- Question
- To determine whether a short course of oral anticoagulation after TAVI reduces the prevalence of subclinical leaflet thickening (HALT) compared with single antiplatelet therapy in patients without an indication for anticoagulation.
- Design
- Randomized 1:1, open-label (no masking) trial designed to show superiority of the experimental strategy; 352 patients were randomized shortly after successful TAVI, and HALT was assessed by cardiac computed tomography.
- Population
- Patients without an indication for oral anticoagulation, randomized shortly after successful transcatheter aortic valve replacement.
- Intervention
- Direct oral anticoagulant (DOAC) for 3 months, followed by lifelong single antiplatelet therapy.
- Control
- Lifelong single antiplatelet therapy.
- Primary outcome
- Prevalence of HALT (hypoattenuated leaflet thickening) at 12 months on computed tomography.
- Results
- At 12 months, HALT occurred in 32.2% with single antiplatelet therapy and 28.3% with 3 months of DOAC (risk difference: -3.9%; 95% CI: -14.4% to 6.6%; P = 0.54). At 3 months, HALT was 31.8% with single antiplatelet therapy vs 12.1% with DOAC.
- Safety
- The combined risk of all-cause death, stroke, or major/life-threatening bleeding at 12 months was 2.3% with single antiplatelet therapy vs 8.2% with 3 months of DOAC (risk difference: 5.9%; 95% CI: 1.2% to 10.6%).
- Conclusion
- Three months of DOAC reduced HALT at 3 months, but the effect attenuated after stopping the anticoagulant, with no significant difference at 12 months.
- Why it matters
- It showed that the benefit of brief anticoagulation on subclinical leaflet thickening is transient and comes with more adverse clinical events, which does not support routine use of this 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 14, 2026