Key result
The Phase III OCEANIC-AF trial was halted due to the inferior efficacy of the Factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation.
Why the study?
Following the early termination of the Phase III OCEANIC-AF trial due to inferior efficacy of asundexian versus apixaban, the future clinical role of FXIa inhibitors in patients with AF required re-evaluation.
What is the future position of Factor XIa inhibitors compared to standard treatment for patients with atrial fibrillation?
What is the future position of Factor XIa inhibitors compared to standard treatment for patients with atrial fibrillation?
Despite promising Phase II data showing reduced bleeding, the Phase III OCEANIC-AF trial was halted due to inferior efficacy of the Factor XIa inhibitor asundexian compared to apixaban in patients with atrial fibrillation.
Asundexian not noninferior to apixaban in AF; challenges Factor XIa inhibitors for this indication and leaves class role open.
Factor XIa (FXIa) may be involved in thrombus formation, but only to a lesser extent involved in haemostasis. Several novel FXIa inhibitors are under investigation, and Phase II trials demonstrated marked reduction of bleeding compared with standard treatment by factor Xa inhibitors. Asundexian is a small molecule that selectively inhibits FXIa. A large-scale Phase III clinical trial, OCEANIC-AF, has been initiated to compare the efficacy and safety between asundexian and apixaban. However, the OCEANIC-AF study was recently halted due to the inferior efficacy of asundexian versus the apixaban control arm. The present report describes up-to-date evidence of FXIa inhibitors and discusses the future position of FXIa inhibitors for patients with AF.
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Komiyama et al. (2024) conducted a review in Atrial Fibrillation. Factor XIa inhibitors (asundexian) vs. Factor Xa inhibitors (apixaban) was evaluated. The Phase III OCEANIC-AF trial was halted due to the inferior efficacy of the Factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation.
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