Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials.

A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking atherectomy versus balloon angioplasty for treatment of femoropopliteal artery occlusive disease. PubMed (MEDLINE), EMBASE, AMED, Scopus, online content and meeting abstracts were searched in May 2014 for eligible RCTs following the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Pooled risks were calculated with a random effects model to account for clinical and conceptual heterogeneity. Sensitivity analysis was employed to test the robustness of the results. Six RCTs comprising 287 patients (328 lesions) treated with either debulking atherectomy or balloon angioplasty for femoropopliteal artery disease were analyzed and synthesized. Technical success was similar between the atherectomy and the angioplasty group (93.6% vs. 96.2%, RR: 0.99. 95%CI: 0.95-1.03, P=0.57, I(2)=0%). Need for bail-out stenting and distal arterial embolization were largely similar between atherectomy and balloon angioplasty alone. After a median follow-up of 9 months the 2 groups showed similar primary patency (RR: 0.90, 95%CI: 0.56-1.46, P=0.68, I(2)=69%). Only 2 low-quality studies reported amputation and mortality rates, both of which were found significantly less in the atherectomy arms. Analysis of a limited body of low quality evidence with high risk of bias showed that debulking atherectomy of the femoropopliteal artery does not seem to confer any procedural advantage or improvement of clinical outcomes over balloon angioplasty alone.