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

Background: Femoral-popliteal (F-P) bypass is the standard treatment for lower extremity peripheral artery disease with severe femoropopliteal (F-P) 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. Methods: 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 +/- 9 years, 66% male, 60% claudication) were treated with EVT with nitinol self-expandable stents, and 102 lesions in 92 patients (71 +/- 9 years, 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. Results: 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 (<= 18 kg/m(2)) or an elevated CRP level (>= 1 mg/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 groups in patients with BMI <= 18 kg/m(2) or CRP >= 1 mg/dL (57% vs. 45%, P = 0.84). Conclusions: 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.