- Question
- Is transcatheter aortic valve implantation (TAVI) noninferior to surgical aortic valve replacement for 1-year all-cause mortality in patients with aortic stenosis and moderately increased operative risk?
- Design
- Randomized noninferiority clinical trial conducted at 34 UK centers, with 913 patients enrolled between April 2014 and April 2018 and followed up through April 2019. The noninferiority margin was 5% for the upper limit of the 1-sided 97.5% CI of the absolute difference in mortality.
- Population
- Patients aged 70 years or older with severe symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity. Median age was 81 years, 46% were female, and the median STS mortality risk score was 2.6%.
- Intervention
- TAVI using any CE-marked valve and any access route (n = 458).
- Control
- Surgical aortic valve replacement (n = 455).
- Primary outcome
- All-cause mortality at 1 year.
- Results
- At 1 year there were 21 deaths (4.6%) in the TAVI group and 30 (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Postprocedural hospital stay was shorter with TAVI (median 3 days vs 8 days).
- Safety
- TAVI was associated with fewer major bleeding events (7.2% vs 20.2%; adjusted HR, 0.33; 95% CI, 0.24 to 0.45), but more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42; 95% CI, 2.54 to 7.71), more conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05; 95% CI, 1.43 to 2.94), and more mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation.
- Conclusion
- In patients aged 70 years or older with severe symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery for 1-year all-cause mortality.
- Why it matters
- It provided pragmatic trial evidence, using commonly available valves and access routes, supporting TAVI as an alternative to surgery in intermediate-risk patients, with a distinct complication profile that must be weighed when choosing a 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 18, 2026