ArticleJournal of atherosclerosis and thrombosis2024
Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity: Prespecified Subgroup Analysis of the ANNEXA-4 Study in Japan.
Article in Journal of atherosclerosis and thrombosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Major Bleeding During Factor Xa Inhibitor Therapy: Lessons from the Pre-Andexanet Era in Japan.Journal of atherosclerosis and thrombosis · 2026Article
- Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank.Internal medicine (Tokyo, Japan) · 2026Article
- Residue‑resolved dynamically averaged interaction analysis of direct factor Xa inhibitors by MD‑FMO combination calculations.Journal of computer-aided molecular design · 2026Article
- Andexanet Alfa for Life-Threatening Bleeding Following Factor Xa Inhibitor Treatment: Postmarketing Surveillance Study in Japan.JACC. Asia · 2026Article
- Current Status of the Safety and Efficacy of Antidotes for Direct Oral Anticoagulants in Japan.JACC. Asia · 2026Article
- Controversies in Antithrombotic Therapy for Patients With Coronary Artery Disease and Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Literature Review.Clinical Medicine Insights. Cardiology · 2025Review
- Predictors of hematoma expansion in intracerebral hemorrhage associated with factor Xa inhibitors.Frontiers in neurology · 2025Article
- Visualized Efficacy of Andexanet Alfa in an Elderly Trauma Patient with an Unstable Pelvic Fracture.JMA journal · 2024Article
- Real-World Safety and Effectiveness of a 4-Factor Prothrombin Complex Concentrate in Japanese Patients Experiencing Major Bleeding: A Post-marketing Surveillance Study.Cardiology and therapy · 2024Article
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Authors and funding
13 authors.
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Abstract
aimsAndexanet alfa, a specific antidote to factor Xa (FXa) inhibitors, has been approved for clinical use in several countries, including Japan, based on the results from the phase 3 trial ANNEXA-4. We aimed to assess the efficacy and safety of andexanet alfa treatment in FXa inhibitor-related acute major bleeding in patients enrolled for ANNEXA-4 in Japan.
methodsThis prespecified analysis included patients enrolled at Japanese sites in the prospective, open-label, single-arm ANNEXA-4 trial. Eligible patients had major bleeding within 18 hours of oral FXa inhibitor administration. The coprimary efficacy endpoints were percent change in anti-FXa activity and proportion of patients achieving excellent or good hemostatic efficacy 12 hours post-treatment.
resultsA total of 19 patients were enrolled, all of whom had intracranial hemorrhage; 16 patients were evaluable for efficacy. Median percent reduction in anti-FXa activity from baseline to nadir was 95.4% in patients taking apixaban, 96.1% in patients taking rivaroxaban, and 82.2% in patients taking edoxaban. Overall, 14/16 patients (88%) achieved excellent or good hemostasis (apixaban, 5/5; rivaroxaban, 6/7; edoxaban, 3/4). Within 30 days, treatment-related adverse events (AEs) and serious AEs occurred in 2 and 5 patients, respectively. One patient died during follow-up, and 2 patients experienced thrombotic events.
conclusionTreatment with andexanet alfa rapidly reduced anti-FXa activity with favorable hemostatic efficacy in Japanese patients with acute major bleeding. Serious AEs of thrombotic events during rapid reversal of anti-FXa activity arose as particular safety concerns in this population as with previous studies.
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