Asundexian Versus Apixaban in Patients With Atrial Fibrillation

ABSTRACT Background Anticoagulation therapy is central to the prevention of thromboembolic disorders but is limited by bleeding complications associated with traditional agents such as warfarin and direct oral anticoagulants (DOACs). Factor XIa inhibition has emerged as a novel strategy aimed at reducing thrombotic risk while preserving hemostasis. Asundexian, a selective Factor XIa inhibitor, represents a promising advancement in this evolving therapeutic landscape. Methods This narrative review synthesizes available preclinical and clinical evidence on Asundexian, with a focus on its pharmacological mechanism, efficacy, safety profile, and potential clinical applications. Key data from major clinical trials, including PACIFIC‐AF and PACIFIC‐STROKE, were reviewed to evaluate its role in contemporary anticoagulation therapy. Results Clinical trial evidence indicates that Asundexian effectively reduces the incidence of stroke and systemic embolism in patients with atrial fibrillation and those at risk of recurrent ischemic stroke. Importantly, these benefits are achieved with a lower risk of major bleeding compared to conventional anticoagulants. Asundexian's fixed dosing regimen, oral administration, and lack of routine coagulation monitoring enhance treatment convenience and patient adherence. Emerging data also suggest potential applicability in other conditions requiring long‐term anticoagulation, such as venous thromboembolism and acute coronary syndrome. Conclusion Asundexian offers a novel and potentially safer approach to anticoagulation by selectively targeting Factor XIa, balancing thromboembolic protection with reduced bleeding risk. While early clinical results are encouraging, further large‐scale and long‐term studies are required to establish its safety and efficacy across diverse patient populations. Asundexian has the potential to redefine standards of care in anticoagulation therapy and improve patient outcomes.