Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation remains the predominant strategy in the setting of acute coronary syndrome (ACS). However, in recent years there has been growing interest in reducing the amount of permanent metal in the arteries, primarily to preserve future therapeutic options. In this context, drug-coated balloons (DCB) have emerged as a strategy to consider.
The SELUTION DeNovo subanalysis, presented at SCAI 2026, evaluated the use of the SELUTION SRL sirolimus-eluting balloon (SEB) in patients with non-ST-elevation ACS. This was a prespecified analysis including patients with NSTEMI or unstable angina, comparing a strategy of SEB with provisional bailout stenting versus systematic DES implantation.
The overall SELUTION DeNovo trial included 3,323 patients in a 1:1 comparison between both strategies. Within this population, 32.7% presented with NSTEMI or unstable angina. In the SEB arm, 553 patients were analyzed, while 529 patients were included in the DES arm. The mean age was 65.9 years, and 73.1% presented with NSTEMI. In the SEB group, bailout stenting was required in 21% of cases.
The primary endpoint (PEP) was target vessel failure (TVF) at one year, defined as a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target vessel revascularization.
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Low and similar event rates were observed between both strategies. TVF occurred in 5.3% of patients in the SEB group and 4.9% in the DES group. Cardiac mortality was 0.6% vs. 0.8%, target vessel myocardial infarction was 3.1% vs. 2.8%, and clinically indicated target vessel revascularization was 3.1% vs. 2.7%, respectively.
Conclusions: Sirolimus-eluting balloon vs. drug-eluting stent in non–ST-elevation acute coronary syndrome
The SELUTION DeNovo subanalysis in ACS suggests that sirolimus-eluting balloons may represent a valid alternative to DES in selected NSTEMI or unstable angina scenarios. It is important to highlight the short follow-up period and the fact that this is a subanalysis of a non-inferiority trial.
Original Title: Sirolimus Eluting Balloons for Patients with Acute Coronary Syndrome – Evidence from the SELUTION DeNovo Trial.
Presented by: Andy Ladwiniec en el SCAI 2026 Scientific Sessions & CAIC-ACCI Summit, Montreal, Canadá.
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