Methodology 3/5
Usefulness 3/5
Connolly SJ, et al. N Engl J Med. 2024 May 16;390(19):1745-1755.
Editorial: Reversing Oral Anticoagulation in Intracerebral Hemorrhage.
Question and Methods: This unblinded, multicentre randomized controlled trial studied whether Andexanet improved hemostatic efficacy compared to usual care in patients with acute intracerebral hemorrhage using factor Xa inhibitors.
Findings: Andexanet improved hemostatic efficacy (67.0% vs. 53.1%; NNT 8) and reduced anti-factor Xa activity (94.5% vs. 26.9%) but was associated with increased thrombotic events (10.3% vs. 5.6%; NNH 21) and showed no differences in modified Rankin scores or mortality at 30 days.
Limitations: Industry sponsored and designed, unblinded treatment, outcomes were not patient-oriented, usual care did not always include PCC use, multiple protocol amendments, and exclusion of patients with severe neurological impairment (GCS <7, NIHSS >35).
Interpretation: Andexanet demonstrates benefit in reducing hematoma expansion in patients with mild to moderate neurological impairment on anti-Xa inhibitors presenting with intracerebral hemorrhage. However, the lack of patient-centered outcomes, high cost and associated thrombotic events limit its integration into clinical practice and warrants ongoing study.
JC Supervisor: Dr. Krishan Yadav
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Authors
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Dr. Courtney Price is an FRCPC Emergency Medicine resident at the University of Ottawa, and junior editor for the EMOttawa Blog.
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Dr. Rosenberg is an emergency physician at the Ottawa Hospital, associate professor at the University of Ottawa, and Director of the Digital Scholarship and Knowledge Dissemination Program.
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Dr. Krishan Yadav is an FRCPC Emergency Medicine Physician, and Epidemiologist with a special interest in non-purulent skin and soft tissue infectious disease.
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