Among patients with atrial fibrillation, oral anticoagulants remain a standard strategy for stroke prevention, but their long-term use is frequently linked with an increased risk of bleeding.
In atrial fibrillation, left atrial appendage closure offers comparable efficacy to NOACs with fewer non–procedure-related bleeding events.
Among patients with atrial fibrillation, oral anticoagulants remain a standard strategy for stroke prevention, but their long-term use is frequently linked with an increased risk of bleeding. Device-based left atrial appendage closure has emerged as an alternative for those unable to tolerate chronic anticoagulation; however, its comparative potency in patients eligible for anticoagulant therapy has not been fully clarified. This randomized trial aimed to fill this gap.
This international, prospective study evaluated atrial fibrillation sufferers who were ideal candidates for oral anticoagulation. Subjects were randomized in a 1:1 ratio:
The key efficacy endpoint was a composite of cardiovascular death, stroke, or systemic embolism, assessed for noninferiority after 3 years using a predefined margin of 4.8 percentage points. The primary safety outcome was non–procedure-related bleeding, checked for superiority.
A total of 3000 patients underwent randomization, with 1499 assigned to the device-based closure group and 1501 to the NOAC therapy group. The mean age was 71.7±7.5 years, women represented 31.9% of participants, and the average CHA2DS2-VASc score was 3.5±1.3. At 3 years, the key efficacy outcome occurred in 81 subjects in the device group (Kaplan–Meier estimate, 5.7%) and 65 subjects in the anticoagulation group (Kaplan–Meier estimate, 4.8%), illustrating noninferiority for device-based therapy (difference, 0.9 percentage points). Non–procedure-related bleeding was markedly lower in the device group, impacting 154 patients (10.9%) vs. 260 patients (19.0%) in the NOAC group (hazard ratio, 0.55).
For those with atrial fibrillation eligible for anticoagulation, device-based left atrial appendage closure provided stroke prevention outcomes comparable to NOAC therapy while reducing non–procedure-related bleeding over 3 years. These findings support it as a promising alternative to long-term oral anticoagulation in appropriately selected patients with atrial fibrillation.
The New England Journal of Medicine
Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation
Shephal K. Doshi et al.
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