Paclitaxel Versus Sirolimus-Coated Balloons for Coronary Artery Disease: 2-Year Follow-Up of 2 Large Registries

Drug-coated balloons (DCB) have emerged as a valuable alternative to drug-eluting stents for obstructive coronary artery disease (CAD). While paclitaxel-coated balloons (PCB) are the most employed DCB, sirolimus-coated balloons (SCB) have been evaluated in recent years to address potential safety concerns associated with PCB. However, real-world comparisons of the clinical outcomes of PCB and SCB remain limited. We combined 2 large prospective registries involving patients undergoing percutaneous coronary intervention with DCB: the EASTBOURNE registry (n = 2,078 patients, treated with MagicTouch SCB) and the PEARL registry (n = 513 patients, treated with Protégé PCB). The primary outcome was major adverse cardiac events (MACE), a composite of all-cause mortality, myocardial infarction (MI), and target lesion revascularization (TLR) at 2-year follow-up. All analyses were stratified according to clinical presentation: de novo CAD and in-stent restenosis (ISR). Hazard ratios (HRs) with corresponding 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression. Adjustment was performed for clinical and angiographic variables that differed between the 2 groups. At 24 months, the risk of MACE was similar between SCB and PCB both in de novo CAD (unadjusted HR 0.80, 95% CI 0.43-1.50; p = 0.487; adjusted HR 0.94, 95% CI 0.47-1.95; p = 0.849) and ISR (unadjusted HR 0.96, 95% CI 0.70-1.32; p = 0.544; adjusted HR 0.90, 95% CI 0.63-1.28; p = 0.555). This real-world comparison demonstrated comparable outcomes between new-generation PCB and SCB with respect to MACE at 2 years of follow-up.