SELUTION DeNovo Trial Demonstrates Non-Inferiority of Drug-Eluting Balloon to Standard-of-Care for In-Stent Restenosis: Late-Breaking Results from TCT 2025

This news is covered by the Medical Dialogues Bureau present at the TCT Conference 2025, being held in San Francisco, USA.

The SELUTION DeNovo randomized clinical trial, presented at TCT 2025, found that a percutaneous coronary intervention (PCI) strategy using the SELUTION SLR sirolimus-eluting balloon (SEB) with provisional stenting was non-inferior to the systematic use of drug-eluting stents (DES) for the treatment of de novo coronary lesions at one year.

The findings were simultaneously detailed by Dr. Christian Spaulding and colleagues, representing 62 participating sites across 12 countries in Europe and Asia.

The trial was designed to test whether a stent-minimizing approach could achieve outcomes comparable to standard DES implantation. Drug-eluting stents remain the mainstay of PCI, but are associated with a persistent annual 2–4% rate of very-late adverse cardiovascular events. Drug-coated balloon (DCB) therapy offers the potential advantage of limiting metal implantation, although earlier paclitaxel-based DCB trials showed mixed results. The SELUTION SLR device, incorporating micro-reservoirs of sirolimus within a biodegradable polymer and a proprietary phospholipid coating for controlled release, maintains therapeutic drug concentrations in the vessel wall for up to 90 days.

In this prospective, multicenter, open-label non-inferiority trial, 3,341 patients scheduled for PCI were randomized 1:1 before the procedure to either a SELUTION DEB strategy (lesion preparation, balloon inflation ≥30 seconds, provisional DES if needed) or a systematic DES strategy according to local practice. The primary endpoint was target-vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction (TVMI), or clinically driven target-vessel revascularization (TVR) at one year.

The full analysis set included 3,323 patients (1,661 in the SEB arm, 1,662 in the DES arm). Baseline characteristics were well balanced: mean age around 67 years, 25% female, 26% with diabetes, and about one-third presenting with acute coronary syndromes. Lesions were most commonly in the left anterior descending artery, and 80% of patients treated with the SELUTION DEB did not require a stent.

At one year, TVF occurred in 5.3% of patients in the SELUTION DEB group and 4.4% in the DES group (risk difference 0.91%, 95% CI –0.55 to 2.38; p = 0.02 for non-inferiority), meeting the pre-specified non-inferiority margin of 2.44%. Rates of cardiac death, target-vessel MI, and clinically driven revascularization were similarly low between groups.

Safety outcomes were favorable, with no acute or late device-related safety concerns. Rates of all-cause death, stroke, myocardial infarction, lesion thrombosis, and major bleeding (BARC 3–5) were comparable across both strategies.

According to the investigators, SELUTION DeNovo represents a large, pragmatic, investigator-driven study demonstrating that a DCB-based PCI approach with minimal stenting can achieve outcomes equivalent to DES implantation. The broad inclusion criteria make the findings applicable to a wide range of PCI procedures, including those in high-risk and complex lesion subsets.

The authors noted that the study excluded patients with STEMI, chronic total occlusions (CTO), in-stent restenosis (ISR), left-main, or graft lesions, indicating that dedicated trials are needed for these populations. A planned five-year follow-up will evaluate long-term non-inferiority and possible superiority of the SELUTION DEB strategy.

At one year, PCI with the SELUTION SLR sirolimus-eluting balloon and provisional stenting was non-inferior to systematic DES implantation for target-vessel failure (TVF), with low event rates and no new safety signals. These findings support the feasibility of a stent-sparing strategy in appropriately selected patients undergoing PCI.

Reference: Christian Spaulding et al., One-year results of the SELUTION DeNovo trial comparing a strategy of PCI with a sirolimus-eluting balloon and provisional stenting versus systematic DES implantation to treat de novo coronary lesions, SELUTION DeNovo Clinical Trial, TCT Conference 2025. https://www.tctconference.com/

About the Study Presenter: Dr. Christian Spaulding is a Professor of Cardiology and Interventional Cardiologist at the European Hospital Georges Pompidou and Université Paris Cité in Paris, France. He heads the hospital’s catheterisation laboratory and has over 20 years of experience in interventional cardiology, clinical care, and teaching medical students, residents, and fellows.