- Question
- In patients with severe aortic stenosis at low surgical risk, is transcatheter aortic-valve replacement (TAVR) with a self-expanding valve noninferior to conventional surgery?
- Design
- Open-label (unmasked) randomized noninferiority trial that assigned 1468 patients to TAVR or surgery; the primary endpoint was analyzed with Bayesian methods once 850 patients had reached 12 months of follow-up.
- Population
- Adults with severe aortic stenosis at low surgical risk, with a mean age of 74 years.
- Intervention
- TAVR with a self-expanding supra-annular bioprosthesis (Medtronic CoreValve/Evolut R system).
- Control
- Surgical aortic-valve replacement with a commercially available prosthesis.
- Primary outcome
- Composite of all-cause death or disabling stroke at 24 months.
- Results
- The estimated 24-month incidence of the primary endpoint was 5.3% with TAVR and 6.7% with surgery (difference, -1.4 percentage points; 95% Bayesian credible interval, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, TAVR had less disabling stroke (0.5% vs. 1.7%).
- Safety
- At 30 days, TAVR had fewer bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%) and atrial fibrillation (7.7% vs. 35.4%), but more moderate or severe aortic regurgitation (3.5% vs. 0.5%) and more pacemaker implantation (17.4% vs. 6.1%). At 12 months, TAVR had lower valve gradients (8.6 vs. 11.2 mm Hg) and larger effective orifice areas (2.3 vs. 2.0 cm2).
- Conclusion
- In patients with severe aortic stenosis at low surgical risk, TAVR with a self-expanding supra-annular valve was noninferior to surgery for the composite of death or disabling stroke at 24 months.
- Why it matters
- Together with other low-risk trials, it supported extending TAVR to younger, lower-risk patients, previously limited to those at elevated surgical risk, and reinforced the importance of shared decision-making between the heart team and the patient.
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