- Design
- Prespecified subgroup of a randomised trial
- Population
- 522 high-bleeding-risk patients undergoing PCI
- Primary outcome
- Target vessel failure at 1 year
- Effect
- 4.9% vs 7.9%; risk difference -3.05% (95% CI -7.27 to 1.17)
SELUTION DeNovo randomised 3,323 patients undergoing PCI to a sirolimus-eluting balloon with provisional stenting or to routine drug-eluting stents. This prespecified subgroup analysis looked at the 522 who met Academic Research Consortium high-bleeding-risk criteria; two-thirds left hospital on an oral anticoagulant. One in six in the balloon arm needed a bailout stent.
At one year, target vessel failure was 4.9% with the balloon strategy against 7.9% with stents, major bleeding 2.3% against 3.2%, and net adverse events 6.8% against 10.7%. None of these differences reached statistical significance. More patients in the balloon arm were off all antiplatelet therapy at 30 days (7.7% vs 2.5%) and six months (27.8% vs 14.9%).
The appeal is a shorter antiplatelet course in patients who bleed easily, without leaving metal behind. This subgroup is consistent with that idea but cannot confirm it. For now, drug-eluting stents with abbreviated antiplatelet therapy remain the standard for high-bleeding-risk PCI.
- Drug-eluting stents with a short antiplatelet course remain standard for high-bleeding-risk PCI.
- A balloon-only strategy may suit selected lesions where avoiding a stent matters, discussed case by case.
- Expect about 1 in 6 balloon procedures to need a bailout stent.
- Record bleeding-risk criteria before PCI so the antiplatelet plan can be set from the start.
Why it matters
Most high-bleeding-risk patients also take an anticoagulant, and anything that shortens antiplatelet exposure is worth testing properly.
Don't overread it
A subgroup that was not powered on its own; every difference between the arms could be chance.
The statistics, in plain English
Each absolute risk difference has a 95% confidence interval that crosses zero, for example -7.27 to 1.17 for target vessel failure. That means the data fit a real benefit, no difference, or a small harm. The antiplatelet difference is firmer, but it reflects prescribing choices that operators knew about.
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