Internal Vascular and Emergency Medicine and Stroke Unit, University of Perugia, Via G Dottori 1, 06129, Perugia, Italy.
J Thromb Thrombolysis. 2017 Nov;44(4):527-535. doi: 10.1007/s11239-017-1555-4.
Major bleeding occurs in about 4% of patients while on treatment with direct oral anticoagulants (DOACs). The case-fatality rate associated with these events is estimated to be about 5%. The specific roles of antidotes, when used with DOACs in reducing the case fatality or improving the overall clinical course of these events, are not thoroughly understood. To this regard, the US Food and Drug Administration as well as European Medicines Agency have recently licensed idarucizumab for the management of patients with life-threatening bleeding or the need for urgent surgery/procedures while on treatment with dabigatran. Specifically, idarucizumab is a humanized monoclonal antibody fragment that rapidly reverses the anticoagulant effect of dabigatran. Two other antidotes, andeXanet and ciraparantag are currently under evaluation for reversal of DOACs. Here, we report on the use of idarucizumab in two patients who experienced life-threatening bleeding while on treatment with dabigatran for atrial fibrillation and provide a review highlighting the need for antidotes use with DOACs.
在使用直接口服抗凝剂 (DOACs) 治疗的过程中，约有 4%的患者会发生大出血。这些事件相关的病死率估计约为 5%。在减少这些事件的病死率或改善整体临床病程方面，解毒剂与 DOACs 联合使用的确切作用尚未得到充分了解。在这方面，美国食品和药物管理局以及欧洲药品管理局最近批准了idarucizumab 用于治疗因生命受到威胁的出血或需要紧急手术/程序而正在接受达比加群治疗的患者。具体来说，idarucizumab 是一种人源化单克隆抗体片段，可迅速逆转达比加群的抗凝作用。另外两种解毒剂 andeXanet 和 ciraparantag 目前正在评估用于逆转 DOACs 的作用。在这里，我们报告了idarucizumab 在两名因心房颤动而接受达比加群治疗时发生危及生命的出血的患者中的应用，并回顾强调了在 DOACs 治疗中使用解毒剂的必要性。
