Vein Bypass Versus Nitinol Stent in Long Femoropopliteal Lesions

Abstract

Objectives: The aim of this study was to compare technical success, patency rates and clinical outcomes of vein bypass (VBP) with angioplasty and nitinol stents (NS) in femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) II C and D lesions. Summary Background Data: Guidelines widely recommend an endovascular-first strategy for long femoropopliteal lesions without sufficient data comparing it with vein bypass surgery. Methods: A single-center prospective, randomized controlled trial (RCT) was performed, after approval of the local ethics committee, with technical success, primary and secondary patency as primary endpoints. Secondary endpoints were limb salvage, survival, complications, and clinical improvement. Results: Between 2016 and 2020, 218 limbs (109 per group) in 209 patients were included. Baseline and lesion characteristics were similar in both groups with a mean lesion length of 268 mm. The indication for treatment was chronic limb threatening ischemia in 53% of limbs in both groups. Technical success was feasible in 88% in the stent group. During a 4-year follow-up, primary patency, freedom from target lesion revascularizations, limb salvage, survival and complications showed no significant differences between the groups. At 48 months secondary patency for the bypass group was 73% versus 50% in the stent group (P = 0.021). Clinical improvement was significantly superior in the bypass group with 52% versus 19% reaching a Rutherford 0 category (P < 0.001). Conclusions: This is the largest RCT comparing angioplasty with NS and vein bypass in femoropopliteal TASC II C and D lesions and the first to report 4-year results. The data underline the feasibility of endovascular treatment in long lesions but also emphasize the advantages of VBP.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease

“…16 Since the publication of this metaanalysis, 4 additional randomized controlled trials using a strategy with stent implantation have been performed. [5][6][7][8][9] These studies found similar primary 1.…”

“…Whereas in the past, BSx has been regarded as the standard of care 13 and remains indicated especially in patients with complex disease, 10-12,14 notable advancements in the EVT armamentarium and technique, including the introduction of stent implantation over the past decades, have resulted in promising evidence suggesting similar primary patency rates in EVT vs BSx. 5,7,9,15 With respect to clinical endpoints, the BASIL (Bypass Versus Angioplasty in Severe Ischemia of the Leg) amputation-free and overall survival rates were found in the BSx group. 16 The inclusion of observational studies and studies not using a strategy with stent implantation limit the applicability of these findings to contemporary endovascular practice.…”

“…However, no conclusions on clinical endpoints such as major adverse limb events (MALE) or amputation-free survival could be made because of the small sample sizes of the trials. [3][4][5][6][7][8][9] In light of the lack of robust evidence, we aimed to perform a pooled analysis of individual patient data from all randomized controlled trials comparing outcomes of patients with femoropopliteal PAD who are undergoing EVT with stent implantation vs BSx. 3 independent reviewers (S.F., H.K., and P.K.).…”

“…Six trials were identified as meeting the eligibility criteria. [3][4][5][6][7][8][9] Principal investigators of all trials were invited to contribute to the study. Five principal investigators agreed to pool their data for this analysis.…”

Atherektomie mit einem neuen System, das noch mehr kann

“…Die von Farhan et al veröffentlichten 24-Monats-Daten nach endovaskulärer oder offen chirurgischer Therapie von Oberschenkelläsionen zeigte keine Differenz in Bezug auf die MAE-Rate (40,1 % vs. 36,4 %; p = 0,447) oder das amputationsfreie Überleben mit 88,1 % vs. 90,0 % (p = 0,455) bei einer signifikant niedrigeren Komplikationsrate (6,8 % vs. 22,6 %; p < 0,001) zugunsten der endovaskulären Versorgung [23]. Sogar nach 4 Jahren Nachbeobachtungszeit konnten die angewendeten Stentverfahren im Oberschenkel Ergebnisse aufweisen, die hinsichtlich der Beinerhaltungs-und MAE-Rate keinen Unterschied zum Venenbypass zeigen [24]. Eine Kostenanalyse hinsichtlich der Implantate liegt nicht vor.…”