Innovative method to manage high-risk AF under investigation

Is medical therapy still the best option for patients with atrial fibrillation (AF) who are at high risk of both bleeding and stroke? A group of researchers investigated an alternative approach for managing these patients.  

The CLOSURE-AF trial (NCT03463317) randomised 912 participants (mean age 79.1 years) with AF at high risk for both stroke and bleeding in a 1:1 ratio to catheter-based left atrial appendage closure (LAAC) or physician-directed best medical care. “Physicians were asked to keep antithrombotic treatment short in the LAAC arm,” explained Prof. Ulf Landmesser (Charité University of Medicine Berlin, Germany). “In the investigational arm, 3 months of dual antiplatelet therapy (DAPT) was recommended for participants at high-bleeding risk, and aspirin was to be discontinued after 6 months unless there was another clear indication.” In the best medical care arm, treatment with direct oral anticoagulants (DOACs) was recommended. The primary endpoint was a composite of stroke, systemic embolism, cardiovascular or unexplained death, or major bleeding (BARC ≥3), tested for non-inferiority.

“About 80% of the participants in the LAAC arm received DAPT around the time of implantation,” said Prof. Landmesser. “This rate dropped to approximately 20% at 3 months and 1 week.” In the best medical care arm, nearly 90% of the participants received a DOAC, with or without dual or single antiplatelet therapy.

Procedural complications included periprocedural pericardial tamponade in 5 participants and major bleeding requiring transfusion in 18 participants within 7 days of the procedure in the LAAC arm. At a median follow-up of 3 years, the non-inferiority criterion was not met. The primary outcome occurred in 16.83% of the participants in the LAAC arm versus 13.27% in the best medical care arm (adjusted HR 1.28; 95% CI 1.01-1.62; non-inferiority P=0.44). Analysis of the individual components of the composite outcome did not indicate a specific increase in either ischaemic or bleeding events in the LAAC arm, but rather a moderate increase across several of the selected events.

“LAAC was associated with a higher risk of the composite outcome of ischaemic events, bleeding, and death in these elderly, high-risk AF patients,” concluded Prof. Landmesser.

1. Landmesser U, et al. CLOSURE-AF: left atrial appendage closure in patients with atrial fibrillation at high risk of stroke and bleeding compared to medical therapy. AHA scientific sessions 2025, 7-10 November, New Orleans, LA, USA.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 11 November 20255 December 2025