Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy

Abstract

BACKGROUND: Drug-eluting stents (DES) are the current mainstay of percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients. However, drug-coated balloons may be an alternative that reduces reliance on prolonged courses of antiplatelet therapy. AIMS: The SELUTION DeNovo trial randomised 3,323 PCI candidates 1:1 to treatment with either sirolimus-eluting balloons (SEBs) and provisional stenting or systematic DES implantation. We report on a prespecified subgroup of HBR patients. METHODS: A total of 522 enrolled patients met the Academic Research Consortium-HBR criteria. At 1 year, we assessed target vessel failure (TVF; a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation), major bleeding (Bleeding Academic Research Consortium [BARC] 3-5) and net adverse clinical events (NACE; a composite of TVF and BARC 3-5 bleeding). Antithrombotic treatment was prescribed according to current guidelines and local practice. RESULTS: Altogether, 269 and 253 patients were identified as HBR in the SEB strategy and DES strategy arms, respectively. In the SEB arm, 17.1% of patients had bailout stenting. Overall, 67% of patients were discharged on oral anticoagulants. At 1 year, TVF occurred in 4.9% of the SEB arm vs 7.9% of the DES arm (absolute risk difference [RD] -3.05%, 95% confidence interval [CI]: -7.27 to 1.17). BARC 3-5 bleeding occurred in 2.3% vs 3.2% (absolute RD -0.91%, 95% CI: -3.71 to 1.89) and NACE in 6.8% vs 10.7% (absolute RD -3.94%, 95% CI: -8.80 to 0.92) in the SEB and DES arms, respectively. While the proportion of patients on dual antiplatelet therapy and single antiplatelet therapy did not differ significantly between the two groups during follow-up, all antiplatelet medication was stopped in 7.7% vs 2.5% at 30 days (p=0.005) and in 27.8% vs 14.9% of patients at 6 months (p<0.001) in the SEB and DES arms, respectively. CONCLUSIONS: Although this subset analysis is not powered for definitive conclusions, our data suggest that an SEB strategy with minimal stenting appears to be a safe and effective alternative to systematic DES implantation for HBR patients.

The authors' abstract, as published at the source. EuroIntervention, 2026 · DOI ↗