Pawel Kermer1, Christoph C Eschenfelder2, Hans-Christoph Diener3, Martin Grond4, Yasser Abdalla5, Alexej Abraham6, Katharina Althaus7, Gebhard Becks8, Jörg Berrouschot9, Jörg Berthel10, Felix J Bode11,12, Lothar Burghaus13, Hakan Cangür14, Michael Daffertshofer15, Sebastian Edelbusch16, Jürgen Eggers17, Rüdiger Gerlach18, Klaus Gröschel19, Florian Große-Dresselhaus16, Albrecht Günther20, Claus G Haase21, Carl-Albrecht Haensch22, Andreas Harloff23, Joseph G Heckmann24, Valentin Held25, Maren Hieber23, Andreas Kauert6, Rolf Kern26, Thomas Kerz27, Martin Köhrmann3, Peter Kraft28,29, Peter Kühnlein30, Jan Latta31, Elke Leinisch32, Arne Lenz33, Christoph Leithner34, Tobias Neumann-Haefelin10, Mathias Mäurer35, Wolfgang Müllges29, Christian H Nolte36, Mark Obermann37, Someieh Partowi38, Peer Patzschke39, Sven Poli40, Ulrich Pulkowski41, Jan Purrucker42, Torsten Rehfeldt43, Peter A Ringleb42, Joachim Röther44, Raluca Rossi45, Hazem El-Sabassy46, Oliver Sauer47, Gabriele Schackert48, Niklas Schäfer11, Peter D Schellinger49, Andreas Schneider21, Ramona Schuppner50, Stefan Schwab51, Olav Schwarte52, Rüdiger J Seitz53, Sebastian Senger54, Yogesh P Shah55, Eckhart Sindern56, Paul Sparenberg57, Thorsten Steiner58, Kristina Szabo25, Christian Urbanek59, Bettina von Sarnowksi60, Karin Weissenborn50, Peter Wienecke61, Karsten Witt62, Robert Wruck15, Silke Wunderlich63. 1. Department of Neurology, Nordwestkrankenhaus Sanderbusch, Sande and Department of Neurology, University Medicine Göttingen, Göttingen, Germany. 2. Medical Affairs Germany, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany. 3. Department of Neurology, University Hospital, Essen, Germany. 4. Department of Neurology, Siegen, Germany. 5. Department of Neurosurgery, Nordwestkrankenhaus Sanderbusch, Sande, Germany. 6. Department of Neurology, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany. 7. Department of Neurology, University of Ulm, Ulm, Germany. 8. Department of Neurology, Klinikum Itzehoe, Itzehoe, Germany. 9. Department of Neurology, Klinikum Altenburger Land GmbH, Altenburg, Germany. 10. Department of Neurology, Klinikum Fulda, Fulda, Germany. 11. Department of Neurology, University Bonn, Bonn, Germany. 12. Department of Neurology, German Center for Neurodegenerative Disease, Bonn, Germany. 13. Department of Neurology, Heilig Geist-Krankenhaus, Köln, Germany. 14. Department of Neurology, Klinikum Wolfsburg, Wolfsburg, Germany. 15. Department of Neurology, Klinikum Mittelbaden, Rastatt, Germany. 16. Department of Neurology, Herz-Jesu-Krankenhaus Hiltrup, Münster, Germany. 17. Department of Neurology, Sana Kliniken Lübeck, Lübeck, Germany. 18. Department of Neurosurgery, Helios Klinikum Erfurt, Erfurt, Germany. 19. Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany. 20. Department of Neurology, University Jena, Jena, Germany. 21. Department of Neurology and clinical Neurophysiology, Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany. 22. Department of Neurology, Kliniken Maria-Hilf, Mönchengladbach, Germany. 23. Department of Neurology and Neurophysiology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany. 24. Department of Neurology, Klinikum Landshut, Landshut, Germany. 25. Department of Neurology, Universitätsmedizin Mannheim, Mannheim, Germany. 26. Department of Neurology, Klinikverbund Kempten-Oberallgäu, Kempten, Germany. 27. Department of Neurosurgery, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany. 28. Department of Neurology, Klinikum Main-Spessart, Lohr, Germany. 29. Department of Neurology, University Hospital Würzburg, Würzburg, Germany. 30. Department of Neurology, Regiomed-Kliniken, Coburg, Germany. 31. Department of Neurology, Helios Klinik, Hildburghausen, Germany. 32. Department of Neurology, Helios Klinikum, Erfurt, Germany. 33. Department of Neurology, Sozialstiftung Bamberg, Bamberg, Germany. 34. Department of Neurology, Campus Virchow-Klinikum, Charité, Berlin, Germany. 35. Department of Neurology, Klinikum Würzburg Mitte, Würzburg, Germany. 36. Department of Neurology, Campus Benjamin Franklin, Charité, Berlin, Germany. 37. Center for Neurology, Asklepios Hospitals Schildautal, Seesen, Germany. 38. Stroke Unit, Marienhaus Klinikum, Kreis Ahrweiler, Bad Neuenahr-Ahrweiler, Germany. 39. Westküstenkliniken, Brunsbüttel, Germany. 40. Department of Neurology with Focus on Neurovascular Diseases and Neurooncology and Hertie Institute for Clinical Brain Research, University Hospital Tübingen, Tübingen, Germany. 41. Department of Neurology, imland Klinik, Rendsburg, Germany. 42. Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany. 43. Department of Neurology, Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany. 44. Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany. 45. Department of Neurology, Main-Kinzig-Kliniken, Gelnhausen, Germany. 46. Department of Neurology, Klinikum Lippe, Lemgo, Germany. 47. Department of Neurology, Diakonie-Klinikum, Schwäbisch-Hall. 48. Department of Neurosurgery, University Hospital Dresden, Dresden, Germany. 49. Department of Neurology and Neurogeriatry, Johannes Wesling Klinikum Minden, University Hospital, Minden, Germany. 50. Department of Neurology, Hannover Medical School, Hannover, Germany. 51. Department of Neurology, University Hospital Erlangen, Erlangen, Germany. 52. Department of Neurology, Kreiskliniken Altötting-Burghausen, Altötting, Germany. 53. Department of Neurology, Centre of Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. 54. Department for Neurosurgery, Saarland University Hospital, Homburg, Germany. 55. Department of Neurology, Klinikum Kassel, Kassel, Germany. 56. Department for Neurology, Diakovere Friederikenstift, Hannover, Germany. 57. Department for Neurology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany. 58. Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, Germany. 59. Department for Neurology, Klinikum Ludwigshafen, Ludwigshafen, Germany. 60. Department of Neurology, University Medicine Greifswald, Greifswald, Germany. 61. Department for Neurology, Asklepios Fachklinik Teupitz, Teupitz, Germany. 62. Department for Neurology and Research Center Neurosensory Science, Carl von Ossietzky-University, Oldenburg, Germany. 63. Department for Neurology, Klinikum rechts der Isar, TU München, München, Germany.
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.
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 strokepatients 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.
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