Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries: a meta-analysis.

Abstract

Our aim was to perform a meta-analysis to investigate the outcomes of patients undergoing percutaneous revascularisation with drug-coated balloon (DCB) angioplasty because of femoropopliteal in-stent restenosis (ISR). We searched scientific databases for studies of DCB angioplasty for femoropopliteal ISR. The primary outcome was target lesion revascularisation (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were Rutherford class (RC) improvement, ankle-brachial index (ABI) and death. A total of 367 patients enrolled in four studies received DCB (n=188) or plain balloon angioplasty (n=179). Median follow-up was 12 months. Patients treated with DCB angioplasty displayed a lower risk for TLR (odds ratio [OR] 0.20, 95% confidence interval [CI]: 0.07-0.55, p=0.002) and recurrent ISR (OR 0.24, 95% CI: 0.09-0.61, p=0.003), and a sustained RC improvement (OR 2.57, 95% CI: 1.40-4.72, p=0.002) with similar ABI and mortality as compared to those patients treated with plain balloon angioplasty. In comparison to plain balloon angioplasty, DCB therapy for femoropopliteal ISR is associated with superior clinical and antirestenotic efficacy. Further randomised trials comparing DCB with therapies alternative to plain balloon, in a larger number of patients, and with extended follow-up are needed to address definitively the role of DCB for femoropopliteal ISR.