Clinical Outcomes of Sirolimus-Coated Balloons for the Treatment of Coronary Disease. The Metal-Free Registry.

BACKGROUND

Long-term clinical outcomes are lacking for patients treated with sirolimus-eluting balloons (SEBs). We sought to evaluate long-term clinical outcomes of the SELUTION SLR (Selution; MedAlliance; Nyon, Switzerland) SEB in various clinical settings.

METHODS

From 2021 to 2025, we included patients treated with the Selution SEB. Patients were divided into 3 groups: drug-eluting stent in-stent restenosis (DES-ISR), small vessel (SV; diameter < 3 mm) and big vessel (BV). Inverse probability of treatment weighting analysis was used to account for baseline differences. The primary end point was target lesion failure, defined as the composite of cardiovascular death, target vessel myocardial infarction, and target lesion revascularization.

RESULTS

A total of 495 patients were included in the study. Of these, 33.1% were included for DES-ISR, 40.4% for de novo SV lesions, and 26.5% for de novo BV lesions. In patients treated for de novo lesions, bail out stenting occurred in 16.6% of patients. Up to 3 years, there were no significant differences in any end points between DES-ISR and SV, nor between DES-ISR and BV. A significantly lower bail out rate was observed in the second half of patients included in the registry (12.6%) compared with the early inclusion group (20.5%; P = 0.049), without an increase in clinical events.

CONCLUSIONS

Patients treated with the Selution SEB were associated with favourable clinical outcomes at mid- and long-term follow-up. There were no significant differences in any end points between DES-ISR and SV, nor between DES-ISR and BV.