Sirolimus-Coated Versus Paclitaxel-Coated Balloons in the Treatment of Coronary Artery Lesions: A Systematic Review and Meta-Analysis

Abstract

Coronary artery lesions are either de novo lesions, where the arterial lumen is narrowed for the first time, or in-stent restenosis, where re-narrowing of a previously stented arterial segment occurs. Sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) are drug-coated balloons used in percutaneous coronary interventions to prevent restenosis without leaving a permanent implant. We conducted a systematic review and meta-analysis comparing SCBs versus PCBs for the treatment of coronary artery lesions, including de novo lesions and in-stent restenosis. Major databases were searched through September 2025. Pooled analyses were performed using random-effects models to calculate risk ratios (RRs) with 95% confidence intervals (CIs). Ten studies involving 5246 patients (SCBs: n = 2964; PCBs: n = 2282) were included. Safety outcomes showed no significant differences in all-cause mortality (RR: 1.39, 95% CI, 0.50-3.89, P = 0.53), cardiac death (RR: 1.21, 95% CI, 0.50-2.92, P = 0.67), or myocardial infarction (RR: 0.98, 95% CI, 0.59-1.64, P = 0.95). Efficacy outcomes were similarly equivalent for target lesion failure (RR: 1.13, 95% CI, 0.85-1.50, P = 0.39), target lesion revascularization (RR: 1.23, 95% CI, 0.98-1.55, P = 0.068), major adverse cardiac events (RR: 1.14, 95% CI, 0.91-1.43, P = 0.27), and binary restenosis (RR: 1.18, 95% CI, 0.63-2.20, P = 0.61). None of the interventions (SCBs or PCBs) demonstrated superiority in terms of efficacy or safety for the treatment of coronary artery lesions. Therefore, device selection should be guided by lesion characteristics and overall clinical context.