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Asundexian was inferior to apixaban with respect to stroke prevention in patients with atrial fibrillation (AF) and an increased risk for stroke, results of the large OCEANIC-AF trial demonstrated.

“Although direct oral anticoagulants [DOACs] are accepted as first-line therapy for patients with AF, patients treated with DOACs still face a bleeding risk for 2.7–3.5% per year,” explained Dr. Manesh Patel, MD, from the Duke Clinical Research Institute, in NC, US. Undertreatment, underdosing, and poor treatment compliance are other challenges linked to treatment with DOACs. The OCEANIC-AF trial (NCT05643573) compared the factor XIa inhibitor asundexian (50 mg, once daily) to the established DOAC apixaban in a large population of patients with AF at risk for stroke or systemic embolism (n=14,830). Although the planned sample size was 18,000, the trial was terminated early due to inferiority of the investigational agent in the primary efficacy endpoint of stroke/systemic embolism.

After a median follow-up of 160 days, the rate of stroke/systemic embolism was 1.3% in the asundexian arm versus 0.4% in the apixaban arm (HR 3.79; 95% CI 2.46–5.83). ISTH major bleeding appeared to be less common among participants treated with asundexian than among those treated with apixaban (0.2% vs 0.7%; csHR 0.32; 95% CI 0.18-0.55).

The OCEANIC-AF study revealed that asundexian was inferior to apixaban for the prevention of stroke and systemic embolism in a population of patients with AF and a high risk for stroke.

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