BACKGROUND: Sirolimus-coated balloons (SCB) are a potential alternative to paclitaxel-coated balloons (PCB) in the context of percutaneous coronary intervention (PCI). However, comparative data between SCB and PCB remain limited. We aimed to compare the outcome of PCI with contemporary PCB or SCB in a real-world clinical setting.

METHODS: The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) was used to include all patients undergoing PCI with PCB or SCB between January 1, 2022 and May 16, 2025. The primary outcome was target segment revascularization assessed on coronary artery segment level. Outcome was assessed using multivariable-adjusted Cox regression.

RESULTS: A total of 7855 PCB-treated and 502 SCB-treated segments were included. PCB was less frequently used for in-stent restenosis (28.0% vs 34.3%). After a 1-year follow-up period, no difference was observed between PCB and SCB in terms of target segment revascularization (3.3% vs 5.8%; hazard ratio [HR], 1.37; 95% CI, 0.83-2.25), target vessel revascularization (5.2% vs 8.1%; HR, 1.24; 95% CI, 0.78-1.97), restenosis (2.8% vs 4.4%; HR, 1.44; 95% CI, 0.85-2.44), myocardial infarction (3.1% vs 4.9%; HR, 0.74; 95% CI, 0.41-1.32), repeat PCI (8.8% vs 10.8%; HR, 1.04; 95% CI, 0.72-1.51), or all-cause mortality (4.4% vs 3.2%; HR, 1.37; 95% CI, 0.34-1.15).

CONCLUSIONS: In this study investigating outcome after PCI with drug-coated balloons, no statistically significant differences in 1-year clinical outcomes were observed between PCB and SCB.