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Evaluating the Safety and Efficacy of Asundexian in Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Clin Appl Thromb Hemost
July 2025
School of Medicine, The Maldives National University, Malé, Maldives.
BackgroundThromboembolic events remain a major cause of morbidity and mortality in cardiovascular diseases, particularly myocardial infarction, atrial fibrillation (AF), and ischemic stroke. While standard anticoagulants reduce these events, their use is limited by bleeding risks. Asundexian, a Factor XIa inhibitor, has emerged as a potential agent to prevent thrombosis while preserving hemostasis.
View Article and Find Full Text PDFSafety of factor XI inhibitors compared to factor X inhibitors in atrial fibrillation: a systematic review and meta-analysis.
J Thromb Thrombolysis
July 2025
Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, UK.
Atrial fibrillation (AF) increases the risk of ischemic stroke (IS) and systemic embolism, necessitating thromboprophylaxis with direct oral anticoagulants (DOAC), which increase bleeding. Drugs that inhibit factor XI (FXI) have been developed to provide thromboprophylaxis with lower bleeding risk. We performed a systematic review and meta-analysis of randomised controlled trials comparing FXI inhibitors versus DOAC in patients with AF, reporting primary outcomes of International Society of Thrombosis and Haemostasis (ISTH) major bleeding or clinically relevant non-major bleeding (CRNMB), and exploratory outcomes of ischaemic stroke (IS), intracranial hemorrhage (ICH) and death.
View Article and Find Full Text PDFAnticoagulation in Atrial Fibrillation: Is a Paradigm Shift From Xa to XIa Inhibitors on the Horizon?
Cardiol Rev
May 2025
From the Internal Medicine Department, Conemaugh Memorial Medical Center, Johnstown, PA.
Atrial fibrillation constitutes a substantial global health issue, with its prevalence expected to increase significantly in the coming years. The effective management of atrial fibrillation, particularly regarding the prevention of ischemic stroke and systemic embolism, has progressed with the introduction of direct oral anticoagulants, which have shown a reduction in bleeding risks when compared to warfarin. The oral factor Xa inhibitors, such as apixaban and rivaroxaban, are considered the first line for anticoagulation in cases of atrial fibrillation.
View Article and Find Full Text PDFAn External Control Arm for the Oral Factor XIa Inhibitor Asundexian Phase 2 Trial in Atrial Fibrillation (PACIFIC-AF) Using Electronic Health Records.
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September 2025
Medical Affairs and Pharmacovigilance, Bayer AG, Berlin, Germany.
Introduction: The aim of this study was to assess the applicability of an external control arm (ECA) approach in the clinical development of the oral factor XIa inhibitor asundexian for stroke prevention in patients with atrial fibrillation (AF), using prospectively collected data from the phase 2 PACIFIC-AF trial (NCT04218266) and real-world individual-level data from patients with AF treated with apixaban in the Optum de-identified Electronic Health Record data set (Optum EHR) 2013-2019.
Methods: To build ECAs, real-world patients meeting trial eligibility criteria were matched to patients enrolled in PACIFIC-AF. The primary outcome was the composite of International Society on Thrombosis and Haemostasis-defined major bleeding or clinically relevant non-major bleeding.