- Question
- In women with severe symptomatic aortic stenosis, is transcatheter aortic valve implantation (TAVI) non-inferior or superior to surgical valve replacement for death, stroke or rehospitalization at 1 year?
- Design
- Open-label, 1:1 randomized multicenter trial conducted at 48 European centers, with 443 women randomized and 420 treated as randomized. Non-inferiority (pre-specified 6% margin) and superiority testing were performed in the as-treated population.
- Population
- Women with severe symptomatic aortic stenosis requiring valve replacement, with a mean age of 73 years and a mean estimated surgical risk of death of 2.1% by the STS score.
- Intervention
- Transfemoral TAVI with a balloon-expandable valve.
- Control
- Surgical aortic valve replacement.
- Primary outcome
- Composite of death, stroke, or rehospitalization (valve-, procedure- or heart failure-related) at 1 year.
- Results
- Kaplan-Meier estimates of the primary endpoint at 1 year were 8.9% with TAVI and 15.6% with surgery; the difference of -6.8% (upper 95% confidence limit -1.5%) showed non-inferiority of TAVI (P < .001), and the two-sided 95% CI of -13.0% to -0.5% further showed superiority (P = .034). By component: all-cause death 0.9% vs. 2.0%, stroke 3.3% vs. 3.0%, and rehospitalization 5.8% vs. 11.4%.
- Conclusion
- Among women with severe aortic stenosis, the incidence of the composite of death, stroke or rehospitalization at 1 year was lower with TAVI than with surgery.
- Why it matters
- It provides randomized evidence specific to women, a group under-represented in earlier trials, and supports considering transfemoral TAVI as an alternative to surgery in this group, even at low to intermediate surgical risk.
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