Why the study?
While DOACs carry bleeding risks and leave many AF patients undertreated, novel FXI inhibitors offer potential stroke prevention with lower bleeding risk, though their efficacy remains uncertain across recent trials.
Do Factor XI inhibitors reduce thromboembolic events while minimizing bleeding risks compared to DOACs in patients with atrial fibrillation?
Design
Review
Key result
The phase III OCEANIC-AF trial was terminated early because the Factor XI inhibitor asundexian significantly increased the risk of stroke or systemic embolism (HR 3.79) compared to apixaban in patients with atrial fibrillation.
Authors
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Clinicians should avoid asundexian in AF; challenges Factor XI inhibitor efficacy versus DOACs and leaves other agents' trials open.
Do Factor XI inhibitors reduce thromboembolic events while minimizing bleeding risks compared to DOACs in patients with atrial fibrillation?
Effect estimate: HR 3.79 (95% CI 2.46-5.83)
Factor XI inhibitors offer a promising approach to uncouple thrombosis from hemostasis with lower bleeding risks, but their efficacy for stroke prevention in atrial fibrillation remains uncertain pending ongoing phase III trials.
Falama et al. (2026) conducted a review in Atrial Fibrillation (n=14,810). Asundexian vs. Apixaban was evaluated on Incidence of stroke or systemic embolism (HR 3.79, 95% CI 2.46-5.83). The phase III OCEANIC-AF trial was terminated early because the Factor XI inhibitor asundexian significantly increased the risk of stroke or systemic embolism (HR 3.79) compared to apixaban in patients with atrial fibrillation.