Early Surgery for Patients With Asymptomatic Aortic Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Combination of overall mortality and cardiac morbidity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early surgery
Surgical aortic valve replacement
干预措施: Early surgical aortic valve replacement (Other)
Delayed surgery according to guidelines
Surgical aortic valve replacement
干预措施: Delayed Surgical aortic valve replacement (Other)
结局指标
主要结局
Combination of overall mortality and cardiac morbidity
时间窗: 1 year after randomization.
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.
次要结局
- 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)