OCEANIC-AF
Oral Factor XIa Inhibitor Asundexian versus Apixaban in Patients With Atrial Fibrillation
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 14,810 patients with atrial fibrillation at high stroke risk, asundexian was inferior for prevention of stroke or systemic embolism compared with apixaban.
N
14.810
Design
Phase 3 double-blind double-dummy active-controlled RCT, stopped early for inferiority
Endpunkt
Stroke or systemic embolism
Relevanz
3
Ergebnis1.3% vs 0.4% (HR 3.79, 95% CI 2.46-5.83); asundexian inferior to apixaban. Major bleeding lower with asundexian (HR 0.32, 95% CI 0.18-0.55). Trial stopped early.
Piccini JP, et al. N Engl J Med. 2025;392(1):23-32. 10.1056/NEJMoa2407105
Diskussion & Kritik
Possible underdosing of asundexian may have contributed to inferior efficacy, leaving the factor XIa hypothesis unresolved. Halted development of asundexian for stroke prevention in AF.