Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial
Study context
- Population
- All-comers with de novo coronary lesions (2–5 mm) and chronic coronary syndrome, unstable angina or NSTEMI; excluding left main, chronic total occlusions, STEMI and unstable NSTEMIplanned, 50 sites
- Participants
- 3,326 participants
- Planned comparison
- Percutaneous coronary intervention (PCI) with SEB and provisional drug eluting stents (DES) vs PCI with systematic DES
- Primary endpoint
- TVF (non-inferiority; superiority tested if non-inferiority met at 5 years)
- Follow-up
- 1 and 5 years
Methodological detailsdesign and rationale, multicentre, international, open-label, non-inferiority, 1:1 randomisation, target vessel failure (TVF) and components assessed at 30 days, 6 months and annually up to 5 years, Secondary endpoints include bleeding events, cost-effectiveness and net clinical benefit
- Design and rationale
- Multicentre
- International
- Open-label
- Non-inferiority
- 1:1 randomisation
- TVF and components assessed at 30 days, 6 months and annually up to 5 years
- Secondary endpoints include bleeding events, cost-effectiveness and net clinical benefit
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. Published 13 January 2023. doi:10.
Summarised from the published abstract; every number is checked against it