OCEANIC-AF: Asundexian Fails Stroke Prevention Versus Apixaban

This phase 3 trial demonstrates that the factor XIa inhibitor asundexian at 50 mg once daily is substantially inferior to apixaban for stroke prevention in atrial fibrillation, despite lower bleeding, closing the door on this dose and challenging the factor XIa-in-AF hypothesis.

asundexianapixabanfactor XIa inhibitordirect oral anticoagulantatrial fibrillationstroke preventionanticoagulationOCEANIC-AFbleedingphase 3 trial Cardiology / Anticoagulation

Background Information

Asundexian falls short on stroke prevention in AFib but cuts bleeding.

There is a need for effective stroke prevention with reduced bleeding risk in atrial fibrillation (AFib). Asundexian showed higher stroke or systemic embolism rates but fewer major bleeds compared to apixaban. The study suggests that while asundexian reduces bleeding, its lower efficacy for stroke prevention in AFib limits its use compared to apixaban. Asundexian offers less stroke protection but fewer bleeds than apixaban in AFib.

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Authors: Piccini JP, Patel MR, Steffel J, Ferdinand K, Van Gelder IC, Russo AM, Ma CS, Goodman SG, Oldgren J, Hammett C, Lopes RD, Akao M, De Caterina R, Kirchhof P, Gorog DA, Hemels M, Rienstra M, Jones WS, Harrington J, Lip GYH, Ellis SJ, Rockhold FW, Neumann C, Alexander JH, Viethen T, Hung J, Coppolecchia R, Mundl H, Caso V, OCEANIC-AF Steering Committee and Investigators

Citation: Piccini JP, Patel MR, Steffel J, et al. Asundexian versus Apixaban in Patients with Atrial Fibrillation. The New England journal of medicine. 2025;392(1):23-32. doi:10.1056/NEJMoa2407105

Article Links: PubMed · Journal / DOI

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Executive Summary

Study Design

Patient Population

Primary Outcomes

Secondary Outcomes & Safety Profile

Pharmacist Implications

Clinical Pearls

Limitations

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Cost & Logistics

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