Abstract 4370517: Comparative Efficacy of Limus-, and Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis: A Pairwise and Network Meta-Analysis of Randomized Controlled Trials

Background: Drug-coated balloon angioplasty is an established treatment strategy for coronary in-stent restenosis (ISR). While paclitaxel-coated balloons (PCB) have been studied most extensively, limus-coated balloons—including sirolimus- (SCB) and biolimus-coated balloons (BCB)—offer potential advantages due to their antiproliferative effects and pharmacokinetic profiles. However, direct comparisons remain limited. Objectives: To compare the efficacy of SCB, BCB, and PCB for the treatment of coronary ISR using a pairwise and network meta-analysis of randomized controlled trials (RCTs). Methods: A systematic search of PubMed, Scopus, and Cochrane was performed to identify RCTs comparing any combination of SCB, BCB and PCB angioplasty for ISR lesions. Outcomes of interest include target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR), as well as these individual outcomes. A pairwise and frequentist network meta-analysis with random-effects models was used to estimate risk ratios (RR) and 95% confidence intervals (CIs) for each comparison. Treatments were ranked with P-scores. Results: Five RCTs with 977 patients with ISR were included in the analysis (SCB 25.8%; BCB 27.6%; PCB 46.6%). In pairwise comparisons, limus-coated balloons demonstrated similar efficacy to PCB across all endpoints. Network meta-analysis revealed no significant differences among SCB, BCB, and PCB in the risk of TLF, TV-MI, cardiac death, or TLR (Figure 1) . P-score rankings indicated that PCB was most favorable for reducing TLF and TLR, while SCB and BCB ranked highest for reducing cardiac death and TV-MI, respectively. Conclusions: In this network meta-analysis of RCTs, limus-coated balloons and PCB demonstrated comparable efficacy profiles for the treatment of coronary ISR. P-score rankings suggest potential outcome-specific differences that warrant further investigation in adequately powered head-to-head trials.