Abstract 84: Idarucizumab in Patients Treated With Dabigatran Suffering Cerebral Ischemia or Intracranial Hemorrhage: A Retrospective Case Series From Germany

Abstract

Reversal of anticoagulation in patients treated with NOACs is a rare but sometimes urgently needed therapeutic demand. Idarucizumab is a monoclonal antibody fragment with high affinity for dabigatran reversing its anticoagulant effects within minutes. It is approved for patients on dabigatran with life-threatening or uncontrolled bleeding and those requiring emergency intervention. Case reports and smaller case series suggest a benefit for dabigatran-treated patients suffering ischemic stroke to regain eligibility for rt-PA thrombolysis. To provide insights into the clinical use of idarucizumab in patients under effective dabigatran anticoagulation presenting with signs of ischemic stroke or intracranial hemorrhage in clinical routine, we asked all German Departments of Neurology and Neurosurgery to contribute their retrospective data on the use of idarucizumab collected following product launch in January 2016 to June 2018. In 64 responding stroke centers 112 patients presenting with signs of stroke received idarucizumab. 74 patients treated with dabigatran presented with ischemic stroke. In patients receiving rt-PA thrombolysis following idarucizumab, 87% had a benefit from i.v. thrombolysis with a median NIHSS improvement of 6 points. No symptomatic bleeding complications were observed. Nine patients did not improve functionally. Of those, 4 patients deceased during hospital stay (5.4%). Bolus administration of idarucizumab did not delay thrombolysis indicating its value in this emergency situation. A total of 38 patients had intracranial bleeding (SAH n=1, SDH n=12, ICH n=25). Out of 25 patients presenting with intracerebral hemorrhage and treated with idarucizumab, hematoma growth with clinical worsening was documented in three. Outcome was favorable with a median NIHSS improvement of 4 points in 35 patients. Overall mortality was 13%. In conclusion, idarucizumab is a beneficial therapeutic option for patients under dabigatran treatment presenting with ischemic stroke or intracranial hemorrhage in daily German stroke center routine. A prospective registry with controls is ongoing in Germany.