Use of the SELUTION drug-eluting balloon (DEB) and provisional drug-eluting stent (DES) during percutaneous coronary intervention (PCI) is non-inferior to systemically using DES, results from the SELUTION DeNovo trial show. Christian Spaulding, MD, PhD, from the Port-Royal Hospital, Rene Descartes University, Paris, presented these findings during a late-breaking clinical trials session on Sunday at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference in San Francisco. Most patients undergoing PCI receive DES, but DCB may be a feasible alternative so there is less of a need for stents. Mixed results came from trials investigating paclitaxel DCBs, but few trials have examined sirolimus DCBs. “The SELUTION SLR drug-eluting balloon delivers sustained drug release that maintains therapeutic tissue concentration for 90 days,” Dr. Spaulding said during a press conference Sunday morning at TCT. The SELUTION DeNovo study was a prospective, randomized, open-label, multicenter trial examining the noninferiority of the SELUTION DEB (Cordis) versus standard DES strategy. Enrollment took place across 62 sites total in the UK, France, Italy, Germany, Finland, Switzerland, Austria, the Netherlands, Spain, the Czech Republic and Singapore. Patients were randomized 1:1 to receive the SELUTION DEB or standard DES before the procedure. Patients who received the DEB strategy received provisional DES if it was needed. Key exclusion criteria included ST-elevation myocardial infarction (STEMI) or unstable NSTEMI, left main lesion, saphenous or arterial graft lesions, chronic total occlusion (CTO), in-stent restenosis (ISR) or previous PCI on a target vessel. The co-primary endpoint was non-inferiority for target vessel failure (TVF) — consisting of cardiac death, target vessel-related myocardial infarction and clinically driven target vessel revascularization — at 1-year along with non-inferiority for TVF at 5-years follow-up. A total of 1,661 patients (mean age=67.1 years, 24.7% female, 17.8% with high bleeding risk [HBR]) were analyzed after PCI with SELUTION DEB and 1,662 patients (mean age=66.7 years, 26.0% female, 16.3% HBR) were analyzed after PCI with DES between August 2021 and July 2024. At 12-months, data were available for 1,632 SELUTION DEB patients and 1,628 DES patients. At 1-year, 5.3% of SELUTION DES patients and 4.4% of DES patients met the primary endpoint (risk difference=0.91%; upper 2-sided 95% confidence interval [CI]=2.38%; p for non-inferiority=0.02). No safety concerns were observed in either group. Both groups (DEB, DES) had similar, low rates of cardiovascular death (0.70% vs 1.00%), late lesion thrombosis (0.1% vs 0.3%) and target vessel myocardial infarction (TV-MI; 2.70% vs 2.60%). Additionally, 80% of SELUTION DEB patients did not need a stent. Overall, this large, investigator-driven study showed that there are no significant safety differences between the SELUTION DEB and standard DES during PCI, and the SELUTION DEB was noninferior to standard DES. “With no acute or late safety concerns, these results apply to a significant segment of PCI procedures including high-risk patients and complex lesions. We look forward to obtaining five-year data to determine long-term noninferiority or possible superiority of this strategy,” Dr. Spaulding concluded in a news release on Sunday. This study was sponsored by Cordis. Image Caption: Christian Spaulding, MD, PhD, presents during a press conference Sunday, October 26, at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference in San Francisco. Image Credit: Screenshot by Bailey G. Salimes, CRTonline.org