TY - JOUR
T1 - Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial
AU - Richardson, Carla
AU - Gilbert, Tom
AU - Aslam, Saadia
AU - Brookes, Cassandra L
AU - Singh, Anvesha
AU - Newby, David E
AU - Dweck, Marc R
AU - Stewart, Ralph A H
AU - Myles, Paul S
AU - Briffa, Tom
AU - Selvanayagam, Joseph
AU - Chow, Clara K
AU - Murphy, Gavin J
AU - Akowuah, Enoch F
AU - Lord, Joanne
AU - Barber, Shaun
AU - Paola, Ana Suazo Di
AU - McCann, Gerry P
AU - Hillis, Graham S
PY - 2024/9
Y1 - 2024/9
N2 - Background: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’. Methods: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes necessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. Results: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. Conclusions: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.
AB - Background: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of ‘watchful waiting’. Methods: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes necessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. Results: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. Conclusions: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.
KW - Aortic stenosis
KW - Valve replacement
KW - Heart
UR - http://www.scopus.com/inward/record.url?scp=85197739384&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2024.05.013
DO - 10.1016/j.ahj.2024.05.013
M3 - Article
C2 - 38821453
AN - SCOPUS:85197739384
SN - 0002-8703
VL - 275
SP - 119
EP - 127
JO - American Heart Journal
JF - American Heart Journal
ER -