Early aortic valve replacement versus conservative management in asymptomatic severe aortic stenosis: Meta-analysis of time-to-event data of randomized controlled trials.
Summary
Across four randomized trials (n=1,427), early AVR in asymptomatic severe AS reduced all-cause mortality (HR 0.72), cardiovascular mortality (HR 0.56), and heart failure hospitalization (HR 0.31) versus conservative care. Conversion to AVR was common in the conservative arm, with median time 13.4 months and 95% conversion by 5 years.
Key Findings
- Early AVR reduced all-cause mortality (HR 0.72, 95% CI 0.53–0.97).
- Cardiovascular mortality decreased with early AVR (HR 0.56, 95% CI 0.36–0.89).
- Heart failure hospitalization was markedly lower (HR 0.31, 95% CI 0.18–0.53).
- High crossover from conservative management to AVR: median 13.4 months; 94.9% by 5 years.
Clinical Implications
For selected asymptomatic severe AS patients, earlier AVR (SAVR or TAVR) should be considered during shared decision-making to reduce mortality and HF hospitalizations, with careful patient selection and procedural risk assessment.
Why It Matters
This meta-analysis of RCTs directly informs the contentious timing of AVR in asymptomatic severe AS, demonstrating survival and morbidity benefits that may shift guideline recommendations.
Limitations
- Use of reconstructed Kaplan–Meier data rather than individual patient data may introduce estimation error.
- Heterogeneity in trial inclusion criteria and follow-up durations; generalizability to all asymptomatic AS populations may vary.
Future Directions
Prospective head-to-head randomized trials comparing early TAVR vs watchful waiting with longer follow-up and subgroup analyses (age, calcification burden, biomarkers) to refine selection criteria.
Study Information
- Study Type
- Meta-analysis
- Research Domain
- Treatment
- Evidence Level
- I - Meta-analysis of randomized controlled trials
- Study Design
- OTHER