A prospective randomized trial on endovascular recanalization with stenting versus remote endarterectomy for the superficial femoral artery total occlusive lesions

Abstract

Objective: The objective of this randomized study was to compare the short- and long-term safety and efficacy of endovascular recanalization with stenting (EI) and remote endarterectomy (RE) for patients with superficial femoral artery (SFA) total occlusive lesions (≥250 mm).

Methods: Between July 2013 and July 2017, eligible patients with SFA total occlusive lesions were randomized to EI or RE. The EI group underwent recanalization and stenting of long SFA atherosclerotic occlusive lesions. The RE group underwent semiclosed endarterectomy. Short- (30-day) and long-term (48-month) morbidity, mortality, and patency rates were compared between both groups.

Results: Of 400 patients assessed, 238 were ultimately randomized (119 EI and 119 RE). The cumulative primary patencies were 83% (EI) vs 82% (RE) at 12 months and 28% (EI) vs 46% (RE) at 48 months (P = .04). The limb salvage was 98% (EI) vs 95% (RE) at 12 months and 87% (EI) vs 92% (RE) at 48 months (P = .26). One-year and 4-year secondary patencies were 98% and 87% in the EI group and 100% and 90% in the RE group, respectively (P = .4). A total of 65 patients in the stenting group and 32 patients in the endarterectomy group underwent endovascular reintervention. Four-year patencies of endovascular reintervention subgroups were 37% and 60% (P = .04), respectively.

Conclusions: RE shows significantly better results in the long term than primary stenting of SFA long lesions (TASC-II D lesions). In case of loss patency, a desobliterated artery can be successfully subjected to endovascular revascularization and stenting with good short- and long-term results.

Keywords: Endovascular intervention; Remote endarterectomy; Superficial femoral artery; Total occlusion of SFA.