Early Surgery for Patients With Asymptomatic Aortic Stenosis (ESTIMATE)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Aortic Valve Stenosis; Aortic Valve Surgery

Treatments: Other: Delayed Surgical aortic valve replacement; Other: Early surgical aortic valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT02627391

AOM 140460

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Early surgery

Experimental group

Description:

Surgical aortic valve replacement

Treatment:

Other: Early surgical aortic valve replacement

Delayed surgery according to guidelines

Active Comparator group

Description:

Surgical aortic valve replacement

Treatment:

Other: Delayed Surgical aortic valve replacement