April 23, 2026
2 min read
Key takeaways:
- A strategy using a drug-eluting balloon with minimal stenting was noninferior vs. a DES for ACS treatment.
- The balloon was a safe alternative vs. DES in patients with non-STEMI or unstable angina.
A strategy of using a drug-eluting balloon with minimal stenting was noninferior compared with systematic drug-eluting stent use for treatment of acute coronary syndrome, a speaker reported.
A sirolimus-eluting balloon (Selution SLR, MedAlliance/Cordis) with minimal stenting was a safe alternative to DES use at 1 year for patients who presented with non-STEMI or unstable angina, according to the results of the SELUTION DeNovo study presented at the Society for Cardiovascular Angiography & Interventions Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention Summit.
A strategy using a drug-eluting balloon with minimal stenting was noninferior vs. a DES for ACS treatment. Image: Adobe Stock
“At 1 year, in the intention-to-treat analysis, the noninferiority endpoint was met. But the trial included patients with acute coronary syndromes as well as chronic coronary syndromes, and the pathophysiology causing those presentations is quite different, with acute coronary syndromes having a preponderance of plaque erosion, plaque rupture and greater presence of thrombus,” Andrew Ladwiniec, MA, MD, MRCP, consultant cardiologist and director of cardiac catheterization laboratories at Glenfield Hospital, University Hospitals of Leicester NHS Trust and honorary senior lecturer at University of Leicester, U.K., said during a press conference. “Given the pathophysiology is different, it may be that the efficacy of a drug-eluting balloon-only approach is also different. So that was the rationale for conducting this substudy.”
As Healio previously reported, in the main results of the SELUTION DeNovo trial, the sirolimus-eluting balloon was noninferior vs. standard care for treatment of de novo coronary lesions and in-stent restenosis.
For the present subanalysis, researchers evaluated use of the sirolimus-eluting balloon vs. DES among participants with ACS — defined as non-STEMI or unstable angina — which comprised approximately 33% of the main cohort (n = 1,082). Patients with STEMI or unstable non-STEMI were excluded from the analysis.
Researchers reported that the risk difference for 1-year target vessel failure in patients with ACS was not significantly different between the two groups (sirolimus-eluting balloon, 5.3%; DES, 4.9%; risk difference, 0.37 percentage points; 95% CI, 2.28 to 3.01).
The sirolimus-eluting balloon and provisional stenting strategy remained noninferior vs. the DES strategy in subgroup analyses based on clinical presentation (ACS vs. chronic coronary syndrome; P for interaction < .65) and ACS subtype (non-STEMI vs. unstable angina; P for interaction < .57), according to the presentation.
Rates of cardiac death, target vessel-related MI and clinically driven target vessel revascularization were low in both groups and were not significantly different, according to the presentation.
“Use of Selution with minimal stenting appears to be safe and effective as an alternative to DES implantation for patients presenting with non-STEMI or unstable angina. At 1 year, target vessel failure event rates were low and similar in both groups, consistent with the outcomes that we’ve observed in patients with chronic coronary syndromes, and there was not a significant interaction. Importantly, there were no acute or late safety concerns,” Ladwiniec said during the press conference. “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.”
Sources/Disclosures
Source:
Ladwiniec A, et al. Late-breaking clinical trials. Presented at: Society for Cardiovascular Angiography & Interventions Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention Summit; April 23-25, 2026; Montreal.
Disclosures:
This research was supported by MedAlliance, a Cordis company. Ladwiniec reports serving on advisory boards for Abbott Vascular, Boston Scientific and Shockwave; receiving honoraria from Abbott Vascular, Biotronik, Boston Scientific, Brosmed, Cordis, Shockwave, SMT and Teleflex; and receiving support for traveling from Cordis.
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