Valvular & structural heart diseaseTrial design
Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves
- randomized 1:1 noninferiority trial (design and rationale)
- all-comers
- head-to-head comparison
- 1-sided test
- noninferiority margin of 4.5%
Study context
- Population
- Patients undergoing transcatheter aortic valve implantation (TAVI)estimated necessary sample size (planned)
- Participants
- 1,364 patients
- Planned comparison
- Evolut FX+ vs Sapien 3 Ultra Resilia
- Primary endpoint
- Combined primary composite endpoint of:
- All-cause mortality
- Stroke
- Moderate/severe total aortic regurgitation
- Moderate/severe hemodynamic THV deterioration
- According to VARC-3 criteria
- Follow-up
- 1-year
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves. Am Heart J. Published 23 February 2026. doi:10.1016/j.ahj.2026.107387
Summarised from the published abstract; every number is checked against it