Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany—Updated series of 120 cases
Authors: Kermer Pawel , Eschenfelder Christoph C , Diener Hans-Christoph , Grond Martin , Abdalla Yasser , Abraham Alexej , Althaus Katharina , Becks Gebhard , Berrouschot Jörg , Berthel Jörg , Bode Felix J. , Burghaus Lothar , Cangür Hakan , Daffertshofer Michael , Edelbusch Sebastian , Eggers Jürgen , Gerlach Rüdiger , Gröschel Klaus , Große-Dresselhaus Florian , Günther Albrecht , Haase Claus G , Haensch Carl-Albrecht , Harloff Andreas , Heckmann Joseph G , Held Valentin , Hieber Maren , Kauert Andreas , Kern Rolf , Kerz Thomas , Köhrmann Martin , Kraft Peter , Kühnlein Peter , Latta Jan , Leinisch Elke , Lenz Arne , Leithner Christoph , Neumann-Haefelin Tobias , Mäurer Mathias , Müllges Wolfgang , Nolte Christian H , Obermann Mark , Partowi Someieh , Patzschke Peer , Poli Sven , Pulkowski Ulrich , Purrucker Jan , Rehfeldt Torsten , Ringleb Peter A , Röther Joachim , Rossi Raluca , El-Sabassy Hazem , Sauer Oliver , Schackert Gabriele , Schäfer Niklas , Schellinger Peter D , Schneider Andreas , Schuppner Ramona , Schwab Stefan , Schwarte Olav , Seitz Rüdiger J , Senger Sebastian , Shah Yogesh P , Sindern Eckhart , Sparenberg Paul , Steiner Thorsten , Szabo Kristina , Urbanek Christian , Sarnowksi Bettina von , Weissenborn Karin , Wienecke Peter , Witt Karsten , Wruck Robert , Wunderlich Silke 
Published: January 2020

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.