Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy.
EuroInterventionOct 5, 2026 (epub)
Tuomas T Rissanen, Simon Eccleshall, Florian Krackhardt et al.
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In 30 seconds
The SELUTION DeNovo trial, a randomized controlled trial, evaluated sirolimus-eluting balloons (SEBs) versus drug-eluting stents (DES) in 522 high bleeding risk (HBR) patients. At 1 year, target vessel failure (TVF) was 4.9% in the SEB group compared to 7.9% in the DES group, indicating a potential benefit of SEBs in this population.
Key findings
- Target vessel failure occurred in 4.9% of the SEB arm vs 7.9% in the DES arm.
- BARC 3-5 bleeding rates were 2.3% in the SEB group compared to 3.2% in the DES group.
- Net adverse clinical events were 6.8% in the SEB arm vs 10.7% in the DES arm.
- 7.7% of patients in the SEB arm stopped all antiplatelet medication by 30 days compared to 2.5% in the DES arm.
Why it matters
This study suggests that sirolimus-eluting balloons may provide a safer alternative to drug-eluting stents for high bleeding risk patients, potentially reducing the need for prolonged antiplatelet therapy and associated bleeding complications.