- Question
- In patients with severe aortic stenosis considered unsuitable for surgery, does transcatheter aortic-valve implantation (TAVI) improve survival compared with standard therapy?
- Design
- Randomized, open-label (unmasked) trial with 358 patients assigned at 21 centers, 17 of them in the United States. It corresponds to cohort B of the PARTNER program.
- Population
- Patients with severe aortic stenosis and coexisting conditions who were not considered suitable candidates for surgical valve replacement according to surgeon assessment.
- Intervention
- Transfemoral implantation of a balloon-expandable bovine pericardial bioprosthetic valve (TAVI).
- Control
- Standard therapy, which included balloon aortic valvuloplasty.
- Primary outcome
- Death from any cause at 1 year, analyzed by the Kaplan-Meier method.
- Results
- One-year all-cause mortality was 30.7% with TAVI versus 50.7% with standard therapy (HR 0.55; 95% CI 0.40 to 0.74; P<0.001). The composite of death or repeat hospitalization was 42.5% vs. 71.6% (HR 0.46; 95% CI 0.35 to 0.59; P<0.001).
- Safety
- At 30 days, TAVI was associated with more major strokes (5.0% vs. 1.1%; P=0.06) and more major vascular complications (16.2% vs. 1.1%; P<0.001). There was no deterioration in bioprosthetic valve function during the first year.
- Conclusion
- In patients unsuitable for surgery, TAVI reduced all-cause mortality, the composite of death or repeat hospitalization, and cardiac symptoms, at the cost of more major strokes and major vascular events.
- Why it matters
- It was the first randomized trial to show a survival benefit of TAVI in inoperable patients with severe aortic stenosis, and it laid the groundwork for adopting TAVI as a treatment option in this group.
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