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Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany-Updated series of 120 cases.
International Journal of Stroke ( IF 6.7 ) Pub Date : 2020-01-19 , DOI: 10.1177/1747493019895654
Pawel Kermer 1 , Christoph C Eschenfelder 2 , Hans-Christoph Diener 3 , Martin Grond 4 , Yasser Abdalla 5 , Alexej Abraham 6 , Katharina Althaus 7 , Gebhard Becks 8 , Jörg Berrouschot 9 , Jörg Berthel 10 , Felix J Bode 11, 12 , Lothar Burghaus 13 , Hakan Cangür 14 , Michael Daffertshofer 15 , Sebastian Edelbusch 16 , Jürgen Eggers 17 , Rüdiger Gerlach 18 , Klaus Gröschel 19 , Florian Große-Dresselhaus 16 , Albrecht Günther 20 , Claus G Haase 21 , Carl-Albrecht Haensch 22 , Andreas Harloff 23 , Joseph G Heckmann 24 , Valentin Held 25 , Maren Hieber 23 , Andreas Kauert 6 , Rolf Kern 26 , Thomas Kerz 27 , Martin Köhrmann 3 , Peter Kraft 28, 29 , Peter Kühnlein 30 , Jan Latta 31 , Elke Leinisch 32 , Arne Lenz 33 , Christoph Leithner 34 , Tobias Neumann-Haefelin 10 , Mathias Mäurer 35 , Wolfgang Müllges 29 , Christian H Nolte 36 , Mark Obermann 37 , Someieh Partowi 38 , Peer Patzschke 39 , Sven Poli 40 , Ulrich Pulkowski 41 , Jan Purrucker 42 , Torsten Rehfeldt 43 , Peter A Ringleb 42 , Joachim Röther 44 , Raluca Rossi 45 , Hazem El-Sabassy 46 , Oliver Sauer 47 , Gabriele Schackert 48 , Niklas Schäfer 11 , Peter D Schellinger 49 , Andreas Schneider 21 , Ramona Schuppner 50 , Stefan Schwab 51 , Olav Schwarte 52 , Rüdiger J Seitz 53 , Sebastian Senger 54 , Yogesh P Shah 55 , Eckhart Sindern 56 , Paul Sparenberg 57 , Thorsten Steiner 58 , Kristina Szabo 25 , Christian Urbanek 59 , Bettina von Sarnowksi 60 , Karin Weissenborn 50 , Peter Wienecke 61 , Karsten Witt 62 , Robert Wruck 15 , Silke Wunderlich 63
Affiliation  

BACKGROUND Idarucizumab is a monoclonal antibody fragment with high affinity for dabigatran reversing its anticoagulant effects within minutes. Thereby, patients with acute ischemic stroke who are on dabigatran treatment may become eligible for thrombolysis with recombinant tissue-type plasminogen activator (rt-PA). In patients on dabigatran with intracerebral hemorrhage idarucizumab could prevent lesion growth. AIMS To provide insights into the clinical use of idarucizumab in patients under effective dabigatran anticoagulation presenting with signs of acute ischemic stroke or intracranial hemorrhage. METHODS Retrospective data collected from German neurological/neurosurgical departments administering idarucizumab following product launch from January 2016 to August 2018 were used. RESULTS One-hundred and twenty stroke patients received idarucizumab in 61 stroke centers. Eighty patients treated with dabigatran presented with ischemic stroke and 40 patients suffered intracranial bleeding (intracerebral hemorrhage (ICH) in n = 27). In patients receiving intravenous thrombolysis with rt-PA following idarucizumab, 78% showed a median improvement of 7 points in National Institutes of Health Stroke Scale. No bleeding complications were reported. Hematoma growth was observed in 3 out of 27 patients with ICH. Outcome was favorable with a median National Institutes of Health Stroke Scale improvement of 4 points and modified Rankin score 0-3 in 61%. Six out of 40 individuals (15%) with intracranial bleeding died during hospital stay. CONCLUSION Administration of rt-PA after reversal of dabigatran activity with idarucizumab in case of acute ischemic stroke seems feasible, effective, and safe. In dabigatran-associated intracranial hemorrhage, idarucizumab appears to prevent hematoma growth and to improve outcome.

中文翻译:

idarucizumab 拮抗达比加群在德国缺血性卒中或颅内出血的病例中 - 更新系列 120 例。

背景 Idarucizumab 是一种单克隆抗体片段,对达比加群具有高亲和力,可在数分钟内逆转其抗凝作用。因此,接受达比加群治疗的急性缺血性卒中患者可能适合使用重组组织型纤溶酶原激活剂 (rt-PA) 进行溶栓。在使用达比加群的脑出血患者中,idarucizumab 可以防止病变生长。目的 提供对依达赛珠单抗在有效达比加群抗凝治疗下出现急性缺血性中风或颅内出血体征的患者的临床应用的见解。方法 使用从 2016 年 1 月至 2018 年 8 月产品发布后从德国神经病学/神经外科部门收集的使用 idarucizumab 的回顾性数据。结果 在 61 个卒中中心,120 名卒中患者接受了依达赛珠单抗治疗。80 名接受达比加群治疗的患者出现缺血性卒中,40 名患者出现颅内出血(n = 27 的脑出血 (ICH))。在 idarucizumab 后接受 rt-PA 静脉溶栓的患者中,78% 的患者在美国国立卫生研究院卒中量表中显示中位改善为 7 分。没有出血并发症的报道。27 名 ICH 患者中有 3 名观察到血肿生长。结果是有利的,美国国立卫生研究院卒中量表中位数改善 4 分,改良 Rankin 评分 0-3 分,占 61%。40 名颅内出血患者中有 6 名 (15%) 在住院期间死亡。结论 在急性缺血性中风的情况下,在使用依达赛珠单抗逆转达比加群活性后使用 rt-PA 似乎是可行、有效和安全的。在达比加群相关的颅内出血中,依达赛珠单抗似乎可以防止血肿生长并改善预后。
更新日期:2020-01-19
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