One-Year Results of Endovascular Treatment of Long Femoropopliteal Lesions With Viabahn® Stent Graft.

Abstract

Purpose: The performance of self-expanding stent graft (Gore^® Viabahn^®) in femoropopliteal interventions has been proven through trials with long lesions. However, there are limited data on the incorporation of additional edge-protection to reduce focal edge stenosis. The aim of this study was to assess the clinical safety and efficiency of Viabahn^® stent graft incorporating additional edge-protection in the treatment of long femoropopliteal lesions [TransAtlantic Inter-Society Consensus (TASC) C/D] in patients with symptomatic peripheral arterial disease.

Methods: This is 2 centers, retrospective, observational, single-arm study. Patients with symptomatic (Rutherford category 2-6) de novo and restenosis TASC C/D lesions of the femoropopliteal segment were treated with Viabahn^® stent graft. Additional edge-protection bare metal stent (BMS), drug-coated balloon (DCB), or drug-eluting stent (DES) were allowed at the proximal and distal edges of the Viabahn^® stent graft. The primary endpoint was the primary patency.

Results: Between October 2019 and October 2022, 188 symptomatic patients with 198 limbs were treated (TASC D=68, 34%). The mean lesion length was 256±118 mm, and 88% were total occlusion. Additional BMS, DCB, or DES were used at Viabahn^® edges in 24%, 16%, and 13% of cases, respectively. The mean follow-up was 12 months. The primary patency rate at 12 months was 70.8%. A significantly lower rate of primary patency was reported in the Viabahn^® + BMS group (54.3%) compared to Viabahn^® group (76.5%), Viabahn^® + DCB group (81.4%), and Viabahn^® + DES group (72.5%; p=0.01). The primary sustained clinical improvement rate was 85%. The Rutherford category assessment was significantly improved at last follow-up compared to baseline (p<0.0001). There were 2 cases of acute ischemia.

Conclusion: The use of Viabahn^® stent graft in long lesions (TASC C/D) with drug-coated devices as additional edge-protection seems to improve the results in the treatment of long and complex femoropopliteal lesions. These results reinforce the need for randomized clinical trials to assess the value of self-expanding stent graft for long femoropopliteal lesions.Clinical ImpactThis study evaluates the clinical impact of the performance of a self-expanding stent graft (Gore® Viabahn®) in femoropopliteal lesions and demonstrates its safety and efficacy in the treatment of long and complex lesions. The results indicate that the combination of the Viabahn® with paclitaxel-eluting devices on its proximal and distal edges increases clinical improvement and decreases the incidence of restenosis. Overall, this study highlights the benefit of active therapy in the Viabahn® edges and supports its increased use in clinical practice to optimise long-term outcomes in long and complex femoropopliteal lesions.