- Question
- Does early transcatheter aortic-valve replacement (TAVR) improve clinical outcomes compared with standard clinical surveillance in patients with asymptomatic severe aortic stenosis and preserved ejection fraction?
- Design
- Open-label (unmasked), multicenter randomized 1:1 trial of 901 patients at 75 centers in the United States and Canada. Median follow-up was 3.8 years, and superiority was tested in the intention-to-treat population.
- Population
- Patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction. Mean age was 75.8 years, mean STS Predicted Risk of Mortality score was 1.8%, and 83.6% were at low surgical risk.
- Intervention
- Early transfemoral TAVR with a balloon-expandable valve (455 patients).
- Control
- Clinical surveillance (446 patients), with valve replacement performed as clinically indicated; 87.0% of this group ultimately underwent aortic-valve replacement during follow-up.
- Primary outcome
- Composite of death, stroke, or unplanned hospitalization for cardiovascular causes.
- Results
- A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and 202 (45.3%) in the clinical surveillance group (HR 0.50; 95% CI 0.40 to 0.63; P<0.001). Death occurred in 8.4% vs 9.2%, stroke in 4.2% vs 6.7%, and unplanned cardiovascular hospitalization in 20.9% vs 41.7%.
- Safety
- There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who later underwent aortic-valve replacement.
- Conclusion
- In asymptomatic severe aortic stenosis, an early TAVR strategy was superior to clinical surveillance in reducing death, stroke, or unplanned cardiovascular hospitalization.
- Why it matters
- It provided the first randomized TAVR evidence in this setting and challenges the traditional watchful-waiting approach, prompting discussion about intervening before symptoms develop.
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