Efficacy of Sirolimus Versus Paclitaxel-Coated Balloons for Coronary Revascularization: An Updated Meta-Analysis with GRADE Assessment.

Drug-coated balloons are an emerging strategy for coronary revascularization. Despite their increasing use, the comparative efficacy of sirolimus-versus paclitaxel-coated balloons (SCB vs PCB) remains uncertain. This updated meta-analysis evaluated clinical and angiographic outcomes of SCB and PCB in percutaneous coronary intervention (PCI). A comprehensive search of PubMed, Scopus, and ScienceDirect was performed on August 28, 2025. Studies directly comparing SCB and PCB were included. The primary endpoint was target lesion failure (TLF), which was defined as cardiac death, target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR). On follow-up angiography, secondary endpoints consisted of minimal lumen diameter (MLD), late lumen loss (LLL), and diameter stenosis. Pairwise meta-analyses, subgroup analyses, and sensitivity analyses were performed. The certainty of evidence was evaluated with GRADE. Thirteen studies with 5947 patients (4097 SCB and 1850 PCB) were analyzed. SCB and PCB showed no significant differences in TLF (RR 1.10, 95% CI 0.84 to 1.44), cardiac death (RR 1.19, 95% CI 0.56 to 2.53), TLR (RR 1.12, 95% CI 0.91 to 1.37), and TVMI (RR 1.82, 95% CI 0.58 to 5.72). Subgroup analyses by lesion type and study design were consistent. Angiographic outcomes were comparable between groups, except for smaller insegment MLD with SCB (MD -0.10 mm, 95% CI -0.18 to -0.02; p = 0.01), although this finding was not robust in sensitivity analysis. Certainty of evidence was moderate for clinical outcomes and low to moderate for angiographic outcomes, primarily downgraded due to imprecision and inconsistency. In conclusion, SCB and PCB demonstrated comparable efficacy in PCI, with no significant differences in clinical and angiographic endpoints, irrespective of lesion types.