The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis
University of Leicester
2,844 participants
Mar 10, 2020
INTERVENTIONAL
Conditions
Summary
Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \~3% of people \>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.
Eligibility
Inclusion Criteria9
- Age \>18 years
- Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:
- Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR
- Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area \>1.0 - ≤1.2cm2 OR \>0.6 - ≤0.7cm2/m2 body surface area AND high sex specific calcium score\* OR
- Peak Velocity ≥3.5m/s - 3.9m/s AND mean pressure gradient \<40 mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area AND high sex specific calcium score\* \*Sex specific high calcium scores (Agatston units): \>1200 females; \>2000 males
- The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.
- Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk
- Willing to provide informed consent and be randomised to early AVR or expectant management
- An ability to understand one of the written languages that the study has provided written and visual materials in, or the availability of a translator to explain the study documentation
Exclusion Criteria7
- Symptoms related to AS
- Additional severe valvular heart disease
- Other cardiac surgery planned pre-randomisation (eg CABG)
- Left ventricular systolic dysfunction (LVEF \<50%)
- Pregnancy
- Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to \<2 years
- Patient has previously undergone AVR or TAVI with restenosis
Interventions
Participants will be assessed by a member of the surgical team performing aortic valve replacement (AVR), and by any other relevant medical professionals identified by the doctors overseeing their care in hospital. When deemed ready for AVR, a member of the surgical team will ask for consent to proceed with the AVR. They will discuss the surgical procedure, covering information on the basic technical procedure, risks and expected recovery time.
Locations(110)
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NCT04204915