Early Surgery for Patients With Asymptomatic Aortic Stenosis

Assistance Publique - Hôpitaux de Paris360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

360

Conditions

Aortic Valve Stenosis Aortic Valve Surgery

Interventions

Early surgical aortic valve replacementOTHER

Delayed Surgical aortic valve replacementOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Henri Mondor Hospital

Créteil, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year after randomization.

Secondary Outcomes

Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity

Time frame: 1 year after randomization

Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group

Time frame: assessed at 3 months after surgery

Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group

Time frame: assessed at 3 months after surgery

Postoperative Exercise test (Exercise Electrocardiogram)

Time frame: assessed at 3 months after surgery

Central Contacts

Jean-Luc MONIN, MD PhD.

CONTACT

(0)1 49 81 28 10 jean-luc.monin@aphp.fr

Data from ClinicalTrials.gov

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