Hopes of a bright new future in stroke risk management in AF were dashed when asundexian failed against apixaban in the OCEANIC-AF trial, but is the concept of factor XI inhibition over? Experts discuss.
with the promise of a reduction in thrombotic risk without a significant increase in bleeding. The early phase 2 data were encouraging, and the trials in orthopedic patients looked good., trial comparing the novel factor XI inhibitor asundexian vs the direct-acting oral anticoagulant apixaban in patients with atrial fibrillation was stopped early for futility.
Coupled with a projected increase in the prevalence of atrial fibrillation and in the incidence of stroke over the next 20 years, “the opportunity is huge,” he said. This, he explained, is because factor XI is primarily involved with hemostatic thrombus formation via the tissue factor pathway but is not involved to a significant degree in the development of pathologic thrombi.
The patients who took asundexian had a several-fold higher risk for ischemic stroke. “The entire reason we give these medications is to prevent ischemic stroke, so…at least at this dose, in this population, the medication cannot effectively achieve its therapeutic goal.” Gragnano said the finding is “interesting,” although “it is not really clear why this should be the case.” From a biologic perspective, he added, “it is difficult to explain.”
AF Afib A-Fib Afib Afib Atrial Fib Atrial Fibrillation (AF) Atrial Fibrillation (A-Fib) Anticoagulation Therapy Anticoagulant Anticoagulation Thromboembolism Stroke Cerebrovascular Accident CVA Cerebrovascular Accident (CVA) Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study
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