- Question
- Does TAVR provide clinical benefit on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction (HFrEF) and moderate aortic stenosis?
- Design
- Investigator-initiated, international randomized trial with 1:1 allocation; 178 patients were randomized between January 2017 and December 2022. Median follow-up was 23 months (Q1-Q3: 12-33).
- Population
- Patients with HFrEF on guideline-directed medical therapy and moderate aortic stenosis, suitable for transfemoral TAVR with a balloon-expandable valve. Mean age was 77 years, 20.8% were women and 55.6% were in NYHA class III-IV.
- Intervention
- Transfemoral TAVR with a balloon-expandable valve (n = 89) in addition to medical therapy.
- Control
- Clinical aortic stenosis surveillance (n = 89), with valve replacement upon progression to severe stenosis.
- Primary outcome
- Hierarchical endpoint analyzed with the win ratio: 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score.
- Results
- TAVR won in 47.6% of pairs versus 36.6% for surveillance, giving a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, the KCCQ score improved more with TAVR (12.8 ± 21.9 vs 3.2 ± 22.8 points; P = 0.018). In the surveillance group, 38 patients (43%) underwent TAVR at a median of 12 months after randomization (35 of them had progressed to severe stenosis).
- Safety
- The authors describe preemptive TAVR for moderate stenosis as safe.
- Conclusion
- TAVR was not superior to surveillance for the primary hierarchical endpoint, although it may provide clinically meaningful quality-of-life benefits.
- Why it matters
- This is the first randomized trial of TAVR in moderate aortic stenosis with HFrEF; it did not show superiority on the primary endpoint but suggests symptomatic improvement and supports larger trials.
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