- Question
- In high-risk patients with atrial fibrillation, is percutaneous left atrial appendage closure noninferior to direct oral anticoagulants (DOACs)?
- Design
- Multicenter, randomized, open-label, noninferiority trial comparing left atrial appendage closure (LAAC) with DOACs; primary analysis by modified intention to treat, with a median follow-up of 19.9 months.
- Population
- Patients with nonvalvular atrial fibrillation indicated for oral anticoagulation and a history of bleeding requiring intervention or hospitalization, a cardioembolic event while on anticoagulation, and/or CHA2DS2-VASc ≥3 together with HAS-BLED >2. High-risk cohort (CHA2DS2-VASc: 4.7 ± 1.5).
- Intervention
- Percutaneous left atrial appendage closure (201 patients); the procedure was successful in 181 of 201 (90.0%).
- Control
- DOAC therapy (201 patients), mostly apixaban (192 of 201; 95.5%).
- Primary outcome
- Composite of stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure- or device-related complications.
- Results
- Annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (sHR 0.84; 95% CI 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There was no difference in all-stroke/TIA (sHR 1.00; 95% CI 0.40 to 2.51).
- Safety
- Major LAAC-related complications occurred in 9 (4.5%) patients. Clinically significant bleeding did not differ between groups (sHR 0.81; 95% CI 0.44 to 1.52).
- Conclusion
- In patients at high risk for stroke and bleeding, LAAC was noninferior to DOACs in preventing major AF-related cardiovascular, neurological, and bleeding events.
- Why it matters
- It provided randomized evidence that appendage closure is a reasonable alternative to DOACs in high-risk patients, broadening options for those with bleeding or events despite anticoagulation.
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