Abstract
BACKGROUND: Paclitaxel-coated balloon (PCB) and paclitaxel-eluting stent (PES) are widely used in femoropopliteal arterial disease (FPAD), while the comparison of their clinical benefit is inconclusive. This meta-analysis aimed to compare the efficacy between PCB and PES for FPAD. METHODS: Three internet databases were searched for eligible randomized controlled trials (RCTs). Random-effects model was used for pooled clinical outcomes grouped by PCB or PES, following with an indirect comparison. Subgroup analysis was planned according to age, gender, history of smoking, hypertension, and diabetes. RESULTS: Twenty-five RCTs encompassing 2806 patients were included. There were no significant differences between PCB and PES concerning the incidence of primary patency rate (risk of restenosis [RR]: 0.925; 95% CI: 0.815-1.049; P = .222), target lesion revascularization (TLR) (RR: 1.248; 95% CI: 0.798-1.952; P = .332), death (RR: 1.130; 95% CI: 0.436-2.930; P = .801), restenosis (RR: 1.012; 95% CI: 0.647-1.581; P = .959), amputation (RR: 1.000; 95% CI: 0.314-3.181; P = 1.000), and thrombosis (RR: 0.240; 95% CI: 0.049-1.180; P = .079). Subgroup analysis showed a lower primary patency rate in patients ≥ 70-year-old (RR: 0.703; 95% CI: 0.510-0.968; P = .031) and an increased risk of TLR when diabetes proportion was ≥ 40.0% (RR: 1.755; 95% CI: 1.013-3.042; P = .045) with PCB. Moreover, PCB might increase mortality in smokers (RR: 1.957; 95% CI: 1.000-3.828; P = .050). CONCLUSIONS: Regarding safety, no significant differences was found between PCB and PES. Further large-scale RCTs should be conducted based on the direct comparison results.