Sirolimus-Coated versus Paclitaxel-Coated Balloons for Coronary Artery Disease: A Grade Assessed Systematic Review and Meta-Analysis

Despite advances in percutaneous coronary procedures, in-stent restenosis remains a significant challenge. Although sirolimus- and paclitaxel-coated balloons are promising alternatives, but their comparative safety and efficacy remain uncertain. PubMed, Embase and Cochrane databases were searched using relevant keywords from inception until August 2025. A total of 11 studies (7 RCTs and 4 observational cohort studies) were included, comprising 3,633 participants overall. The primary outcomes assessed were target lesion revascularization (TLR) and target lesion failure (TLF). Meanwhile, the Secondary outcomes included stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events (MACE), survival, binary restenosis, and angiographic endpoints (acute gain, diameter stenosis, in-segment late lumen loss, in-lesion late lumen loss, and in-segment minimal lumen diameter). Interstudy heterogeneity was assessed using I2 and X2 statistics (I2>50%=significant heterogeneity). Interstudy heterogeneity was low for most outcomes, including all primary clinical endpoints, with moderate heterogeneity observed only for select angiographic measures (notably in-segment late lumen loss and diameter stenosis). Statistical calculations were performed using Review Manager 5.4.1, with a p-value of < 0.05 indicating statistical significance.This meta-analysis examined studies that compared paclitaxel-coated balloon (PCB) versus standard balloon (SCB) angioplasty. Regarding primary outcomes, there were no notable variations in target lesion failure (RR 1.08, 95% CI 0.90-1.29, p=0.36) or target lesion revascularization (RR 1.16, 95% CI 0.98-1.37, p=0.08). With all aggregated estimates being nonsignificant, secondary outcomes such as stent thrombosis, all-cause mortality, myocardial infarction, MACE, and survival were similar between groups. Angiographic endpoints revealed no discernible variations in late lumen loss (in-lesion and in-segment), acute gain, or diameter stenosis. Nonetheless, the SCB group's minimal lumen diameter was significantly smaller than that of the PCB group (MD -0.08 mm, 95% CI -0.14 to -0.01, p=0.02). In treating coronary ISR, sirolimus- and paclitaxel-coated balloons show similar overall safety and effectiveness; lesion-specific angiographic variations indicate that customized selection may improve patient outcomes.