Sirolimus-Eluting Balloons Show Promise in PCI Treatments

A recent study has demonstrated that a strategy utilizing sirolimus-eluting balloons combined with bailout stenting when necessary is as effective as the standard approach of drug-eluting stent (DES) implantation for patients undergoing percutaneous coronary interventions (PCI). This finding was presented on October 26, 2025, during TCT 2025, the annual scientific symposium organized by the Cardiovascular Research Foundation (CRF).

The research focused on a large, international group of PCI candidates. Conducted between August 2021 and July 2024, the study involved 3,341 participants who were randomized to receive either the SELUTION SLR Drug-Eluting Balloon (DEB) or the traditional DES at 62 sites across 12 countries in Europe and Asia. The DEB is designed to deliver a sustained drug release that maintains therapeutic tissue concentration for up to 90 days, aiming to replicate the elution profile of existing DES.

Study Findings and Implications

The results revealed that the primary endpoint, known as target vessel failure, occurred in 5.3% of patients in the DEB group, compared to 4.4% in the DES group at the one-year mark. This difference represents a risk difference of 0.91 (95% confidence interval: -0.55 to 2.38%), meeting the criteria for noninferiority with a P value of 0.02. Notably, the study reported no significant safety concerns, with low rates of cardiac death (0.70% for DEB vs 1.0% for DES), lesion thrombosis (0.1% vs 0.3%), and myocardial infarction (2.7% vs 2.6%).

The findings suggest that a significant majority, approximately 80% of patients treated with the DEB did not require stenting, indicating a potential strategy to minimize metallic stent implantation. This approach could lead to reduced long-term complications associated with stent placement, which have shown annual adverse event rates between 2-4% in long-term follow-ups.

Expert Commentary

Dr. Christian M. Spaulding, Chief of the Integrated Interventional Laboratory at European Hospital Georges Pompidou in Paris, expressed optimism about the implications of the study. He noted that the SELUTION DeNovo trial offers the first direct comparison between sirolimus-eluting balloons and systematic DES implantation in a diverse population of PCI candidates, including those with complex lesions and high-risk profiles.

Dr. Spaulding stated, “With no acute or late safety concerns, these results apply to a significant segment of PCI procedures. We look forward to obtaining five-year data to determine long-term noninferiority or possible superiority of this strategy.”

The study was financed by M.A. Med Alliance SA, a subsidiary of Cordis, Switzerland. Dr. Spaulding has disclosed receiving research support from the French Ministry of Health and various consultancy roles in the medical field, which underscores the collaborative nature of this research.

As the medical community anticipates further data on long-term outcomes, this study could pave the way for shifts in PCI practices, potentially enhancing patient care and outcomes in coronary artery disease treatments.