SELUTION DeNovo Trial Results
The SELUTION DeNovo randomized clinical trial, presented at TCT 2025 in San Francisco, USA, demonstrates 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 (SEB) 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.
The trial, conducted across 62 sites in 12 countries in Europe and Asia, aimed to test whether a stent-minimizing approach could achieve outcomes comparable to standard DES implantation.
According to the findings, drug-eluting stents are associated with a persistent annual 2–4% rate of very-late adverse cardiovascular events.
Dr. Christian Spaulding and colleagues presented the findings, representing 62 participating sites across 12 countries in Europe and Asia.
Author's summary: SELUTION DeNovo trial shows non-inferiority of drug-eluting balloon.
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