Atrial fibrillation (AF) is a complex condition in which patients often present with multiple comorbidities, including high bleeding risk. Percutaneous left atrial appendage occlusion (LAAO) is proposed as an alternative to oral anticoagulation (OAC); however, large-scale studies directly comparing it with contemporary medical therapy, including direct oral anticoagulants (DOACs), were lacking.
The CLOSURE-AF study was a randomized (1:1) trial comparing percutaneous LAAO with best available medical therapy (including DOACs when indicated). It included a total of 912 very high-risk patients, defined by CHA₂DS₂-VASc >2 and high bleeding risk (HAS-BLED >3, prior major or intracranial bleeding, chronic kidney disease with clearance 15–29 mL/min, among others). The median follow-up was approximately 3 years.
The primary endpoint (PEP) was time to occurrence of stroke (either ischemic or hemorrhagic), systemic embolism, cardiovascular or unexplained death, or major bleeding (BARC >3).
LAAO did not meet the noninferiority criterion versus medical therapy. Moreover, it showed a higher risk of the composite endpoint, mainly driven by an increase in embolic events.
Conclusions
In this elderly, high-risk population, LAAO did not demonstrate clinical equivalence to optimized medical therapy and was associated with worse outcomes in the composite endpoint.
Presented by Ulf Landmesser during the Late-Breaking Science session at AHA 2025, New Orleans, USA.
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