotes have been reported about the efficacy of covered stents (i.e., PTFE-covered nitinol stents), but no data exist to suggest that these will provide a break-through.

Sarac and colleagues (2008) stated that percutaneous angioplasty and stenting (PTAS) is emerging as a therapeutic option for patients with chronic mesenteric ischemia (CMI). This study evaluated patency and mortality, and their relationship between degree of vessel occlusion (stenotic or totally occluded), stent characteristics, and co-morbidities in patients who were treated with PTAS of the visceral vessels for CMI. A retrospective review was performed of the records of all patients who underwent PTAS of the celiac, superior mesenteric, or inferior mesenteric arteries, or both, for symptomatic CMI between January 2001 and December 2005. Patient demographics, lesion characteristics (stenosis or occlusion), interventional details, and early and late mortality rates were recorded. Cumulative mortality and patency rates and factors associated with outcomes were determined using Kaplan-Meier method and Cox proportional hazards modeling. A total of 87 mesenteric vessels (57 superior mesenteric, 23 celiac, and 7 inferior mesenteric arteries) were treated in 65 patients (29 men and 36 women). Completely occluded vessels were treated in 18 patients (28 %), and greater than 60 % stenosis was treated in 47 patients (72 %). Mesenteric angina was the most common symptom (97 %). For the entire series, the cumulative 1-year results were primary patency, 65 % (95 % CI: 50 % to 80 %); primary assisted patency, 97 % (95 % CI: 92 % to 100 %); secondary patency, 99 % (95 % CI, 96 % to 100 %); and survival, 89 % (95 % CI, 80 % to 98 %). All deaths occurred less than or equal to 60 days after treatment. The endovascular treatment of visceral artery occlusion was not associated with diminished patency or survival, irrespective of stent size or number. Patients requiring bowel resection were less likely to survive than those who did not (odds ratio [OR], 26; 95 % CI: 3.5 to 192; p < 0.001). One-year primary patency was worse among patients with chronic obstructive pulmonary disease (OR, 3.2; 95 % CI: 1.4 to 7.7; p = 0.009) or who had femoral access (OR, 3.0; 95 % CI: 1.1 to 7.9; p = 0.015). The authors concluded that for patients with CMI, the results of endovascular treatment of occluded mesenteric arteries are indistinguishable from those treated for stenotic vessels. Patients requiring bowel resection are less likely to survive, and those with chronic obstructive pulmonary disease or who had femoral access have higher re-intervention rates.

Heiss et al (2008) evaluated the technical and clinical success rates of percutaneous stent re-vascularization in the treatment of CMI. A total of 17 patients (12 females) with typical symptoms of CMI were treated by percutaneous stent placement for stenoses of the splanchnic arteries (celiac trunk; superior mesenteric artery, SMA; inferior mesenteric artery, IMA). The primary and secondary technical success, primary and secondary clinical success, and the long-term clinical outcome were determined. A total of 24 stents were implanted in 21 splanchnic arteries (12 stents in the celiac trunk, 11 in the SMA and 1 in the IMA). The primary technical success rate was 91 % (19/21 arteries), the secondary technical success rate was 95 % (21/22 arteries). Clinical follow-up was available for 16 patients. The primary clinical success rate was 81 % (13/16 patients). Following 2 secondary interventions, the secondary clinical success rate was 94 % (15/16 patients). Long-term clinical success was achieved in 15 of 16 patients (94 %) with a mean follow-up of 26 months. One patient died within 30 days of the intervention and 2 patients demonstrated major complications (1 dissection, 1 stent dislocation). None of the patients required surgical re-vascularization and none of the patients died due to recurrent mesenteric ischemia. The authors concluded that percutaneous stent placement for the treatment of CMI can be performed with a high technical and clinical success rate as well as an excellent long-term clinical outcome.

Penugonda et al (2009) discussed stent placement in mesenteric arteries in older patients with an increasingly common diagnosis of CMI. They reviewed the articles that focused on the treatment of this gastrointestinal disorder by stenting/open surgical re-vascularization to avoid further ischemic episodes and bowel infarction and necrosis. The advantages of stent placement in mesenteric arteries were discussed in comparison to open surgical re-vascularization. In summary, the low morbidity and high technical success rate of catheter-based techniques have made this approach the first- line of therapy for CMI due to superior mesenteric artery stenosis for many elderly patients especially high-risk operative candidates.

Peck et al (2010) documented the intermediate-term anatomic and functional outcomes of endovascular mesenteric re-vascularization for symptomatic CMI. This was a retrospective review of all patients undergoing endovascular treatment of symptomatic CMI from July 2002 to March 2008. Study endpoints included peri-procedural mortality, major morbidity, patency, symptomatic recurrence, and survival. Endpoints were analyzed using actuarial methods. A total of 66 mesenteric arteries (78.8 % stenotic; 21.2 % occluded) were treated in 49 patients. One or more vessels were treated in each case; however, 4 mesenteric artery total occlusions (3 SMAs; 1 IMA) could not be crossed. Initial symptom relief was noted in 89.8 % (n = 44) with no change in 5 patients. Single-vessel treatments were performed in 32 patients (65.3 %) and 2-vessel interventions in 17 (34.7 %). The 30-day mortality rate was 2.0 % (n = 1). Major complications occurred in 8 patients (16.3 %). The mean follow-up duration was 37.4 +/- 2.98 months (range of 0 to 66). Re-stenosis on follow-up imaging occurred in 64.9 % (n = 24) of the 37 patients who had radiographical surveillance at a mean follow-up interval of 8.5 +/- 1.9 months and was diagnosed most often by Duplex scan or computed tomographic angiography (CTA). Fourteen patients (28.6 %) developed recurrent symptoms with 13 requiring a re-intervention. Actuarial 36-month freedom from symptomatic recurrence was 60.9 % +/- 9.4 %. Two-vessel treatment was protective against symptom recurrence (p = 0.0014) and re-intervention (p = 0.0060) by uni-variate analysis. A total of 19 re-interventions were required in 14 patients (28.6 %) at a mean of 17 months from the original treatment. Primary patency at 36 months was 63.9 +/- 8.5 %. Actuarial survival at 48 months was 81.1 % +/- 6.1 % with no CMI-related deaths in the study cohort. The authors concluded that intermediate (3-year) follow-up indicates that significant re-stenosis and symptom recurrence are common following the endovascular treatment of symptomatic CMI – 30 % of the cohort required a re-intervention, 1/3 of which were converted to surgical reconstruction. Similar to the surgical paradigm of 2-vessel re-vascularization, endovascular treatment of multiple mesenteric arteries produced better outcomes. A first-line endovascular approach to patients with CMI is a reasonable clinical strategy, but close follow-up is mandatory.

Fioole et al (2010) noted that open re-vascularization in patients with CMI is considered the gold standard. Percutaneous transluminal angioplasty and stenting is often reserved for patients not suitable for open re-vascularization. In the authors' institute, endovascular re-vascularization is the first-choice treatment. The purpose of this study was to report the technical and clinical success rates after endovascular re-vascularization as the first-choice treatment in a series of 51 consecutive patients with CMI at a single tertiary vascular referral center. A retrospective review was performed of all consecutive patients with CMI who underwent PTAS from July 2001 to July 2008. Only symptomatic patients treated for atherosclerotic CMI were included. Patency was evaluated using CTA. Kaplan-Meier curves were used to calculate patency rates of the treated mesenteric arteries. A total of 60 mesenteric arteries (30 celiac trunks, 24 superior mesenteric, and 6 inferior mesenteric arteries) were treated in 51 patients (26 men). Major morbidity was 4 %. After dissection of the SMA (n = 1) and brachial artery (n = 1), respectively, both patients underwent endarterectomy and patch plasty. In 3 arteries, the lesion could not be crossed endovascularly and they were deemed immediate intention-to-treat failures. The initial technical success rate was 93 %. No 30-day mortality was observed. Median follow-up was 25 months. During follow-up, 2 patients died from intestinal ischemia. Complete symptom relief was achieved in 78 % of patients. Primary 1- and 2-year patency rates were 86 % +/- 5 % and 60 % +/- 9 %, respectively; primary-assisted patency rates were 88 % +/- 5 % and 79 % +/- 7 %, respectively. During follow-up, 6 patients underwent open re-vascularization due to failure of PTAS. The authors concluded that the initial technical success rate of PTAS as first-choice treatment of CMI is greater than 90 %. The 2-year primary patency rate dropped to 60 %, but symptomatic in-stent stenoses could often be treated successfully with renewed endovascular techniques. Including 1 conversion, 14 % of patients needed open re-vascularization during follow-up.

Loffroy and colleagues (2010) noted that percutaneous transluminal angioplasty with stent placement is now recognized as a minimally invasive means of obtaining good long-term results with an acceptable recurrence rate for the treatment of CMI. Gibbons and Roberts (2010) stated that endovascular treatment for CMI is growing in popularity because of its lower peri-procedural morbidity and mortality than open surgery. It is especially suitable for the high-risk surgical candidate and for those who have a poor nutritional state, although endovascular surgery may not be possible in patients with ostial occlusions or heavily calcified vessels. A positive response to angioplasty is helpful to secure a diagnosis in patients with slightly atypical symptoms. There are little data at present to suggest that primary stenting is better than angioplasty alone, but insertion of a stent may be valuable as a rescue procedure following dissection, vascular recoil, or thrombosis during angioplasty. The superior mesenteric artery is probably the most important vessel to treat but, where this is impossible, celiac or inferior mesenteric artery dilatation may have therapeutic benefit. However, there is some evidence at present favoring multiple, as opposed to single-vessel, angioplasty or stenting. Long-term patency is better after mesenteric bypass, which may be preferred in the younger and fitter patient. Treatment of the celiac artery compression syndrome is primarily surgical, but stent insertion may have a role as a secondary procedure where there is a residual stenosis after median arcuate ligament division. Furthermore, the Society for Vascular Surgery (2009) stated that angioplasty and stenting is used for the treatment of CMI.

Wang et al (2010) stated that endovascular therapy is a treatment option for localized occlusion of the subclavian artery (SA). In this report the long-term experience with 59 patients was presented. Between June 1998 and September 2008, these investigators used endovascular therapy to treat 61 subclavian arterial obstructive lesions in 59 patients (46 males and 13 females, 34 to 82 years of age with a mean age (61.9 +/- 11.0 years). Twenty patients (34 %) had clinical symptoms due to vertebro-basilar insufficiency, 26 (44 %) had disabling arm ischemia, and 13 (22 %) had both symptoms. These researchers performed all procedures under local anesthesia. The approaches were from the femoral artery (n = 47), brachial artery (n = 1, involving bilateral subclavian disease) or both (n = 11). A total of 60 stents were implanted. All patients were followed-up at 1, 3, 6, and 12 months post-procedure, and annually thereafter. These investigators achieved technical success in 58 (95.1 %) arteries, all of which were stented. There were 3 technical failures; 2 were due to the inability to cross over an occlusion, necessitating the switch to an axillo-axillary bypass, and the 3rd was due to shock after digital subtraction angiography and prior to stenting. Arterial stenosis pre- and post-stenting was 83.6 +/- 10.8 % and 2.5 +/- 12.5 %, respectively (p < 0.01). Clinical success was achieved in 55 of the 59 patients (93.4 %). Of the 4 clinical failures, 3 were technical and the remaining patient had a stent thrombosis. Systolic blood pressure difference between the 2 brachial arteries was 44.7 +/- 18.5 versus 2.2 +/- 3.9) mm Hg (p < 0.01). Primary patency was 98 % at 12 months, 93 % at 24 months, and 82 % at 5 years. Five patients were lost to follow-up by 12 months post-stenting. Significant recurrent obstruction developed in 5 patients with resumption of clinical symptoms. The overall survival rate was 98.2 % at 12 months, 89.5 % at 24 months, and 84.5 % at 5 years. The authors concluded that endovascular therapy for proximal subclavian arterial obstructive lesions is effective and successful. This minimally invasive treatment may be the first choice of treatment for proximal sub-clavical arterial obstructive lesions.

Babic et al (2012) studied the initial and long-term results of angioplasty and primary stenting for the treatment of chronic total occlusion (CTO) of the SA. From January 1999 to February 2010, a total of 56 patients (25 men with a mean age of 58 +/- 8 years) underwent endovascular treatment for CTO of the SA. Duplex scans and arteriograms confirmed occlusion in all cases. Indications for re-canalization were subclavian steal syndrome in 33 patients (58.1 %), arm claudication in 13 patients (23.2 %), and coronary ischemia in 7 patients (12.5 %) who had a history of previous coronary artery bypass grafting that included left internal thoracic artery graft. Three patients (5.4 %) were treated before the scheduled coronary artery bypass surgery, which included left internal thoracic artery graft. After successful re-canalization, all arteries were stented, and all of the patients were followed-up at 1, 3, 6, and 12 months after surgery and annually thereafter. Successful re-canalization of the SA was achieved in 46 patients (82.1 %), and the complication rate was 7.1 %. During follow-up (mean 40 +/- 26 months; range of 2 to 125), the primary patency rates after 1 and 3 years were 97.9 % and 82.7 %, respectively. At the end of follow-up, 76 % of the arteries showed no evidence of re-stenosis. Uni-variate analysis failed to identify any variable predictive of long-term patency of successfully re-canalized SA. The authors concluded that percutaneous transluminal angioplasty with stenting of the complete total occlusion of the SA is a safe and effective procedure associated with low risks and good long-term results.

Furthermore, an UpToDate review on "Overview of upper extremity peripheral artery disease" (Mohler, 2012) states that "Options for the treatment of symptomatic subclavian stenosis or occlusion include surgical revascularization (e.g., carotid-subclavian bypass, subclavian transposition) and percutaneous transluminal angioplasty and stenting. Percutaneous catheter-based treatment is less invasive and associated with lower complication rates, and shorter hospitalization".

Also, the American College of Cardiology Foundation; American Stroke Association; American Association of Neurological Surgeons; American College of Radiology; American Society of Neuroradiology; Congress of Neurological Surgeons; Society of Atherosclerosis Imaging and Prevention; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of NeuroInterventional Surgery; Society for Vascular Medicine; Society for Vascular Surgery's guideline on "Management of patients with extracranial carotid and vertebral artery disease" (Brott et al, 2011) stated that percutaneous endovascular angioplasty and stenting is reasonable for patients with symptomatic posterior cerebral or cerebellar ischemia caused by subclavian artery stenosis (subclavian steal syndrome) who are at high-risk of surgical complications.

Dake et al (2011) stated that sustained benefits of drug-eluting stents in femoro-popliteal arteries have not been demonstrated. A prospective, multi-national, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoro-popliteal peripheral artery disease. In this study patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238) and demographics and lesion characteristics were similar between groups. One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). The 12-month rates of event-free survival and patency in the primary DES and PTA groups were evaluated. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001). In secondary evaluations, the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001). The provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and the stent fracture rate (both DES and BMS) was 0.9% (4/457). The authors concluded that femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.

Lammer et al (2011) stated that a novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. They reported on the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial, which was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease. One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. Enrolled patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm and ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients and primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture. The authors concluded that the everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.

In November, 2012 the FDA approved use of the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent),which is the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoro-popliteal artery) when narrowed or blocked as a result of PAD. The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent, patients who cannot receive recommended drug therapy due to bleeding disorders, or women who are pregnant, breastfeeding, or plan to become pregnant in the next five years (FDA, 2012).

The Gore Viabahn endoprosthesis has been approved by the FDA for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. The Gore Viabahn endoprosthesis is a flexible, metallic (made from nitinol) stent which is lined with expanded polytetrafluoroethylene [ePTFE]). The device is mounted on the end of a delivery catheter and held in place by a release mechanism. The delivery catheter with the mounted endoprosthesis is inserted in the femoral artery through a puncture in the leg and threaded to the blocked section of the femoral artery. Once the device is positioned within the blocked area, it is freed from the delivery catheter by activation of the release mechanism. The device is expanded within the artery , opening the blocked area to improve blood flow. The delivery catheter is removed from the patient leaving the device within the femoropoplitealartery of the patient. According to the FDA (2012), the Gore Viabahn Endoprosthesis is used in patients who have a blockage within their femoral artery, which is caused by atherosclerotic disease. This blockage can cause pain by preventing adequate blood flow from reaching the lower leg and foot. According to the FDA, the Gore Viabahn Endoprosthesis should not be used in patients who have a blockage where full expansion of a balloon dilatation catheter has not been achieved or where blockages cannot be dilated sufficiently to allow passage of the delivery system.

Saxon et al (2012) evaluated the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoro-popliteal artery (FPA). In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age of 67 yrs), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56 % of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio less than 2.5. At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6 ± 0.2 to 0.9 ± 0.19; p < 0.0001). Primary and secondary patency rates were 73 % and 92 %. The primary patency for devices oversized less than 20 % at the proximal landing zone was 88 %, whereas the primary patency for devices oversized by greater than 20 % was 70 % (p = 0.047). Primary patency was not significantly affected by device diameter (5 versus 6 versus 7 mm) or lesion length (less than or equal to 20 cm versus greater than 20 cm). The 30-day major adverse event rate was 0.8 %. The authors concluded that the heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73 % at 1 year in the treatment of long-segment FPA disease.

Sixt et al (2008) reported that percutaneous transluminal angioplasty is an accepted and successful treatment strategy in obstructive disease of the SA. These researchers evaluated the technical and clinical long-term outcome following endovascular therapy. These researchers retrospectively analyzed 99 patients (mean age of 65 +/- 10 years) with 100 interventions of the SAs and the brachiocephalic trunk with different etiologies [atherosclerosis (90 %); Takayasu's arteritis (5 %); thrombo-embolism (2 %); external compression (1 %); iatrogenic dissection (1 %) and occlusion after graft implantation in type B dissection (1 %)]. Primary success rate was 97 % (100 % for stenoses and 90 % for total occlusions). Treatment modalities included balloon angioplasty (PTA) alone (16 %), stent implantation (78 %), rotational thrombectomy (2 %) and atherectomy (1 %). The primary 1-year patency rate of the whole study cohort was 87 % being not significantly lower after PTA (75 %) compared to stent assisted angioplasty (89 %). After thrombectomy and atherectomy no relevant restenosis were found. Multi-variable analysis of 1-year restenosis-free survival revealed younger age (p = 0.03) and stenting (p = 0.04) as independent predictor. The blood pressure difference between both limbs at baseline was 42 +/- 24 mmHg and dropped to 10 +/- 14 mmHg after the intervention and 15 +/- 20 mmHg after 12 months, respectively (p = 0.01). The authors concluded that endovascular therapy of SA obstructions of various etiologies offers good acute success rates even in total occlusions; long-term patency rate is in favor of stent placement.

Park et al (2011) stated that since they reported about a landmark technique to re-open an occluded SA, they have faced difficulty in using protection devices in the vertebral artery to protect against thromboembolism from the reversed steal phenomenon after angioplasty and stenting. Thus, they presented an optimal solution in using a protection device while re-canalizing the occluded SA. Among 21 cases of stenting for SA steno-occlusion, they applied the landmark technique at the opposite end of an occluded segment in 4 patients and used a protection device in 2 patients. Because the embolic protection device was placed in the vertebral artery via the brachial artery, optimal angioplasty and stenting via the brachial route were limited. Therefore, angioplasty via the trans-brachial approach was needed to be followed by stenting through a trans-femoral approach. They estimated the safe and optimal steps for placement and retrieval of the protection devices in addition to stenting. The procedure was safely performed when a stent was introduced via the femoral artery and a protection device was used via the brachial artery. However, in cases when a guide-wire wasn't passed via the transfemoral route, simultaneous use of 2 systems via the brachial route could cause friction of devices or trapping of protection devices in a stent. When a protection device was trapped in a deployed stent, they retrieved the protection device with a 4F angio-catheter by selectively rotating the catheter tip. To avoid such procedural difficulty, they recommended using a trans-brachial angioplasty followed by trans-femoral stenting while placing the protection device in the vertebral artery via the trans-brachial route. The authors concluded that if a guide-wire was not passed through using a trans-femoral approach while performing the landmark technique, changing the stenting route from brachial to the femoral artery can be useful after securing the lumen in the occluded SA after angioplasty via the brachial artery.

Chatterjee et al (2013) stated that SA stenosis has long been treated with great success with bypass surgery. Percutaneous intervention, often used in combination with stent placement, has come into vogue for the past few years as a safe and effective therapeutic modality. These investigators compared angioplasty alone with angioplasty followed by stent placement by combining available data. The objective of this study was to perform a review of the available literature to compare the efficacy of percutaneous transluminal angioplasty (PTA) alone with PTA followed by stent placement for proximal SA stenosis. Successful re-canalization was defined as patency at the end of 1 year, and re-occlusions and re-stenoses were noted as events for the purpose of pooling the data. The authors searched the Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, PubMed, EMBASE, and CINAHL databases for relevant trials/studies comparing PTA and PTA with stenting. Review authors independently assessed the methodological quality of studies (focusing on the adequacy of the randomization process, allocation concealment, blinding, completeness of follow-up evaluation, and intention-to-treat analysis) and selected studies for inclusion. All retrospective observational studies were also included in the analysis in the absence of double-blinded randomized trials for increasing sample size. All analyses were done using RevMan 5.0. Odds ratio was calculated using Mantel-Haenszel test with a fixed effect model. All included studies were assessed by all authors for potential sources of bias. A total of 8 studies were included in the analysis having 544 participants. Stenting after PTA was significantly superior to angioplasty alone for treatment of SA stenosis and maintenance of patency at 1 year, as indicated by absence of events (p = 0.004; 95 % confidence interval, odds ratio 2.37 [1.32 to 4.26]) without significant complication rates for either procedure. The authors concluded that there is evidence in favor of stent placement after angioplasty for successful re-canalization of stenosed SAs and long-term maintenance of patency without significant increase in risk for major complications in subjects.

An UpToDate review on "Overview of upper extremity peripheral artery disease" (Mohler, 2013) states that "Patients who do not have symptoms do not require intervention. Options for the treatment of symptomatic subclavian stenosis or occlusion include surgical revascularization (e.g., carotid-subclavian bypass, subclavian transposition) and percutaneous transluminal angioplasty and stenting. Percutaneous catheter-based treatment is less invasive and associated with lower complication rates, and shorter hospitalization".

In a prospective, randomized, single-blind, multicenter study, Lammer and colleagues (2013) hypothesized that endovascular treatment with covered stents has equal risks but higher efficacy than BMS in long FP artery disease. A total of 141 patients with symptomatic PAD were assigned to treatment with heparin-bonded, covered stents (Viabahn; n = 72) or BMS (n = 69). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4 %. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9 % (95 % CI: 0.58 to 0.80) and 55.1 % (95 % CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1 % (95 % CI: 0.65 to 0.86) and 53.5 % (95 % CI: 0.39 to 0.65) (HR: 2.23 [95 % CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions greater than or equal to 20 cm, (TASC class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3 % versus BMS 36.8 %; p = 0.01) and the TPP analysis (VIA 73.3 % versus BMS 33.3 %; p = 0.004). Freedom from TLR was 84.6 % for Viabahn (95 % CI: 0.72 to 0.91) versus 77.0 % for BMS (95 % CI: 0.63 to 0.85; p = 0.37). The ABI in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. The authors concluded that this randomized trial in symptomatic patients with PAD who underwent endovascular treatment for long FP lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions greater than or equal to 20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5 % of the patients, the difference was not significant.

Cooper et al (2014) noted that atherosclerotic RAS is a common problem in the elderly. Despite 2 randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. These researchers randomly assigned 947 participants who had atherosclerotic RAS and either systolic hypertension while taking 2 or more anti-hypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end-point of death from cardiovascular or renal causes, MI, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). Over a median follow-up period of 43 months (interquartile range: 31 to 55), the rate of the primary composite end-point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1 % and 35.8 %, respectively; HR with stenting, 0.94; 95 % CI: 0.76 to 1.17; p = 0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end-point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95 % CI: -4.4 to -0.2; p = 0.03). The authors concluded that renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multi-factorial medical therapy in people with atherosclerotic RAS and hypertension or chronic kidney disease.

The accompanying editorial (Bittl, 2014) of the afore-mentioned study concluded that "The CORAL trial is a definitive test of the usefulness of renal-artery stents for moderately severe atherosclerotic disease. The trial results send a clear message to patients and referring physicians. Until new treatments are found to be safe and effective, patients in everyday practice who have moderately severe atherosclerotic renovascular disease and either hypertension or stage 3 chronic kidney disease should receive medical therapy to control blood pressure and prevent the progression of atherosclerosis but should not be corralled into getting a renal-artery stent".

In a Cochrane review, Chowdhury et al (2014) examined the effect of PTA compared with PTA with BMS for SFA stenoses on vessel patency in people with symptomatic (Rutherford categories1 to 6; Fontaine stages II to IV) lower limb PVD. In addition, these researchers assessed the effectiveness of PTA and stenting in improving quality of life, ABI and treadmill walking distance. For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Coordinator searched the Specialized Register (last searched August 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 6). Randomized trials of angioplasty alone versus angioplasty with BMS for the treatment of superficial femoral artery stenosis were selected for analysis. Two review authors independently selected suitable trials, assessed trial quality and extracted data. Furthermore, these 2 review authors performed assessments of methodological quality and wrote the final manuscript. The third review author cross-checked all stages of the review process. These investigators included 3 new studies in this update, making a total of 11 included trials with 1,387 participants. The average age was 69 years and all trials included men and women. Participants were followed for up to 2 years. There was an improvement in primary duplex patency at 6 and 12 months in participants treated with PTA plus stent over lesions treated with PTA alone (6 months: OR 2.90, 95 % CI: 1.17 to 7.18, p = 0.02, 6 studies, 578 subjects; 12 months: OR 1.78, 95 % CI: 1.02 to 3.10, p = 0.04, 9 studies, 858 participants). This was lost by 24 months (p = 0.06). There was a significant angiographic patency benefit at 6 months (OR 2.49, 95 % CI: 1.49 to 4.17, p = 0.0005, 4 studies, 329 participants) which was lost by 12 months (OR 1.30, 95 % CI: 0.84 to 2.00, p = 0.24, 5 studies, 384 participants). Ankle brachial index and treadmill walking distance showed no improvement at 12 months (p = 0.49 and p = 0.57, respectively) between participants treated with PTA alone or PTA with stent insertion. Three trials (660 participants) reported quality of life, which showed no significant difference between participants treated with PTA alone or PTA with stent insertion at any time interval. Anti-platelet therapy protocols and inclusion criteria regarding affected arteries between trials showed marked heterogeneity. The authors concluded that although there was a short-term gain in primary patency there was no sustained benefit from primary stenting of lesions of the SFA in addition to angioplasty. Moreover, they stated that future trials should focus on quality of life for claudication and limb salvage for critical ischemia.

Humphries et al (2014) evaluated midterm outcomes of balloon-expandable bare-metal stents (BMSs) versus covered balloon-expandable (CBE) stents placed in the common iliac artery (CIA) for aorto-iliac occlusive disease. All endovascular interventions for symptomatic peripheral arterial occlusive disease performed at a single institution from 2006 to 2012 were reviewed. Patients undergoing stent placement in the CIA segment were included in the analysis. Demographic data, TASC classification, stent type, patency, and limb re-interventions were compared. For treatment of de-novo distal aorta or CIA stenosis, 254 procedures were performed in 162 patients. Balloon-expandable bare-metal stents were used in 190 arteries; CBE stents were used in 64 arteries. There was no difference in age, gender, or TASC classification between the 2 groups. Mean follow-up was 22 ± 16 months. Primary patency, assisted patency, and secondary patency were significantly better in the BMS group. Common iliac arteries treated with covered stents were more likely at 1 year or longer to require repeated intervention (HR, 2.5; 95 % CI: 1.2 to 5.3; p = 0.009); TASC classification did not predict need for re-intervention in either group. Multi-variate analysis revealed dual anti-platelet therapy to be the only other factor to affect patency during long-term follow-up. The authors concluded that in this study, BMSs had significantly better patency compared with CBE stents for treatment of aorto-iliac occlusive disease. Moreover, they stated that a randomized trial comparing patency as well as re-stenosis rates with long-term follow-up is needed to determine if there is any benefit from use of covered stents in the aorto-iliac segment.

Marmagkiolis et al (2014) stated that endovascular approach to SFA disease, the most common cause of symptomatic PAD, remains fraught with high failure rates. Newer devices including second-generation nitinol stents, drug-coated stents, drug-coated balloons (DCBs), covered stents, cryotherapy, laser, and directional atherectomy have shown promising results. Clinical equipoise still persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study population, length of lesions treated, definition of "patency" and "restenosis," and follow-up methods in the pivotal trials. A prospective protocol was developed. These investigators performed a literature search using PubMed from January 2006 to November 2013. Published articles including endovascular interventions in SFA or popliteal arteries with reported 12-month "primary patency" or "binary restenosis" rates as end-points were included. They identified 6,024 patients in 61 trials reporting 12-month primary patency rates in patients with FP disease. Primary patency rates were (weighted average) 77.2 % for nitinol stents, 68.8 % for covered stents, 84 % for DES, 78.2 % for DCB, 60.7 % for cryo-balloon, 51.1 % for laser atherectomy, 63.5 % for directional atherectomy and 70.2 % with a combination of endovascular devices. The authors concluded that the most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 51 % to 85 %. The increased variation in inclusion criteria, length, and complexity of lesions between studies did not allow direct comparison between them. They stated that larger RCTs in specific patient populations comparing those modalities are needed before one can make safe recommendation of the superiority of one device over the other.

Jaff and colleagues (2015) noted that atherosclerotic PAD is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical re-vascularization, and, more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular re-vascularization has evolved over the past 2 decades, from PTA to self-expanding stents, atherectomy, laser angioplasty, and DES. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation (ACCF)/American Heart Association (AHF) guidelines. However, re-stenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant. Drug-coated balloons have the potential to address this need. Several RCTs of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe (N Engl J Med 2008;358:689-699) (Circulation 2008;118:1358-1365) (Circ Cardiovasc Interv 2012;5:831-840) (JACC Cardiovas Interv 2014;7:10-19) and demonstrated more durable efficacy than PTA with comparable safety. These studies were limited by small sample sizes and powered solely for an angiographic primary end-point. The pivotal LEVANT 2 trial was designed in collaboration with the FDA to demonstrate safety and effectiveness in a large population and to obtain FDA approval. A prospective, multi-center, single-blind trial comparing the Lutonix DCB (Bard Lutonix; New Hope, MN) versus PTA for treatment of FP PAD (LEVANT 2) is the first US-based 2:1 RCT of 476 patients with femoral-popliteal PAD designed to demonstrate superior effectiveness and non-inferior safety of a novel paclitaxel DCB compared with PTA. The primary effectiveness end-point is primary patency at 12 months. The primary safety end-point is composite freedom at 12 months from peri-operative death, index limb amputation, re-intervention, and limb-related mortality. A series of important secondary end-points include physical functioning, quality of life, re-vascularization, and alternative measures of patency. To minimize bias potential for confounding variables, LEVANT 2

excluded patients stented after pre-dilation before randomization,
incorporated very stringent criteria for bailout stenting,
did not count bailout stenting as a target lesion re-vascularization or failure of any end-point,
required a blinded clinician to perform clinical evaluations at follow-up, and
required clinical assessment before review of duplex ultrasound results.

The authors concluded that the LEVANT 2 represents the first US-inclusive multi-center RCT to evaluate the safety and effectiveness of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy.

An UpToDate review on "Percutaneous interventional procedures in the patient with lower extremity claudication" (Zaetta et al, 2016) states that "Although PTA in the femoro-popliteal segment is associated with restenosis, a clear advantage to primary stenting has not been definitively demonstrated in meta-analyses of randomized trials. In general, longer lesions probably benefit from stenting, but whether a self-expanding metal stent or covered stents should be used remains debated. Local delivery of medical therapies aimed at preventing stenosis using drug-eluting stents has also been tried, as well as the use of biodegradable stents. The use of drug-eluting stents should be considered experimental therapy".

The iCast Stent

The Atrium Medical iCast stent is a PTFE-coated stent indicated for use in trachea-bronchial strictures. A case-series study by Oderich and colleagues (2013) reported that the iCast coated stent had less re-stenosis than BMS for the treatment of CMI disease. However, an accompanying discussion (no authors listed, 2013) noted that the differences in rates of re-stenosis may have been due to changes in surgical approach or factors other than the conversion from BMS to PTFE-coated stents

Current guidelines on CMI have no recommendations for PTFE-coated stents as standard of care (Pecoraro et al, 2013). Furthermore, an UpToDate review on "Chronic mesenteric ischemia" (Tendler and Lamont, 2015) states that "Therapeutic options for patients suspected to have symptoms attributable to chronic mesenteric ischemia include surgical reconstruction and percutaneous transluminal angioplasty (PTA) with or without placement of a stent". It does not mention PTFE-coated stent as a therapeutic option. There have been no large RCTs comparing PTA, PTA with stenting, and surgical re-vascularization. In most patients angioplasty is preferred, with surgery reserved for younger patients with fewer co-morbid conditions.

Chang et al (2008) noted that common femoral artery (CFA) endarterectomy with iliac stenting or stent grafting can be an alternative to traditional open surgery in patients with aorto-iliac occlusive disease. In a retrospective study, these investigators reported the long-term outcomes of this approach. Patients undergoing CFA endarterectomy with simultaneous iliac stenting/stent grafting between 1997 and 2006 were retrospectively reviewed. Technical success, clinical and hemodynamic outcomes, and 5-year patency using life-table methodology were determined. Factors associated with re-intervention and mortality were determined by logistic regression analysis. A total of 171 patients (mean age of 67 +/- 10 years; 38 % women; 35 % diabetic) underwent 193 CFA endarterectomies and iliac stent/stent grafting. Indications were rest pain (32 %), tissue loss (22 %), and claudication (46 %). External iliac artery (EIA) lesions were present in 39 %, and combined common iliac artery (CIA) and EIA lesions were observed in 61 % of patients. Complete CIA/EIA occlusions were present in 41 % of patients. Stent grafts were used in 41 % of patients. Technical success occurred in 98 % of patients. Clinical improvement was observed in 92 % of patients. Mean ankle-brachial index (ABI) increased from 0.38 +/- 0.32 to 0.72 +/- 0.24. Median length of stay (LOS) was 2 days (range of 1 to 51 days); 30-day mortality was 2.3 % and 5-year survival was 60 %; 5-year primary, primary-assisted, and secondary patencies were 60 %, 97 %, and 98 % respectively. Endovascular re-intervention was required in 14 % of patients; inflow surgical procedures were required in 10 %. By logistic regression analysis, use of stent grafts compared with bare stents was associated with significantly higher primary patency (87 % +/- 5 % versus 53 % +/- 7 %; p < 0.01). The authors concluded that combined CFA endarterectomy with iliac intervention yielded acceptable long-term results. The use of stent grafts compared with bare stents was associated with improved primary patency.

The authors stated that this trial was limited by its retrospective nature. Furthermore, the case number was not robust enough to compare differences between devices employed. Similarly, these investigators found no difference in patency rates in patients with occlusions compared with stenotic lesions, which was surprising and may be due to small sample size. Nevertheless, the long-term durability of this procedure compared favorably to more invasive and extensive procedures.

In a single-center study, Sabri et al (2010) examined the outcomes with the use of balloon-expandable covered iliac kissing stents as compared with bare metal stents (BMSs) in the treatment of atherosclerotic disease at the aortic bifurcation. These investigators carried out a review of consecutive patients from a single center with atherosclerotic occlusive disease at the aortic bifurcation treated with balloon-expandable kissing stents between January 1, 2002, and September 1, 2007. A total of 54 patients were identified and divided into 2 groups: those with BMSs and those with covered stents. Technical and clinical success (Fontaine classification), complications, and patency at follow-up were documented. A total of 26 patients (17 men, 9 women; mean age of 61 years; age range of 39 to 79 years) received covered stents and 28 patients (15 men, 13 women; mean age of 61 years; age range of 38 to 82 years) received BMSs. Technical success was achieved in 100 % of patients in both groups. Major complications occurred in 3 of the 26 (11 %) with covered stents (p = 0.66) and 2 of the 28 patients (7 %) with BMSs. The median follow-up was 21 months (20 months for covered stents versus 25 months for BMSs; range of 1 to 62 months); 22 of the 26 patients (85 %) with covered stents had sustained improvement in clinical symptoms during the follow-up period compared with 15 of the 28 patients (54 %) with BMSs (p = 0.02). Primary patency rates at 1 and 2 years were 92 % and 92 %, respectively, for covered stents and 78 % and 62 % for BMS (p = 0.023). The authors concluded that the data presented suggested that covered stents may provide some protection from the effect of having bare metal in the lumen of the distal aorta. These investigators stated that the use of covered balloon-expandable iliac kissing stents, especially when the stents extend into the aorta, appeared to be superior to the use of bare metal balloon-expandable stents at 2 years of follow-up; and suggested that employment of this technology for atherosclerotic aortoiliac occlusive disease, in appropriately selected patients, may be warranted.

Kumar (2013) stated that BMSs have been employed as an alternative therapy for aorto-iliac occlusive disease. Although, these stents perform well in TransAtlantic Inter-Society Consensus (TASC) A and B lesions, their patency remains inferior to surgical bypass in TASC C and D lesions, requiring re-interventions or surgical bypass in the future. Covered stents (balloon-expandable and self-expanding) are introduced with the intention to achieve better long-term patency and reduce re-intervention, especially in complex aorto-iliac lesions. Multiple recent studies have showed improved long-term patencies in a covered stent group in comparison with BMSs in simple, as well as complex, lesions. The authors concluded that based on current data, the use of covered stents will definitely be beneficial, especially in TASC C and D lesions. Moreover, these researchers stated that the US randomized iCARUS Trial has finished enrolling and results are awaiting.

Mwipatayi et al (2016) stated that Covered versus Balloon Expandable Stent Trial (COBEST) is the 1st multi-center study to examine the patency of covered stents (CSs) and BMSs in the treatment of aorto-iliac arterial disease. The short-term results showed that CSs were superior to BMSs in maintaining patency for TASC C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. In a retrospective, post-hoc analysis of the COBEST Trial, these researchers examined if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up. Originally, 125 patients with 168 iliac arteries were prospectively enrolled and randomly assigned to receive a CS or BMS. In this study, 77 of the 125 patients (61.6 %; 119 limbs) were assessed at 60 months for the primary and secondary endpoints, with particular attention paid to the outcomes stratified according to TASC lesion severity. The primary endpoint was the rate of binary stenosis or freedom from stent occlusion of the treated area, as determined by ultrasound (US) imaging or quantitative visual angiography. The 5-year results of the COBEST Trial showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1 %, 82.1 %, 79.9 %, 74.7 % for CS versus 73.9 %, 70.9 %, 63 % and 62.5 % for BMS; log-rank test, p = 0.01). On multi-variate analysis, the type of stent used (hazard ratio [HR], 2.797; 95 % confidence interval [CI]: 1.471 to 5.318; p = 0.002) and the Rutherford classification (HR, 2.019; 95 % CI: 1.278 to 3.191; p = 0.026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95 % CI: 54.253 to 75.753; p = 0.003). Moreover, fewer patients received target limb revascularization (TLR) in the CS group than in the BMS group (odds ratio [OR], 2.32; 95 % CI: 1.47 to 3.36; p = 0.02); however, there was no statistically significant difference in the rate of amputations between the groups. The authors concluded that the 5-year results of the COBEST Trial showed that the CS has an enduring patency advantage over the BMS in both the short- and long-term. In addition, the CS showed acceptable patency rates for the treatment of more severe TASC C and D lesions, and patients who received a CS required fewer revascularization procedures. However, the choice of stent did not affect the rate of major limb amputations.

The authors stated that this study had several drawbacks. First, the 5-year follow-up was not specified in the original study protocol; thus, making this a post-hoc analysis. Consequently, the retrospective nature of this study may have led to subtle biases between the groups. Second, most of the lesions in this series were TASC type B with a small number of type C and D lesions included; the differences in patency rates observed between balloon-expandable CSs and BMSs on the advanced lesions may be subject to a type II error. Third, there has been an evolution in stent design since the original study; BMSs have evolved, and newer designs of CSs have become available from other manufacturers. Therefore, whether better patency results may be achieved from these newer technologies should be examined in the future. The differences in patency rates observed between CSs and BMSs in the advanced lesions may be subject to a type II error because of a difference of sample size between the groups of patients included in the study.

In a prospective, single-arm, multi-center study, Laird et al (2019a) examined the safety and effectiveness of the iCAST covered stent for treatment of iliac artery atherosclerotic lesions. The iCARUS Trial enrolled 152 per protocol subjects at 25 sites in the U.S. and Germany. Subjects with multiple lesions and/or stents were eligible. The primary endpoint was the composite rate of death within 30 days, target lesion revascularization (TLR) within 9 months, or re-stenosis at 9 months after procedure. Secondary endpoints included major adverse vascular events (MAVEs), primary patency, freedom from TLR, and clinical success. Device and acute procedural success were achieved in 98.7 % and 92.7 % of cases, respectively. MAVE rate was 4.6 % at 30 days. The 9-month primary composite endpoint rate was 8.1 % (10/123), which was below the performance objective of 16.57 %; 9-month primary patency, defined as continuous flow without re-vascularization, bypass, or target limb amputation, was 96.4 %. Freedom from TLR at 9 months and 3 years was 97.2 % and 86.6 %, respectively. Early clinical success was observed in 88.7 % of subjects at 30 days with sustained clinical benefit in 72.4 % of subjects at 3 years. The authors concluded that the iCARUS study showed that the iCAST covered stent was safe and effective for treatment of atherosclerotic iliac artery lesions with sustained clinical benefit out to 3 years. Moreover, these researchers stated that although the 3-year clinical outcomes of the iCARUS study are promising, further studies are needed to examine the long-term effectiveness of iliac covered stents. An important limitation of the iCARUS study was that long-term effectiveness was based only on re-intervention; it did not provide patency data confirmed by imaging beyond 9 months. In addition, this study did not directly compare alternative treatments to the iCAST covered stent. This question will be more directly addressed in the DISCOVER trial (Dutch Iliac Stent trial: Covered Balloon-Expandable versus Uncovered Balloon-Expandable Stents in the Common Iliac Artery), which initiated randomization of patients in 2012.

In a systematic review, Mwipatayi et al (2020) compared studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aorto-iliac occlusive disease. These researchers carried out a systematic literature search to identify studies that examined the use of CBE stents for the treatment of aorto-iliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. A total of 15 published articles about 14 studies were included in the review. Of these, 8 studies were prospective clinical trials; and 6 studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TASC class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7 % at 5 years. The authors concluded that CBE stents are a viable therapeutic option for patients with complex aorto-iliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years. Moreover, these researchers stated that further robust comparative studies with long-term data will provide more information.

The authors stated that further research should also include a cost effectiveness analysis comparing costs and outcomes of BMS and CBE stents to inform healthcare resourcing and reimbursement decisions. These investigators stated that another area of interest for future research is of patients treated with a hybrid approach (endovascular stenting with planned distal re-vascularization such as common femoral artery endarterectomy) versus an endovascular-only approach. A limitation of the current review was the lack of level 1 evidence comparing CBE stents to other treatment options for aorto-iliac occlusive disease; there was only 1 RCT about this topic.

Qi et al (2023) stated that covered stent has become one of the mainstream therapies for aorto-iliac obstructive disease (AIOD), with a higher patency rate than MBS. Covered balloon-expandable (CBE) stent can be placed more accurately with higher a radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and effectiveness between the CSE stent and CBE stent in AIOD to-date. These investigators attempt to compare the safety and effectiveness of CBE stent (BARD LIFESTREAM) and CSE stent (GORE VIABAHN) in AIOD. This trial is a prospective, single-center, parallel, non-inferiority, randomized controlled trial (RCT). A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or the CSE stent group. The primary endpoint of the study is the occurrence of target lesion revascularization (TLR) at 12 months after the intervention. The authors concluded that the ballooN sElf cOver steNt AorToiliAc occuLusive (NEONATAL) Trial is the 1st RCT to compare CBE and CSE stent in AIOD patients. The main objective is to compare the TLR of the target lesion between CBE stent and CSE stent at 12 months post-procedure. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in the treatment of AIOD patients.

On March 24, 2023, Getinge’s iCast covered stent system received premarket approval from the FDA for the treatment of patients with iliac arterial occlusive disease.

Recurrent Cephalic Arch Stenosis

Shemesh et al (2008) stated that early recurrent cephalic arch stenosis (CAS) in autogenous arterio-venous (AV) access for hemodialysis is a common problem that requires stenting to prevent thrombosis. Because the results of stenting are unsatisfactory, these researchers compared the effectiveness of stent grafts with bare stents in these patients in a prospective, randomized clinical trial. All patients who presented with recurrent CAS greater than 50 % within 3 months of successful balloon angioplasty were randomized to have angioplasty and stenting with either a bare nitinol stent or a stent graft. Outcome was assessed by angiography 3 months later. Re-stenosis was defined as greater than 50 % narrowing of the stent lumen or of the vessel margin up to 0.5 cm adjacent to the stent. There were no exclusions. This study included data on the outcome of 25 consecutive patients with recurrent CAS who were treated from April to August 2006. At 3 months, 3 patients had died and 1 had undergone a renal transplant. The 21 patients who had angiography at 3 months had patent stents. Re-stenosis rates were 7 of 10 (70 %) in the bare stent group and 2 of 11 (18 %) in the stent graft group (p = 0.024). Life-table analysis at 3 and 6 months showed that primary patency was 82 % in the stent graft group and 39 % in the bare stent group. One-year primary patency was 32 % in the stent graft group and 0 % in the bare stent group (p = 0.0023). During a mean follow-up of 13.7 months, 9 patients died, 4 in the bare stent group and 5 in the stent graft group. Two patients in the stent graft group had received a renal transplant. The number of interventions per patient-year was 1.9 in the bare stent group and 0.9 in the stent graft group (p = 0.02). The authors concluded that the use of stent grafts in angioplasty for recurrent CAS significantly improved short-term re-stenosis rates and long-term patency compared with the use of bare stents. The significant improvement that emerged during the study caused accrual of patients to be halted for ethical reasons. They stated that the findings of this study changed their usage of stents for venous stenoses in AV accesses by eliminating bare nitinol stents in favor of stent grafts.

Sivananthan et al (2014) stated that AV hemodialysis fistulas (AVFs) serve as a lifeline for many individuals with end-stage renal failure. A common cause of AVF failure is CAS. Its high prevalence compounded with its resistance to treatment makes CAS important to understand. Proposed etiologies include altered flow in a fistulized cephalic vein, external compression by fascia, the unique morphology of the cephalic arch, large number of valves in the cephalic outflow tract and biochemical changes that accompany renal failure. Management options are also in debate and include angioplasty, cutting balloon angioplasty, bare metal stents, stent grafts and surgical techniques including flow reduction with minimally invasive banding as well as more invasive veno-venostomy with transposition surgeries for refractory cases.

Dukkipati et al (2015) stated that CAS is a common complication in maintenance hemodialysis (MHD) patients with brachial artery-cephalic vein fistulas and frequently leads to loss of the functioning brachial artery-cephalic vein fistula. There is paucity of conclusive data to guide appropriate management. These researchers examined the risk of recurrence of CAS after angioplasty compared to angioplasty after stent placement determined by angiography of the involved upper extremity over time in a contemporary cohort of MHD patients treated in 2 interventional nephrology practices from March 2008 through May 2011. These investigators retrospectively identified 45 MHD patients with evidence of CAS (age of 60 ± 30 years, 45 % men) on elective angiograms. The median number of days until another angioplasty was required decreased, starting with a median of 91.5 days after the first, 70.5 days after the second, 85 days after the third, and 56 days after the fourth. Angioplasty is associated with a faster rate of recurrence of CAS. The authors concluded that the placement of intra-vascular stent appeared to prolong the patency compared to angioplasty alone. Moreover, they stated that clinical trials with a larger sample size will better elucidate the value and timing of angioplasty versus stent placement in CAS.

Vasanthamohan et al (2015) performed a systematic review of management of recurrent CAS and associated outcomes in the context of dysfunctional HD access. PubMed, Web of Science, and Cochrane Library were searched to retrieve literature on the management of CAS. Studies had to focus on management of access stenosis solely in the cephalic arch. Case reports and literature reviews were excluded. Studies were categorized by intervention, and primary and secondary patency data were compiled. Studies were aggregated, and meta-analyses were performed where possible. A total of 9 papers met the afore-mentioned criteria: 5 were retrospective studies and 4 were prospective studies; CAS management strategies have included PTA, peripheral cutting balloons, surgical cephalic vein transpositions, bare stents, and stent grafts. Reporting strategies varied between studies. Meta-analyses showed that results were variable even within studies using the same modality, particularly for PTA. The authors concluded that no singular, definitive management strategy exists for CAS. Current studies are limited by being primarily single-center retrospective trials featuring heterogeneous patient populations, interventions, and end-points. They stated that priorities for future studies should include larger randomized trials, more uniform management strategies and end-points, and a longer duration of follow-up.

An UpToDate review on "Percutaneous intervention for the treatment of stenosis in the arteriovenous access" (Beathard, 2016) states that "Cephalic arch stenosis – The cephalic vein passes though the coraco-clavicular ligament just before it joins the subclavian vein, and is accompanied by the thoraco-acromial artery and vein, and lateral pectoral nerve. The unique anatomy appears to predispose to recurrent and resistant stenosis for several reasons … Due to recurrent problems with angioplasty treatment of the cephalic arch, the placement of a stent/stent-graft has been used to salvage the access. No randomized trials are available comparing angioplasty alone with stent/stent-graft placement for this lesion. A trial [Shemesh et al, 2008] that compared stent devices randomly assigned 25 patients with recurrent cephalic arch stenosis associated with a brachial-cephalic fistula to angioplasty and either a bare metal stent or a stent-graft. Among the 21 patients available to undergo angiography at 3-month follow-up, the rate of stenosis greater than or equal to 50 % was significantly higher for stents compared with stent grafts (70 versus 18 %). Unfortunately, half of the patients were lost to longer-term follow-up".

Bioresorbable Stents in Peripheral Arterial Disease

van Haelst and colleagues (2016) provided an overview of currently available data on the use of bio-resorbable stents in lower limb PAD and summarized the needs for future research focus. These researchers performed a systematic search in the databases of Medline, Embase, and the Cochrane Library. Studies using pre-defined inclusion and exclusion criteria were included and critically appraised by 2 independent reviewers. Inclusion criteria were

original data on
bio-resorbable stents in
lower limb arteries including the iliac tract.

Primary end-points were safety and feasibility of bio-resorbable stents, including 30-day adverse events (AEs). Secondary end-points included radial force, bio-resorption process, long-term primary and secondary patency, and clinical outcomes, such as amputation rate, Rutherford category, and ABI improvement. A total of 7 published studies with 316 patients were included, and 5 conference abstracts including 272 patients were assessed. Median follow-up time was 12 months. Overall technical success rate was 99 % (range of 95.0 % to 100 %). The 30-day AE rates were reported in 5.0 % of patients (range of 0 % to 13.3 %); these included 1 death, 2 major amputations, and 7 re-interventions. Mean primary patency rate was 61.6 % in the femoral arteries (range of 32.1 % to 80.0 %) after 6 to 12 months compared with 50.3 % in below-the-knee lesions (range of 31.8 % to 92.9 %). Secondary patency rates were 91.5 % (range of 84 % to 97.1 %) and 72.1 % (range of 62.9 % to 100 %), respectively. The 1-year amputation rate was 3.0 % in the whole group (range of 0 % to 12.4 %). The authors concluded that experience with the use of bio-resorbable stents in PAD is still limited and was examined only in small studies. They noted that the use of bio-resorbable stents in PAD appeared to be feasible and safe; with current published results, they are unable to fully answer all of the questions about the future use of bio-resorbable stents in PAD, and use should be limited to study-related cases in PAD.

In a prospective, multi-center, observational registry, Bontinck and associates (2016) evaluated the performance and safety of the bio-resorbable REMEDY stent in the treatment of short femoro-popliteal stenosis or occlusion. The registry was set up of patients in Rutherford-Becker categories 2 to 5 with femoro-popliteal lesions that could be treated with 1 REMEDY stent. Clinical examination and duplex ultrasound (US) imaging were performed at 1, 6, and 12 months. The primary end-point was absence of clinically driven TLR at 12 months. Secondary end-points were technical and clinical success, primary and secondary patency rate, clinically driven TLR, major complications, and Rutherford-Becker classification at 6 and 12 months. The registry enrolled 99 patients between January 2011 and July 2013 in 12 centers in Belgium. Most lesions were determined as TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A (n = 80) and located in the superficial femoral artery (n = 91). There were 19 total occlusions (mean length of 41.3 mm) and 80 stenoses (mean length of 37.5 mm). Technical success was achieved in 96 patients, and clinical success was obtained in 95; TLR, which equaled target vessel revascularization, was 19 % at 6 months and rose to 33 % at 12 months. Primary patency was 68 % at 6 months and 58 % at 12 months. Secondary patency was 85 % at 6 months and 86 % at 12 months. After 12 months, 2 patients had undergone an amputation. The authors concluded that the 1-year follow-up results of the REMEDY stent did not meet current standards set by nitinol stents. They stated that given the significant issues concerning bio-resorbable stents in femoro-popliteal arteries, their use outside of clinical trials should be withheld until improvements are made and better data are available.

Biodegradable Stents in Peripheral Arterial Disease

Chu and colleagues (2017) examined the published literature on the use of biodegradable stents in the treatment of PAD. Systematic review was formulated under the instruction of PRIMSA guideline. Papers published from January 2005 to March 2015 in English language were included. Published studies on biodegradable scaffolds or stents in the treatment of PAD were systematically searched and reviewed through a computerized search of PubMed and Ovid Medline and cross-referenced. Key words include "biodegradable scaffolds", "biodegradable stents", "femoral", "lower limb", "peripheral arterial disease" and "peripheral vascular disease". All relevant published papers which fulfilled these criteria were reviewed. On-going studies from other electronic databases were also examined. A total of 75 non-duplicated publications were identified, but only 6 articles were eligible into the qualitative analysis (1 animal study, 3 case-cohort studies, and 2 randomized studies). In all, a total of 325 stents were used in 282 patients. Technical success rates were 100 %. These studies had a short-to-medium follow-up period up to 58 months. The primary and secondary patency rates were 60.8 % (range of 32 to 77 %) and 88.4 % (range of 79 to 97 %) respectively. There were also 4 on-going studies internationally. The authors concluded that contemporary published literature suggested that biodegradable scaffold/stent is safe and effective in the treatment of PAD, but these studies were heterogeneous and were limited by their study design, relatively small sample size, and short follow-up period; and therefore did not produce a high enough level of evidence to show superiority that leads to a change in current treatment guidelines.

Stenting in Infra-Popliteal Disease

Liu and colleagues (2017) noted that DES have been proposed for the treatment of infra-popliteal arteries disease. However, the long-term clinical impact of DES treatment in the vascular territory still remains uncertain. In a meta-analysis, these researchers compared DES versus control therapy in the treatment of infra-popliteal disease. PubMed, Embase, Cochrane data, CNKI and Wanfang Data were searched until December 20, 2016 for eligible studies according to identical strategies. Additional data were manually retrieved; STATA ver. 12.0 software were used to meta-analyze the efficacies of DES and control treatment (BMS or PTA) for infra-popliteal arteries disease. A total of 927 patients from 10 studies (8 RCTs and 2 cohort studies) were assigned to DESs (n = 484) versus control treatment (n = 443). The results showed that infra-popliteal DES therapy yielded higher primary patency and EFS, while decreased the risk of re-stenosis at 12-months compared to controls significantly. At 3 years there were no significant differences between 2 groups, pooled RRs and 95 % CI were 1.639 [0.526 to 5.105], p = 0.394; 1.197 [0.432 to 3.317], p = 0.729 and 0.992 [0.960 to 1.024], p = 0.661, respectively. Subgroup analysis showed that infra-popliteal DES therapy using sirolimus-eluting stents rather than everolimus-eluting stents provided higher clinic benefits. Infra-popliteal DES therapy yielded no significant difference for TLR, overall survival, Rutherford-Becker class improvement, limb amputation at 12-months and 3-years compared with control treatment. The authors concluded that the findings of the present meta-analysis indicated the non-superiority of infra-popliteal DES therapy over control therapies (BMS/PTA) at 3 years, although short-term benefits at 12 months after DES therapy were evident. They stated that further RCTs with longer follow-up are needed to provide the best scientific evidence regarding the preferred endovascular treatment for patients with occlusive disease of infra-popliteal arteries.

Hammad and Prasad (2017) stated that CLI is associated with significant morbidity, mortality, and increased health care expenses. Re-vascularization has a central role in the treatment of CLI. Following publication of BASIL (bypass versus angioplasty in severe ischemia of the leg) trial 10 years ago, an "endovascular first" approach had gained momentum and the technologies available for endovascular therapy have exponentially increased. Both the development of technology and technique have allowed operators to treat complex infra-popliteal lesions which are central to CLI pathology. The role of atherectomy remains controversial but for calcified lesions it has become an accepted adjunctive tool for plaque modification. The place of drug delivery technologies requires further trials. The use of a drug-coated balloon (DCB) makes intuitive sense; however, choice of excipient, lower limit of vessel size, and impact on re-modeling and thrombosis remain uncertain. The authors concluded that the optimal treatment of infra-popliteal disease remains an area of active investigation. The end-points in CLI trials continue to be challenging and calibration of patency in relation to wound healing remains a moving target. In addition, unaccounted variables continue to confound interpretation of CLI trials –including quality and nature of wound care, status of pedal-plantar loop patency, and management of underlying diabetes and other co-morbidities. These researchers stated that these challenges will also need to be addressed as the CLI field continues to mature in the 21st century.

Peripheral Artery Stenting for Ischemic Nephropathy

Bohlke and Barcellos (2015) stated that the prevalence of atherosclerotic RAS is high; approximately 7 % in individuals older than 65 years and about 50 % in patients with diffuse arterial disease, and it is increasingly frequent in an aging population. About 10 % to 15 % of atherosclerotic RAS cases led to the development of resistant hypertension and/or ischemic nephropathy. The management of ischemic nephropathy may include medical therapy and/or re-vascularization. In the past, re-vascularization required surgical bypass or endarterectomy, accompanied by the morbidity and mortality associated with a major surgical procedure. During the last few decades, less invasive endovascular procedures such as percutaneous transluminal renal angioplasty (PTRA) with stent placement have become available. At the same time, new anti-hypertensive and cardiovascular drugs have been developed, which may preclude re-vascularization, at least in some cases. The indications of each of these therapeutic options have changed over time. These researchers provided a temporal perspective on the course of technical and scientific advances and the accompanying change in clinical practice for the treatment of ischemic nephropathy. The latest RCTs, including the CORAL trial, the largest on the subject, as well as a meta-analysis of these studies, have indicated that the best approach is medical therapy alone. There is evidence that re-vascularization brings no additional benefit, at least in low-risk and stable atherosclerotic RAS. High-risk patients, especially those with recurrent flash pulmonary edema, could benefit from PTRA and stent placement, but there is no definitive evidence and the therapeutic choice should take into account the risks and potential benefits of the procedure.

Viabahn for the Treatment of Peripheral Artery Occlusive Disease

Johnston and co-workers (2012) stated that optimal selection of a re-vascularization strategy in femoro-popliteal occlusive disease (FPOD) remains controversial. Among endovascular therapeutic options for FPOD, covered stent placement has become increasingly used. In a retrospective, single-center study, these researchers examined the influence of clinical, anatomic, and device-related characteristics on the clinical performance of these devices. This trial included consecutively treated limbs that underwent Viabahn (W. L. Gore, Flagstaff, AZ) stent graft placement for FPOD from 2005 to 2010. Clinical, anatomic, and device-related characteristics were obtained from review of medical records and angiograms. End-points were occurrence of any re-intervention, major adverse limb event (e.g., major amputation, thrombolysis/thrombectomy, or open bypass surgery), or thrombolysis/thrombectomy treatment alone. Uni-variate predictors were calculated and multi-variate models constructed for each clinical end-point using Cox proportional hazards models. The study cohort included 87 limbs in 77 unique patients, with a median follow-up time of 382 days. The indication for intervention was claudication in 56 %. In 25 cases (29 %), the index procedure was a secondary intervention for FPOD, including treatment of in-stent restenosis (ISRs) in 22 cases (25 %). Lesions treated included 45 % TransAtlantic Inter-Society Consensus (TASC) II D and 58 % chronic total occlusions. The observed Kaplan-Meier 1-year event rates for re-intervention, major adverse limb event (MALE), and thrombolysis were 43 %, 28 %, and 17 %, respectively. MALE occurred in 18 patients, 9 of whom presented with acute limb ischemia; no patient underwent major amputation. Uni-variate predictors of negative outcomes included lack of dual-antiplatelet usage, advanced TASC II classification, smaller implant diameter, increased number of devices used, longer total implant length, and coverage of a patent distal collateral vessel. Multi-variate analysis demonstrated that the presence of dual-antiplatelet usage was protective against all 3 outcomes, 5-mm device diameter was a risk factor for both re-intervention and MALE, and the use of multiple devices and distal collateral coverage were significant risk factors for thrombolysis events. The authors concluded that re-intervention was common in the 1st year following Viabahn placement for FPOD, with more than 50 % of the events being a MALE. Procedural factors such as anti-platelet therapy, stent graft diameter, implant length/number, and distal collateral coverage were strongly associated with adverse clinical outcomes. These factors should be carefully considered to optimize patient selection and intra-operative decision-making for this procedure.

Geraghty and associates (2013) noted that the predominant mode of bare nitinol stent failure was diffuse ISR, and failure rates correlated to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene (PTFE) lining to a nitinol stent frame, as found in the Viabahn endoprosthesis, mitigated the ingrowth of intimal hyperplasia. These researchers compared the long-term outcomes of complex superficial femoral artery disease intervention using the Viabahn endoprosthesis to those obtained with bare nitinol stent implantation. A total of 148 patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or non-heparin bonded Viabahn endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life (QOL) were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8 % of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio of less than or equal to 2.0 and no target lesion revascularization [TLR]) did not significantly differ between patients treated with the Viabahn stent graft and those who received a bare nitinol stent (24.2 % versus 25.9 %; p = 0.392). Stent fractures were significantly more common in bare nitinol stents (50.0 %) than in the Viabahn endoprostheses (2.6 %). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the Viabahn stent graft (88.8 % versus 69.8 %; p = 0.04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3 % versus 79.5 %; p = 0.304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The authors concluded that the long-term outcomes of complex superficial femoral artery disease intervention using the Viabahn endograft and bare nitinol stents were similar. Although primary patency rates were low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and QOL measures. Patency rates diminished most rapidly in the 1st year following device implantation.

The authors stated that this study had several drawbacks. In retrospect, the VIBRANT trial would have been strengthened by the incorporation of a physical functioning end-point. Future trials would benefit from addition of a supervised-exercise rehabilitation comparison arm. Over 3 years of surveillance, attrition rates were substantial, albeit similar between treatment groups. Device iterations progress as clinical trials were conducted, but the pace of innovation should not deter physicians from engaging in careful evaluation of each generation of devices. Since the study completion, there have been multiple manufacturing changes to the Viabahn device, including addition of a heparin bioactive surface, a contoured proximal edge, and an SFA treatment indication for the 5-mm-diameter device. In addition, bare nitinol stents with improved flexibility have been released to market, which may reduce the incidence of stent fracture, although these new devices await evaluation in complex lesions comparable to the VIBRANT trial.

Zhang and colleagues (2015) examined the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease. These researchers carried out a systematic review and meta-analysis of published studies to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled versus uncontrolled design and analyzed using random-effects models. Outcomes were reported as the RR and 95 % CI. A total of 4 prospective RCTs, 1 retrospective controlled study, and 9 uncontrolled studies were identified. In controlled studies, primary patency with the Viabahn was superior to other interventions at 1 year (RR 0.63, 95 % CI: 0.49 to 0.82, p < 0.001) and ankle-brachial index (ABI) improvement was greater at 6 months (mean difference [MD] 0.05, 95 % CI: 0.01 to 0.09, p = 0.01) compared with other interventions. Subgroup analysis demonstrated a lower incidence of stent fracture in lesions with greater than 15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up. The authors concluded that current evidence suggested that the Viabahn stent-graft was a safe and effective option for symptomatic SFA lesions. Moreover, these researchers stated that prospective, multi-center RCTs with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.

Golchehr and associates (2015) noted that self-expanding covered stents for SFA occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73 % to 78 % in long lesions. These researchers presented the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease. All patients treated with a heparin-bonded Viabahn in 3 centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes (ABI), and duplex ultrasound (US) scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end-points of the study were the 3-year primary, primary assisted, and secondary patency rates. A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study; 54 patients were men (77 %), and the mean age was 70.0 ± 9.1 years. The mean lesion length was 17.4 ± 7.0 cm, and 84 % were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range of 2 to 55 months). The 3-year primary, primary assisted, and secondary patency rates were 59 %, 71 %, and 82 %, respectively, with a 3-year freedom from amputation of 100 %. The authors concluded that the use of a heparin-bonded Viabahn for SFA occlusive disease was related to patency rates within limits of surgical reconstruction. The procedure was related to low morbidity and amputation rates. They stated that the 3-year patency rates were promising but need to be established in comparative studies with both other endovascular options and surgery.

The authors stated that drawbacks of this study were the retrospective design of the study and small sample size, rendering any sub-analysis unreliable. The small sample size was related to the fact that the use of self-expanding covered stents for SFA occlusive disease was not a widely accepted treatment modality in the Netherlands. In addition, the entire cohort did not complete the 36 months of follow-up. These investigators could not exclude a selection bias as patients were treated according to the institutional standards and at the discretion of the surgeon and interventional radiologist. Unfortunately, a reliable comparison with other treatment modalities was not feasible owing to the retrospective design of the study. Moreover, an identification of performed alternative treatments for the same indication was not possible with the current hospital registration databases.

In a prospective, multi-center study, Ohki and co-workers (2017) examined 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (greater than or equal to 10 cm) in the SFA as a substitute for above-knee open bypass surgery. This trial evaluated heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease (PAD). Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ABI of less than or equal to 0.9, and color flow duplex ultrasound (US)-assessed SFA lesions with cumulative length of greater than or equal to 10 cm and greater than or equal to 50 % stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events (AEs), respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio of less than 2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria. Of 103 enrollees (aged 74.2 ± 7.0 years; 17.5 % women; 97.1 % claudicants), 100 subjects were evaluated through post-operative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7 % were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1 % (95 % CI: 87.3 % to 97.3 %) at 12 months. The primary patency-surgical rate was 92.1 % (95 % CI: 84.8 % to 96.0 %), the primary patency-interventional rate was 88.1 % (95 % CI: 80.0 % to 93.1 %), and freedom from TLR was 93.1 % (95 % CI: 86.1 % to 96.7 %). Mean ABI increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (p < 0.0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through post-operative 30 days. No life- or limb-threatening intra-operative or peri-operative AEs and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6 % ± 15.7 % to 72.9 % ± 18.6 % at 12 months (p < 0.0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median post-operative hospital stay was 2.0 days (mean of 3.4 ± 2.9 days) in the Viabahn claudicant subgroup, values that were significantly lower than the 76.5 % general anesthesia rate (p < 0.0001) and 11.0 days median hospitalization stay (mean of 12.7 ± 5.3 days; p < 0.0001) in the 51 open bypass claudicant subjects. The authors concluded that stent grafting appeared to be a safe and less invasive alternative to above-knee bypass surgery, providing 88 % to 92 % primary patency at 12 months in long, complex lesions.

The authors stated that the main drawbacks of this study were its single-arm design, relatively small sample size (n = 103), and inclusion of mainly claudicants that limited generalizability across critical limb ischemia (CLI) patients. Only 1-year results were reported; however, 2-year efficacy results will be collected, and AE assessment and fracture analysis will be conducted through 5 years. Longer-term multi-national RCTs such as the Surgical versus Percutaneous Bypass (SuperB) study, which directly compares outcomes of stent graft implantation versus bypass surgery for treating long SFA lesions, will provide essential confirmation of these findings in diverse populations. Device limitations included the necessity for at least 1 patent runoff vessel and unsuitability for across-the-knee applications. A prior single-center retrospective series showed less favorable results with a population that did not adhere to these limitations, had a larger proportion of CLI patients, and included in-stent restenosis. Nonetheless, these findings showed that stent grafts could safely provide improvement to patients with extensive PAD through 1 year of follow-up and constitute a viable alternative to above-knee bypass without the morbidity risks inherent to open surgery.

In a systematic review, Hajibandeh and associates (2019) examined the outcomes of different treatment strategies for ISR in patients with peripheral arterial disease (PAD) of the lower limbs. This systematic review was carried out in accordance with the PRISMA statement standards. These investigators searched Medline, Embase, CINAHL and the Cochrane Central Register of Controlled Trials to identify RCTs comparing different treatments for ISR in PAD. Recurrent ISR and freedom from TLR were defined as the primary outcome measures. They performed an indirect comparison meta-analysis of different treatments. These researchers identified 4 RCTs that fulfilled the inclusion criteria enrolling a total of 491 patients and another 4 ongoing trials. Each of the included trials reported 1 of the 4 comparisons: drug-coated balloon angioplasty versus standard balloon angioplasty; treatment with heparin-bonded Viabahn endoprosthesis versus standard balloon angioplasty; excimer laser atherectomy plus standard balloon angioplasty versus standard balloon angioplasty alone; and peripheral cutting balloon angioplasty versus standard balloon angioplasty. The risk of recurrent ISR at 12 months was significantly higher with standard balloon angioplasty than with drug-coated balloon angioplasty (p = 0.004). There was no significant difference in the risk of recurrent ISR at 6 months between cutting balloon angioplasty and standard balloon angioplasty (p = 0.73). Freedom from TLR at 12 months was significantly higher with drug-coated balloon angioplasty (p < 0.001) and treatment with the heparin-bonded Viabahn endoprosthesis (p < 0.001) than with standard balloon angioplasty. Freedom from TLR at 6 months was also significantly higher with excimer laser atherectomy plus standard balloon angioplasty than with standard balloon angioplasty (p = 0.003). Tested indirect comparisons revealed large CIs and no statistically significant difference between treatments. The authors concluded that the findings from individual trials suggested that drug-coated balloon angioplasty, treatment with the heparin-bonded Viabahn endoprosthesis and adjuvant excimer laser atherectomy conferred improved outcomes compared with standard balloon angioplasty. These researchers stated that ongoing clinical trials may elucidate uncertainties in the optimal management of ISR in this setting.

The authors stated that the reported outcomes of this review should be viewed and interpreted in the context of inherent limitations. Only 4 RCTs were identified with each of them comparing different treatment strategies. The included studies had small sample sizes, and 1 of them was a pilot study; thus, their results should be interpreted with caution as the possibility of type 2 error could not be excluded. The long-term outcomes and cost-effectiveness of treatment strategies for ISR in PAD remain unknown. The included studies reported mainly technical outcomes, but it remains unknown if such outcomes translate to improved clinical outcomes, such as QOL. On the other hand, ISR and TLR as outcome measures are very open to bias if the investigators were the same clinicians who interpreted follow-up imaging and/or decided who to intervene on. In the included studies, outcome adjudication was not independent of the clinical team, subjecting their findings to bias as imaging interpretation could be very subjective, and the decision to re-intervene may be equally so. The available studies did not provide stratified data according to clinical (claudication or critical limb ischemia) or anatomic (inflow or outflow vessels) severity of the disease. Indirect comparison analysis produced very wide CIs that did not allow these investigators to draw solid conclusions on the comparative efficacy of different endovascular treatments for ISR in PAD of the lower limbs. The wide CI estimates were the result of the of direct evidence and large number of RCTs per comparison to inform the treatment network.

LifeStream Balloon-Expandable Covered Stent for the Treatment of Iliac Artery Stenosis

The LifeStream balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesion lengths up to 100 mm.

In a prospective, single-arm study (the BOLSTER trial), Laird et al (2019b) examined the performance of the LifeStream balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. A total of 155 patients were treated at 17 centers in Europe, New Zealand, and the U.S. The primary end-point was a composite of device- or procedure-related death or MI over the course of 30 days, or TLR, major amputation of the target limb, or re-stenosis through 9-months. Secondary end-points included primary patency, TLR, sustained clinical success, quality of life (QOL), and major AEs (MAEs). At 9 months, the primary composite end-point rate was 16.2 % (93.5 % CI: 10.6 % to 23.2 %), primary patency was 89.1 % (95 % CI: 82.6 % to 93.7 %), and freedom from TLR was 96 %. There was a cumulative clinical improvement of at least 1 Rutherford category from baseline to 9 months of 90.5 % (95 % CI: 84.3 % to 94.9 %); QOL, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category; 7 of 150 patients (4.7 %; 95 % CI: 1.9 % to 9.4 %) experienced MAEs, but none was determined to be related to device or procedure. The authors concluded that the LifeStream balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of TLR for the treatment of stenotic and occlusive lesions of the iliac arteries.

Furthermore, an UpToDate review on "Endovascular techniques for lower extremity revascularization" (Dosluoglu, 2020) states that "Common iliac artery lesions are typically treated with balloon-expandable stents or stent-grafts. Balloon angioplasty of the iliac arteries without stenting is rarely used, except for the most focal lesions; however, stenting would still be required for a focal lesion if there is flow-limiting dissection or residual stenosis of > 30 %. If the lesions in the common iliac artery extend to the iliac bifurcation and into the aorta, kissing stent-grafts or stents can be used; these elevate the bifurcation and ensure unimpeded flow to both lower extremities …Treat the diseased segment(s) to achieve a patent lumen followed by completion arteriography. The general goal is to establish in-line flow to the foot. Lesions are treated from proximal to distal in sequence. For apparent occlusions, intraluminal crossing is attempted first; however, if this is not successful, subintimal crossing with the aid of a reentry device may be successful. A variety of devices are available by which to accomplish angioplasty (standard balloon, cutting balloon, atherectomy) and/or stenting (bare metal, covered stent, stent-graft). The selected devices depend upon the severity of the lesion and its location".

VENOVO Venous Stent System for the Treatment of May-Thurner Syndrome

May-Thurner syndrome (MTS) is caused when the left iliac vein is compressed by the right iliac artery, which increases the risk of deep vein thrombosis (DVT) in the left extremity.

Bondarev et al (2019) identified factors independently associated with disease recurrence after venoplasty and stent placement for MTS. A total of 59 consecutive patients (age of 47 ± 15 years; 93 % women) were identified who had undergone endovascular stent placement for MTS. Patient charts were reviewed for demographic data, risk factors for venous thrombosis, co-morbidities, and venous inflow or outflow at 1st follow-up (3 weeks to 6 months after treatment). Logistic regression was used to identify independent predictors of symptom recurrence or repeat intervention, and multi-variate analysis of variance and receiver operator characteristic curve (ROC) analysis were used to examine relationships between degrees of in-stent stenosis and other variables in the 73 % of patients with available cross-sectional imaging. Median follow up was 20.7 months (inter-quartile range [IQR], 4.7 to 49.5 months). All procedures were technically successful. Disease recurrence, defined as symptom recurrence following initial post-procedural resolution, was observed in 38 % of patients. No pre-procedural variable was found to be independently predictive of disease recurrence; however, poor venous inflow or outflow were both strongly associated with recurrent disease, with adjusted ORs and 95 % CIs of 38.02 (3.76 to 384.20; p = 0.002) and 7.00 (1.15 to 42.71; p = 0.04), respectively. Higher degrees of in-stent stenosis were also associated with symptom recurrence, with an area under the curve (AUC) of 0.93 (p = 0.000002) and 39 % to 41 % stenosis being 78 % to 83 % sensitive and 88 % to 92 % specific for symptom recurrence. The authors concluded that these findings suggested that cross-sectional imaging could help differentiate patients in whom closer follow-up may be needed following venoplasty and stent placement for MTS and also guide counseling regarding prognosis.

Jayaraj et al (2019) noted that MTS patients with lifestyle-limiting symptoms undergo stenting of the iliac vein for relief of compressive disease. These researchers carried out a retrospective review of contemporaneously entered data of 202 patients who underwent stenting for MTS between 2005 and 2011. Classification into 3 groups based on luminal area obtained by intra-operative intravascular ultrasound (IVUS) interrogation of the involved femoro-ilio-caval segments was performed. Normal luminal diameters and areas were defined as 12 mm and 125 mm^2, 14 mm and 150 mm², and 16 mm and 200 mm² in the common femoral, external iliac, and common iliac veins, respectively. Mild (less than 60 %), moderate (60 % to 89 %), and severe (greater than 90 %) compression groups were defined using the normal values noted previously and observed after stenting to evaluate outcomes. Kaplan-Meier analysis was carried out to evaluate primary, primary assisted, and secondary patencies. Visual analog scale (VAS) for pain scores, grade of swelling, and Venous Clinical Severity Score (VCSS) before and after stenting at 6, 24, and 48 months were analyzed using paired t-test and Tukey test. Logistic regression was used to gauge the impact of multiple variables including degree of stenosis on stent re-intervention. There were 55 patients who had mild, 87 patients who had moderate, and 60 patients who had severe iliac vein compression. Baseline demographic characteristics and co-morbidities were similar across all groups. In addition, there was no statistically significant difference in median baseline VAS score, grade of swelling, and VCSS among the groups. Compression was treated with angioplasty and stenting encompassing all areas of disease as determined by IVUS. Stent technique involved use of Wallstent only in 183 patients and Wallstent-Z stent combination in the remainder. No difference in median stent patency was noted on follow-up. Clinically, at 48 months, a statistically significant recurrence of pain, swelling, and worsening of VCSS were noted in the severe stenosis group but not in the other 2 groups. No variable was noted to have an impact on stent re-intervention. The authors concluded that severity of MTS stenosis was not a predictor of initial clinical symptoms. Long-term, patients with greater than or equal to 90 % initial MTS stenosis experienced recurrence of symptoms. The degree of iliac venous stenosis did not appear to affect stent patency.

Jayaraj et al (2020) stated that symptoms of chronic venous insufficiency (CVI) secondary to obstructive ilio-femoral disease are often bilateral. The impact of ilio-femoral stenting of the more symptomatic lower extremity (LE) on clinical outcomes in the less affected contralateral extremity is unclear. Such benefit, secondary to off-loading of collaterals, may potentially be of the magnitude that the contralateral extremity does not require intervention. These researchers carried out a retrospective review of contemporaneously entered electronic medical record data of 368 patients/limbs with initial unilateral ilio-caval stents (240 left and 128 right) placed during a 3-year period from 2015 to 2017. Patients who underwent simultaneous bilateral stenting or had occlusive disease were excluded. Of the remainder, the impact of stenting on contralateral leg symptoms was evaluated by analyzing VAS pain score (1 to 10), grade of swelling (1 to 3), and VCSS. The duration of any improvement and need for intervention on the contralateral side were also appraised. Kaplan-Meier analysis was used to evaluate stent patency after intervention, whereas paired t-tests were used to examine clinical outcomes. Of the 368 limbs that underwent stenting with a combination of a Wallstent with a Z stent for stenotic lesions, 304 patients (89 men and 215 women) had contralateral symptoms (200 left and 104 right). The cause was post-thrombotic syndrome in 229 limbs and MTS or non-thrombotic iliac vein lesion in 75 limbs. In this contralateral group, at 12 months, the VAS pain score improved from 5 to 0 (p < 0.0001), the grade of swelling went from 3 to 1 (p < 0.0001), and VCSS went from 5 to 3 (p < 0.0001) after stenting of the ipsilateral side. During the median follow-up of 20 months, 15 contralateral limbs underwent stenting. Median time to stenting of the contralateral limb after ipsilateral stenting was 9 months. The median VAS pain score, grade of swelling, and VCSS in this group before stenting were 6.5, 2, and 5 compared with 0 (p < 0.0001), 1 (p = 0.27), and 3 (p = 0.0021), respectively, in those members of the contralateral group who did not require stenting. Primary and primary assisted patencies at 12 months after contralateral stenting were 78 % and 100 %, respectively. There were no stent occlusions after contralateral stenting. The authors concluded that patients with bilateral obstructive ilio-femoral venous lesions often experienced improvement of the contralateral limb symptoms (95 %) after stenting of the worse ipsilateral limb. Only 15 of 304 (5 %) symptomatic contralateral limbs had to undergo stenting during the follow-up period because of a worsening clinical picture. Based on this, a staged approach to ilio-femoral stenting in patients with bilateral symptoms focusing initially on the more symptomatic limb was suggested.

Furthermore, an UpToDate review on "May-Thurner syndrome" (Mousa, 2020) states that "Since its inception and use over the last decade, IVUS has become an integral component of the treatment of MTS. IVUS is useful for determining vessel diameter, aiding accurate stent placement, ensuring full stent expansion, estimating the gain in cross-sectional area, and, with follow-up, identifying the severity of in-stent restenosis … For moderate-to-severe symptomatic MTS in the absence of DVT, treatment is targeted toward reducing the severity of the chronic venous stenosis/occlusion. We suggest angioplasty and stenting of the affected segment, rather than angioplasty alone".

Device recalls of venous stents were recently initiated by Boston Scientific Corporation and Bard Peripheral Vascular, Inc. On May 12, 2021, Becton, Dickinson and Company (BD) announced it expanded the scope of the Urgent Medical Device Safety Notice for the Venovo venous stent system to include all sizes and lots within the expiration date. As previously communicated in the Safety Notice of January 13, 2021, BD received reports on the Venovo device indicating that the proximal end of the stent does not immediately expand upon deployment but remains connected to the stent cushion on the delivery system. The Customer Letter provided an illustration of the proximal section adhering to the stent cushion. According to the BD’s notice, if the proximal end of the stent does not immediately expand upon deployment, over-manipulation or forcing the catheter delivery system as well as use of other intravascular devices or techniques to assist the stent’s expansion, could potentially have a varying degree of harm associated with it. This issue was initially observed on the 14-mm diameter device. After the issuance of the safety notice, there have been reported complaints across other sizes of the product offering. To-date, BD has received approximately 250 reported complaints across various sizes of the product offering, advised the company notice.

Eluvia Drug-Eluting Vascular Stent System for the Treatment of Superficial Femoral Artery and Proximal Popliteal Artery Disease

The Eluvia Drug-Eluting Vascular Stent System is indicated for improving luminal diameter in the treatment of symptomatic de-novo or re-stenotic lesions in the native SFA and/or proximal popliteal artery (PPA) with reference vessel diameters ranging from 4.0 to 6.0 mm and total lesion lengths up to 190 mm.

In a randomized, single-blind, non-inferiority study, Gray and colleagues (2018) compared the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoro-popliteal artery segment lesions. Patients with symptomatic lower-limb ischemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native SFA or PPA were enrolled at 65 centers in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the U.S. Patients were randomly assigned (2:1) with a site-specific, web-based randomization schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy end-point was primary patency (defined as a duplex US peak systolic velocity ratio less than or equal to 2.4, without clinically driven TLR or bypass of the target lesion) and the primary safety end-point was major AEs (i.e., all causes of death through 1 month, major amputation of target limb through 12 months, and TLR through 12 months). These investigators set a non-inferiority margin of -10 % at 12 months. Primary non-inferiority analyses were carried out when the minimum sample size needed for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major AE through 12 months. Between December 2, 2015 and February 15, 2017, a total of 465 patients were randomly assigned to Eluvia (n = 309) or to Zilver PTX (n = 156). Non-inferiority was demonstrated for both efficacy and safety end-points at 12 months: primary patency was 86.8 % (231/266) in the Eluvia group and 81.5 % (106/130) in the Zilver PTX group (difference 5.3 % [1-sided lower bound of 95 % CI: -0·66]; p < 0·0001); 259 (94.9 %) of 273 patients in the Eluvia group and 121 (91.0 %) of 133 patients in the Zilver PTX group had not had a major AE at 12 months (difference 3.9 % 1-sided lower bound of 95 % CI: -0·46]; p < 0.0001). No deaths were reported in either group; 1 patient in the Eluvia group had a major amputation and 13 patients in each group required TLR. The authors concluded that the Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major AE at 12 months after treatment of patients for femoro-popliteal PAD. These researchers stated that based on these findings, the use of a polymer-coated paclitaxel-eluting stent in patients who require superficial femoral artery or popliteal intervention is a reasonable approach to maximize intermediate-term patency and to maintain hemodynamic and clinical improvement without repeat re-intervention.

Golzar and associates (2020) reported the clinical effect of a drug-eluting stent on femoro-popliteal occlusive disease in patients with long lesions. The global IMPERIAL Long Lesion sub-study was a prospective, single-arm, multi-center trial of the Eluvia Drug-Eluting Vascular Stent for treating femoro-popliteal lesions of greater than140 mm and less than or equal to 190 mm in length. A total of 50 patients (mean age of 68.2 years; 32 men) with long lesions (mean length of 162.8 ± 34.7 mm) were enrolled; 20 patients had diabetes; 14 of the lesions were severely calcified and 16 were occluded. Primary patency (duplex US peak systolic velocity ratio of less than or equal to 2.4 in the absence of clinically-driven TLR or bypass of the target lesion) and major AEs [30-day all-cause death and 1-year target limb major amputation or TLR] were evaluated at 12 months. At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0 % (95 % CI: 82.5 % to 99.6 %). The major AE (MAE)-free rate at 12 months was 93.5 % due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9 % (95 % CI: 87.2 % to 100 %). The authors concluded that the IMPERIAL Long Lesion sub-study showed excellent patency and safety through 1 year among patients with long femoro-popliteal occlusive disease treated with the Eluvia stent.

Eluvia Drug-Eluting Vascular Stent System for the Treatment of Iliac Artery Stenosis

Ontario’s Medical Advisory Secretariat’s evidence-based analysis on "Stenting for peripheral artery disease of the lower extremities" (2010) stated that "Based on a very low quality of evidence, at 6 months of follow-up, sirolimus drug-eluting stents are associated with a reduction in target vessel revascularization and re-stenosis rates in patients with atherosclerotic lesions of crural (tibial) arteries compared with balloon-expandable bare metal stent. The OR and their corresponding 95 % CI are: re-stenosis 0.09 (0.03, 0.28) and TVR 0.15 (0.05, 0.47) in patients with atherosclerotic lesions of the crural arteries at 6 months follow-up. Both types of stents offer similar immediate success. Limitations of this study include: short follow-up period, small sample and no assessment of mortality as an outcome. Further research is needed to confirm its effect and safety". It also noted that "drug-eluting stents are not licensed by Health Canada for peripheral artery disease".

Kalmar and colleagues (2014) examined immediate results and mid-term outcome of the hemoparin-coated (HC) stainless-steel stent (camouflage coating) in the treatment of occlusive lesions of the iliac arteries. A total of 28 patients were prospectively treated with the use of a HC stent between January 2007 and March 2010. Clinical examination and color-Doppler US were performed at 1, 3, 6 and 12 months, CTA or magnetic resonance angiography (MRA) at 12 months. Indication for treatment was a high-grade stenosis of the common iliac and/or external iliac artery. Successful placement was achieved in all patients. Significant decrease in translesional pressure gradient (greater than 10 mm Hg) was measured in 27 patients (96 %). In 1 patient, proximal dissection occurred without flow limitation. A minor complication (small access site hematoma) occurred in 1 patient (4 %); 2 patients (7 %) were lost to follow-up. After 12 months, stent patency in CTA, MRA and US was 100 %; 20 patients (77 %) experienced an initial improvement of at least 1 clinical stage. In 1 patient (4 %), mild intimal hyperplasia without significant stenosis was observed. In 3 patients (12 %), proximal or distal stenosis occurred. A non-significant increase of mean ABI following treatment was measured (0.85 ± 0.27 versus 0.75 ± 0.22, respectively; p = 0.328). The authors concluded that the use of HC stents in patients with iliac artery occlusive disease may lead to a lower rate of intimal hyperplasia and thus to increased patency rates even in heavily calcified vessels. Moreover, these researchers stated that large, prospective trials are needed to examine the long-term patency rates of the HC coated stents.

Kayssi and associates (2019) noted that stents are placed in the femoro-popliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis". It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. In a systematic review, these researchers examined the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). These researchers examined the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoro-popliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, TLR, binary restenosis rate, and death. They defined "in-stent restenosis" as 50 % or greater narrowing of a previously stented vessel by Duplex US or angiography. The authors concluded that based on a meta-analysis of 3 trials with 263 participants, evidence suggested an advantage for DEBs compared with uncoated balloon angioplasty for anatomical end-points such as TLR and binary restenosis, and for 1 clinical end-point – improvement in Rutherford category post-intervention for up to 24 months. However, the certainty of evidence for all these outcomes was very low due to the small number of included studies and participants and the high risk of bias in study design. These researchers stated that adequately powered and carefully constructed RCTs are needed to adequately examine the role of drug-eluting technologies in the management of in-stent restenosis.

An UpToDate review on "Overview of lower extremity peripheral artery disease" (Berger and Davies, 2020) states that "Concern over paclitaxel — Following percutaneous intervention, a number of medical therapies aimed at preventing restenosis, but only local delivery of the drug paclitaxel has been shown to improve the longevity of interventions for lower extremity PAD. However, the overall safety of paclitaxel-coated balloons and stents placed into the legs of patients with PAD has come into question".

Furthermore, an UpToDate review on "Endovascular techniques for lower extremity revascularization" (Dosluoglu, 2020) states that "A number of medical therapies aimed at preventing restenosis related to percutaneous angioplasty have been tried, but only local delivery of the drug paclitaxel has been shown to improve the longevity of interventions. The outcomes of reported trials studying paclitaxel-coated devices have overwhelmingly used lesion-oriented outcome measures, such as TLR or primary restenosis, rather than functional or patient-oriented measures, such as increased limb salvage or improved walking distance. The indications and percutaneous techniques for treating lower extremity peripheral artery disease (PAD) are reviewed separately. However, the overall safety of paclitaxel-coated balloons and stents placed into the legs of patients with PAD has come into question. Based on a review of long-term follow-up data from premarket randomized trials, the US Food and Drug Administration (FDA) has urged that health care providers should consider the potential benefits of paclitaxel-coated devices (i.e., reduced reinterventions) in individual patients along with potential risks (i.e., late mortality) before using paclitaxel-coated devices for the treatment of PAD. The long-term data from the pivotal premarket trials were presented by the FDA at a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. In the FDA's meta-analysis of these trials (1,090 patients), overall mortality at 5 years was significantly increased for patients treated with paclitaxel-coated devices compared with those treated with uncoated devices (19.8 versus 12.7 %, relative risk 1.57, 95 % CI 1.16 to 2.13). These results confirmed a meta-analysis by Vascular InterVentional Advances (VIVA) clinicians of patient-level data provided by manufacturers (hazard ratio of 1.38, 95 % CI 1.06 to 1.80) and an earlier meta-analysis (mortality risk ratio 1.93, 95 % CI 1.27 to 2.93). Nevertheless, the Panel, the FDA, and others agree that the magnitude of the potential increased mortality should be interpreted with caution given the multiple limitations in the available data (e.g., pooling of studies of different paclitaxel-coated devices that were not intended to be combined, substantial amounts of missing study data, no clear evidence of a paclitaxel dose effect on mortality, and no identified pathophysiologic mechanism for the late deaths). Recommendations for informed consent, monitoring patients, and adverse event reporting can be found on the FDA website".

Renal Artery Stenting for Stenosis due to Fibromuscular Dysplasia

Schwarzwalder and Zeller (2009) noted that significant RAS is a well-accepted cause of deterioration of arterial hypertension and of renal insufficiency. Recently, more interest has been focused on the impact of RAS on structural heart disease and patient survival. Technical improvements of diagnostic and interventional endovascular tools have led to a more widespread use of endoluminal renal artery re-vascularization and extension of the indications for this type of therapy during the past 20 years. Since the 1st renal artery angioplasties performed by Felix Mahler and Andreas Gruntzig, numerous single-center studies have reported the beneficial effect of percutaneous transluminal renal angioplasty, and since the early 1990's stenting of RAS caused either by atherosclerosis or fibro-muscular dysplasia (FMD). However, none of the so far published or presented RCTs could prove a beneficial outcome of RAS re-vascularization compared with medical management. As a result of these negative trials including the recently presented ASTRAL trial, referrals to endovascular renal artery re-vascularization went down and moreover, reimbursement of these procedures became a matter of debate. The authors summarized the background and the limitations of the so far published and still ongoing controlled trials. Moreover, they discussed why well-designed registries might give important insight on the impact of endovascular re-vascularization of hemodynamically relevant atherosclerotic RAS.

Henry and associates (2010) stated that RAS is common among patients with atherosclerosis, up to 1/3 of patients undergoing cardiac catheterization; FMD is the next cause of RAS, commonly found in young women. Atherosclerosis RAS generally progresses overtime and is often associated with loss of renal mass and worsening renal function (RF). Percutaneous renal artery stent placement is the preferred method of re-vascularization for hemodynamically significant RAS according to ACC and AHA guidelines. Several randomized trials have shown the superiority of endovascular procedures to medical therapy alone. However, 2 studies ASTRAL and STAR studies were recently published and did not find any difference between renal stenting and medical therapy. But these studies have a lot of limitations and flaws as discussed by the authors (poor indications, poor results, numerous complications, failures, poor technique, inexperienced operators, etc.). Despite these questionable studies, renal stenting keeps indications in patients with: uncontrolled hypertension; ischemic nephropathy; cardiac disturbance syndrome (e.g., "flash" pulmonary edema, uncontrolled heart failure or uncontrolled angina pectoris); solitary kidney. To improve the clinical response rates, a better selection of the patients and lesions is mandatory with: good non-invasive or invasive imaging; physiologic lesion assessment using transluminal pressure gradients; measurements of biomarkers (e.g., BNP); fractional flow reserve study. A problem remains after renal angioplasty stenting, the deterioration of the RF in 20 to 30 % of the patients. Athero-embolism appeared to play an important role and is probably the main cause of this RF deterioration. The use of protection devices alone or in combination with IIb/IIIa inhibitors has been proposed and appeared promising as shown in different recent reports. The authors concluded that renal angioplasty and stenting is still indicated but we need: a better patient and lesion selection; improvements in techniques and maybe the use of protection devices to reduce the risk of RF deterioration after renal stenting.

Yang and co-workers (2016) noted that RAFMD is a non-atherosclerotic cause of RAS often affecting the young; PTRA is the treatment of choice but there are few studies of the outcome of the procedure. This retrospective analysis included 64 patients (56.2 % female; mean age at diagnosis of 28.0 years) with RAFMD who underwent PTRA between November 2003 and August 2015. Technical and clinical success rates and re-stenosis rates were evaluated. A total of 76 procedures were performed on 64 RAFMD patients. Technical success was 96.9 %, as defined by less than 30 % residual stenosis, with stent placement required in 11 patients (17.2 %). In the short-term (1 month), the majority (79.7 %) had an immediate clinical benefit, with cure of hypertension in 35.9 %, and improvement in hypertension and a lower requirement for anti-hypertensive medications in 43.8 %. In the long-term (mean of 47.5 months; range of 5 to 141 months), the survival rate was 96.9 %, freedom from re-stenosis was 84.4 %, and 76.6 % of patients showed a sustained clinical benefit (cure rate 40.6 %, improvement rate 35.9 %); 8 patients were treated with a 2nd procedure and 2 had a 3rd procedure, with 50 % of these patients showing an improvement in hypertension. The authors concluded that PTRA for symptomatic RAFMD was safe and clinically successful; more than 50 % of patients experienced an immediate clinical benefit with sustained long-term effects. For patients with re-stenosis, there was a good response to a 2nd PTRA.

Plouin and colleagues (2017) stated that FMD commonly affects the renal and cervical arteries but has been described to affect other vascular beds as well. The prevalence of and clinical characteristics associated with multi-site FMD (string-of-beds or focal stenoses affecting at least 2 vascular beds) are not known. In the prospective ARCADIA registry (Assessment of Renal and Cervical Artery Dysplasia), symptomatic patients with RA FMD underwent tomographic- or magnetic resonance-angiography from the aortic arch to the intracranial arteries and those with cervical FMD from the diaphragm to the pelvis. Of 469 patients (84.0 % women), 225 (48.0 %) had multi-site FMD. In addition, 86 of 244 patients with single-site disease had dissections or aneurisms affecting other vascular beds, totaling 311 patients (66.3 %) with lesions in greater than 1 vascular bed. Among patients with a cerebrovascular presentation, the prevalence of RA lesions was higher in patients with than in those without hypertension (OR, 3.4; 95 % CI: 1.99 to 6.15). Among patients with a renal presentation, the prevalence of cervical lesions was higher in patients with bilateral than in those with unilateral RA lesions (OR, 1.9; 95 % CI: 0.99 to 3.57). The authors concluded that FMD is a systemic arterial disease. At least 2 vascular beds were affected by dysplastic stenoses in 48.0 % of cases and by dysplastic stenoses, aneurysms, and dissections in 66.1 % of cases. They stated that RA imaging should be proposed to hypertensive patients with a cerebrovascular presentation; cervical artery imaging should be considered in patients with a renal presentation and bilateral RA lesions.

Furthermore, an UpToDate review on "Treatment of fibromuscular dysplasia of the renal arteries" (Olin, 2018) states the following:

The 2 options for re-vascularization include percutaneous transluminal angioplasty (PTA, typically without placing a stent) or surgery.

Percutaneous transluminal angioplasty (PTA) is typically performed without placement of stent (unlike PTA for atherosclerotic renal artery stenosis). In general, stents are only placed when a dissection results from the performance of PTA or in the rare instance in which a perforation of the renal artery occurs during angioplasty. There are several reasons why a stent should not be used as 1st-line endovascular therapy in patients with FMD:

Patients do very well with angioplasty alone, so there is no reason to place a stent. If the lesion is so fibrotic that the pressure gradient cannot be obliterated with an angioplasty, a stent will not correct this problem (and stent deformation will likely occur). Such patients should be referred for surgery.
Patients with renal FMD usually have stenoses in the mid and distal portions of the artery rather than at the ostium or proximal portion (as occurs with atherosclerosis). Should surgical re-vascularization become necessary due, e.g., to in-stent restenosis, patients may require more complex branch repair to bypass the occluded stent since the stent often covers the renal artery up to the point of the first intrarenal branch.

Gore Viabahn Stent for the Treatment of Dialysis Fistula

Marsh and colleagues (2020) noted that the brachiocephalic fistula is an upper arm fistula created by anastomosing the cephalic vein to the brachial artery. A transverse incision is made over the antecubital fossa. The brachial artery and cephalic vein are dissected, mobilized, and secured using vessel loops. Any small tributaries can be ligated and divided. An arteriotomy is made, and the artery is flushed with heparinized saline. An end-to-side anastomosis is carried out by ligating and dividing the distal cephalic vein and spatulating the end to match the size of the arteriotomy. The AV anastomosis is then carried out using a running non-absorbable mono-filament suture. Vascular Doppler should be used to confirm thrill through the fistula, as well as the distal radial artery signal. Hemostasis is achieved, subcutaneous tissues are approximated, and skin is closed using non-absorbable suture. Thrombosis is the most common fistula complication and occurs at areas of stenosis, either at the anastomosis or fistula vein. The risk of thrombosis increases with the degree of stenosis. Compared to AV grafts, fistulas have lower rates of thrombotic events.

Garcia-Medina et al (2020) stated that the current evidence is insufficient to determine the contribution of stent grafts as treatment in partially thrombosed aneurysms or residual wall-adherent thrombi in AV fistulae (AVFs) for hemodialysis. In a retrospective study, these researchers analyzed the patency rates of post-interventional covered stent deployment in those cases. In addition, they examined if the patency rates differed when fistulas were punctured through the stent during dialysis sessions. This trial was conducted between 2006 and 2014 analyzing post-intervention primary patency rates using the Kaplan–Meier log-rank test. Multi-variate Cox proportional regression models were carried out to determine if cannulation within the stent graft area was a potential risk factor for occlusion, by adjusted HR. A total of 27 procedures were included in the study. Primary patency rates (%) after stent deployment at 3, 6, 12, 24, 36 and 72 months were, respectively: total 59, 32, 32, 21, 11 and 5; stent puncture 53, 21, 21, 16, 5 and 0; and no stent puncture 80, 80, 80, 40, 40 and 40. Cannulation through the stent graft was not significantly associated with increased risk of obstruction in multi-variate analysis (HR = 3.01; p = 0.286). The authors concluded that stent graft treatment may be a feasible procedure in partially thrombosed aneurysms and residual thrombi in AVF. Although fistulas punctured through the stent presented lower patency rates, this practice was not associated with a higher risk of obstruction. Moreover, these researchers stated that giving the impossibility of comparing with similar approaches, further prospective studies with higher sample sizes are needed to confirm the advantages of this technique.

The authors stated that this study had several drawbacks. First, there was no comparison between stent graft implantation in aneurysms with residual thrombi and aneurysmal surgical resection because of the impossibility of making this randomization in this working environment. Second, some important data such as flow, vessel diameter and lesion size were not available in this trial; thus, these researchers could not rule out the possibility of residual confounding in the adjusted analysis. Third, although procedures were carried out by 2 expert interventional radiologists from a single center, data were retrospectively reviewed; and operators were not blinded to the study. Fourth, this study has been focused on fistulas with partially thrombosed aneurysm and residual thrombi, which may have increased the internal validity; however, it may limit the generalizability to other stent graft indications. Finally, although this was the largest study reported to-date and represented the standard clinical practice in the authors’ vascular radiology unit, the sample size was small and could lead to a lack of statistical significance. These investigators stated that RCTs with larger sample size are needed to confirm these findings and to allow comparability between different techniques in terms of patency and safety results.

KDOQI guidelines state that "KDOQI suggests the appropriate use of self-expanding stent-grafts in preference to angioplasty alone to treat clinically significant graft-vein anastomotic stenosis in AVG when the goal is overall better 6-month post-intervention outcomes after carefully considering the patient’s ESKD Life-Plan. (Conditional Recommendation, Moderate Quality of Evidence)." The guidelines further state that "KDOQI suggests that the use of an appropriately placed stent-graft is preferred to angioplasty alone for the treatment of in-stent restenosis in AVG and AVF for overall better 6-month post-intervention outcomes. (Conditional Recommendation, Moderate Quality of Evidence)"

Hybrid Foot Vein Arterialization

Ferraresi and colleagues (2019) described their preliminary experience in treating no-option critical limb ischemia (CLI) patients with a hybrid foot vein arterialization (HFVA) technique combining open and endovascular approaches. Between May 2016 and January 2018, a total of 35 consecutive patients (mean age of 68 ± 12 years; 28 men) with 36 no-option CLI limbs underwent HFVA in the authors’ center. All limbs had grade-3 Society for Vascular Surgery (SVS) WIfI (wound, ischemia, and foot infection) ischemia, and the wound classification was grade-1 in 4 (11 %) limbs, grade-2 in 4 (11 %), and grade-3 in 28 (78 %). Surgical bypass was performed on the medial marginal vein or a posterior tibial vein, followed by endovascular removal of foot vein valves and embolization of foot vein collaterals. A "tension-free" surgical approach was employed to treat foot lesions. At a mean follow-up of 10.8 ± 2 months, limb salvage was achieved in 25 (69 %) limbs and wound healing in 16 (44 %); 9 patients presented an unhealed wound; 11 (31 %) patients underwent a major amputation (2 below the knee and 9 thigh); and 1 patient with an unhealed wound and open bypass died of MI. The authors concluded that HFVA is a promising technique able to achieve acceptable rates of limb salvage and wound healing in no-option CLI patients generally considered candidates for an impending major amputation. Moreover, these researchers stated that further studies are needed to standardize the technique and better identify patients who could benefit from this approach.

The authors stated that this cohort study was limited in its potential to standardize the procedure. The lack of a hybrid surgical room explained why the primary endovascular procedure occurred following the surgical bypass and not concomitantly, which would have been more proper. Finally, only a better standardization of the technique and a randomized, multi-center study could determine whether these findings are reproducible and improvable.

iCast / Gore Viabahn VBX Stent for the Treatment of Celiac Artery Pseudoaneurysms

An UpToDate review on “Treatment of visceral artery aneurysm and pseudoaneurysm” (Sumpio, 2021) does not mention iCast or PTFE-coated stent as management / therapeutic options.

LimFlow Stent Graft System

LimFlow is a minimally invasive technology designed to divert blood around diseased arteries in the lower extremity and into the tibial veins that feed the foot. This technique would bring blood and oxygen to the starved tissues in the foot, relieving pain and promoting healing of chronic wounds.

In a pilot study, Kum and colleagues (2017) reported the initial clinical experience with percutaneous deep vein arterialization (pDVA) to treat CLI via the creation of an arterio-venous (AV) fistula. A total of 7 patients (median age of 85 years; 5 women) with CLI and no traditional endovascular or surgical re-vascularization options (no-option CLI) were recruited to determine the safety of pDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia; 6 were classified at high risk of amputation based on the SVS WIfI classification. The primary safety end-points were major adverse limb events and major adverse coronary events through 30 days and serious AEs through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO2), clinical improvement at 6 months, and wound healing. The primary safety end-points were achieved in 100 % of patients, with no deaths, above-the-ankle amputations, or major re-interventions at 30 days. The technical success rate was 100 %; 2 MIs occurred within 30 days, each with minor clinical consequences. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. Complete wound healing was achieved in 4 of 7 patients and 5 of 7 patients at 6 and 12 months, respectively, with a median healing time of 4.6 months (95 % CI: 84 to 192). Median post-procedure peak TcPO2 was 61 mm Hg compared to a pre-procedure level of 8 mm Hg (p = 0.046). At the time of wound healing, 4 of 5 of patients achieved TcPO2 levels of greater than 40 mm Hg. There were 2 major amputations, 1 above the knee after pDVA thrombosis and 1 below the knee for infection; 3 patients died of causes unrelated to the procedure or study device at 6, 7, and 8 months, respectively. Limb salvage was 71 % at 12 months. The authors concluded that pDVA was an innovative approach for treating no-option CLI and represented an alternative option for the "desert foot", potentially avoiding major amputation. These researchers stated that the findings of this pilot study on pDVA demonstrated its safety and feasibility, with promising early clinical results in this small cohort.

Schreve and co-workers (2019) stated that CLI is the clinical end stage of peripheral artery disease and is associated with high amputation, mortality rates and poor QOL. For no-option CLI patients, venous arterialization could be an alternative technique for limb salvage. A systematic review and meta-analysis published in 2017 concluded that venous arterialization may be considered a viable alternative. A recent development is pDVA. This procedure, also known as LimFlow, is a novel, minimally invasive, endovascular approach to carry out venous arterialization. The limited evidence for its use necessitates a scientific judgement of the pDVA; thus, these investigators initiated a prospective, clinical post-market trial to examine the outcome of the pDVA in no-option CLI. This prospective trial is to collect "real-life" clinical data among a population of patients treated with the pDVA to examine the safety and effectiveness of the LimFlow System in patients with no-option CLI. This study is a prospective, open-label, single-arm, post-market follow-up study to be conducted on up to 50 eligible patients with a 12-month follow-up period. The primary end-point is measured by amputation free survival (AFS); and secondary end-points are complete wound healing, primary and secondary patency, limb salvage, renal function and technical and procedural success. Participants will be evaluated at regular intervals during 1 year after the initial pDVA procedure through clinical evaluation and self-completed questionnaires. The authors stated that in the last decade several studies have been published with promising results and the number of treated patients has considerably grown. Venous arterialization could be a valuable therapeutic option in patients with often no other options than amputation of the affected limb. The first results in men were promising although more research and long-term follow-up is needed to establish the effectiveness of this new treatment modality. With this prospective study, these investigators will examine the safety and effectiveness of pDVA (the LimFlow System) in patients with no-option CLI.

Mustapha and associates (2019) examined the feasibility, safety, and effectiveness of the LimFlow Stent-Graft System in performing pDVA for the treatment of patients with no-option CLI. A total of 10 subjects (mean age of 67 ± 11 years; 30 % women) were enrolled. All patients were classified as Rutherford class 5 or 6 and were deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow; 80 % of subjects were categorized as stage 4 (high risk of amputation) based on SVS WIfI scoring index. The primary safety end-point was AFS at 30 days; and a secondary safety end-point evaluated AFS at 6 months. Other secondary end-points included primary patency, wound healing, and technical success; AFS was achieved in 100 % of patients, with no deaths or index limb above-ankle amputations observed at 30 days and 6 months. Technical success rate was 100 %. No procedural complications were reported. Primary patency rates at 1 month and 6 months were 90 % and 40 %, respectively, with re-intervention performed in 30 % of patients. By 6 months, 30 % of patients experienced complete (100 %) wound healing, 50 % of patients had 84 % to 93 % wound healing, and 20 % of patients experienced 60 % healing. The authors concluded that pDVA using the LimFlow Stent-Graft System was a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom it would otherwise be considered inevitable. These researchers stated that initial findings from this early feasibility trial were promising and additional study via ongoing enrollment and follow-up in the early feasibility trial, as well as a larger-scale trial, is needed.

The authors stated that the initial analysis of the PROMISE I trial was limited to a small sample size (n = 10) with enrollment carried out at 3 medical centers. Despite the small number of medical centers included, the investigators had varied specialties, including endovascular interventionists and vascular surgeons. The current data only extended to 6 months; these researchers noted that patient enrollment is ongoing, with inclusion of additional medical centers, and long-term follow-up will continue through 2 years.

In a retrospective study, Schmidt and colleagues (2020) reported the findings of 32 patients suffering from no-option CLI who were treated with the LimFlow device between July 2014 and June 2018. Of all patients, 21 (66 %) had diabetes, 8 (25 %) were on immunosuppressed, 4 (16 %) had dialysis-dependent renal failure, 9 (28 %) had Rutherford category 6 ischemia, and 25 (78 %) were deemed at high risk of amputation. The primary outcome was AFS at 6 months; and secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Technical success was attained in 31 patients (96.9 %). The median follow-up was 34 months (range of 16 to 63). At 6, 12, and 24 months, estimates were 83.9 %, 71.0 %, and 67.2 % for AFS, 86.8 %, 79.8 % and 79.8 % for limb salvage, as well as 36.6 %, 68.2 %, and 72.7 % for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range of 0.5 to 15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Re-intervention for occlusion was carried out in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. The authors concluded that pDVA could be a recommended treatment to prevent amputation and heal wounds.

In a commentary on the afore-mentioned study by Schmidt et al (2020), Ysa (2020) stated that “Despite these encouraging results, the exact mechanism of action of pDVA remains unclear. It has been suggested that the use of the venous bed as a conduit for perfusion successfully increases flow through existing hibernating collaterals, improves tissue perfusion and nutrition in the capillary beds, and stimulates angiogenesis … At this time there are also several practical aspects to pDVA that generate controversy and remain unsolved”. Some of the unanswered questions are: First, is it better to perform a distal or a proximal pDVA? Second, would pDVA be indicated for the treatment of rest pain? Third, is a pre-operative venous assessment mandatory before a pDVA? Fourth, is it necessary to implant a cross-over covered stent to secure the AV communication?

In a single-arm, early feasibility study, Clair et al (2021) reported the 6- and 12-month outcomes of the PROMISE I Trial after treatment of no-option chronic limb-threatening ischemia (CLTI) with pDVA using the LimFlow System. A total of 32 patients with no-option CLTI, previously offered major amputation, were enrolled in this early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial re-vascularization. Patients were assessed for clinical status, pain, wound healing, and Duplex ultrasound (US) at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. Of 32 enrolled patients, 31 (97 %) were successfully treated with the LimFlow System at the time of the procedure, and 2 (6.3 %) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91 %, 74 %, and 70 % respectively. The wound healing status of fully healed or healing was 67 % at 6 months, and 75 % at 12 months. Re-intervention was performed in 16 patients (52 %) with 14 (88 %) of the maintenance re-interventions occurring within the first 3 months. The majority of re-interventions (n = 12; 75 %), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of re-intervention. The authors concluded that the LimFlow pDVA System was used in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggested early safety and provided an initial assessment of the effectiveness of the LimFlow pDVA System that supports the need for further evaluation of this procedure in a larger study with additional patients. These researchers stated that the drawbacks of this study included its small size (n = 32), the lack of a control group, and the limitations of 12-month follow-up. This early feasibility provided a positive signal for the potential for this technique.

In a retrospective study, Nakama et al (2022) examined the clinical outcomes of pDVA in Japanese patients with no-option CLTI. Data of 18 consecutive patients with CLTI (18 limbs; mean age of 75.5 ± 8.5 years; 14 men) who underwent pDVA between January 2016 and November 2020 were reviewed. The limb salvage, AFS, and wound healing rates were evaluated using the Kaplan-Meier method. Among 18 patients, 14 (77.8 %) had diabetes, 6 (33.3 %) had a non-ambulatory status, 16 (88.9 %) received hemodialysis, and 15 (83.3 %) had wound, ischemia, and foot infection of clinical stage 4. Rutherford 5 was observed in 33.7 % of the patients and Rutherford 6 in 66.7 %. The technical success rate of pDVA was 88.9 %; and 4 patients required major amputation within 30 days; pDVA failed in 2 of these patients. At 6 and 12 months, the limb salvage rates, AFS rates, and complete wound healing rates were 72.2 % and 72.2 %, 55.6 % and 49.4 %, and 23.0 % and 53.2 %, respectively. The median time to complete wound healing was 234 (IQR, 127 to 306) days. The authors concluded that the findings of this study provided the clinical outcomes of patients with CLTI who underwent pDVA in Japan. These researchers stated that acceptable, safe, and effectiveness results were reported. They stated that before major amputation, pDVA can be considered for patients with no-option CLTI. Level of Evidence = III.

Ilyas and Powell (2022) stated that the incidence of PAD continues to rise worldwide, with a concomitant rise in the subset of patients who manifest with CLTI. A mainstay of CLTI treatment is re-vascularization via open surgical bypass, endovascular therapy, or hybrid approaches combining the 2 modalities. However, a significant proportion of these patients are considered to have non-reconstructable, or no-option, CLTI. This is related to either significant pedal arterial occlusive disease or lack of a bypass conduit. DVA has been used as a potential therapeutic option for this cohort of patients. These investigators examined the various described methodologies of DVA, including open, hybrid, and totally percutaneous. These studies suggested that DVA is a promising treatment paradigm for patients with no-option CLTI, with encouraging results in terms of technical feasibility, wound healing, and ultimately limb salvage. Moreover, these researchers stated that further investigations of appropriate patient selection, standardization of techniques, and long-term follow-up are needed.

Saab et al (2022) stated that pDVA is a minimally invasive technique connecting the tibial arteries below the knee to the tibial venous system into plantar venous circulation to deliver oxygenated blood to otherwise non-perfused foot. In a retrospective, single-center study, these researchers reported outcomes of pDVA with commercially available equipment and described their experience on pDVA for CLI patients with small artery diseases and end-stage plantar disease (ESPD) who were deemed no-option cases. Primary endpoints were successful establishment of tibial vein flow with venous pedal loop, rate of major amputation, and major AEs over 6 months. Secondary endpoints were primary and secondary patency rates, minor amputation rates, and wound healing over 6 months. A total of 42 patients with ESPD underwent pDVA. Risk factors identified were hypertension (92.8 %), hyperlipidemia (85.7 %), diabetes (78.6 %), tobacco abuse (42.9 %), and chronic kidney disease of stage-3 or higher (42.8 %); 3 patients were categorized as Rutherford Class 4, 14 patients Class 5, and 25 patients (59.5 %) Class 6. Of 42 procedures, 33 (78.6 %) were deemed successful. Amputation-free survival at 6 months was reported in 25 patients (60.9 %); 16 patients (38.1 %) reported minor amputations. Wound healing rate reported at 6 months was 23.8 %. The authors concluded that this was one of the largest case series to-date with real-world no-option patients undergoing pDVA. These investigators stated that pDVA appeared a reasonable option for limb salvage in patients with ESPD where traditional arterial re-vascularization is not feasible. Identifying criteria for patient selection and advanced wound care is important to ensure clinical success. Moreover, these researchers stated that further investigations are needed to establish diagnostic guidelines for patients being evaluated for pDVA.

Shishehbor et al (2023) noted that approximately 20 % of patients with CLTI have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins (TADV) is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. In a prospective, single-group, multi-center study (PROMISE II Trial), these researchers examined the effect of TADV in patients with non-healing ulcers and no surgical or endovascular re-vascularization therapeutic options. The composite primary endpoint was AFS (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54 %. Secondary endpoints included limb salvage, wound healing, and technical success of the procedure. These investigators enrolled 105 patients who had CLTI and were of a median age of 70 years (inter-quartile range [IQR], 38 to 89). Of the patients enrolled, 33 (31.4 %) were women and 45 (42.8 %) were Black, Hispanic, or Latino. TADV was performed successfully in 104 patients (99.0 %). At 6 months, 66.1 % of the patients had AFS. According to Bayesian analysis, the posterior probability that AFS at 6 months exceeded a performance goal of 54 % was 0.993, which exceeded the pre-specified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0 % by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25 %) and were in the process of healing in 32 of 63 patients (51 %). No unanticipated device-related AEs were reported. The authors found that TADV was safe and could be performed successfully in patients with CLTI and no conventional surgical or endovascular re-vascularization therapeutic options.

In a commentary on the afore-mentioned study by Shishehbor et al (2023), Cormican et al (2023) stated that the PROMISE II Trial was carried out to describe the effectiveness of TADV on AFS and limb salvage. In consideration of that primary endpoint, the PROMISE II Trial was certainly a positive one -- not only did the study exceeded the pre-specified objective for expected success, but it offered a glimmer of hope to many of the patients with CLTI who do not qualify for interventional therapy, and, thus, continue to suffer with debilitating wounds (and the related complications associated with non-healing wounds) and the loss of form and function associated with amputations. Avoiding amputation in this population can be truly life-changing -- in older patients with CLTI who undergo lower extremity amputation, the 1-year mortality rate approaches 50 %. However, the PROMISE II Trial left much for consideration when assessing the study results in total. First and foremost, this was not an RCT, which is the standard of care for “proof” of the benefit of an intervention. The PROMISE II authors addressed this study limitation within the manuscript, and noted that “random assignment of patients destined for major amputation was practically and ethically unfeasible”. This is questionable because the inclusion criteria were for patients who would otherwise have no intervention -- so not undergoing the intervention in a control group could be considered standard of care. Moreover, contemporary trials that considerably have influenced modern practice have placed patients expected to have poor outcomes into randomized control trials -- the PARTNER B Trial (which evaluated transcatheter aortic valve replacement versus medical management of patients with severe aortic stenosis at prohibitive risk for open cardiac surgical valve replacement), and the REMATCH Trial (which evaluated durable left ventricular assist device placement versus medical management in patients with severe heart failure who were ineligible for heart transplant), are notable examples. Moreover, the study design at enrollment was to follow patients for 3 years after TA intervention, but follow-up was extended to only 12 months post-intervention, which limited the ability to evaluate the durability of the intervention over time. The reason for this limitation was not clearly addressed within the primary manuscript.

Cormican et al (2023) also stated that items not acknowledged as study limitations within the manuscript deserved a brief review. Within the study population who underwent TADV, 19 out of 105 (18.1 %) patients were dialysis-dependent (DD); the DD cohort had much worse outcomes than the study group who did not require dialysis. Among the 19 DD patients, the primary endpoint of AFS was only reached in 36.8 % of patients. In contrast, those not requiring dialysis had 72.7 % AFS. The vast majority of that difference was driven by death -- of the DD patients, 36.2 % died within the study period, whereas only 8.6 % of dialysis-free patients died. This striking contrast deserves further consideration because such a small component (less than 20 % of study participants) carried a disproportionate outcome of death. Investigation into potential mechanisms for the worse outcomes was not offered, and the specific cause/mechanism of death was not outlined within the PROMISE II manuscript. Because the risk factors associated with end-stage renal disease (ESRD) and CLTI are so closely shared, it will be important as the study and implementation of forward TAV progress to see if the abysmal outcomes in DD patients were a true signal or only noise. Moe importantly, 2 essential elements of the CLTI symptom profile were not directly addressed in the PROMISE II manuscript -- rest pain and functional status. Although amputation avoidance and wound healing are of paramount importance, those patients who have CLTI without a functional limb may, in fact, be better served with amputation in some cases. Furthermore, although the technology, technique, experience, and equipment used for TADV will hopefully advance over time to be more friendly to both proceduralists and patients, it must be noted that the vast majority of patients (almost 75 %) required some re-intervention on the TADV circuit to ensure primary patency. Moreover, 93.3 % had at least 1 of the trial's pre-defined AEs during the study period; although many of the AEs may have been comparatively minor to limb amputation or other significant events, it should be underscored that almost every subject had an AE. Finally, the study protocol was designed and sponsored by LimFlow “with input from” the principal investigators; although this conduct in important, well-designed, ethical trials is not unheard of, it is important to consider this fact when evaluating some of the afore-mentioned limitations. Cormican et al (2023) noted that the PROMISE II Trial provided some early promise as an intervention that may benefit patients with CLTI who would otherwise not have another management option. They stated that further investigations, especially those comparing TA intervention to a control group as well as studies to define the outcomes in particular subgroups (i.e., patients who are DD with CLTI), are needed before moving this experimental therapy to all patients with CLTI.

Powell et al (2023) noted that patients with no-option CLTI have limited therapeutic options. The PROMISE II Trial examined TADV as a therapeutic option for no-option CLTI. In this study, patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI). These researchers used propensity matching to compare patients from the prospective, PROMISE II Trial of the TADV intervention with simultaneously enrolled CLTI patients that were not candidates for PROMISE II but were enrolled in to CLariTI natural history registry. CLariTI patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and p-values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was AFS. Diabetes was present in over 75 % of patients. All patients had tissue loss and 35 % to 46 % had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6 months, was 66.1 % by Kaplan-Meier (KM) estimate for PROMISE II patients (n = 105) compared to 39.1 % in the no-option cohort of CLariTI (n = 121) and 44.0 % in the full cohort (no-option and patients not meeting entry criteria combine, n = 180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29 % improved (p < 0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45 % compared to the no-option control patients. The authors concluded that TADV resulted in improved 6-month AFS in no-option CLTI patients and appeared to be a promising therapy in patients with no-option CLTI.

Stenting for the Treatment of Popliteal Artery Aneurysm

Jung et al (2010) stated that popliteal artery aneurysms (PAAs) have traditionally been repaired with an open surgical approach. However, endovascular popliteal artery repair (EVPAR) has been used in selected patients because of its less invasive nature. These investigators presented their long-term outcomes for EVPAR. They performed a retrospective review of all patients who underwent EVPAR at a single academic institution between September 2002 and March 2006. These patients were evaluated for patency, need for secondary intervention, amputation-free survival, and overall survival. A total of 15 limbs in 13 patients were treated with EVPAR during the study period. All EVPAR were performed using the Viabahn® endoprostheses, with an average of 1.67 stents per limb. The mean age of the patients was 74.6 years (range of 66 to 84). Technical success was achieved in 100 % and all limbs had initial post-operative ankle-arm indices of greater than or equal to 1.0. Mean duration of follow-up was 54 months (range of 42 to 70). Two patients died of unrelated causes at 3 and 38 months with intact limbs, and 1 patient was lost to follow-up. Two limbs developed type I or III endoleaks, and were successfully treated with additional endovascular stent placement, resulting in a primary patency rate of 84.6 % and secondary patency rate of 100 %. There were no instances of limb loss during the follow-up period, yielding both amputation-free survival and overall survival rates of 85.7 %. The authors concluded that long-term follow-up of this cohort of EVPAR patients suggested that in selected patients, this is a durable technique, capable of achieving excellent patency rates and limb preservation. Moreover, they stated that further large-scale clinical trials are needed to help define optimal candidates for this technique.

Pulli and colleagues (2012) retrospectively compared peri-operative (less than 30 days) and 2-year results of open and endovascular management of PAAs in a single-center experience. From January 2005 to December 2010, a total of 64 PAAs in 59 consecutive patients were operated on at the authors' institution; in 43 cases, open repair was performed (group 1), whereas the remaining 21 cases had an endovascular procedure (group 2). Data from all the interventions were prospectively collected in a dedicated database, which included main pre-operative, intra-operative, and post-operative parameters. Early results in terms of mortality, graft thrombosis, and amputation rates were analyzed and compared by χ(2) text or Fisher exact text. The surveillance program consisted of clinical and ultrasonographic examinations at 1, 6, and 12 months and yearly thereafter. Follow-up results (survival, primary and secondary patency, limb salvage) were analyzed by Kaplan-Meier curves, and differences in the 2 groups were assessed by log-rank test. There were no differences between the 2 groups in terms of sex, age, risk factors for atherosclerosis, and co-morbidities; PAAs were symptomatic in 48 % of cases in group 1 and in 29 % in group 2 (p = 0.1). Fifteen patients with mild-to-moderate acute ischemia due to PAA thrombosis underwent pre-operative intra-arterial thrombolysis, 13 in group 1 and 2 in group 2. In open surgery group, 9 cases were treated with aneurysmectomy and prosthetic graft interposition, and in 7 cases, the aneurysm was opened and a prosthetic graft was placed inside the aneurysm. In 27 cases, ligation of the aneurysm with bypass grafting (21 prosthetic grafts and 6 autologous veins) was carried out. In group 2, 20 patients had endoprosthesis placement, whereas in the remaining patient, a multi-layer nitinol stent was used. There was 1 peri-operative death in a patient of group 2 who underwent concomitant endovascular aneurysm repair and PAA endografting. Cumulative 30-day death and amputation rate was 4.5 % in group 1 and 4.7 % in group 2 (p = 0.9). Follow-up was available in 61 interventions (96 %) with a mean follow-up period of 22.5 months (range of 1 to 60). Estimated primary patency rates at 24 months were 78.1 % in group 1 and 59.4 % in group 2 (p = 0.1). Freedom from re-intervention rates at 24 months were 79 % in group 1 and 61.5 % in group 2 (p = 0.2); estimated 24-month secondary patency rates were 81.6 % in group 1 and 78.4 % in group 2 (p = 0.9), and freedom from amputation rates were 92.7 % and 95 %, respectively (p = 0.7). The authors concluded that endovascular treatment of PAAs provided, in the authors' initial experience, satisfactory peri-operative and 1-year results, not significantly different from those obtained with prosthetic open repair in patients with similar clinical and anatomical status. There is, however, a trend toward poorer primary patency rates among patients endovascularly treated, who also seem to require more frequently a re-intervention.

Antoniou and associates (2012) noted that endovascular repair of PAAs is an emerging treatment in high-risk surgical patients. The location in a functionally demanding anatomical area creates limitations in terms of endograft patency. Technological advancements have been conscripted in an effort to circumvent such constraints. The multi-layer stent technology effects via hemodynamic modulation. These investigators employed the multi-layer stent to treat 6 asymptomatic PAAs in 3 patients. All procedures were successfully accomplished without any complications. Over a mean follow-up period of 9 months, thrombosis occurred in 2 limbs, and blood flow was restored with thrombolysis, achieving a primary and secondary patency rate at 6 months of 67 % and 100 %, respectively. Partial or complete thrombosis of the aneurysm sac was achieved in all aneurysms. The authors concluded that even though the use of the multi-layer stent in PAAs was safe in the short-term, their experience showed that close surveillance is needed. Furthermore, an UpToDate review on "Popliteal artery aneurysm" (Reed, 2012) does not mention the use of stenting as a therapeutic option.

Joshi and colleagues (2019) stated that PAA is a focal dilatation and weakening of the popliteal artery. If left untreated, the aneurysm may thrombose, rupture or the clot within the aneurysm may embolize causing severe morbidity. PAA may be treated surgically by performing a bypass from the arterial segment proximal to the aneurysm to the arterial segment below the aneurysm, which excludes the aneurysm from the circulation. It may also be treated by a stent graft that is inserted percutaneously or through a small cut in the groin. The success of the procedure is determined by the ability of the graft to stay patent over an extended duration. While surgical treatment is usually preferred in an emergency, the evidence on first-line treatment in a non-emergency setting is unclear. These investigators updated a Cochrane review first published in 2014. They examined the effectiveness of an endovascular stent graft versus conventional open surgical repair (OSR) for the treatment of asymptomatic PAA on primary and assisted patency rates, hospital stay, length of the procedure and local complications. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialized Register, CENTRAL, Medline, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to January 29, 2019. They included all RCTs comparing endovascular stent grafting versus conventional open surgical repair in patients undergoing unilateral or bilateral prophylactic repair of asymptomatic PAAs. These investigators collected data on primary and assisted primary patency rates (primary endpoints) as well as operating time, the hospital length of stay (LOS), limb salvage and local wound complications (secondary endpoints). they presented results as risk ratio (RR) or MD with 95 % CIs and evaluated the certainty of the evidence using GRADE. No new studies were identified for this update. A single RCT with a total of 30 PAAs met the inclusion criteria. There was a low risk of selection bias and detection bias; however, the risks of performance bias, attrition bias and reporting bias were unclear from the study. Despite being an RCT, the certainty of the evidence was down-graded to moderate due to the small sample size, resulting in wide CIs; only 30 PAAs were randomized over a period of 5 years (15 PAAs each in the groups receiving endovascular stent graft and undergoing conventional open surgery). The primary patency rate at 1 year was 93.3 % in the endovascular group and 100 % in the surgery group (RR 0.94, 95 % CI: 0.78 to 1.12; moderate-certainty evidence). The assisted patency rate at 1 year was similar in both groups (RR 1.00, 95 % CI: 0.88 to 1.13; moderate-certainty evidence). There was no clear evidence of a difference between the 2 groups in the primary or assisted patency rates at 4 years (13 grafts were patent from 15 PAA treatments in each group; RR 1.00, 95 % CI: 0.76 to 1.32; moderate-certainty evidence); the effects were imprecise and compatible with the benefit of either endovascular stent graft or surgery or no difference. Mean hospital LOS was shorter in the endovascular group (4.3 days for the endovascular group versus 7.7 days for the surgical group; MD of -3.40 days, 95 % CI: -4.42 to -2.38; p < 0.001; moderate-certainty evidence). Mean operating time was also reduced in the endovascular group (75.4 mins in the endovascular group versus 195.3 mins in the surgical group; MD -119.90 mins, 95 % CI: -137.71 to -102.09; p < 0.001; moderate-certainty evidence). Limb salvage was 100 % in both groups. Data on local wound complications were not published in the trial report. The authors concluded that evidence to determine the effectiveness of endovascular stent graft versus conventional open surgery for the treatment of asymptomatic PAAs was limited to data from 1 small study. At 1 year there was moderate-certainty evidence that primary patency may be improved in the surgery group but assisted primary patency rates were similar between groups. At 4 years there was no clear benefit from either endovascular stent graft or surgery to primary or assisted primary patency (moderate-certainty evidence). As both operating time and hospital LOS were reduced in the endovascular group (moderate-certainty evidence), it may represent a viable alternative to open repair of PAA. Moreover, these researchers stated that a large, multi-center RCT may provide more information in the future. However, difficulties in recruiting enough patients are likely, unless it is an international collaboration including a number of high-volume vascular centers.

In a review on “Management of asymptomatic popliteal artery aneurysms”, Kim and Sumpio (2019) concluded that as endovascular techniques and technology advance, it is likely that patency and outcomes will continue to improve, further challenging the status of OSR as the gold standard. For now, OSR is the preferred choice of repair for asymptomatic PAA provided there is available venous conduit in younger, active patients without significant co-morbidities. Moreover, ER is appropriate for patients without good venous conduit, or in older/frail patients with several co-morbidities placing them at high risk. Furthermore, consideration should be given to a patient's overall condition and life expectancy, as no benefit from repair may be observed.

In a prospective, descriptive, and analytical study, Lauricella et al (2021) examined the effectiveness of endovascular repair (ER) of PAAs with a wire-interwoven nitinol stent. From January 2016 to December 2018, a total of 28 consecutive patients (29 lower limbs) were treated for a PAA with the deployment of the Supera stent (Abbott Vascular, IL); 23 (79.3 %) PAAs were asymptomatic; 6 (20.7 %) presented with symptoms. The mean diameter and length of the aneurysm were 26.8 mm (20 to 40 mm) and 47.1 mm (23 to 145 mm), respectively. The primary endpoint was the prevention of embolic symptoms; while the secondary endpoints were aneurysm exclusion, aneurysm diameter decrease, freedom from re-intervention, and preservation of pre-operative run-off vessels. Technical success was 100 %, with a median of 2.4 run-off vessels at completion angiography, without any loss of run-off vessels. A double Supera stent was deployed in 10 cases. At completion angiography, a median of 2.4 run-off vessels were present, without any loss of run-off vessels. The mean follow-up time was 24.3 (12 to 35) months. Primary endpoints were reached in 100 % of the cases and vessels run-off was preserved in all cases. In 2 PAAs, complete sac thrombosis was witnessed at 6-month follow-up, while at 12-month follow-up, it was observed in 10 of 29 (34.4 %) limbs. In all the other cases the diameter of the aneurysm remained stable, with a freedom from sac enlargement of 100 %. No fractures or stent thromboses were detected. The authors concluded that for ER of PAAs with the use of a thick interwoven-wire stent that could work like a multi-layer flow modulator showed encouraging mid-term results with no cases of stent fracture, occlusion or aneurysm increase.

In a case-control study, Cervin et al (2021) identified factors affecting the outcome after OSR and ER of PAA in comparable cohorts. These researchers carried out a matched comparison in a national, population-based cohort of 592 legs treated for PAA (2008 to 2012), with long-term follow-up. Registry data from 899 PAA patients treated from 2014 to 2018 were analyzed for time trends. The 77 legs treated by ER were matched, by indication, with 154 legs treated with OSR. Medical records and imaging were collected. Analyzed risk factors were anatomy, co-morbidities, and medication. Elongation and angulations were examined in a core laboratory; the main outcome was occlusion. Patients in the ER group were older (73 versus 68 years, p = 0.001), had more lung disease (p = 0.012), and were treated with dual anti-platelet therapy or anti-coagulants more often (p < 0.001). The HR for occlusion was 2.69; with 95 % [CI: 1.60 to 4.55, p < 0.001) for ER, but 3.03; 95 % CI: 1.26 to 7.27, p = 0.013) for poor outflow. For permanent occlusion, the HR after ER was 2.47 (95 % CI: 1.35 to 4.50, p = 0.003), but 4.68 (95 % CI: 1.89 to 11.62, p < 0.001) for poor outflow. In the ER subgroup, occlusion was more common after acute ischemia (HR 2.94; 95 % CI: 1.45 to 5.97, p = 0.003; and poor outflow HR 14.39; 95 % CI: 3.46 to 59.92, p < 0.001). Larger stent graft diameter reduced the risk (HR 0.71; 95 % CI: 0.54 to 0.93, p = 0.014). In Cox regression analysis adjusted for indication and stent graft diameter, elongation increased the risk (HR 1.020 per degree; 95 % CI: 1.002 to 1.033, p = 0.030). PAAs treated for acute ischemia had a median stent graft diameter of 6.5 mm, with those for elective procedures being 8 mm (p < 0.001). Indications and outcomes were similar during both time-periods (2008 to 2012 and 2014 to 2018). The authors concluded that in comparable groups, ER had a 2.7-fold increased risk of any occlusion, and 2.4-fold increased risk of permanent occlusion, despite more aggressive medical therapy. Risk factors associated with occlusion in ER were poor outflow, smaller stent graft diameter, acute ischemia, and angulation/elongation. An association between indication, acute ischemia, and small stent graft diameter was identified. These investigators stated that the potential benefit of a minimally invasive treatment for elderly and frail patients should be weighed against the increased risk of complications and re-interventions. Patients with slender, elongated popliteal arteries, and/or with acute ischemia, have higher risk of occlusion after ER, which should be considered in surgical decision-making.

Wrede et al (2022) stated that ER of PAA is an alternative to OSR; however, there is no standardized protocol for when to opt for ER. Thus, the decision is at the discretion of the clinician. These researchers examined the adherence to the “Instruction for Use (IFU)” in patients undergoing ER for PAA and factors associated with stent graft patency at 1 year. The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn Endoprosthesis with heparin bioactive surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex US follow-up was carried out at 30 days and 1 year. The 2 groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome; 45 patients (81.8 %) received stent graft placement with at least 1 deviation according to IFU. Distal over-sizing of greater than 20 % was the most frequent deviation against IFU (n = 22, 40.0 %). Primary patency at 1 year was 72 %. Diameter size difference of greater than 1 mm between overlapping stent grafts (6/14 [43 %], p = 0.013) and renal insufficiency (5/12 [42 %], p = 0.0086) were associated with lower primary patency at 1 year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95 % CI: 1.17 to 2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95 % CI: 1.018 to 2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. The authors concluded that the majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference of greater than 1 mm between overlapping stent grafts was associated with a higher loss of primary patency at 1 year.

An UpToDate review on surgical and endovascular repair of popliteal artery aneurysms (Reed, 2021) explain that the goal of popliteal artery aneurysm repair is to eliminate the aneurysm from the circulation and maintain perfusion to the extremity. Open surgical bypass and endovascular stent-grafting each accomplish these goals with differing advantages, disadvantages, and types of complications.

Furthermore, guidelines from the Society for Vascular Surgery on popliteal artery aneurysms (Farber et al, 2022) state that "When surgical treatment of a PAA is indicated, both open and endovascular approaches can be used. Endovascular PAA repair (EPAR) is a less invasive procedure in which a stent-graft is deployed across the PAA".

Balloon Angioplasty and Stenting for the Treatment of Ilio-Caval Venous Occlusion

Mahnken et al (2014) stated that CVI as an advanced stage of chronic venous disease is a common problem that occurs in approximately 1 % to 5 % of the adult population. CVI has either a non-thrombotic (primary) or post-thrombotic (secondary) cause involving reflux, obstruction, or a combination of both. The role of venous obstruction is increasingly recognized as a major cause of CVI, with obstructive lesions in the ilio-caval segment being markedly more relevant than lesions at the levels of the crural and femoral veins. Approximately 70 % to 80 % of iliac veins develop a variable degree of obstruction following an episode of acute DVT. Non-thrombotic iliac vein obstruction also known as May-Thurner or Cockett's syndrome is the most common cause of non-thrombotic iliac vein occlusion. While compression therapy is the basis of therapy in CVI, in many cases, venous re-canalization or correction of obstructive iliac vein lesions may result in resolution of symptoms. The authors reviewed the current evidence on ilio-caval vein recanalization and provided standards of practice for ilio-caval stenting in primary and secondary causes of chronic venous disease.

Hardy et al (2015) noted that inferior vena cava (IVC) thrombosis is rare, but its incidence is increased in those with IVC filters or inflammatory bowel disease (IBD). Once the IVC is thrombosed, venous return is via collateral channels on the torso and retroperitoneum. Limitations in this collateral venous return can result in symptoms, usually in the lower extremities. Syncope and dyspnea are rare. These investigators reported the case of a patient with a 1-year history of worsening syncope when working with his upper extremities. Ilio-caval venous occlusion with lack of accommodation of venous return at the thoracic outlet was diagnosed. Treatment with ilio-caval stenting resolved his symptoms.

Partovi et al (2017) stated that the long-term effectiveness of endovascular re-canalization for chronic ilio-caval occlusion secondary to IVC filters is unknown. These researchers examined the effectiveness of endovascular re-canalization and stent placement across the filter in patients with filter-associated chronic ilio-caval occlusion. A total of 7 patients (mean age of 56 ± 15 years; 7 men) with symptomatic chronic ilio-caval occlusion and occluded IVC filter were included. Immediate technical success rate, long-term clinical effectiveness of endovascular re-canalization and patency rate of the stents were assessed. In all patients, the endovascular treatment consisted of percutaneous venous access, re-canalization of the occluded iliac veins and the IVC, transluminal angioplasty and stenting of the infra-renal IVC and iliac veins with self-expanding stents. The IVC filter was not removed, but rather the stents were extended across the filter. In 4 of 7 patients (57 %), adjunctive pharmaco-mechanical thrombolysis was carried out. All patients received anti-coagulation post-procedure. The mean clinical follow-up was 51.1 ± 27 months. Technical success rate was 100 %. Clinical success rate with symptomatic improvement was 85.7 %; 1 patient developed post-thrombotic syndrome on long-term follow-up despite initial symptomatic improvement. Post-stenting, the primary patency rate was 85.7 % (6 of 7 patients) and the secondary patency rate was 100 % (7 of 7 patients). The authors concluded that endovascular re-canalization with balloon angioplasty and placement of a self-expanding stent across a chronically occluded IVC filer could be carried out safely and effectively for patients with symptomatic ilio-caval thrombosis. An adjunctive pharmacologic-mechanical thrombolysis may be considered for selected patients.

In a retrospective analysis, Barbati et al (2020) reported the safety and effectiveness of a skip stent technique using nitinol stents in patients with chronic bilateral ilio-caval venous occlusions. This trial included 48 consecutive patients (32 men; mean age of 40.7 years; age range of 18 to 68 years) with chronic bilateral ilio-caval obstructions treated using a non-overlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Ilio-caval confluence was treated by deploying a nitinol stent in IVC and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was evaluated by Duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter. Re-canalization and stent reconstruction was technically successful in 47 (98 %) patients. The sinus-XL venous stent was used to treat IVC (95 [100 %]). Common iliac and external iliac veins were treated with sinus-venous and VENOVO stents (80 [83 %] and 16 [17 %] limbs, respectively). External iliac and common femoral veins were treated with sinus-venous and VENOVO stents (83 [92 %] and 7 [18 %] limbs, respectively). Early thrombosis (less than 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74 %, 83 %, and 97 %, respectively. The authors concluded that findings of this study suggested that leaving a skipped lesion at the level of ilio-caval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of ilio-caval confluence.

Kaufman et al (2021) noted that patients with chronic ilio-caval occlusions after thrombosis often present with exercise intolerance, which improved after venous reconstruction. In this study, 3 male patients with chronic ilio-caval occlusions underwent a cardio-respiratory fitness test before and 2.5 to 11 months after venous reconstruction using stents. After the intervention, average absolute oxygen consumption increased by 29.5 %, maximal oxygen consumption relative to body weight increased by 38.7 %, total work at maximum exercise increased by 74.4 %, and exercise time increased by 18.7 %. The authors concluded that the cardio-respiratory fitness test may be a useful non-invasive tool to objectively evaluate exercise intolerance due to chronic venous occlusions and response to therapy.

Furthermore, an UpToDate review on “Endovenous intervention for iliocaval venous obstruction” (Mousa, 2022) provides the following information:

Intervention for ICVO is undertaken in a stepwise fashion, including:

Using intravascular ultrasound (ideal if available) to confirm and characterize the degree of stenosis and for determining measurements for stent placement.
Performing angioplasty/stenting of stenotic venous lesions and completion venography to confirm unobstructed venous patency and optimal stent positioning.

Renal Artery Stenting for the Treatment of Stenosis Due to Atherosclerotic Disease

In an updated comparative effectiveness review on “Renal artery stenosis management strategies”, Balk et al (2016) noted that therapeutic options for atherosclerotic RAS (ARAS) include medical therapy alone or renal artery re-vascularization with continued medical therapy, most commonly by percutaneous transluminal renal angioplasty with stent placement (PTRAS). This review updated a prior comparative effectiveness review of management strategies for ARAS from 2006, which was updated in 2007. These investigators compared the effectiveness and safety of PTRAS versus medical therapy, and also versus surgical re-vascularization, to treat ARAS. They also identified predictors of outcomes by intervention. Data sources included Medline, Embase, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews from inception to March 16, 2016; eligible studies from the original reports and other relevant existing systematic reviews; and other sources. These researchers included studies comparing ARAS interventions, single-group prospective PTRAS and medical therapy studies, and prospective or retrospective surgery studies. They also included 20 recent case reports of patients with acute ARAS decompensation. Outcomes included all-cause and cardiovascular mortality, cardiovascular events, renal replacement therapy (RRT), other kidney events and function, hypertension events, BP, medication use, and AEs. From 1,454 citations, these investigators included 78 studies and 20 case reports. They included 9 RCTs, 11 non-randomized comparative studies, 67 cohorts (in 63 studies) of PTRAS; 20 cohorts (in 17 studies) of medical therapy alone; and 4 cohorts of surgery. For the primary comparison of PTRAS versus medical therapy, 7 RCTs found no difference in mortality, RRT, cardiovascular events, or pulmonary edema. They mostly found no difference in kidney function or BP control after PTRAS. Procedural AEs were rare but medication-related AEs were not reported. The non-randomized studies were more variable than the RCTs and found no significant difference in mortality, but heterogeneous effects on kidney function and BP control after PTRAS. All 20 case reports described patients with successful clinical and symptomatic improvement following re-vascularization. In subgroup analyses, 2 RCTs found no patient characteristics associated with outcomes between PTRAS and medical therapy. In 1 retrospective comparative study, patients with flash pulmonary edema or both rapidly declining kidney function and refractory hypertension had decreased mortality with PTRAS (versus medical therapy). Single-intervention studies found that various factors predicted outcomes. The authors concluded that there was a low strength of evidence of non-statistically significant or minimal clinically important differences in important clinical outcomes (death, cardiovascular events, RRT) or BP control between PTRAS and medical therapy alone, and that kidney function may improve with PTRAS. Clinically important AEs related to PTRAS were rare; however, studies generally did not report medication-related AEs. Based on the evidence, subsets of patients benefited from re-vascularization, but the evidence did not clearly define who these patients were, except that case reports demonstrated that some patients with acute decompensation benefit from re-vascularization. Evidence is limited regarding differences in outcomes based on different PTRAS-related treatments. The RCTs had limited applicability to many patients for whom PTRAS is recommended, especially those who presented with pulmonary edema or rapidly declining kidney function. All non-randomized trials were inadequately adjusted to account for underlying differences between patients undergoing different interventions. New studies or re-analyses of data in existing studies are needed to better understand the comparative effectiveness of PTRAS versus medical therapy.

Manolis et al (2017) stated that RAS has a high prevalence in the elderly, especially in the context of general atherosclerosis. It is frequently associated with resistant hypertension and impaired renal function and their attendant consequences. The issue whether re-vascularization via percutaneous renal angioplasty and stenting (PRA/S) could benefit these patients remains unsettled. These investigators presented a case series of patients with refractory hypertension and RAS undergoing PRA/S and also provided an extensive review of the literature on the current status of PRA/S for resistant hypertension. Data of all consecutive patients undergoing PRA/S by a single operator over a 1-year period were prospectively collected. These were 9 patients with hypertension refractory to drug therapy who also had other clinical cardiac problems that led to their hospitalization, including flash pulmonary edema and coronary artery disease (CAD). They were all receiving 3 or more anti-hypertensive drugs and renal angiography revealed critical RAS (unilateral in 3 and bilateral in 6). Furthermore, an extensive literature review of the topic was performed in PubMed, Scopus and Google Scholar. PRA/S was successful in all 9 high-risk RAS patients with resistant hypertension (5 men, mean age of 71 years) without complications and helped in bringing under control their elevated BP and in maintaining their renal function over a mean of 21 months. Literature review of this controversial topic indicated that in carefully selected patients, PRA/S may play an important role in controlling BP, alleviating symptoms and perhaps preventing renal failure, albeit without concrete evidence of significantly affecting hard endpoints of renal events, major cardiovascular events and death. RCTs, including a large one (CORAL trial), although heavily criticized, have not provided evidence in favor of re-vascularization. Although RCTs are rather neutral, a multitude of prospective, observational cohort studies, comparing the outcomes of patients after PRA/S have demonstrated significant improvement in systolic and diastolic BP in about 2/3 and improvement and/or stabilization in renal function in 30 % to 40 % of patients undergoing PRA/S. Nevertheless, the issue remains unsolved and a subject of future studies for more definitive settlement. Suggestions have been made to adopt physiological and functional renal lesion assessment that may enhance patient selection, at least for RAS cases of moderate lesion severity. The authors concluded that in high-risk RAS patients with truly resistant hypertension, flash pulmonary edema, and/or rapid deterioration of renal function, PRA/S, a procedure with currently high technical success, may constitute the only viable option. More importantly, despite the unfavorable results of RCTs, current guidelines have not yet changed; and clinicians should continue to abide by them. They recommended PRA/S as a reasonable option for patients with hemodynamically significant (especially ostial) RAS and uncontrolled, resistant or malignant hypertension, recurrent, unexplained congestive heart failure or pulmonary edema or unstable angina.

Courand et al (2019) noted that the effect of renal artery angioplasty on BP in patients with true resistant hypertension and ARAS has not been fully examined due to the exclusion of these patients from most trials. In a retrospective, single-center study, these researchers examined the benefits of renal angioplasty on daytime ambulatory BP (dABP) in this subgroup of patients. Medical records of the authors’ hypertension department were retrospectively analyzed from 2000 to 2016. A total of 72 patients were identified with resistant hypertension (dABP [systolic BP/diastolic BP] of greater than 135/85 mm Hg despite at least 3 anti-hypertensive drugs, including a diuretic) and ARAS treated by angioplasty. ARAS was unilateral in 57 patients and bilateral in 15 patients. The mean age of the patients was 67.8 ± 11.2 years; dABP was 157 ± 16 / 82 ± 10 mm Hg despite 4.0 ± 1.0 anti-hypertensive treatments; eGFR was 52 (41 to 63) ml/min. After renal angioplasty, dABP decreased by 14.0 ± 17.3 / 6.4 ± 8.7 mm Hg (p < 0.001 for both), and the number of anti-hypertensive treatments decreased to 3.6 ± 1.4 (p = 0.002) with no significant change in eGFR. A high baseline systolic dABP and a low body mass index (BMI) were independent predictors of systolic dABP changes. The decrease in dABP was confirmed in a subgroup of patients at 1 and 3 years of follow-up (n = 31 and n = 18, respectively, p ≤ 0.001 for systolic and diastolic BP at both visits). The authors concluded that angioplasty in patients with ARAS and with true resistant hypertension significantly decreased dABP, reducing the need for anti-hypertensive treatment with no change in eGFR

Iwashima and Ishimitsu (2020) stated that reno-vascular hypertension (RVH) is one of the most common causes of secondary hypertension and could lead to resistant hypertension. RVH is associated with an increased risk for progressive decline in renal function, cardiac destabilization syndromes including "flash" pulmonary edema, recurrent congestive heart failure, and cerebrocardiovascular disease. The most common cause of RAS is atherosclerotic lesions, followed by fibromuscular dysplasia. The endovascular technique of PTRA with or without stenting is one of the standard treatments for RAS. RCTs comparing medical therapy with PTRA to medical therapy alone have failed to show a benefit of PTRA; however, the subjects of these randomized clinical trials were limited to atherosclerotic RAS patients, and patients with the most severe RAS, who would be more likely to benefit from PTRA, might not have been enrolled in these trials.

Chen et al (2021) noted that for patients with ARAS, the role of PTRA remains inconclusive. In a systematic review and meta-analysis, these researchers compared the benefits of best medical therapy (BMT) plus PTRA and BMT alone in treating ARAS. They searched for all RCTs that reported patients with ARAS. The safety and effectiveness in the BMT plus PTRA and BMT alone groups were estimated, taking into account hypertension, stroke, renal events, cardiac events, and mortality. A total of 9 RCTs entailing 2,309 patients were included. In the BMT plus PTRA group, the incidence of refractory hypertension was significantly lower compared with that in the BMT alone group (OR of 0.09; 95 % CI: 0.01 to 0.70). However, there were no significant differences in the rates of stroke, renal events, cardiac events, cardiac mortality, and all-cause mortality between the 2 groups. The authors concluded that PTRA plus BMT improved BP in patients with ARAS; however, there was insufficient evidence for this therapy in improving stroke, renal events, cardiac events, and cardiac and all-cause mortality.

In a prospective, cohort, 2-center study, Reinhard et al (2022) examined the effects of renal artery stenting in consecutive patients with severe ARAS and high-risk clinical presentations as defined in a national protocol developed in 2015. Since the protocol was initiated, a total of 102 patients have been referred for re-vascularization according to the following high-risk criteria: severe RAS (70 %or higher) with true resistant hypertension, rapidly declining kidney function, or recurrent heart failure/sudden pulmonary edema. At baseline, the mean 24-hour ambulatory systolic BP was 166.2 mm Hg (95 % CI: 162.0 to 170.4), the defined daily dose of anti-hypertensive medication was 6.5 (95 % CI: 5.8 to 7.3), and the eGFR was 41.1 ml/min per 1.73 m2 (95 % CI: 36.6 to 45.6). In 96 patients with available 3-month follow-up data, mean 24-hour ambulatory systolic BP decreased by 19.6 mm Hg (95 % CI: 15.4 to 23.8; p < 0.001), the defined daily dose of anti-hypertensive medication was reduced by 52 % (95 % CI: 41 % to 62 %; p < 0.001), and eGFR increased by 7.8 ml/min per 1.73 m2 (95 % CI: 4.5 to 11.1; p < 0.001). All changes persisted after 24-month follow-up. Among 17 patients with a history of hospitalization for acute decompensated heart failure, 14 patients had no new episodes after successful re-vascularization. The authors reported a decrease in BP and anti-hypertensive medication, an increase in eGFR, as well as a decrease in new hospital admissions attributable to heart failure/sudden pulmonary edema following renal artery stenting.

Furthermore, an UpToDate review on “Treatment of unilateral atherosclerotic renal artery stenosis” (Textor, 2022) states the following:

For patients with unilateral RAS who meet 1 or more of the following 4 criteria, the author suggests re-vascularization rather than medical therapy alone; re-vascularization is usually achieved by percutaneous angioplasty with stenting (or surgical re-vascularization in patients with complex anatomic lesions):

A short duration of BP elevation before the diagnosis of renovascular disease, since this is the strongest clinical predictor of a fall in BP following renal re-vascularization
Failure of optimal medical therapy to control the BP
Intolerance to optimal medical therapy
Recurrent flash pulmonary edema and/or refractory heart failure.

Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoro-Popliteal Lesions

In a systematic review and meta-analysis, Zenunaj et al (2023) compared DCB with DES angioplasty as a primary option in patients with FP lesions in terms of primary patency as well as freedom from clinically driven TLR (cdTLR) and MALE. These investigators carried out a comprehensive literature search using the PubMed and Embase databases. All studies written in English and reporting data presenting a comparison between patients receiving primary percutaneous balloon angioplasty using the DCB versus primary percutaneous stenting with DES for native FP lesions were included in this meta-analysis. There were 984 patients with 1,078 FP lesions, of which procedures with DCB and DES were performed in 514 and 564 lesions, respectively. Overall, majority patients were men with a mean age of 70.9 years, and there were no significant differences between the 2 groups regarding the cardiovascular co-morbidities. With regards to the procedural strategy, there was significant heterogeneity in the DCB group. This included adjunctive procedures such as atherectomy besides the angioplasty of the target vessel, which was reported in 1 study as a part of 32.1 % of the procedures in the DCB group. Provisional BMS (pBMS) for residual stenosis and dissection were used in 4 studies with a percentage varying from 14.8 % to 25.3 %. Overall, at 1 year, all outcomes were similar for all the endpoints; however, where adjunctive procedures were performed (atherectomy + pBMS) in the DCB group, the outcomes were better (primary patency p 0.001, freedom cdTLR p 0.001, and freedom form MALE p 0.002). In studies where no adjunctive procedures were carried out in the DCB group, the results favored the DES group for the primary patency (p 0.026) and freedom from cdTLR (p 0.044). The authors concluded that DES appeared to be superior in terms of cdTLR and primary patency at 1 year when compared to the procedures performed solely with DCB. For DCB to achieve optimal results, further adjunctive procedures such as pBMS and atherectomy are needed. These researchers stated that further investigations are needed to confirm the superiority of the primary stenting with DES at the FP segment.

Paclitaxel-Coated Devices in the Femoro-Popliteal Arteries

Zhang and Yin (2022) noted that clinical benefit of paclitaxel-coated devices for patients with PAD has been confirmed in RCTs. A meta-analysis published in 2018 identified late mortality risk over a long follow-up period due to use of paclitaxel-coated devices in the FP arteries, which caused enormous controversy and debates globally. In a systematic review and meta-analysis, these investigators examined the safety of paclitaxel-coated devices by incorporating the most recently published data. They searched for candidate studies in PubMed (Medline), Scopus, Embase (Ovid) online databases, government web archives and international cardiovascular conferences. Safety endpoints of interest included all-cause mortality rates at 1, 2, and 5 years and the RR was used as the summary measure. The primary analysis was carried out using random-effects models to account for potential clinical heterogeneity. A total of 39 RCTs including 9,164 patients were identified. At 1 year, the random-effects model yielded a pooled RR of 1.06 (95 % CI: 0.87 to 1.29) indicating no difference in short-term all-cause deaths between the paclitaxel and control groups (crude mortality, 4.3 %, 214/5,025 versus 4.5 %, 177/3,965). The 2-year mortality was reported in 26 RCTs with 382 deaths out of 3,788 patients (10.1 %) in the paclitaxel arm and 299 out of 2,955 patients (10.1 %) in the control arm and no association was found between increased risk of death and usage of paclitaxel-coated devices (RR 1.08, 95 % CI: 0.93 to 1.25). A total of 8 RCTs recorded all-cause deaths up to 5 years and a pooled RR of 1.18 (95 % CI: 0.92 to 1.51) demonstrated no late mortality risk due to use of paclitaxel-coated devices (crude mortality, paclitaxel 18.2 %, 247/1,360 versus control 15.2 %, 122/805). The authors found no significant difference in either short- or long-term all-cause mortalities between patients receiving paclitaxel-coated and uncoated devices. Moreover, these researchers stated that further investigations including more RCTs with longer follow-up periods (e.g., 8- or 10-year) and individual patient-level data are needed to shed more light on the risk-benefit profiles of paclitaxel usage in PAD patients.

Gore Viabahn VBX Stent for the Treatment of Celiac Artery Aneurysm with Dissection

Sachdev et al (2006) noted that aneurysms involving branches of the superior mesenteric and celiac arteries are uncommon and require proper management to prevent rupture and death. In a retrospective study, these investigators compared surgical and endovascular treatment of these aneurysms and analyzed outcome. Patients treated for aneurysms in the branches of the celiac artery and superior mesenteric artery were identified via a search of medical records and endovascular database. Patient demographics, history, clinical presentation, aneurysm characteristics, treatments, and follow-up outcome were recorded. Significant differences between patients treated by surgical or endovascular therapy were determined by using Student's t-test and Chi-square analysis. Between January 1, 1991, and July 1, 2005, a total of 59 patients with 61 aneurysms were treated at a single institution; 24 patients had surgical repair, and 35 underwent endovascular treatment, which included coil embolization and stent-graft therapy. Splenic (n = 28) and hepatic (n = 22) artery aneurysms predominated; 89 % of splenic artery aneurysms were true aneurysms and were treated by endovascular and surgical procedures in near equal numbers (14 and 11, respectively). Pseudo-aneurysms were significantly more likely to be treated by endovascular means (p < 0.01). The technical success rate of endovascular treatment for aneurysms was 89 %, and failures were successfully treated by repeat coil embolization in all patients who presented for re-treatment. Patients treated by endovascular techniques had a significantly higher incidence of malignancy than patients treated with open surgical techniques (p = 0.03). In addition, patients treated by endovascular means had a shorter in-hospital LOS (2.4 days versus 6.6 days, p < 0.001). The authors concluded that endovascular management of visceral aneurysms was an effective means of treating aneurysms involving branches of the celiac and superior mesenteric arteries and was especially useful in patients with co-morbidities, including cancer. It was associated with a decreased hospital LOS in the elective setting, and failure of primary treatment could often be successfully managed percutaneously.

Keschenau et al (2020) stated that visceral artery aneurysms (VAA) are rare and the literature regarding management strategies is limited. In a retrospective, single-center study, these researchers reported their 13-year experience with VAA treatment including conservative, open surgical, and endovascular therapy. This trial included 37 patients (31 men, median age of 70 years [46 to 79 years]) with true and dissecting VAA treated bet ween January 2006 and December 2018. Indications for invasive therapy were ruptured (n = 1) and symptomatic (n = 8) VAA or asymptomatic VAA of greater than 20 mm (n = 15). The decision on the treatment type was made after inter-disciplinary (vascular surgeons/radiologists) discussion. The aneurysms affected the celiac trunk (n = 18, 49 %), the splenic artery (n = 11, 30 %), the superior mesenteric artery (SMA, n = 6, 16 %), the hepatic artery (n = 5, 14 %) and proximal SMA side branches (n = 2, 5 %). A total of 6 patients had multiple VAA, 1 had an intra-hepatic artery aneurysm and 1 had peripheral mesocolic artery aneurysms plus a VAA. A total of 46 % of the patients (n = 17) had co-existing aneurysms in other vascular territories. A total of 13 patients were managed conservatively (median VAA diameter 15 [14 to 25] mm), 18 underwent open surgery with venous or prosthetic bypass or interposition graft implantation, and 6 were treated by endovascular means (coiling [n = 3] or endograft [n = 3]). Median follow-up (FU) was 21 months (4 to 123 months). In-hospital mortality was 0 %. Median hospital LOS was 11 days (5 to 28 days) after surgical and 3 days (2 to 71 days) after endovascular treatment. Complications included an early type-I endoleak, 3 secondary open abdominal surgeries for bleeding/peritonitis after endovascular treatment of a ruptured intrahepatic aneurysm, an asymptomatic aorto-truncal bypass occlusion and aneurysm recurrence after a venous SMA interposition graft. None of the conservatively treated VAA required invasive treatment during FU. The authors concluded that small (less than 20 mm) asymptomatic VAA can be managed conservatively. Whenever invasive treatment was indicated, both open and endovascular treatments could be performed with low complication rates. In order to choose the optimal therapeutic approach, anatomical features and patient co-morbidities should be considered and, ideally, discussed inter-disciplinarily.

The Society for Vascular Surgery’s clinical practice guidelines on “The management of visceral aneurysms” (Chaer et al, 2020) recommended the following:

Treatment of non-ruptured celiac artery pseudoaneurysms of any size in patients of acceptable operative risk because of the possibility of rupture. Level of Recommendation: Grade 1 (Strong), Quality of Evidence: B (Moderate).
Treatment of non-ruptured celiac artery true aneurysms of greater than 2 cm, with a demonstrable increase in size, or with associated symptoms in patients of acceptable risk because of the risk of rupture. Level of Recommendation: Grade 1 (Strong), Quality of Evidence: C (Low).

Saiga et al (2022) reported on the case of a 61-year-old man who presented with retro-peritoneal hemorrhage caused by an aneurysm rupture of the pancreaticoduodenal arcade (PDA), and acute celiac artery dissection distal to celiac axis stenosis. Owing to the gradual growth of the false lumen, these investigators planned to deploy a stent to the celiac artery dissection and embolize the PDA aneurysm. Before stent placement, these researchers evaluated the acute celiac artery dissection distal to the stenosis using four-dimensional (4D) computed tomography angiography (CTA) via the expiration/inspiration/expiration cycle. They diagnosed median arcuate ligament syndrome considering that the celiac axis showed a hooked narrowing at end-expiration, and the compression decreased at end-inspiration. Furthermore, the true lumen distal to the stretched axis dilated in the inspiration phase; thus, they could advance a catheter into the true lumen during inspiration and successfully deployed a stent. Subsequently, laparoscopic median arcuate ligament release was carried out following the stent deployment. A post-operative CT scan showed good patency in the stent, with disappearance of the blood filling the false lumen and with reduced celiac axis stenosis.

Furthermore, an UpToDate review on “Treatment of visceral artery aneurysm and pseudoaneurysm’ (Sumpio, 2024) states that “Endovascular management of celiac artery aneurysm (CAA) has been described and may be appropriate in high-risk patients without liver dysfunction and without disease of the collateral circulation including the SMA and gastroduodenal arteries. A retrospective series reported an 89 % success rate in the treatment of CAA with the endovascular approach using coil embolization or stent grafting”.

Gore Viabahn VBX Stent for the Treatment of Aorto-Iliac or Femoro-Popliteal Occlusive Disease

In a prospective, non-randomized, single-arm, multi-center study, Panneton et al (2020) examined the mid-term safety and effectiveness of the Gore Viabahn balloon-expandable endoprosthesis (VBX stent-graft) in the treatment of patients with de-novo or re-stenotic aorto-iliac lesions. This trial included 134 patients (mean age of 66 ± 9.5 years; 79 men) up to 3 years after treatment with the VBX stent-graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were assessed via 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion re-vascularization (TLR), target vessel re-vascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A uni-variate analysis determined any correlation between baseline variables and TLR. The observed composite percentage of MAEs was 2.3 %, well below the 17 % performance objective (p < 0.001). Of the 134 patients in the per protocol analysis, 107 (80 %) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5 % and primary assisted patency was 99.0 %. The estimate of freedom from TLR per-lesion/vessel was 97.6 % at 9 months and 91.2 % at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6 % and the 3-year estimate was 98.1 %. The 3-year mean resting ABI was 0.93 ± 0.19, an improvement of 0.17 ± 0.26 from baseline (p < 0.001). At 3 years, 82 patients (92.1 %) improved 1 or more Rutherford category from baseline, and 77 patients (86.5 %) maintained or improved upon their baseline functional status. The authors concluded that the VBX stent-graft was a robust and durable therapeutic option for aorto-iliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Holden et al (2023) presented a physician-initiated study that provided 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, non-randomized, single-arm, multi-center VBX FLEX clinical study (Panneton et al, 2020). It examined the long-term treatment durability of the Gore Viabahn balloon-expandable endoprosthesis (VBX stent-graft) in the treatment of subjects with de-novo or re-stenotic aorto-iliac lesions. A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 ITT subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from TLR, freedom from TVR, as well as resting ABI, Rutherford category, EuroQol 5 Dimensions, and walking impairment status. A total of 59 subjects participated and 28 (47.5 %) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5 % and 81.7 %, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0 % and 89.5 % (by lesion) and 91.7 % and 84.4 % (by subject). Primary assisted patency at 3 and 5 years were 93.3 % and 93.3 %. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1 %. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72 %), and at 5-year follow-up (18/28; 64 %). The 5-year mean resting ABI was 0.95 ± 0.18, an improvement of 0.15 ± 0.26 from the baseline (p < 0.001); and QOL measures also showed sustained improvement through long-term follow-up. The authors concluded that the 5-year long-term follow-up data underscored the robustness and durability of the Viabahn balloon-expandable endoprosthesis for the treatment of aorto-iliac occlusive disease.

Gornik et al (2024) stated that the "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provided recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease (LE-PAD) across its multiple clinical presentation subsets (i.e., asymptomatic, chronic symptomatic, chronic limb-threatening ischemia [CLTI], and acute limb ischemia). These investigators carried out a comprehensive literature search from October 2020 to June 2022, encompassing studies, reviews, and other evidence carried out on human subjects that was published in English from PubMed, Embase, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer-reviewed process, were also considered by the writing committee and added to the evidence tables where appropriate. The authors updated recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" with new evidence to guide clinicians. Furthermore, new recommendations addressing comprehensive care for patients with PAD have been developed. The updated guidelines provided the following recommendations (Class of Recommendation; Level of Evidence):

In patients with functionally limiting claudication and hemodynamically significant aorto-iliac or femoro-popliteal disease with inadequate response to guideline-directed management and therapy (GDMT) (including structured exercise), endovascular re-vascularization is effective to improve walking performance and QOL. 1 (strong; benefit >>> risk), A (high quality evidence).

Gore Viabahn VBX Stent for the Treatment of Chronic Mesenteric Ischemia

van Dijk et al (2019) stated that chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastro-intestinal (GI) tract and is caused by atherosclerotic stenosis of 1 or more mesenteric arteries in over 90 % of cases. Re-vascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the 1st choice of treatment in CMI; BMS are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS).

Girault et al (2021) noted that despite the continuing controversy of CS versus BMS, the use of CS in mesenteric occlusive disease (MOD) has been recommended by expert centers. These researchers reported mid-term results with CS of the superior mesenteric artery (SMA). Between January 2014 and October 2019, patients with MOD with a severe atheromatous stenosis or occlusion of the SMA treated by mesenteric CS were included. Clinical presentation included both acute mesenteric ischemia (AMI), CMI, and asymptomatic patients planned for major surgery. Demographics, procedure details, and follow-up data were prospectively collected and retrospectively reviewed. Study endpoints included primary patency, primary assisted patency, and secondary patency. During the study period, a total of 86 patients (mean age of 70 ± 9 years; 57 % men) were included. Clinical presentation was AMI (n = 42 [49 %]), CMI (n = 31 [36 %]), and asymptomatic (n = 13 [15 %]). The technical success rate was 97 %. A total of 96 stents were implanted, including 86 proximal CS (Advanta V12, n = 73; Lifestream, n = 13). The mean length and mean diameter of the CS were 31.5 ± 6.3 mm and 6.9 ± 0.5 mm, respectively. Additional distal BMS were used in 10 patients (12 %) to overcome a kinking (n = 9) or a dissection (n = 1) down-stream of the CS. All post-operative deaths occurred in patients with AMI (n = 11, 13 %). During a median follow-up of 15.6 months (95 % CI: 15.6 ± 3.6 months), 12 patients (14 %) underwent re-interventions for either stent misplacement (n = 3), stent recoil (n = 3), stent thrombosis (n = 2), de-novo stenosis at the distal edge of the CS (n = 2), or gastric ischemia (n = 1). At 1 year, the overall primary patency, primary assisted patency, and secondary patency rates were 83 % (95 % CI: 83 % ± 9 %), 99 % (95 % CI: 99 % ± 3 %), and 99 % (95 % CI: 99 % ± 3 %), respectively. At 2 years, the overall primary patency, primary assisted patency, and secondary patency rates were 76 % (95 % CI: 76 % ± 13 %), 95 % (95 % CI: 95 % ± 8 %) and 95 % (95 % CI: 95 % ± 8 %), respectively. The authors concluded that mesenteric CS provided very satisfactory mid-term results in patients with MOD, with an excellent primary assisted patency rate at 2 years, at the price of a significant re-intervention rate.

Xhepa et al (2023) stated that CMI arises from the inability to achieve adequate intestinal blood flow after meals, resulting in an imbalance between oxygen and metabolite supply and demand. The true incidence of CMI remains uncertain; however, the occurrence of mesenteric artery occlusive disease (MAOD) is relatively common among the elderly. Delays in diagnosing CMI can often be attributed to several factors, including the variability in patient symptoms and the range of potential causes for chronic abdominal pain with weight loss. Mikkelson pioneered the introduction of a surgical treatment for occlusive lesions of the SMA in 1957. The inaugural performance of endovascular re-vascularization (ER) for visceral vessels took place in 1980. The literature has documented 2 types of ER methods: PTA and primary stenting (PMAS). Despite the limited quality of available evidence, the consensus among experts is strongly in favor of PMAS over PTA alone for the treatment of atherosclerotic mesenteric artery stenosis.

Sardar and White (2023) noted that CMI is an uncommon, potentially under-diagnosed clinical condition. Although there is a high prevalence of mesenteric artery stenoses (MAS), an abundant collateral network in the mesenteric circulation mitigates occurrence of ischemia. The most common etiology of CMI is atherosclerosis. CMI is a clinical diagnosis, based upon typical and atypical symptoms and consistent anatomic findings. Typical symptoms of CMI are post-prandial abdominal pain, unintended weight loss, and food avoidance. The key modalities to diagnose MAS are duplex US, CTA, or MRA, although high-resolution CTA is preferred. Endovascular therapy with balloon expandable stents has become the preferred treatment for MAS.

Brandtzag et al (2024) noted that current management of mesenteric ischemia is primarily endovascular stent treatment. Typical chronic mesenteric ischemia (CMI) symptoms are post-prandial abdominal pain, food fear, weight loss, and diarrhea. Re-vascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated.

Terlouw et al (2024) stated that mesenteric artery stenting with BMS is the current treatment for atherosclerotic CMI; however, long-term patency of BMS is unsatisfactory due to in-stent intimal hyperplasia. Use of CS might improve long-term patency. In a patient- and investigator-blinded, multi-center RCT, these researchers compared the patency of CS and BMS in patients with CMI. This study including patients with CMI undergoing mesenteric artery stenting. A total of 6 centers in the Netherlands participated in this study, including 2 national CMI expert centers. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery re-vascularization was scheduled and a consensus diagnosis of CMI was made by a multi-disciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CTA, or previous TVR. Digital 1:1 block randomization with block sizes of 4 or 6 and stratification by inclusion center was used to allocate patients to undergo stenting with BMS or CS at the start of the procedure. Patients, physicians performing follow-up, investigators, as well as radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study endpoint was the primary patency of CS and BMS at 24 months of follow-up, examined in the modified ITT population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75 % or greater luminal surface area reduction of the target vessel. CTA was carried out at 6 months, 12 months, and 24 months post-intervention to evaluate patency. Between April 6, 2015, and March 11, 2019, a total of 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the CS group (median age of 69.0 years [IQR 63.0 to 76.5], 28 [60 %] women) and 47 patients (66 stents) were assigned to the BMS group (median age of 70.0 years [63.5 to 76.5], 33 [70 %] women). At 24 months, the primary patency of CS (42 [81 %] of 52 stents) was superior to that of BMS (26 [49 %] of 53; OR 4.4 [95 % CI: 1.8 to 10.5]; p < 0.0001). A procedure-related AE occurred in 17 (36 %) of 47 patients in the CS group versus 9 (19 %) of 47 in the BMS group (OR 2.4 [95 % CI: 0.9 to 6.3]; p = 0·065). Most AEs were related to the access site, including hematoma (5 [11 %] in the CS group versus 6 [13 %] in the BMS group), pseudo-aneurysm (5 [11 %] versus 2 [4 %]), radial artery thrombosis (1 [2 %] versus none), and intravascular closure device (none versus 1 [2 %]). A total of 6 (13 %) patients in the CS group versus 1 (2 %) in the BMS group had procedure-related AEs not related to the access site, including stent luxation (3 [6 %] versus none), major bleeding (2 (4 %) versus none), mesenteric artery perforation (1 [2 %] versus 1 [2 %]), mesenteric artery dissection (1 [2 %] versus 1 [2 %]), and death (1 [2 %] versus none). The authors concluded that the findings of this study supported the use of CS for mesenteric artery stenting in patients with CMI.

Furthermore, an UpToDate review on “Surgical and endovascular techniques for mesenteric revascularization” (Smeds and Soult, 2024) states that “For patients with symptomatic chronic mesenteric ischemia, revascularization should be performed only after exclusion of other possible causes for the patient's abdominal complaints. Endovascular first approach -- Initial endovascular revascularization is preferred to open surgical bypass for patients with chronic mesenteric ischemia and suitable vascular anatomy. Perioperative complication rates are lower for endovascular techniques; however, endovascular revascularization is less durable, and repeat intervention may be necessary … We suggest using a covered stent, rather than angioplasty alone or using an uncovered stent for treatment of the SMA (Grade 2C). Restenosis rates are lower for covered compared with uncovered stents. During mesenteric angioplasty and stenting, using embolic protection devices reduces the risk of distal embolization”.

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Last Review 11/12/2024

Effective: 06/19/2009

Next Review: 09/11/2025
Review History
Definitions

Peripheral Vascular Stents

Table Of Contents

Policy

Scope of Policy

Medical Necessity

Experimental, Investigational, or Unproven

Related Policies

CPT Codes / HCPCS Codes / ICD-10 Codes

Peripheral Artery Stenting:

CPT codes covered if selection criteria are met:

Other CPT codes related to the CPB:

HCPCS codes covered if selection criteria are met:

ICD-10 codes covered if selection criteria are met:

ICD-10 codes not covered for indications listed in the CPB:

Eluvia Drug-Eluting Vascular Stent System, Gore Viabahn PTFE-coated Endoprosthesis, Gore Tigris Vascular Stent, LifeStream balloon-expandable covered stent, iCast stent, Gore Viabahn VBX stent:

HCPCS codes covered if selection criteria are met:

ICD-10 codes covered if selection criteria are met:

Peripheral Venous Stents:

CPT codes covered if selection criteria are met:

CPT codes not covered for indications listed in the CPB:

Other CPT codes related to the CPB:

HCPCS codes covered if selection criteria are met:

ICD-10 codes covered if selection criteria are met:

ICD-10 codes not covered for indications listed in the CPB:

Biodegradable stents - no specific code:

Balloon angioplasty and stenting for the treatment of ilio-caval venous occlusion:

CPT codes covered if selection criteria are met:

Other HCPCS codes related to the CPB:

ICD-10 codes covered if selection criteria are met:

Renal Artery Stenting for the treatment of stenosis due to atherosclerotic disease:

CPT codes covered if selection criteria are met:

Other HCPCS codes related to the CPB:

ICD-10 codes covered if selection criteria are met:

Background

The iCast Stent

Recurrent Cephalic Arch Stenosis

Bioresorbable Stents in Peripheral Arterial Disease

Biodegradable Stents in Peripheral Arterial Disease

Stenting in Infra-Popliteal Disease

Peripheral Artery Stenting for Ischemic Nephropathy

Viabahn for the Treatment of Peripheral Artery Occlusive Disease

LifeStream Balloon-Expandable Covered Stent for the Treatment of Iliac Artery Stenosis

VENOVO Venous Stent System for the Treatment of May-Thurner Syndrome

Eluvia Drug-Eluting Vascular Stent System for the Treatment of Superficial Femoral Artery and Proximal Popliteal Artery Disease

Eluvia Drug-Eluting Vascular Stent System for the Treatment of Iliac Artery Stenosis

Renal Artery Stenting for Stenosis due to Fibromuscular Dysplasia

Gore Viabahn Stent for the Treatment of Dialysis Fistula

Hybrid Foot Vein Arterialization

iCast / Gore Viabahn VBX Stent for the Treatment of Celiac Artery Pseudoaneurysms

LimFlow Stent Graft System

Stenting for the Treatment of Popliteal Artery Aneurysm

Balloon Angioplasty and Stenting for the Treatment of Ilio-Caval Venous Occlusion

Renal Artery Stenting for the Treatment of Stenosis Due to Atherosclerotic Disease

Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoro-Popliteal Lesions

Paclitaxel-Coated Devices in the Femoro-Popliteal Arteries

Gore Viabahn VBX Stent for the Treatment of Celiac Artery Aneurysm with Dissection

Gore Viabahn VBX Stent for the Treatment of Aorto-Iliac or Femoro-Popliteal Occlusive Disease

Gore Viabahn VBX Stent for the Treatment of Chronic Mesenteric Ischemia

References

Policy History

Additional Information