OCEANIC-AF
Trial question
Is asundexian noninferior to apixaban in patients with AF at risk of stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 14810
14810 patients (5214 female, 9596 male).
Inclusion criteria: adult patients with AF at risk of stroke.
Key exclusion criteria: mechanical heart valve prosthesis; moderate-to-severe MS; AF due to reversible causes; recent AIS; active bleeding, chronic bleeding disorder, or history of non-traumatic ICH; significant liver disease.
Interventions
N=7415 asundexian (at an oral dose of 50 mg daily).
N=7395 apixaban (at an oral dose of 5 mg BID).
Primary outcome
Stroke or systemic embolism
1.3%
0.4%
1.3 %
1.0 %
0.7 %
0.3 %
0.0 %
Asundexian
Apixaban
Significant
increase ▲
NNH = 111
Significant increase in stroke or systemic embolism (1.3% vs. 0.4%; HR 3.79, 95% CI 2.46 to 5.83).
Secondary outcomes
Significant increase in AIS or systemic embolism (1.3% vs. 0.3%; HR 4.38, 95% CI 2.76 to 6.96).
No significant difference in death from any cause (0.8% vs. 1%; HR 0.84, 95% CI 0.6 to 1.19).
Significant increase in AIS (1.1% vs. 0.3%; HR 4.06, 95% CI 2.52 to 6.54).
Safety outcomes
No significant difference in adverse events.
Significant difference in major bleeding (0.2% vs. 0.7%).
Conclusion
In adult patients with AF at risk of stroke, asundexian was inferior to apixaban with respect to stroke or systemic embolism.
Reference
Jonathan P Piccini, Manesh R Patel, Jan Steffel et al. Asundexian versus Apixaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 2;392(1):23-32.
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