Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation.
Summary
In CLOSURE-AF, catheter-based left atrial appendage closure did not achieve noninferiority to physician-directed best medical therapy for a composite of stroke, systemic embolism, major bleeding, or cardiovascular/unexplained death in high-risk AF. Findings question routine device use over optimized medical therapy in this population.
Key Findings
- Multicenter German RCT (n=912) comparing LAA closure vs physician-directed best medical care in high-risk AF
- Primary composite (stroke, systemic embolism, major bleeding, CV/unexplained death) did not meet noninferiority for LAA closure
- Time-to-event noninferiority margin prespecified as HR 1.3; trial registered (NCT03463317)
Clinical Implications
Prioritize optimized, guideline-directed medical therapy (including DOACs when eligible) for stroke prevention in high-risk AF; reserve LAA closure for carefully selected cases with clear contraindications to anticoagulation after multidisciplinary discussion.
Why It Matters
A large multicenter RCT in NEJM provides definitive comparative effectiveness data, showing LAA closure is not noninferior to medical therapy in high-risk AF. This challenges expanding device indications and may recalibrate guidelines and payer policies.
Limitations
- Abstract does not report detailed subgroup or procedural complication data
- Generalizability may be influenced by regional practice patterns and evolving device technology
Future Directions
Define subgroups (e.g., absolute anticoagulation intolerance) who might benefit from LAA closure; evaluate newer-generation devices and periprocedural strategies in adequately powered, pragmatic trials.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial providing high-level evidence
- Study Design
- OTHER