- Question
- Is apixaban superior to standard of care (anticoagulant or antiplatelet therapy) after successful transcatheter aortic valve implantation (TAVI), regardless of whether there is an indication for anticoagulation?
- Design
- International, randomized (1:1), open-label, superiority trial of 1500 patients after successful TAVI. Randomization was stratified by the need for chronic anticoagulation, and follow-up was 1 year.
- Population
- Patients with aortic stenosis who underwent successful TAVI, with or without an indication for chronic oral anticoagulation (stratum 1 with an indication, stratum 2 without).
- Intervention
- Apixaban 5 mg twice daily (2.5 mg if renal function was impaired or with concomitant antiplatelet therapy); 749 patients.
- Control
- Standard of care (751 patients): a vitamin K antagonist if there was an indication for anticoagulation (stratum 1) or antiplatelet therapy if not (stratum 2).
- Primary outcome
- Composite of death, myocardial infarction, stroke or transient ischaemic attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding at 1 year.
- Results
- The primary outcome occurred in 138 patients (18.4%) with apixaban and 151 (20.1%) with standard of care (HR 0.92; 95% CI 0.73-1.16), with no treatment-by-stratum interaction (P interaction 0.57). In stratum 2, obstructive valve thrombosis was lower with apixaban than with antiplatelet therapy (HR 0.19; 95% CI 0.08-0.46).
- Safety
- The primary safety endpoint (major, disabling, or life-threatening bleeding) was similar between groups (HR 1.02; 95% CI 0.72-1.44). In stratum 2, a signal of higher non-cardiovascular mortality was observed with apixaban.
- Conclusion
- After TAVI, apixaban was not superior to standard of care, irrespective of an indication for oral anticoagulation.
- Why it matters
- It showed that replacing usual antithrombotic therapy with a direct oral anticoagulant gives no overall clinical benefit after TAVI, and reinforced caution with anticoagulation in patients lacking another indication.
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