Outcomes with limus-coated vs. paclitaxel-coated balloons for percutaneous coronary intervention: An updated meta-analysis and reconstructed time-to-event analysis of randomized controlled trials

Background: Paclitaxel drug-coated balloons (DCBs) are an established option for treating coronary in-stent restenosis (ISR) and small vessel disease. However, randomized controlled trials (RCTs) comparing limus-DCBs with paclitaxel-DCBs have reported inconsistent findings. Objectives: This updated meta-analysis compared clinical and angiographic outcomes of limus- versus paclitaxel-DCBs in patients undergoing percutaneous coronary intervention (PCI). Methods: Electronic databases were searched through July 2025 to identify RCTs comparing limus-DCBs with paclitaxel-DCBs in PCI. The primary outcome was target lesion failure (TLF). Summary estimates were generated using a random-effects model. Subgroup analyses were performed based on lesion type and limus agent. Results: Ten RCTs, including 1471 patients, were analyzed. At a mean follow-up of 11.7 months, no significant difference was found in TLF (risk ratio [RR] 1.11; 95% confidence interval [CI] 0.84–1.47). Subgroup analyses showed no interaction for de novo lesions versus ISR (P_interaction = 0.26) or for biolimus- versus sirolimus-DCBs (P_interaction = 0.32). No significant differences were observed in major adverse cardiac events (RR 1.10; 95% CI 0.86–1.41), target lesion revascularization (RR 1.18; 95% CI 0.88–1.57), cardiac mortality (RR 0.71; 95% CI 0.25–2.04), or target vessel myocardial infarction (RR 0.71; 95% CI 0.30–1.69). Angiographic outcomes—including binary restenosis, late lumen loss, minimal lumen diameter, acute gain, net gain, and diameter stenosis—were also comparable. Conclusion: Among patients undergoing DCB-only PCI, there was no statistically significant difference between limus and paclitaxel-DCBs regarding clinical and angiographic outcomes. Larger RCTs with extended follow-up duration are needed to confirm these findings.