- Question
- Is transcatheter aortic-valve replacement (TAVR) with a balloon-expandable valve noninferior, or even superior, to surgery in patients with severe aortic stenosis at low surgical risk?
- Design
- Randomized, multicenter, open-label (unmasked) noninferiority trial (prespecified margin of 6 percentage points) with subsequent superiority testing, conducted at 71 centers with 1000 patients randomized; analysis was in the as-treated population.
- Population
- Patients with severe aortic stenosis at low surgical risk, with a mean age of 73 years and a mean STS risk score of 1.9%.
- Intervention
- Transfemoral TAVR with a balloon-expandable valve (SAPIEN 3).
- Control
- Surgical aortic-valve replacement.
- Primary outcome
- Composite of death, stroke, or rehospitalization at 1 year.
- Results
- The Kaplan-Meier estimate of the primary end point at 1 year was 8.5% with TAVR vs. 15.1% with surgery (absolute difference, -6.6 percentage points; 95% CI, -10.8 to -2.5; P<0.001 for noninferiority; HR 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority). At 30 days, TAVR had a lower stroke rate (P=0.02).
- Safety
- At 30 days, TAVR was associated with lower rates of death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001), and a shorter index hospitalization. There were no significant differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation.
- Conclusion
- In patients with severe aortic stenosis at low surgical risk, TAVR significantly reduced the composite of death, stroke, or rehospitalization at 1 year compared with surgery.
- Why it matters
- It was one of the first large trials to show favorable results with TAVR in low-risk patients, broadening the discussion on its use beyond intermediate- and high-risk patients.
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