Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial
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...
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| Veröffentlicht in: | The American heart journal 2024-09, Vol.275, p.119-127 |
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| creator | Richardson, Carla Gilbert, Tom Aslam, Saadia Brookes, Cassandra L. Singh, Anvesha Newby, David E. Dweck, Marc R. Stewart, Ralph A. H． Myles, Paul S. Briffa, Tom Selvanayagam, Joseph Chow, Clara K. Murphy, Gavin J. Akowuah, Enoch F. Lord, Joanne Barber, Shaun Paola, Ana Suazo Di McCann, Gerry P. Hillis, Graham S. |
| description | 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’.
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 nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction |
| doi_str_mv | 10.1016/j.ahj.2024.05.013 |
| format | Article |
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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 nessessary. 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.
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.
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.
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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 nessessary. 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.
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.
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.
[Display omitted]</description><subject>Aorta</subject><subject>Aortic stenosis</subject><subject>Aortic valve</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Stenosis - surgery</subject><subject>Asymptomatic</subject><subject>Asymptomatic Diseases</subject><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Clinical outcomes</subject><subject>Congestive heart failure</subject><subject>Consent</subject><subject>Coronary artery disease</subject><subject>Cost effectiveness</subject><subject>Cost-Benefit Analysis</subject><subject>Ejection fraction</subject><subject>Female</subject><subject>Heart diseases</subject><subject>Heart failure</subject><subject>Heart surgery</subject><subject>Heart Valve Prosthesis Implantation - methods</subject><subject>Heart valves</subject><subject>Humans</subject><subject>Life expectancy</subject><subject>Life span</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Mortality</subject><subject>Multicenter Studies as Topic</subject><subject>Patients</subject><subject>Pragmatic Clinical Trials as Topic</subject><subject>Pulmonary arteries</subject><subject>Quality of Life</subject><subject>Questionnaires</subject><subject>Rheumatic heart disease</subject><subject>Severity of Illness Index</subject><subject>Surgery</subject><subject>Transcatheter Aortic Valve Replacement - methods</subject><issn>0002-8703</issn><issn>1097-6744</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kE1r3DAQhkVoabZpf0AvRdBLL3bHlvVhegpL-gGBQmnOqiyNExnb2krahf330bJpDzn0NAw878vMQ8i7BuoGGvFpqs3DVLfQdjXwGhp2QTYN9LISsutekA0AtJWSwC7J65SmsopWiVfkkinVNh1nG_L7p8k-rGZGalZHHSZ_v9Iw0vyAFE2cj_Rg5gPSiLvZWFxwzdSvNOEBY8mk47LLYSkllpoQTyNlXEPyiebozfyGvBzNnPDt07wid19ufm2_Vbc_vn7fXt9WlkmRK4HYd6MbnByFHHpEzp2E8hLAIAQyOWDLWlQcjRNq4EogdxYlDsL0yiG7Ih_PvbsY_uwxZb34ZHGezYphnzQDwTohlJIF_fAMncI-Fgcnqme8VdD3hWrOlI0hpYij3kW_mHjUDeiTfj3pol-f9GvgutxaMu-fmvfDgu5f4q_vAnw-A1hUHDxGnazH1aLzEW3WLvj_1D8CVLyWhA</recordid><startdate>202409</startdate><enddate>202409</enddate><creator>Richardson, Carla</creator><creator>Gilbert, Tom</creator><creator>Aslam, Saadia</creator><creator>Brookes, Cassandra L.</creator><creator>Singh, Anvesha</creator><creator>Newby, David E.</creator><creator>Dweck, Marc R.</creator><creator>Stewart, Ralph A. 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H．</au><au>Myles, Paul S.</au><au>Briffa, Tom</au><au>Selvanayagam, Joseph</au><au>Chow, Clara K.</au><au>Murphy, Gavin J.</au><au>Akowuah, Enoch F.</au><au>Lord, Joanne</au><au>Barber, Shaun</au><au>Paola, Ana Suazo Di</au><au>McCann, Gerry P.</au><au>Hillis, Graham S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2024-09</date><risdate>2024</risdate><volume>275</volume><spage>119</spage><epage>127</epage><pages>119-127</pages><issn>0002-8703</issn><issn>1097-6744</issn><eissn>1097-6744</eissn><abstract>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’.
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 nessessary. 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.
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.
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.
[Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38821453</pmid><doi>10.1016/j.ahj.2024.05.013</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-2570-3963</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aorta Aortic stenosis Aortic valve Aortic Valve - surgery Aortic Valve Stenosis - surgery Asymptomatic Asymptomatic Diseases Cardiology Cardiovascular disease Cardiovascular diseases Clinical outcomes Congestive heart failure Consent Coronary artery disease Cost effectiveness Cost-Benefit Analysis Ejection fraction Female Heart diseases Heart failure Heart surgery Heart Valve Prosthesis Implantation - methods Heart valves Humans Life expectancy Life span Male Medical prognosis Mortality Multicenter Studies as Topic Patients Pragmatic Clinical Trials as Topic Pulmonary arteries Quality of Life Questionnaires Rheumatic heart disease Severity of Illness Index Surgery Transcatheter Aortic Valve Replacement - methods |
| title | Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial |
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