Paclitaxel- Versus Sirolimus-Coated Balloons in Percutaneous Coronary Intervention for Coronary Artery Disease: An Updated Systematic Review and Meta-Analysis

Drug-coated balloons are a cornerstone of a "leave nothing behind" strategy in percutaneous coronary intervention. While paclitaxel-coated balloons (PCBs) are established, sirolimus-coated balloons (SCBs) represent a newer alternative. This meta-analysis integrates the latest evidence to compare the efficacy and safety of SCBs versus PCBs for coronary artery disease. We conducted a systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, prospectively registered with International Prospective Register of Systematic Reviews (CRD420251157954). We searched PubMed, Embase, and Cochrane Central Register of Controlled Trial through September 2025 for randomized controlled trials and observational studies comparing PCB-only with SCB-only percutaneous coronary intervention. The primary clinical outcome was target lesion failure at 12 months. Key angiographic outcomes included in-segment late lumen loss, minimal lumen diameter, and diameter stenosis (DS). Fourteen studies (8 randomized controlled trials and 6 observational) with 6420 patients were included (PCB: n = 2042; SCB: n = 4378). The risk of target lesion failure was comparable between SCBs and PCBs [8.5% vs 9.2%; odds ratio 0.86, 95% (confidence interval) CI 0.71-1.05; P = 0.15], with no differences in its individual components. However, PCBs demonstrated superior angiographic outcomes, with significantly lower late lumen loss [Mean Difference (MD) -0.09 mm, 95% CI -0.15 to -0.01; P = 0.02] and larger minimal lumen diameter (MD 0.08 mm, 95% CI 0.01-0.14; P = 0.02). The reduction in DS with PCBs was not statistically significant (MD -2.11%, 95% CI -4.75 to 0.52; P = 0.12). This angiographic advantage was primarily driven by comparisons with the phospholipid-encapsulated SCB (MagicTouch). SCBs and PCBs demonstrate comparable clinical safety and efficacy at 1-year follow-up. Despite this, PCBs maintain an angiographic advantage, which is significantly influenced by the specific SCB excipient technology.