New late-breaking science from TCT 2025 in San Francisco adds new evidence to discussions around the use of drug-eluting balloons (DEBs) – specifically the SELUTION SLR DEB – compared with routine drug-eluting stent (DES) implantation for treating de novo coronary artery disease and for addressing in-stent restenosis (ISR), respectively.

Results from the SELUTION DeNovo trial found that use of the sirolimus-eluting balloons with bailout stenting only if necessary was noninferior to routine DES implantation in patients with de novo coronary artery disease.

The trial randomized 3,341 patients at 62 sites across Europe and Asia to either DEB (n=1,671) or DES (1,670). The primary endpoint of target vessel failure, comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically driven target vessel revascularization at one year, occurred in 5.3% of those assigned to DEB compared with 4.4% of those assigned to DES. Researchers noted low rates of cardiac death (0.70% vs. 1%), lesion thrombosis (0.1% vs. 0.3%), and target vessel MI (2.7% vs. 2.6%) among those assigned to DEB compared with DES. Additionally, of those patients treated with DEB, 80% did not require a stent.

"The SELUTION DeNovo trial provides the first comparison of a PCI strategy based on the use of sirolimus-eluting balloons vs. systematic implantation of DES in a large international all-comer population of PCI candidates," said Christian M. Spaulding, MD, PhD, FACC. "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."

In the SELUTION4ISR trial, researchers randomized a total of 418 patients with ISR to treatment with DEB (n=210) or a blended standard of care (n=208) that included DES (80%) and balloon angioplasty (20%). Researchers noted that the standard of care was designed to mirror device use in ACC’s NCDR registries at the time of study design. The mean age of participants was 69 years, 22.5% were female, nearly 43% had diabetes and approximately 20% had two layers of previous stent.

Overall findings found DEB was noninferior to the standard of care, with the primary endpoint of target lesion failure occurring in 15.2% of those assigned to DEB and 13.5% of those assigned to conventional therapies. No statistical difference between the two groups was observed in the rates of cardiac death (1.9% vs. 1.4%), target vessel MI (7.1% vs. 4.8%), and clinically driven target lesion revascularization (11.9% vs. 11.5%).

"SELUTION DEB is the first and only [DEB] to demonstrate noninferiority against the standard of care, including 80% [DES], for the treatment of ISR," said Donald E. Cutlip, MD, FACC, who presented the findings. "It is a safe and effective ISR treatment which avoids additional layers of stent." He noted that long-term follow-up will assess the role of DEB vs. DES for lifetime management of ISR.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Acute Coronary Syndrome