Paclitaxel‐coated versus sirolimus‐coated balloon angioplasty for coronary artery disease: A systematic review and meta‐analysis

Abstract Background Although use of sirolimus‐based analogs has shown superiority over paclitaxel in drug‐eluting stents, the relative efficacy of these two agents released from drug‐coated balloons (DCB) is unclear. The present meta‐analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel‐coated balloons (PCB) versus sirolimus‐coated balloons (SCB) for either in‐stent restenosis or native de novo lesions. Methods The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow‐up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random‐effects models. Results A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9–12 months of follow‐up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75–1.35) between the two groups. On follow‐up angiography at 6–9 months, MLD (WMD 0.10, 95% CI 0.02–0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD −0.11, 95% CI −0.23–0.02) and diameter stenosis (WMD −3.33, 95% CI −8.11–1.45). Conclusions Among patients undergoing DCB‐only PCI, the risk of TLF was similar during 9–12 months of follow‐up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow‐up angiography.