Valvular & structural heart diseaseRandomised controlled trial
LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial
- Randomised controlled trial
- prospective
- multinational
- open-label
- non-inferiority
- 31 hospitals in 16 countries
Authors' conclusion
In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.
Study context
- Population
- Patients with severe symptomatic native AS
- Participants
- 768 patients
- Comparison
- Myval transcatheter heart valve (THV) vs contemporary THV
- Myvaln = 384
- Contemporary THVn = 384reference
- Primary endpoint
- VARC-3 composite of:
- All-cause mortality
- All stroke
- Bleeding (types 3 and 4)
- AKI (stages 2-4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction disturbances resulting in permanent pacemaker implantation
- Follow-up
- 30 days
Primary result
As reported in the abstract
Risk difference
−2.3%
one-sided upper 95% CI 3.8
P < 0.0001 for non-inferiority
By group
Further findings
Individual components of the primary composite endpoint
- No significant difference
Original publication
LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial. Lancet. Published 22 May 2024. doi:10.1016/s0140-6736(24)00821-3
Summarised from the published abstract; every number is checked against it