- Question
- Is transcatheter aortic valve implantation (TAVI) comparable to surgical valve replacement in low-risk patients aged 75 years or younger with severe symptomatic aortic stenosis, including both tricuspid and bicuspid valves?
- Design
- Multicenter, 1:1 randomized, single-masked trial enrolling 370 patients (100 with bicuspid aortic stenosis). The primary follow-up was 12 months.
- Population
- Patients aged 75 years or younger with severe symptomatic aortic stenosis at low surgical risk. Mean age was 71.1 years and median STS risk score was 1.1%.
- Intervention
- Transcatheter aortic valve implantation (TAVI).
- Control
- Surgical aortic valve replacement.
- Primary outcome
- Composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, the valve, or heart failure) at 12 months.
- Results
- The primary endpoint occurred in 10.2% of the TAVI group and 7.1% of the surgery group (absolute risk difference 3.1%; 95% CI, -2.7% to 8.8%; HR 1.4; 95% CI, 0.7-2.9; P = .3). In bicuspid stenosis it was 14.3% with TAVI and 3.9% with surgery (HR 3.8; 95% CI, 0.8-18.5; P for interaction = .1), versus 8.7% and 8.3% in tricuspid stenosis (HR 1.0; 95% CI, 0.5-2.3).
- Safety
- TAVI was associated with a lower risk of major bleeding and new-onset atrial fibrillation, and a higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation.
- Conclusion
- In low-risk patients aged 75 years or younger, the 1-year rate of death, stroke, or rehospitalization was similar between TAVI and surgery, although outcomes in young patients with bicuspid valves warrant caution.
- Why it matters
- It provided randomized evidence for TAVI in younger low-risk patients, including patients with bicuspid aortic stenosis, a group rarely included in earlier trials. The bicuspid findings call for caution and further investigation.
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