Sirolimus-Eluting Balloons Match Stents in ACS Outcomes: SELUTION DeNovo Substudy
Canada: Researchers have found that a sirolimus-eluting balloon strategy may offer a safe and effective alternative to conventional stent-based treatment in patients with acute coronary syndrome (ACS).
Evidence from a pre-specified subanalysis of the SELUTION DeNovo trial, presented at the SCAI Scientific Sessions 2026, suggests that a drug-coated balloon (DCB) approach with minimal stenting can achieve comparable short-term outcomes to drug-eluting stents (DES), potentially reducing long-term device-related complications.
Percutaneous coronary intervention (PCI) for ACS—particularly in cases of non–ST-elevation myocardial infarction (NSTEMI) and unstable angina—has traditionally relied on DES implantation. While effective, these devices can be associated with late adverse events such as restenosis or thrombosis. Drug-coated balloons have emerged as a “leave nothing behind” strategy, delivering antiproliferative drugs without permanent implants. However, data supporting their use in ACS settings have remained limited until now.
The SELUTION DeNovo sub-study specifically evaluated patients presenting with NSTEMI or unstable angina, comparing outcomes between those treated with a sirolimus-eluting balloon and those receiving standard DES. The analysis included over 1,000 patients, with 553 assigned to the balloon-based strategy and 529 to the stent group. Baseline characteristics, including age, sex distribution, and clinical presentation, were well balanced between the two groups.
Key Findings of the SELUTION Denovo Trial:
- At 1 year, target vessel failure (TVF) rates were low and similar between the two groups.
- TVF occurred in 5.3% of patients treated with the balloon strategy and 4.9% of those receiving drug-eluting stents, indicating comparable efficacy.
- Individual components of TVF, including cardiac death, target-vessel myocardial infarction, and repeat revascularization, were closely comparable between groups.
- Safety outcomes showed no significant differences between the two treatment strategies.
- Rates of all-cause mortality, stroke, and major bleeding were similar in both groups.
- Incidence of acute, subacute, and late thrombosis was also comparable between groups.
- A trend toward lower thrombosis rates was observed in the balloon-treated group.
- These results help alleviate concerns about using balloon-based therapies in thrombus-rich ACS lesions.
The study also highlighted procedural considerations. Approximately one in five patients in the balloon group required bailout stenting, though this rate appeared to decrease with operator experience, suggesting a learning curve effect. With improved technique and patient selection, the need for additional stenting may decline further.
Experts presenting the data noted that these results reinforce earlier findings from the main SELUTION DeNovo trial, which demonstrated non-inferiority of the balloon strategy compared to DES in broader patient populations. They emphasized that while short-term outcomes are encouraging, longer-term follow-up—up to five years—is essential to determine whether avoiding permanent implants translates into sustained clinical benefits.
Overall, the findings suggest that sirolimus-eluting balloons could expand the interventional toolkit for ACS, offering a viable alternative in selected patients. As further data emerge, particularly in more complex subsets such as ST-elevation myocardial infarction, this approach may help redefine PCI strategies by minimizing reliance on permanent coronary implants.
Reference:
Ladwiniec A. Sirolimus eluting balloon for patients with acute coronary syndrome: evidence from the SELUTION DeNovo trial. Presented at: SCAI 2026. April 23, 2026. Montreal, Canada.
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