Valvular & structural heart disease
SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial
Errata to this article were published (Lancet, 21 Jun 2025 ↗ · 21 Feb 2026 ↗ · 29 Aug 2026 ↗)
Primary resultResult — go to the resultRisk difference −0.9% one-sided upper 95% CI 4.4%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
Methodological detailsmulticentre, all-comers, non-inferiority, 3 university hospitals in Denmark, Enrolment paused twice because of patent-related legal proceedings
- Multicentre
- All-comers
- Non-inferiority
- 3 university hospitals in Denmark
- Enrolment paused twice because of patent-related legal proceedings
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
SAPIEN 3vs Myval
risk difference −0.9% (one-sided upper 95% CI 4.4%); P for non-inferiority = 0.019
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.
Composed by AI from the published abstract and checked against it. How Briefs are made →