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. 2020 Jan 19;1747493019895654.
doi: 10.1177/1747493019895654. Online ahead of print.

Antagonizing Dabigatran by Idarucizumab in Cases of Ischemic Stroke or Intracranial Hemorrhage in Germany-Updated Series of 120 Cases

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
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Antagonizing Dabigatran by Idarucizumab in Cases of Ischemic Stroke or Intracranial Hemorrhage in Germany-Updated Series of 120 Cases

Pawel Kermer et al. Int J Stroke. .

Abstract

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.

Keywords: Idarucizumab; dabigatran; intracranial hemorrhage; ischemic stroke; outcome; thrombolysis.

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