Sirolimus-Eluting Balloons Show Comparable Results to Stents in PCI Trial

A significant advancement in cardiovascular treatment has emerged from a large-scale international study. Researchers have found that using a strategy of sirolimus-eluting balloons (SEB), with stenting applied only when necessary, is as effective as the conventional use of drug-eluting stents (DES) for treating de novo coronary artery disease. The findings were presented at the TCT 2025, an annual symposium hosted by the Cardiovascular Research Foundation.

The study involved 3,341 participants who were randomized between August 2021 and July 2024 across 62 sites in 12 countries in Europe and Asia. Participants with a lesion reference vessel diameter (RVD) between 2.0 mm and 5.0 mm were eligible. The primary goal was to compare the efficacy of the SEB strategy to that of routine DES implantation, which is standard in most percutaneous coronary interventions (PCIs).

Key Findings from the SELUTION DeNovo Trial

The results demonstrated that the SEB approach, which delivers a sustained drug release for up to 90 days, was noninferior to the DES method. At the one-year mark, the primary endpoint of target vessel failure—comprising cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization—was recorded at 5.3% in the SEB group and 4.4% in the DES group. The risk difference was 0.910.02).

Remarkably, around 80% of participants treated with the SEB did not require any stenting, suggesting a substantial reduction in the need for metal implants. Additionally, the study found low rates of adverse events, including cardiac death (0.70% vs 1.0%), lesion thrombosis (0.1% vs 0.3%), and target vessel myocardial infarction (2.7% vs 2.6%), indicating that the SEB strategy is safe for patients.

Implications for PCI Procedures

The SELUTION DeNovo trial offers the first extensive comparison of sirolimus-eluting balloons against systematic DES implantation within a diverse international population. According to Christian M. Spaulding, MD, PhD, who leads the Integrated Interventional Laboratory at the European Hospital Georges Pompidou in Paris, France, the results are significant, especially given the study’s focus on high-risk patients and complex lesions.

Dr. Spaulding emphasized the importance of these findings, stating, “We look forward to obtaining five-year data to determine long-term noninferiority or possible superiority of this strategy.”

The trial was funded by M.A. Med Alliance SA, a subsidiary of Cordis, and Dr. Spaulding disclosed receiving various forms of support from multiple medical companies, emphasizing the importance of transparency in research financing.

As the focus on minimizing metallic stent usage grows in the field of interventional cardiology, these findings could influence future treatment protocols and contribute to improved patient outcomes across a significant segment of PCI cases. The complete results of the study were shared on October 26, 2025, at 11:00 a.m. PT during the TCT 2025 conference at the Moscone Center.