Department of Pharmacy, Internal Medicine, NYU Langone Health, 550 First Avenue, New York, NY, 10016, USA.
Department of Pharmacy, Internal Medicine & Anticoagulation, NYU Langone Health, 550 First Avenue, New York, NY, 10016, USA.
J Thromb Thrombolysis. 2018 Nov;46(4):466-472. doi: 10.1007/s11239-018-1723-1.
Idarucizumab, a fully humanized Fab antibody fragment, is indicated for reversal of dabigatran's anticoagulant activity. Idarucizumab neutralizes the anticoagulant effects of dabigatran by binding to dabigatran and its metabolite. In the full analysis of 503 patients, idarucizumab fully reversed the anticoagulant effect of dabigatran in more than 98% of patients. Real-world clinical experience with idarucizumab for dabigatran reversal remains limited. We report 11 real-world clinical cases in which idarucizumab was administered for dabigatran reversal in the setting of bleed (bleeding cohort n = 5) or emergent procedure (emergent procedure cohort, n = 6). Coagulation tests and clinical outcomes were assessed before and after idarucizumab administration. Clinical outcomes included thromboembolic events and hemostasis. The median (IQR) aPTT (seconds) before versus after idarucizumab was 40.4 (36.1) versus 27.3 (6.2) (bleeding cohort) and 50.1 (13.4) versus 26.5 (8.1) (emergent procedure cohort). The median (IQR) INR before and after idarucizumab was 2.0 (1.1) versus 1.2 (0.1) (bleeding cohort) and 1.1 (0.5) versus 1.1 (0.3) (emergent procedure cohort). Hemostasis was achieved in 4/5 patients in the bleeding cohort and 5/6 patients in the emergent procedure cohort. Thrombotic events occurred in four patients with a median time (IQR) from idarucizumab administration of 7.4 (4.3-14.7) days. Idarucizumab achieved adequate dabigatran reversal as evident by normalization of aPTT, INR, and achieving hemostasis. However, our data demonstrates a high thrombotic risk associated with dabigatran reversal with idarucizumab than previously reported.
依达鲁单抗是一种完全人源化的 Fab 抗体片段，用于逆转达比加群的抗凝活性。依达鲁单抗通过与达比加群及其代谢物结合来中和达比加群的抗凝作用。在对 503 名患者的全面分析中，依达鲁单抗在超过 98%的患者中完全逆转了达比加群的抗凝作用。依达鲁单抗逆转达比加群的真实世界临床经验仍然有限。我们报告了 11 例真实世界临床病例，在这些病例中，依达鲁单抗用于达比加群逆转出血（出血组 n=5）或紧急手术（紧急手术组，n=6）的情况。在依达鲁单抗给药前后评估了凝血试验和临床结局。临床结局包括血栓栓塞事件和止血。依达鲁单抗给药前和给药后的平均（IQR）aPTT（秒）分别为 40.4（36.1）比 27.3（6.2）（出血组）和 50.1（13.4）比 26.5（8.1）（紧急手术组）。依达鲁单抗给药前和给药后的平均（IQR）INR 分别为 2.0（1.1）比 1.2（0.1）（出血组）和 1.1（0.5）比 1.1（0.3）（紧急手术组）。在出血组的 4/5 例患者和紧急手术组的 5/6 例患者中实现了止血。在 4 例患者中发生了血栓事件，依达鲁单抗给药后的中位（IQR）时间为 7.4（4.3-14.7）天。依达鲁单抗通过 aPTT、INR 正常化和止血实现了足够的达比加群逆转。然而，我们的数据表明，与之前报道的相比，依达鲁单抗逆转达比加群与较高的血栓形成风险相关。
