Purpose: To evaluate the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease. Methods: A systematic review and meta-analysis of published studies was performed to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled vs uncontrolled design and analyzed using random-effects models. Outcomes are reported as the risk ratio (RR) and 95% confidence interval (CI). Four prospective randomized controlled trials, one retrospective controlled study, and 9 uncontrolled studies were identified. Results: 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 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 >15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up. Conclusions: Current evidence suggests that the Viabahn stent-graft is a safe and effective option for symptomatic SFA lesions. Prospective multicenter randomized controlled trials with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.
SelvinEErlingerTP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004;110:738–743.
2.
WhiteC. Clinical practice. Intermittent claudication. N Engl J Med. 2007;356:1241–1250.
3.
NorgrenLHiattWRDormandyJA. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(suppl 1):S1–S75.
4.
GableD. Role of total endoluminal superficial femoral artery bypass. J Cardiovasc Surg (Torino). 2011;52:683–700.
5.
ChalmersNWalkerPTBelliAM. Randomized trial of the SMART stent versus balloon angioplasty in long superficial femoral artery lesions: the SUPER study. Cardiovasc Intervent Radiol. 2013;36:353–361.
6.
KrankenbergHSchluterMSteinkampHJ. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285–292.
7.
DickPWallnerHSabetiS. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090–1095.
RazzoukLAggarwalSGorganiF. In-stent restenosis in the superficial femoral artery. Ann Vasc Surg. 2013;27:510–524.
10.
LammerJZellerTHauseggerKA. Heparin-bonded covered stents versus bare metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn Endoprosthesis With PROPATEN Bioactive Surface [VIA] Versus Bare Nitinol Stent in the Treatment of Long Lesions in Superficial Femoral Artery Occlusive Disease). J Am Coll Cardiol. 2013;62:1320–1327.
11.
SaxonRRDakeMDVolgelzangRL. Randomized, multicenter study comparing expanded polytetrafluoroethylene–covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. J Vasc Interv Radiol. 2008;19:823-832.
12.
MoherDLiberatiATetzlaffJ. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.
13.
LiberatiAAltmanDGTetzlaffJ. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6:e1000100.
14.
McQuadeKGableDHohmanS. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2009;49:109-116.
15.
KedoraJHohmannSGarrettW. Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg. 2007;45:10-16.
16.
VertaMJSchneiderJRAlonzoM. Percutaneous Viabahn-assisted subintimal recanalization (VASIR) for severe femoropopliteal occlusive disease. Acta Chir Belg. 2007;107:181–186.
17.
HartungOOteroADubucM. Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants. Eur J Vasc Endovasc Surg. 2005;30:300–306.
18.
SaxonRRCoffmanJMGoodingJM. Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial. J Vasc Interv Radiol. 2003;14:303–311.
19.
GeraghtyPJMewissenMWJaffMR. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013;58:386–395.
20.
McQuadeKGableDPearlG. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2010;52:584–591.
21.
JebranAFPopovAFZenkerD. Is there an alternative to the surgical above-knee bypass in treatment of superficial femoral artery disease? Experiences with Viabahn stent graft. Vasc Endovascular Surg. 2013;47:502–506.
22.
SaxonRRChervuAJonesPA. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial. J Vasc Interv Radiol. 2013;24:165–173.
23.
SchneiderJRVertaMJAlonzoMJ. Results with Viabahn-assisted subintimal recanalization for TASC C and TASC D superficial femoral artery occlusive disease. Vasc Endovascular Surg. 2011;45:391–397.
24.
FritschyWMKruseRRFrakkingTG. Performance of ePTFE-covered endograft in patients with occlusive disease of the superficial femoral artery: a three-year clinical follow-up study. J Cardiovasc Surg (Torino). 2010;51:783–790.
25.
FarrajNSrivastavaAPershadA. One-year outcomes for recanalization of long superficial femoral artery chronic total occlusions with the Viabahn stent graft. J Invasive Cardiol. 2009;21:278–281.
26.
VertaMJSchneiderJRAlonzoMJ. Percutaneous Viabahn-assisted subintimal recanalization for severe superficial femoral artery occlusive disease. J Vasc Interv Radiol. 2008;19:493–498.
27.
AlimiYSHakamZHartungO. Efficacy of Viabahn in the treatment of severe superficial femoral artery lesions: which factors influence long-term patency?Eur J Vasc Endovasc Surg. 2008;35:346–352.
28.
FischerMSchwabeCSchulteKL. Value of the Hemobahn/Viabahn endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006;13:281–290.
29.
BrayPJRobsonWJBrayAE. Percutaneous treatment of long superficial femoral artery occlusive disease: efficacy of the Hemobahn stent-graft. J Endovasc Ther. 2003;10:619–628.
30.
LammerJDakeMDBleynJ. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. Radiology. 2000;217:95–104.
31.
McKinseyJFZellerTRocha-SinghKJ. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014;7:923–933.
32.
LairdJRKatzenBTScheinertD. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267–276.
33.
MatsumuraJSYamanouchiDGoldsteinJA. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013;58:73–83.
34.
DakeMDAnselGMJaffMR. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.
35.
LammerJBosiersMZellerT. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011;54:394–401.
36.
MicariACioppaAVadalàG. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv. 2012;5:331–338.
37.
ScheinertDDudaSZellerT. The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7:10–19.
38.
SmolockCJAnaya-AyalaJEKaufmanY. Current efficacy of open and endovascular interventions for advanced superficial femoral artery occlusive disease. J Vasc Surg. 2013;58:1267–1275.
39.
LammerJZellerTHauseggerKA. Sustained benefit at 2 years for covered stents versus bare metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol. 2015;38:25–32.
40.
TamarizLJYoungJHPankowJS. Blood viscosity and hematocrit as risk factors for type 2 diabetes mellitus: the atherosclerosis risk in communities (ARIC) study. Am J Epidemiol. 2008;168:1153–1160.
41.
SimpsonLO. Blood viscosity and diabetes mellitus. N Z Med J. 1988;101:550.
42.
BosiersMDelooseKCallaertJ. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015;22:1–10.
43.
ScheinertDScheinertSSaxJ. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–315.
44.
SchlagerODickPSabetiS. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–684.
45.
LindholtJSGottschalksenBJohannesenN. The Scandinavian Propaten trial—1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses—a randomised clinical controlled multi-centre trial. Eur J Vasc Endovasc Surg. 2011;41:668–673.
46.
ZellerTPeetersPBosiersM. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. 2014;21:765–774.
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
