Sirolimus-Eluting Balloon with Provisional Stenting Yields Outcomes Comparable to Routine DES Implantation in De Novo Coronary Lesions: TCT 2025

DES are implanted in the vast majority of PCIs with well-established immediate and mid-term outcomes. However, long term follow-up studies have reported annual adverse event rates of 2-4%. This has led to a growing interest in strategies that minimize metallic stent implantation to potentially reduce late events. The study used the SELUTION SLR Drug-Eluting Balloon (DEB) which delivers a sustained drug release maintaining therapeutic tissue concentration for up to 90 days designed to have a similar elution profile to current DES.

Between August 2021 and July 2024, a total of 3,341 participants were randomized one to one to either the DEB (n=1,671) or DES strategy (n=1,670) at 62 sites in 12 countries across Europe and Asia. Patients with lesion reference vessel diameter (RVD) ≥2.0 and ≤5.0 mm were eligible for inclusion. Baseline characteristics were similar in both groups, with a relatively high proportion of patients presenting with acute coronary syndromes or having high bleeding risk. Randomization occurred after angiography when all target lesions were considered suitable for either strategy and prior to lesion wiring and lesion preparation. Eighty percent of participants treated with the SEB did not require a stent.

The primary endpoint of target vessel failure, comprised of cardiac death, target vessel-related myocardial infarction and clinically driven target vessel revascularization, occurred in 5.3% of the DEB strategy group and 4.4% of the DES strategy group at one year (Risk Difference 0.91, 95% CI: -0.55, 2.38%, Pnoninferiority=0.02). No acute or late safety concerns were noted with the DEB strategy, with low rates of cardiac death (0.70% vs 1.0%), lesion thrombosis (0.1 %vs 0.3%), and target vessel myocardial infarction (2.7% vs 2.6%) comparable with DES.

“The SELUTION DeNovo trial provides the first comparison of a PCI strategy based on the use of sirolimus-eluting balloons versus systematic implantation of DES in a large international all-comer population of PCI candidates,” said Christian M. Spaulding, MD, PhD, Chief, Integrated Interventional Laboratory at European Hospital Georges Pompidou in Paris, France. “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.”

Reference:

PCI with a sirolimus-eluting balloon and provisional stenting shows comparable outcomes to routine DES implantation for treatment of de novo coronary lesion, Cardiovascular Research Foundation, Meeting: TCT 2025: Transcatheter Cardiovascular Therapeutics.