Early Surgery for Patients With Asymptomatic Aortic Stenosis

Study Overview
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Brief Summary
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Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.

Official Title
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Early Surgery for Patients With Asymptomatic Aortic Stenosis

Conditions
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Aortic Valve Stenosis, Aortic Valve Surgery

Intervention / Treatment
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* Other: Early surgical aortic valve replacement
* Other: Delayed Surgical aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult patient, aged between 18 and 80 years (18 ≤ age ≤80) Low operative risk, defined as EuroSCORE II ≤ 5% No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise No class I indication for surgery No symptom/ fall in blood pressure during exercise test Severe AS according to current echocardiography criteria: Vmax > 4.0 m/s and/ or MPG > 40 mm Hg); AVA < 1.0 cm2 (not mandatory) Preserved LV systolic function: LVEF >50% according to echocardiography ; no LV wall motion abnormality Signed informed consent Exclusion criteria Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II > 5% Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa) Other indication for cardiac surgery (CABG, thoracic aorta) Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value. Patients unable to perform the exercise ECG More than mild AR (>grade 2/4)/ other significant valve disease LVEF ≤ 50% Serum creatinine >160 μmol/L Serious extra cardiac comorbidity/ life expectancy <2 years Patient included in another trial with signed informed consent Patient not affiliated to social insurance Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early surgery<br>Surgical aortic valve replacement | Other: Early surgical aortic valve replacement<br> <br> |
| Active Comparator: Delayed surgery according to guidelines<br>Surgical aortic valve replacement | Other: Delayed Surgical aortic valve replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of overall mortality and cardiac morbidity | Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death. | 1 year after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity |  | 1 year after randomization | 
| Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group |  | assessed at 3 months after surgery | 
| Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group |  | assessed at 3 months after surgery | 
| Postoperative Exercise test (Exercise Electrocardiogram) |  | assessed at 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve, Stenosis, Surgery