SELUTION DeNovo: Sirolimus DCB Safe and Effective in ACS Patients

MONTREAL, Canada—A novel sirolimus-eluting balloon (Selution; Cordis) compares favorably with DES in patients with ACS, according to a subanalysis of the SELUTION DeNovo trial.

These findings support those of the main trial, presented at TCT 2025, which showed that use of the drug-coated balloon (DCB) plus provisional stenting as needed was noninferior at 1 year as an alternative to DES for the primary endpoint of target vessel failure, which included cardiac death, target-vessel MI, and clinically driven target-vessel revascularization.

Andrew Ladwiniec, MD (University Hospitals of Leicester NHS Trust, England), presenting the results here at the Society for Cardiovascular Angiography and Interventions (SCAI) 2026 meeting from the more than 1,000 patients who comprised the trial’s ACS group, showed that the TVF rates at 1 year were 5.3% in those randomized to the DCB and 4.9% in those randomized to DES.

“There was no interaction in treatment effect between patients presenting with acute coronary syndrome and chronic coronary syndrome, and when we looked at patients who presented with NSTEMI or unstable angina, there was no interaction there either,” Ladwiniec said in a media briefing.

The findings address concerns investigators had about treating vessels with a DCB in the presence of thrombus, which are pathologically different from chronic coronary syndrome lesions, with risk for plaque rupture and erosion. “Of course, the potential long-term benefits of a minimal stenting approach are yet to be seen but will be further evaluated with follow-up extending out to 5 years,” he said.

There were a lot of operators on a learning curve with this [DCB]. Andrew Ladwiniec

For now, Ladwiniec said the data suggest it “appears perfectly safe to avoid stenting if there’s any reason not to stent, and there may even be a benefit of not stenting in the long term.”

Antonio Colombo, MD (Columbus Hospital, Humanitas Research Hospital, Milan, Italy), the discussant for the subanalysis, said it provides needed safety data that reassure about using DCB in various patient populations. Although STEMI was excluded, he said forthcoming results in that population will shed even more light on important subgroups and how they fare with this strategy.

Among the questions that remain is whether a DCB strategy should be generalized for de novo lesions or used selectively to treat lesions in which DES are known to be suboptimal, said Colombo.

No Difference in Acute or Late Thrombosis

Of the 553 ACS patients assigned to the DCB strategy and 529 assigned to the DES group—about a third of the whole trial population—the majority had NSTEMI, with about 145 patients in each arm having unstable angina. Lesion size was required to be between 2 and 5 mm. The number of treated lesions per patient was 1.4 in each arm, with approximately 50% of all lesions being located in the left anterior descending artery.

Ladwiniec noted that there were no differences between the DCB and DES groups in terms of antithrombotic regimens at 30 days, 6 months, or 1 year.

The individual components of TVF showed no difference between treatment arms. Similarly, there were no major differences between groups in the secondary safety endpoints of all-cause death, stroke, any MI, periprocedural MI, or BARC 3-5 bleeding. Two other secondary safety endpoints of interest from the ACS perspective—acute/subacute lesion thrombosis and late lesion thrombosis—also were not significantly different and were in fact numerically lower in DEB patients.

In the main analysis, approximately 20% of the DCB arm required bailout stenting. To TCTMD, Ladwiniec said the rate not only was not significantly different when looking specifically at the ACS cohort, it was a little bit lower at 18%.

“Where we have seen a difference in bailout stenting is there were a lot of operators on a learning curve with this [DCB],” he added. Learning curve data based on the first 1,000 patients enrolled suggested that need for bailout stenting decreased after the first 25 cases.

If we’re going to be paying as much as we do in the United States for drug-coated balloons, we need more than a promise. David Cohen

For Colombo, the bailout rate suggests some selection bias on the part of operators, which he said likely makes sense for a strategy designed to minimize stenting.

“Nevertheless, with good selection, they were able to enroll over a thousand patients, prove safety and importantly non-inferiority,” he added.

In Europe, where CE Mark approval was granted for the DCB more than 5 years ago for coronary and peripheral use, Colombo said it has changed practice, with the trial data reinforcing the justification of using it.

While it is approved in the US as well, it is expensive, noted panelist David Cohen, MD (Cardiovascular Research Foundation, New York, and St. Francis Hospital, Roslyn, NY). For operators, he said, this means it needs to deliver on its concept of being effective but leaving nothing behind.

“If we’re going to be paying as much as we do in the United States for drug-coated balloons, we need more than a promise. I’m waiting for that,” he added.  

If the long-term data show separation of the curves in favor of the DCB, “that would really move the needle for me in this whole field,” Cohen said.  ”So, I think we have to continue to pay attention. It is nice to have promise, but it’s better to have the results.”