An early look at the SELUTION DeNovo trial shows that procedural results with a novel drug-eluting balloon (DEB) improve with operator experience and that the trial is truly serving “all comers” patients with de novo coronary lesions. Simon Eccleshall, MB ChB, MRCP, MD, of Norfolk and Norwich University Hospitals, Norwich, England, reported these findings during a late-breaking trials session Tuesday at EuroPCR 2024 in Paris. DEBs are used in the coronaries to treat in-stent restenosis, small vessels ( reference diameter ≤2.75 mm), and side-branch or bifurcation lesions. However, there is no study comparing DEB with drug-eluting stents (DES) in all-comer de novo lesions with clinical endpoints. The SELUTION SLR sirolimus-eluting balloon has microreservoirs made from a biodegradable polymer mixed with the molecular sirolimus drug. This allows for a controlled and sustained drug release and keeps the drug’s therapeutic effect in the tissue for up to 90 days. The device’s proprietary cell-adherence technology (CAT) coating contains and protects the microreservoirs as the drug is delivered, which allows for maximum drug transfer to the vessel wall during balloon inflation. The enhanced drug retention allows for a lower dose concentration on the balloon surface, 1 μg/mm2. The SELUTION DeNovo all-comers study is comparing the SELUTION DEB (MedAlliance) to DES. Patients who have target lesions that are likely to be able to be treated with either DEB or DES are randomized before percutaneous coronary intervention to either the DEB or DES. Bailout iss available in both arms; that is, if needed, a patient receiving DEB could receive a bailout DES, or a patient receiving DES could receive bailout DEB. Co-primary endpoints are noninferiority of the DEB to DES for target vessel failure at 1 year, and noninferiority and conditional superiority of the DEB to DES for TVF at 5 years. Eccleshall presented the results of the first 1,000 patients in the DEB arm Tuesday. Planned enrollment is 3,326 patients at more than 50 sites. This analysis compared the first 20 patients in the DEB arm at each center (called the “early” group) with all subsequent patients (called the “late” group), to evaluate for a learning curve. The early group included 518 patients, and the late group included 482 patients. At baseline, nearly half (about 45%) of patients were age 70 years or older, about a quarter were female, about 28% had diabetes, about one-fifth were considered high bleeding risk, and about 22% presented with non-ST-elevation myocardial infarction. The bailout rate was 21% in the early arm and 15.2% in the late arm, showing the improving operator experience. Eccleshall said this early analysis of the trial is important because it confirms that, this point, patients are truly “all comers” and that the need for bailout stenting fell as center experienced rose. “If the trial endpoints are met,” he said, “the results will be applicable to a large majority of patients who require percutaneous revascularization.” Photo Credit: Screenshot by Jason Wermers/CRTonline.org Photo Caption: Simon Eccleshall, MB ChB, MRCP, MD, discusses the SELUTION DeNovo trial Tuesday at EuroPCR 2024.