Coronary disease & ACSSecondary analysis
Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo high bleeding risk (HBR) substudy
- prespecified subgroup of a randomised trial
Authors' conclusion
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.
Study context
- Population
- Percutaneous coronary intervention (PCI) candidates meeting the Academic Research Consortium-HBR criteriaenrolled patients meeting ARC-HBR criteria, of 3,323 randomised in SELUTION DeNovo
- Participants
- 522 candidates
- Comparison
- SEB strategy with provisional stenting vs systematic drug-eluting stents (DES) implantation
- SEB armn = 269
- DES armn = 253
Primary result
As reported in the abstract
Target vessel failure (TVF) (cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation) · 1 year
Absolute risk difference
−3.05%
95% CI −7.27 to 1.17
By group
SEB arm vs DES arm
absolute risk difference −3.05% (95% CI −7.27 to 1.17)
Further findings
| Outcome | SEB arm | DES arm | absolute RD (95% CI) | |
|---|---|---|---|---|
| NACE (TVF and BARC 3-5 bleeding) · 1 year | 6.8% | 10.7% | −3.94% (−8.80 to 0.92) | |
| −10−505Difference (linear scale) |
All antiplatelet medication stopped · 30 days and 6 months
30 days
6 months
| Outcome | SEB arm | DES arm | Estimate |
|---|---|---|---|
| Bailout stenting | 17.1% | Not reported in the abstract |
- All antiplatelet medication stopped: 30 days p=0.005
- All antiplatelet medication stopped: 6 months p<0.001
Discharged on oral anticoagulants
- Overall
- 67%
All antiplatelet medication stopped · 30 days and 6 months
- Proportion on dual antiplatelet therapy and single antiplatelet therapy did not differ significantly
Safety
| Outcome | SEB arm | DES arm | absolute RD (95% CI) | |
|---|---|---|---|---|
| BARC 3-5 bleeding · 1 year | 2.3% | 3.2% | −0.91% (−3.71 to 1.89) | |
| −4−202Difference (linear scale) |
Original publication
Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy. EuroIntervention. Published 5 October 2026. doi:10.4244/eij-d-26-00889
Summarised from the published abstract; every number is checked against it