Lei Zhang1, Junmin Bao1, Zhiqing Zhao1, Qingsheng Lu1, Jian Zhou2, Zaiping Jing3. 1. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. 2. Department of Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China. 3. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai, China xueguanky@163.com zhoujian1-2@163.com.
Abstract
PURPOSE: To evaluate the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease. METHODS: A systematic review and meta-analysis of published studies was performed to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled vs uncontrolled design and analyzed using random-effects models. Outcomes are reported as the risk ratio (RR) and 95% confidence interval (CI). Four prospective randomized controlled trials, one retrospective controlled study, and 9 uncontrolled studies were identified. RESULTS: In controlled studies, primary patency with the Viabahn was superior to other interventions at 1 year (RR 0.63, 95% CI 0.49 to 0.82, p<0.001) and ankle-brachial index (ABI) improvement was greater at 6 months (mean difference 0.05, 95% CI 0.01 to 0.09, p=0.01) compared with other interventions. Subgroup analysis demonstrated a lower incidence of stent fracture in lesions with >15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up. CONCLUSIONS: Current evidence suggests that the Viabahn stent-graft is a safe and effective option for symptomatic SFA lesions. Prospective multicenter randomized controlled trials with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.
PURPOSE: To evaluate the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease. METHODS: A systematic review and meta-analysis of published studies was performed to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled vs uncontrolled design and analyzed using random-effects models. Outcomes are reported as the risk ratio (RR) and 95% confidence interval (CI). Four prospective randomized controlled trials, one retrospective controlled study, and 9 uncontrolled studies were identified. RESULTS: In controlled studies, primary patency with the Viabahn was superior to other interventions at 1 year (RR 0.63, 95% CI 0.49 to 0.82, p<0.001) and ankle-brachial index (ABI) improvement was greater at 6 months (mean difference 0.05, 95% CI 0.01 to 0.09, p=0.01) compared with other interventions. Subgroup analysis demonstrated a lower incidence of stent fracture in lesions with >15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up. CONCLUSIONS: Current evidence suggests that the Viabahn stent-graft is a safe and effective option for symptomatic SFA lesions. Prospective multicenter randomized controlled trials with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.