Abstract 4370610: Sirolimus Versus Paclitaxel-Coated Balloon Angioplasty for Coronary Artery In-Stent Restenosis: A Meta-Analysis and Trial Sequential Analysis

Background: While sirolimus-based drug-eluting stents have shown better outcomes than paclitaxel-based stents, it remains unclear whether the same advantage exists when these agents are delivered via drug-coated balloons (DCBs). This meta-analysis aims to compare the efficacy and safety of sirolimus-coated balloons (SCB) versus paclitaxel-coated balloons (PCB) in the treatment of coronary in-stent restenosis. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing SCB and PCB in the treatment of coronary in-sent restenosis (ISR). PubMed, Embase, and Cochrane Library databases were systematically searched. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using a random-effects model. Trial Sequential Analysis (TSA) was also performed to evaluate the robustness of the findings. Results: Four RCTs, including a total of 503 patients, were analyzed, of whom 252 underwent percutaneous coronary intervention (PCI) with SCB. There was no significant difference between SCB and PCB in the risk of target lesion revascularization (TLR) (RR 1.09; 95% CI 0.73 – 1.63, P=0.68), major adverse cardiac events (MACE) (RR 1.03; 95% CI 0.67 – 1.59, P=0.88), cardiovascular death (RR 0.63; 95% CI 0.12 – 3.22, P=0.58), stent thrombosis (RR 1.05; 95% CI 0.16 – 7.04, P=0.96), or myocardial infarction (RR 1.28; 95% CI 0.35 – 4.65, P=0.71), as shown in Figure 1A. TSA indicated that, although the required information size was not reached, the current evidence shows a stable trend, suggesting that future studies are unlikely to alter the finding of no significant difference between groups in TLR (Figure 1B). Conclusion: This meta-analysis of RCTs demonstrates no significant difference in clinical outcomes between SCB and PCB angioplasty for coronary ISR. Both DCB types appear to offer comparable efficacy and safety profiles.