Department of Vascular Neurology, University Medical Center Ljubljana, Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, Zaloška 2, 1000, Ljubljana, Slovenia.
CNS Drugs. 2024 Mar;38(3):163-168. doi: 10.1007/s40263-024-01071-6. Epub 2024 Feb 23.
Andexanet alfa is a specific reversal agent for factor Xa inhibitors with immediate reversal of their anticoagulant effect. Andexanet alfa is currently approved for use in patients treated with rivaroxaban and apixaban who have life-threatening or uncontrolled bleeding. New data from both controlled clinical trials and real-world experience are continuously being published, providing greater insight into the clinical characteristics of the drug, such as efficacy and safety. It is worth considering that andexanet alfa could be of benefit in a variety of different clinical scenarios where patients receiving treatment with apixaban and rivaroxaban (and endoxaban) have life-threatening conditions. These different clinical scenarios, which range from pre-treatment of urgent surgery, especially neurosurgical interventions, and concomitant use of andexanet alfa and prothrombin complex concentrate to onset of bleeding more than 6 h prior to admission, should be clarified as well as the issue of "low/high" dose of andexanet alfa and the need for baseline anti-Xa inhibitor levels measured by point-of-care testing. Finally, management of patients at high risk of thrombosis or recent arterial/venous thrombotic events needs to be further explored. In this current opinion, we address these urgent questions in the light of recent literature and clinical trial data.
依达赛珠单抗是一种针对 Xa 因子抑制剂的特效逆转剂，能即刻逆转其抗凝作用。依达赛珠单抗目前被批准用于接受利伐沙班和阿哌沙班治疗且有生命危险或不受控制的出血的患者。来自对照临床试验和真实世界经验的新数据不断发表，为药物的临床特征（如疗效和安全性）提供了更深入的了解。值得考虑的是，在各种不同的临床情况下，依达赛珠单抗可能对接受阿哌沙班和利伐沙班（和依度沙班）治疗的患者有益，这些情况包括有生命危险的疾病需要紧急手术治疗（尤其是神经外科手术），以及依达赛珠单抗和凝血酶原复合物浓缩物的同时使用，或出血发生在入院前 6 小时以上。应明确依达赛珠单抗的“低/高”剂量问题以及使用即时检测（point-of-care testing）测量基线 Xa 抑制剂水平的问题。最后，需要进一步探讨有高血栓形成风险或近期动脉/静脉血栓形成事件的患者的管理问题。在本当前观点中，我们根据最近的文献和临床试验数据来解答这些紧迫的问题。
