SELUTION DeNovo Trial Results
The SELUTION DeNovo randomized clinical trial, presented at TCT 2025 in San Francisco, USA, demonstrated non-inferiority of a drug-eluting balloon to standard-of-care for in-stent restenosis.
A percutaneous coronary intervention (PCI) strategy using the SELUTION SLR sirolimus-eluting balloon with provisional stenting was found to be non-inferior to the systematic use of drug-eluting stents (DES) for the treatment of de novo coronary lesions at one year.
Drug-eluting stents remain the mainstay of PCI, but are associated with a persistent annual 2–4% rate of very-late adverse cardiovascular events.
The trial, conducted across 62 sites in 12 countries in Europe and Asia, was designed to test whether a stent-minimizing approach could achieve outcomes comparable to standard DES implantation.
Author's summary: Drug-eluting balloon shows promise.