Paclitaxel-coated versus uncoated balloon angioplasty for femoropopliteal artery in-stent restenosis

Abstract

Background: Several prospective controlled trials have assessed the safety and efficacy of drug-coated balloon angioplasty (DCBA) versus standard balloon angioplasty (POBA) for femoropopliteal in-stent restenosis (ISR). We therefore performed a meta-analysis of prospective controlled trials to pool the results of these trials and obtain more reliable conclusions.

Methods and results: Prospective controlled trials comparing DCBA versus POBA were searched through PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, ISI Web of Knowledge, and relevant websites without language or publication date restrictions. The keywords were "drug-eluting balloon," "angioplasty," "femoropopliteal," and "in-stent restenosis." We selected recurrent ISR, freedom from clinically driven target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs) as the outcomes of this meta-analysis. Based on the inclusion criteria, we identified 3 prospective clinical trials. The one-year outcomes of DCBA and POBA were as follows: recurrent ISR (34.8% versus 73.1%, respectively; OR, 0.18; 95% CI, 0.10-0.32, Z = 5.56, P < 0.00001), freedom from clinically driven TLR (82.2% versus 54.1%, respectively; OR, 4.20; 95% CI, 2.05-8.61, Z = 3.92, P < 0.0001), clinical improvement (76.2% versus 55.7%, respectively; OR, 2.58; 95% CI, 1.41-4.72, Z = 3.07, P = 0.002), ABI (MD, -0.04; 95% CI, -0.13-0.04, Z = 1.01, P = 0.31), and MAEs (11.0% versus 18.3%, respectively; OR, 0.54; 95% CI, 0.25-1.15, Z = 1.60, P = 0.002).

Conclusions: For femoropopliteal ISR, DCBA is associated with superior efficacy outcomes compared with POBA, with the same safety outcome after a one-year follow-up. In the future, multicenter and large-scale prospective controlled trials comparing DCBA with other endovascular strategies are required to further assess the efficacy and safety profiles of DCBA in the treatment of femoropopliteal ISR.

Keywords: Drug-coated balloon; Femoropopliteal artery; In-stent restenosis.