SnackableHealth™ | SELUTION DeNovo: Sirolimus-Eluting DCB Challenges DES in Native Coronary Lesions

In this SnackableHealth™ edition recorded at TCT 2025, Dr. Christian M. Spaulding joined Dr. C. Michael Gibson to discuss the landmark SELUTION DeNovo trial, evaluating a sirolimus-eluting drug-coated balloon (DCB) as a potential alternative to drug-eluting stents (DES) in de novo coronary lesions.

Dr. Spaulding highlighted that for decades, DES implantation has been the cornerstone of percutaneous coronary intervention (PCI). However, the presence of permanent metallic scaffolds may limit vessel physiology and complicate future interventions. “A drug-coated balloon that delivers sirolimus without leaving a stent behind offers the promise of restoring normal vascular function and reducing late adverse events,” he noted.

The SELUTION DeNovo study compared sirolimus-eluting DCBs with contemporary DES across a broad spectrum of lesion types. Early data suggest non-inferior angiographic and clinical outcomes, with fewer late lumen losses and a trend toward lower rates of target lesion revascularization (TLR) at one year. Importantly, the absence of a permanent implant also translated into shorter dual antiplatelet therapy (DAPT) durations and reduced long-term complication risk.

Dr. Gibson emphasized that these findings could mark a shift in PCI philosophy. “If confirmed in larger populations, sirolimus-eluting DCBs could fundamentally change how we treat de novo disease—particularly in small vessels, bifurcations, or patients where long-term DAPT is a concern,” he said.

Both experts agreed that the SELUTION platform’s micro-reservoir technology—enabling controlled, sustained sirolimus delivery—has been crucial to achieving outcomes comparable to modern DES, with the additional benefit of leaving nothing behind.