TCT 2025 | SELUTION DeNovo: sirolimus-eluting balloon vs. stent in de novo coronary lesions

The use of drug-eluting stents (DES) remains the standard strategy in most percutaneous coronary intervention (PCI) procedures. However, mid- to long-term studies have shown annual adverse event rates of 2–4%, driving the search for alternatives with lower metal burden.

Drug-eluting balloons (DEB) are an attractive option and their use has increased. Nevertheless, sirolimus-eluting devices have had limited clinical adoption due to technical challenges in achieving sustained drug release. Through micro-reservoir technology, the SELUTION balloon enables controlled and prolonged sirolimus release.

The SELUTION DeNovo study was a prospective, randomized, multicenter, open-label, non-inferiority trial comparing a PCI strategy based on sirolimus-eluting DEB (SELUTION SLR) versus routine provisional stenting in de novo coronary lesions.

A total of 3341 patients were enrolled across 62 centers in 12 countries in Europe and Asia, with reference vessel diameters between 2.0 and 5.0 mm. Patients with STEMI, unstable NSTEMI, left main disease, chronic total occlusions, bypass graft lesions, or in-stent restenosis were excluded. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, vessel-related MI, and clinically driven target vessel revascularization at 12 months.

At one year, the TVF rate was 5.3% with SELUTION vs. 4.4% with DES, meeting criteria for non-inferiority (absolute risk difference: 0.91%; 95% CI: −0.55 to 2.38; non-inferiority margin: 2.44; p=0.02).

Read also: IVUS – Measured Optimal Minimal Stent Area in Left Main Crossover Stenting.

No significant differences were observed in the individual components of the primary endpoint or in safety outcomes. Subgroup analyses showed consistent results, including among high bleeding risk patients (ARC-HBR) and those with complex lesions.

Conclusions

This study demonstrates the feasibility of a “minimalist” leave-nothing-behind approach based on sirolimus-eluting DEB, achieving non-inferior clinical outcomes compared with routine DES implantation in de novo coronary lesions.

Presented by Christian Spaulding at TCT 2025 Late-Breaking Clinical Trials, October 26, San Francisco, USA.