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

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/