Comparison of Clinical Outcomes between Endovascular Therapy with Self-Expandable Nitinol Stent and Femoral–Popliteal Bypass for Trans-Atlantic Inter-Society Consensus II C and D Femoropopliteal Lesions

Abstract

Femoral-popliteal (F-P) bypass is the standard treatment for lower extremity peripheral artery disease with severe femoropopliteal (FP) artery lesions. However, in clinical settings, these patients are treated with endovascular therapy (EVT) because of frailty and difficulties with general anesthesia. We compared the clinical outcomes of F-P bypass and EVT for severe FP artery lesions and investigated the types of patients for whom EVT would be as appropriate as F-P bypass. This multicenter, retrospective study included 452 Trans-Atlantic Inter-Society Consensus (TASC) II C and D FP artery lesions in 352 patients. A total of 350 lesions in 260 patients (74±9years, 66% male, 60% claudication) were treated with EVT with nitinol self-expandable stents, and 102 lesions in 92 patients (71±9years, 75% male, 40% claudication) were treated with F-P bypass. The primary outcome measure was primary patency, and the influence of baseline characteristics on its association with the treatment strategy (EVT versus F-P bypass) was assessed using a Cox proportional hazards regression model. Kaplan-Meier analysis indicated that the 3-year primary patency rate was significantly lower for EVT than F-P bypass (60% vs. 74%, P<0.01). The body mass index (BMI) and C-reactive protein (CRP) levels significantly interacted with the treatment strategy for restenosis (P<0.05). The adjusted hazard ratios of EVT versus F-P bypass for restenosis were 0.77 (P=0.46) in cases with a low BMI (≤18kg/m2) or an elevated CRP level (≥1mg/dL) and 3.35 (P<0.01) in other cases. The 3-year primary patency rate was not significantly different between the EVT and F-P bypass groupsin patients with BMI≤18kg/m2 or CRP≥1mg/dL (57% vs. 45%, P=0.84). In TASC II C and D lesions, EVT appears to yield patency comparable to that of F-P bypass in patients with a low BMI or an elevated CRP level, but lower patency in other patients.