Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy
In brief
Vessel failure was 4.9% with sirolimus balloons versus 7.9% with stents
Among 522 patients at high bleeding risk, one-year vessel failure was numerically lower with a sirolimus-balloon strategy than with drug-eluting stents; major bleeding was 2.3% versus 3.2%. More balloon-treated patients stopped all antiplatelet drugs by 6 months, but this subgroup analysis was not powered to prove the strategies equivalent or safer, leaving larger studies to confirm the trade-off.
- Journal
- EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (Q1)
- Published
- 5 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Tuomas T Rissanen, Simon Eccleshall, Florian Krackhardt, Kris Bogaerts, Tanios Akiki, Carlo Briguori, et al.
- PMID
- 42837205
- DOI
- 10.4244/EIJ-D-26-00889
Why clinicians should know about it
- Picked for Cardiology and Cardiovascular Medicine (paper of the day, 8 October 2026): Sirolimus‑eluting balloons vs DES in high‑bleeding‑risk PCI
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.