Endovascular brachytherapy and restenosis following lower limb angioplasty: Systematic review and meta-analysis of randomized clinical trials

Background: Restenosis is a fundamental weakness of percutaneous femoropopliteal angioplasty (PTA). The potential of endovascular brachytherapy (EVBT) to reduce restenosis has been evaluated in randomized clinical trials, but no pooled analysis has been undertaken. Methods: A systematic review was undertaken to identify randomized controlled trials in which PTA alone was compared to PTA plus EVBT. The Pubmed and Medline databases, American Heart Association OASIS database and conference proceedings from the Peripheral Vascular Surgery Society and Vascular Society of Great Britain and Ireland were searched. Eligible studies were randomised controlled trials comparing PTA to PTA plus EVBT in human subjects with at least one clinical outcome reported (restenosis, complications, patency). Study quality was assessed by the Jadad score. Random-effects modeling was used to generate pooled effect size estimates. Results: Six trials (687 patients) were identified. EVBT reduced 12-month restenosis rates (pooled odds ratio 0.50; 95% CI 0.301-0.836; p= 0.008). The benefit disappeared by 24 months. The short-term risk of new lesions elsewhere in the treated artery was significantly increased by EVBT (pooled odds ratio 8.65; 95% CI 2.176-34.391; p= 0.002). Conclusions: While limited by the small sample sizes in the included trials, this analysis suggests that the early benefit of EVBT is counter-balanced by the increased risk of new lesions and the lack of medium- to long-term reductions in restenosis risk. Based upon the best available evidence, EVBT cannot be recommended for routine clinical use.