Sirolimus- Versus Paclitaxel-Coated Balloons for Treatment of Coronary Artery Disease

Abstract

Sirolimus-coated balloons (SCB) have been recently introduced for treatment of coronary artery disease (CAD). Nonetheless, evidence on comparison of SCB versus paclitaxel-coated balloons (PCB) is scant. The aim of the study was to compare clinical outcomes after SCB versus PCB angioplasty for treatment of CAD. This observational, retrospective, investigator-driven cohort study was conducted at 2 Italian centers, and enrolled consecutive all-comer patients treated with SCB or PCB for de novo lesions or in-stent restenosis between 2018 and 2023. Analyses comparing SCB versus PCB included inverse probability of treatment weighting. Primary endpoint was 12-month rate of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization at time-to-first-event analysis. A total of 1320 patients (n = 1569 lesions) were enrolled, of which 990 patients (n = 1161 lesions) treated with SCB and 330 patients (n = 408 lesions) with PCB. The proportion of ISR was higher within SCB versus PCB groups (38% [n = 443] versus 22% [n = 89], p < 0.001). At a median follow-up of 347 [176-681] days, the 12-month event rate of TLF was similar with SCB versus PCB (10.5% [n = 93] vs. 8.2% [n = 21], adjusted hazard ratio [AHR]: 1.00; 95% confidence interval (CI): 0.57-1.75). When compared with PCB, SCB hazard rates for TLF were similar in both ISR (AHR: 0.89; 95% CI: 0.40-1.97) and de novo lesions (AHR:1.07; 95% CI: 0.52-2.20). ISR target lesion was a predictor of TLF (AHR: 2.67; 95% CI: 1.74-4.10). In conclusion, the current study, comparing drug-coated balloons equipped with the 2 most adopted drugs, suggests similar clinical efficacy and safety of SCB versus PCB for treatment of CAD.