- Question
- Does early surgical aortic valve replacement improve clinical outcomes compared with a conservative strategy in asymptomatic patients with severe aortic stenosis and normal left ventricular function?
- Design
- Investigator-initiated, international, prospective, open-label randomized trial, event-driven (minimum of 35 prespecified events). It was conducted in 9 centers in 7 European countries; overall median follow-up was 32 months.
- Population
- Asymptomatic patients with severe aortic stenosis (valve area ≤1 cm2 with aortic jet velocity >4 m/s or mean transaortic gradient ≥40 mm Hg), normal left ventricular function and a mandatory negative exercise test. Mean age was 67 years and 57% were men.
- Intervention
- Early elective surgical aortic valve replacement within 4 weeks of randomization (n=78).
- Control
- Conservative treatment with guideline-based watchful waiting until symptom onset or another surgical indication (n=79).
- Primary outcome
- Composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure.
- Results
- There were 39 events in total: 13 in the early surgery group and 26 in the conservative group. In the intention-to-treat analysis, early surgery reduced the primary endpoint (HR 0.46; 95% CI 0.23-0.90; P=0.02). Secondary endpoints did not differ significantly, although trends were consistent with the primary result.
- Safety
- In the early surgery group, 92.3% of patients underwent surgery (72 patients), with an operative mortality of 1.4%. There were no significant differences in major bleeding or thromboembolic complications.
- Conclusion
- In asymptomatic patients with severe aortic stenosis, early surgery reduced the composite of death, myocardial infarction, stroke or heart failure hospitalization compared with conservative management.
- Why it matters
- It provided randomized, although preliminary and modest-sized, evidence supporting consideration of early surgery once aortic stenosis becomes severe, without waiting for symptoms, and fueled the debate on the optimal timing of intervention.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026