Valvular & structural heart disease
Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial
Study context
- Population
- Asymptomatic severe AS; excluded: other severe valvular disease, planned cardiac surgery, EF <50%, previous AVR, life expectancy <2 yearsplanned
- Participants
- 2,844 participants
- Planned comparison
- Early AVR vs watchful waiting
- Primary endpoint
- Composite of:
- Cardiovascular mortality
- Heart failure hospitalization
Methodological detailspragmatic, international, open, parallel group, 1:1 randomisation, Primary analysis at 663 primary events; 90% power to detect reduction from 27.7% to 21.6% (HR 0.75), Recruitment from March 2020 in UK, Australia, New Zealand and Serbia; feasibility met July 2022; main phase opened October 2022
- Pragmatic
- International
- Open
- Parallel group
- 1:1 randomisation
- Primary analysis at 663 primary events; 90% power to detect reduction from 27.7% to 21.6% (HR 0.75)
- Recruitment from March 2020 in UK, Australia, New Zealand and Serbia; feasibility met July 2022; main phase opened October 2022
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial. Am Heart J. Published 30 May 2024. doi:10.
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