Valvular & structural heart diseaseRandomised controlled trial
SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial
- Randomised controlled trial
- multicentre
- all-comers
- non-inferiority
- 3 university hospitals in Denmark
Enrolment paused twice because of patent-related legal proceedings
Authors' conclusion
Myval THVs were non-inferior to SAPIEN 3 THVs in terms of a 1-year composite endpoint of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration.
Study context
- Population
- Adults ≥18 years scheduled for transfemoral transcatheter aortic valve implantation (TAVI)
- Participants
- 1,031 adults
- Comparison
- Myval vs SAPIEN 3 transcatheter heart valve (THVs) for TAVI
- Myvaln = 514
- SAPIEN 3n = 517reference
- Primary endpoint
- Composite of:
- Death
- Stroke
- Moderate or severe aortic regurgitation
- Moderate or severe haemodynamic THV deterioration (VARC-3)
- Follow-up
- 1 year
Primary result
As reported in the abstract
Risk difference
−0.9%
one-sided upper 95% CI 4.4%
P = 0.019 for non-inferiority
Events by treatment group
Original publication
SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial. Lancet. Published 2 April 2025. doi:10.1016/s0140-6736(25)00106-0
Summarised from the published abstract; every number is checked against it