- Question
- In patients with severe aortic stenosis at intermediate surgical risk, is transcatheter aortic-valve replacement (TAVR) noninferior to surgical aortic-valve replacement?
- Design
- Randomized, open-label (unmasked), multicenter (57 centers) noninferiority trial enrolling 2032 patients. Before randomization, patients were assigned to a transfemoral-access cohort (76.3%) or a transthoracic-access cohort (23.7%) based on clinical and imaging findings.
- Population
- Patients with symptomatic severe aortic stenosis at intermediate surgical risk.
- Intervention
- Transcatheter aortic-valve replacement with the Edwards SAPIEN XT valve.
- Control
- Conventional surgical aortic-valve replacement.
- Primary outcome
- Death from any cause or disabling stroke at 2 years.
- Results
- Kaplan-Meier event rates at 2 years were 19.3% with TAVR and 21.1% with surgery (HR 0.89; 95% CI 0.73 to 1.09; P=0.25), with P=0.001 for noninferiority. In the transfemoral-access cohort, TAVR had a lower rate of the primary end point than surgery (HR 0.79; 95% CI 0.62 to 1.00; P=0.05), whereas outcomes were similar in the transthoracic-access cohort.
- Safety
- TAVR was associated with lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation, and with larger aortic-valve areas. Surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.
- Conclusion
- In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to death or disabling stroke.
- Why it matters
- It extended the evidence supporting TAVR beyond high-risk patients, establishing it as an alternative to surgery in intermediate-risk patients and reinforcing the role of the heart team in choosing the strategy.
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 7, 2026