Objective
to compare catheter-based left atrial appendage closure to physician-directed best medical care (including oral anticoagulants if eligible) in patients with atrial fibrillation at a high risk of stroke and bleeding
Study
prospective, multicentre, randomised non-inferiority trial (margin HR 1.3)
Population
patients with non-valvular AF, CHA2DS2-VASc 2, high bleeding risk (HAS-BLED ≥3, prior major bleeding event (BARC ≥3), CKD with eGFR 15-29mL/min/1.73m2)
Endpoints
composite of stroke (ischaemic or haemorrhagic), systemic embolism, cardiovascular or unexplained death, and major bleeding (BARC ≥3) at 3 years
Conclusion
In patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure did not demonstrate non-inferiority to physician-directed best medical care in terms of a composite endpoint of stroke, systemic embolism, major bleeding, or cardiovascular/unexplained death.
Landmesser et al. N Engl J Med. 2026 Apr 2.