Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease
Patrick J Geraghty, Mark W Mewissen, Michael R Jaff, Gary M Ansel, VIBRANT Investigators, David Lasorda, Michael Rush, Jeffrey Goldstein, Bob Smouse, Manju Kalra, Sean Lyden, R Andrew Blum, Arun Chervu, William Gray, Romi Chopra, Sam Money, David Mego, Mark Bates, Richard Begg, Barry Katzen, W Charles Sternbergh, Patrick J Geraghty, Mark W Mewissen, Michael R Jaff, Gary M Ansel, VIBRANT Investigators, David Lasorda, Michael Rush, Jeffrey Goldstein, Bob Smouse, Manju Kalra, Sean Lyden, R Andrew Blum, Arun Chervu, William Gray, Romi Chopra, Sam Money, David Mego, Mark Bates, Richard Begg, Barry Katzen, W Charles Sternbergh
Abstract
Objective: The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation.
Methods: One hundred forty-eight 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 nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention.
Results: 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 ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .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% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups.
Conclusions: The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.
Trial registration: ClinicalTrials.gov NCT00228384.
Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Source: PubMed