- Question
- In patients with atrial fibrillation at high risk of stroke and bleeding, is percutaneous left atrial appendage closure noninferior to physician-directed best medical care?
- Design
- Multicenter, randomized, open-label (no masking) trial conducted in Germany, with 912 patients randomized. Median follow-up was 3 years (interquartile range, 1.7 to 4.7).
- Population
- Adults with atrial fibrillation and a high risk of both stroke and bleeding. Mean age was 77.9±7.1 years, 38.6% were women, mean CHA2DS2-VASc score was 5.2±1.5, and mean HAS-BLED score was 3.0±0.9.
- Intervention
- Left atrial appendage closure with CE-marked devices, followed by post-procedural antiplatelet therapy.
- Control
- Physician-directed best medical care, including direct oral anticoagulants (if eligible) or vitamin K antagonists, without appendage closure.
- Primary outcome
- Composite of stroke (ischemic or hemorrhagic), systemic embolism, major bleeding, or cardiovascular or unexplained death, analyzed as time to first event and tested for noninferiority with a hazard ratio margin of 1.3.
- Results
- A first primary end-point event occurred in 155 patients in the device group (incidence 16.8 per 100 patient-years) and in 127 in the medical-therapy group (13.3 per 100 patient-years); difference in restricted mean survival time, -0.36 years (95% CI, -0.70 to -0.01; P = 0.44 for noninferiority).
- Safety
- Serious adverse events occurred in 368 patients (82.5%) in the device group and in 342 (77.4%) in the medical-therapy group.
- Conclusion
- Left atrial appendage closure was not noninferior to best medical care for the composite of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death.
- Why it matters
- It challenges the use of percutaneous appendage closure as an alternative to anticoagulation in patients at high risk of stroke and bleeding, and underscores the value of optimized medical therapy in this group.
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 21, 2026