SELUTION DeNovo and SELUTION4ISR Studies Evaluate Cordis’ Selution SLR DEB 

October 26, 2025—Results of two studies evaluating the performance of the Selution SLR sirolimus drug-eluting balloon (DEB; Cordis) were presented in a late-breaking clinical trials session at the TCT 2025 scientific symposium.

The SELUTION DeNovo study was presented by Christian M. Spaulding, MD, and the SELUTION4ISR study was presented by Donald Cutlip, MD.

As summarized in the TCT press release, the SELUTION DeNovo investigators found that utilizing a strategy of sirolimus-eluting balloons with bailout stenting only if necessary was noninferior to routine drug-eluting stent (DES) implantation as part of the treatment for de novo coronary artery disease.

The press release noted that the study was composed of a large international all-comer population of percutaneous coronary intervention candidates. The 3,341 patients were randomized 1:1 to a total of either the Selution SLR DEB (n = 1,671) or DES (n = 1,670) at 62 sites in 12 countries across Europe and Asia between August 2021 and July 2024.

The TCT press release stated that the SELUTION DeNovo study demonstrated the following:

• 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 1 year (risk difference, 0.91; 95% CI, -0.55%-2.38%; P for noninferiority = .02).
• There were no acute or late safety concerns 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,” commented Dr. Spaulding in the TCT press release. “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 5-year data to determine long-term noninferiority or possible superiority of this strategy.”

Additionally, SELUTION4ISR is a prospective, international, single-blind randomized clinical trial.

As reported in the TCT press releae, the SELUTION4ISR investigators found that the Selution SLR DEB was noninferior to a blended standard-of-care (SOC) control group of conventional therapies—DES (80%) and balloon angioplasty (BA, 20%)—for the treatment of bare metal stent and DES in-stent restenosis (ISR) with up to two layers of previously implanted bare metal stents or DES.

The study was composed of 418 patients randomized to DEB (n = 210) or blended SOC (n = 208, 165 DES and 43 BA). The mean age was 68.9 ± 9.1 years; 94 (22.5%) patients were female patients; 179 (42.8%) patients had diabetes; and 83 (19.9%) patients had two layers of previous stent.

The primary endpoint was target lesion failure (TLF) consisting of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 1 year.

The TCT press release summarized the findings as follows:

• TLF occurred in 15.2% of the group randomized to DEB compared with 13.5% in the blended SOC group (difference = 1.8%; 95% credible interval, -4.9%-8.5%; posterior probability for noninferiority, 99.18%) by intention-to-treat.
• Rates of cardiac death (1.9% vs 1.4%), target vessel myocardial infarction (7.1% vs 4.8%), and clinically driven target lesion revascularization (11.9% vs 11.5%) were not statistically different between study arms.

“Selution DEB is the first and only DEB to demonstrate noninferiority against the standard of care, including 80% DES, for the treatment of ISR,” commented Dr. Cutlip in the TCT press release. “It is a safe and effective ISR treatment which avoids additional layers of stent, and we look forward to the long-term follow-up data.”