Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity: Prespecified Subgroup Analysis of the ANNEXA-4 Study in Japan
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- Toyoda Kazunori
- Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center
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- Arakawa Shuji
- Department of Neurology, Steel Memorial Yawata Hospital
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- Ezura Masayuki
- National Hospital Organization Sendai Medical Center
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- Kobayashi Rei
- Department of Neurology, National Hospital Organization Nagoya Medical Center
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- Tanaka Yoshihide
- Yokosuka Kyosai Hospital
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- Hasegawa Shu
- Department of Neurosurgery, Japanese Red Cross Kumamoto Hospital
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- Yamashiro Shigeo
- Division of Neurosurgery, Department of Cerebrovascular Medicine and Surgery, Saiseikai Kumamoto Hospital
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- Komatsu Yoji
- Department of Neurosurgery, Hitachi General Hospital
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- Terasawa Yuka
- Brain Attack Center Ota Memorial Hospital
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- Masuno Tomohiko
- Nippon Medical School Hospital
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- Kobayashi Hiroshi
- Research and Development, Alexion, AstraZeneca Rare Disease
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- Oikawa Suzuko
- Research and Development, Bristol Myers Squibb
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- Yasaka Masahiro
- Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center
抄録
<p> Aims: Andexanet 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.</p><p>Methods: This 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.</p><p>Results: A 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.</p><p>Conclusion: Treatment 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.</p>
収録刊行物
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- Ｊｏｕｒｎａｌ ｏｆ Ａｔｈｅｒｏｓｃｌｅｒｏｓｉｓ ａｎｄ Ｔｈｒｏｍｂｏｓｉｓ
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Ｊｏｕｒｎａｌ ｏｆ Ａｔｈｅｒｏｓｃｌｅｒｏｓｉｓ ａｎｄ Ｔｈｒｏｍｂｏｓｉｓ 31 (3), 201-213, 2024-03-01
一般社団法人 日本動脈硬化学会