- Question
- Is transcatheter aortic-valve replacement with a self-expanding prosthesis a noninferior alternative to surgery in patients with severe symptomatic aortic stenosis at intermediate surgical risk?
- Design
- Randomized, multicenter (87 centers), open-label noninferiority trial using Bayesian methods, with 1746 patients randomized; 1660 underwent an attempted TAVR or surgical procedure.
- Population
- Patients with severe symptomatic aortic stenosis at intermediate surgical risk (mean age 79.8 years; STS Predicted Risk of Mortality 4.5 ± 1.6%).
- Intervention
- Transcatheter aortic-valve replacement (TAVR) with the Medtronic CoreValve self-expanding prosthesis.
- Control
- Surgical aortic-valve replacement.
- Primary outcome
- Composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement.
- Results
- At 24 months, the estimated incidence of the primary end point was 12.6% with TAVR and 14.0% with surgery (95% credible interval for the difference, -5.2 to 2.3%; posterior probability of noninferiority >0.999). TAVR achieved lower mean gradients and larger valve areas than surgery, with no structural valve deterioration in either group at 24 months.
- Safety
- Surgery was associated with higher rates of acute kidney injury, atrial fibrillation and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and pacemaker implantation.
- Conclusion
- TAVR was a noninferior alternative to surgery in severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events for each procedure.
- Why it matters
- It extended the evidence for TAVR beyond high-surgical-risk patients, supporting it as an option at intermediate risk and underscoring the need to choose according to the adverse-event profile of each 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 14, 2026