Abstract Body (Do not enter title and authors here): Background: Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Limus-coated balloons have emerged as an alternative. We aimed to perform a meta-analysis comparing clinical and angiographic outcomes between limus-coated balloons (LCB) and paclitaxel-coated balloons (PCB) in coronary ISR.

Methods: Databases were searched for randomized and non-randomized studies comparing LCB with PCB in patients with coronary ISR. Angiographic outcomes included percent diameter stenosis and in-segment late lumen loss (mm) as assessed by quantitative coronary angiography (QCA). Clinical outcomes included a composite of cardiac death, target lesion myocardial infarction (MI), and target lesion revascularization (TLR). Statistical analysis was performed using Review Manager (Cochrane Collaboration).

Results: A total of 1,224 patients from 7 studies were included, 5 of which were randomized controlled trials. PCBs were used to treat coronary ISR in 577 (47%) patients. The mean follow-up was 13.7±4.5 months. The mean age was 66±10 years, with 76.3% being male. Type 2 diabetes mellitus was present in 44.4% of the patients, and 31.5% had a prior MI. There were no significant differences between PCB and LCB in terms of percent diameter stenosis (mean difference: -4.58%, 95% CI: -10.79 to 1.62, P = 0.15) or in in-segment late lumen loss (mean difference: 0.02 mm, 95% CI: -0.07 to 0.11, P = 0.72) at follow-up QCA. At 12 months, there were no significant differences in the composite outcome of cardiac death, target lesion MI, and TLR (RR: 1.01, 95% CI: 0.77 to 1.32, P = 0.97) between groups. LCB showed similar TLR rates compared to PCBs (RR: 0.64, 95% CI: 0.30 to 1.34, P = 0.23) at 12 months (Figures 1A and 1B).

Conclusion: For patients with coronary in-stent restenosis, both paclitaxel-coated and limus-coated balloons offer effective treatment options with comparable clinical and angiographic outcomes. This provides reassurance and flexibility in treatment choices. The trend favoring PCBs in percent diameter stenosis warrants further investigation in larger, well-powered studies to compare these DCB types in similar populations.