ABSTRACT
BACKGROUND: FDA approved the Gore Viabahn (WL Gore, Flagstaff, AZ, USA) stent for both femoro-popliteal arterial denovo and instent restenosis (ISRS) lesions. To date there is little data on Viabahn stent graft outcomes in ISRS arterial disease. METHODS: Between 2007 and 2014 we identified 734 patients who underwent 1573 endovascular interventions in our institution for infra-inguinal revascularization. Among these, 48 patients had 143 Viabahn stents placed. Of these, 26 patients had 94 stents placed for ISRS and 22 patients had 49 stents placed for denovo lesions. RESULTS: The patients in the ISRS group were younger and more likely to have hypertension, hyperlipidemia, coronary artery disease, compared to the patients in the denovo group. Stents were placed principally for femoro-popliteal lesions, with mean length of 21 ± 12.5 cm (19.2 ± 14, ISRS vs. 22.1 ± 11, denovo; P = 0.2). Both groups had low primary patency rates during one year follow up (54% vs. 33%, OR = 2.3 (0.9-2.2). Target lesion revascularization (TLR) (57% vs. 27%, P < 0.0001, OR = 3.7, CI = 1.8-8) and surgical revascularization (21% vs. 4%, OR = 6.3, CI = 1.4-28) occurred more frequently in the ISRS group than in the denovo group. Amputation rate (17% vs. 31%, OR 0.7, CI = 0.2-1), cumulative blockage (defined as ISRS and thrombosis) (62% vs. 47%, P = 0.09, OR = 1.8, CI = 0.9-3.6), and Restenosis (40% vs. 31%, OR 1.5, CI = 0.7-3.2) were not statistically different between the two groups. Mean duration of follow-up was 12.8 ± 13 months. CONCLUSION: Stent graft treatment using the Gore Viabahn for denovo and ISRS in femoro-popliteal arterial obstructive disease have high restenosis and failure rates, of both stent patency and limb outcomes, which is consistent with existed literature.