- Question
- In patients with severe aortic stenosis and increased surgical risk, is transcatheter aortic-valve replacement (TAVR) with a self-expanding prosthesis noninferior or superior to surgical aortic-valve replacement?
- Design
- Randomized 1:1, open-label (no masking) trial with 795 patients randomized at 45 centers in the United States.
- Population
- Patients with severe aortic stenosis at increased risk of death with surgery, as judged by each center's heart team, using the Society of Thoracic Surgeons risk estimate along with other key risk factors.
- Intervention
- TAVR with the self-expanding CoreValve transcatheter bioprosthesis.
- Control
- Surgical aortic-valve replacement.
- Primary outcome
- All-cause death at 1 year, tested for both noninferiority and superiority.
- Results
- In the as-treated analysis, 1-year all-cause mortality was lower with TAVR than with surgery (14.2% vs. 19.1%), an absolute risk reduction of 4.9 percentage points (upper boundary of the 95% CI, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). Intention-to-treat results were similar.
- Safety
- Exploratory analyses suggested a lower rate of major adverse cardiovascular and cerebrovascular events and no increased risk of stroke with TAVR.
- Conclusion
- In patients with severe aortic stenosis at increased surgical risk, TAVR with a self-expanding valve was associated with significantly higher 1-year survival than surgical replacement.
- Why it matters
- It provided the first randomized evidence of better survival with TAVR than with surgery in increased-risk patients, establishing TAVR as a valid alternative to surgery in this population.
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 14, 2026