Duke University School of Medicine, Durham, NC.
Boehringer Ingelheim International GmbH, Biberach, Germany.
Ann Surg. 2021 Sep 1;274(3):e204-e211. doi: 10.1097/SLA.0000000000003638.
To further examine anticoagulation reversal and clinical outcomes in dabigatran treated patients requiring urgent surgery or procedural interventions.
Idarucizumab, a humanized monoclonal antibody fragment, reverses dabigatran anticoagulation.
Data from surgical and procedural patients in RE-VERSE AD, a multicenter, open-label, single-arm, prospective cohort of dabigatran reversal were evaluated. A total of 202 patients in this group received 5 g of idarucizumab before surgery or procedures.
The interventions included 49 abdominal, 45 orthopedic, 34 vascular, 8 neurologic, and 4 genitourinary surgical procedures, or 29 catheter-based cases, 20 cases for drainage, and 8 diagnostic procedures. Five patients did not undergo their intended intervention after receiving idarucizumab. Complete reversal of the dabigatran anticoagulant effect occurred within minutes in almost all patients, with normal hemostasis in more than 91% of patients. The median time from the first vial of idarucizumab to surgery or procedures was less than 2 hours in all groups except neurosurgery, where it was 3.3 hours. Fresh frozen plasma and packed red cells were the most frequently transfused blood products. Postreversal thromboembolic events occurred in 10 (5%) patients at 30 days, 5 of whom had restarted anticoagulation before the event. Overall 30-day mortality was 12.6%. There were no serious adverse safety signals due to idarucizumab dosing.
Idarucizumab facilitates management of patients requiring urgent procedures by providing rapid dabigatran reversal, and is the only agent of its class studied in surgical patients.
进一步研究达比加群酯治疗患者在紧急手术或操作介入时的抗凝逆转和临床结局。
Idarucizumab 是人源化单克隆抗体片段，可逆转达比加群酯的抗凝作用。
评估了多中心、开放标签、单臂、前瞻性达比加群酯逆转队列研究 RE-VERSE AD 中手术和操作患者的数据。该组共有 202 名患者在手术或操作前接受了 5g 的idarucizumab。
干预措施包括 49 例腹部手术、45 例矫形手术、34 例血管手术、8 例神经科手术和 4 例泌尿生殖系统手术，或 29 例基于导管的病例、20 例引流病例和 8 例诊断性操作。5 名患者在接受idarucizumab 后未进行预期的干预。几乎所有患者在数分钟内即可完全逆转达比加群酯的抗凝作用，超过 91%的患者止血正常。除神经外科外，所有组从第一瓶 idarucizumab 到手术或操作的中位时间均不到 2 小时，神经外科为 3.3 小时。新鲜冷冻血浆和浓缩红细胞是最常输注的血液制品。10 名（5%）患者在 30 天时发生了血栓栓塞事件，其中 5 名在事件发生前已重新开始抗凝治疗。总体 30 天死亡率为 12.6%。idarucizumab 剂量未出现与安全性相关的严重不良事件信号。
idarucizumab 通过提供快速达比加群酯逆转，为需要紧急手术的患者提供了便利的管理，并成为唯一在手术患者中研究的此类药物。
