Key result
Andexanet alfa for FXa inhibitor-associated ICH lacks reported outcomes in a retrospective case series.
Why the study?
Use of andexanet alfa for factor Xa inhibitor-associated intracranial hemorrhage is limited by high cost and thromboembolic concerns, with limited real-world data from regions such as Saudi Arabia.
Case Report (n=2)
No
This case series describes the real-world use of andexanet alfa for reversing factor Xa inhibitor-associated intracranial hemorrhage in Saudi Arabia.
Adds regional data on andexanet alfa in ICH reversal; hypothesis-generating and should not yet change practice.
Review Board in accordance with institutional guidelines.To ensure patient confidentiality, all identifying information was anonymized. Case DesCription Case 1An 83-year-old male patient with coronary artery disease, peripheral arterial disease, type 2 diabetes mellitus, dementia, and hypertension was admitted with dizziness and intracranial epidural hemorrhage.He had been on apixaban 2.5 mg twice daily for atrial fibrillation for 981 days.On admission, his Glasgow Coma Scale (GCS) score was 14/15, hemoglobin 12.2 gm/dL, and brain computed tomography (CT) confirmed hemorrhage.He received andexanet alfa as a 400 mg bolus followed by a 480 mg introDuCtion Direct oral anticoagulants (DOACs), especially factor Xa inhibitors such as apixaban, have largely replaced vitamin K antagonists (VKAs) like warfarin for preventing and managing thromboembolic conditions due to their fixed dosing and fewer monitoring requirements.1 These agents reduce the risks of stroke, deep vein thrombosis, and pulmonary embolism with improved safety profiles and fewer drug interactions.2 However, life-threatening bleeding complications, including intracranial hemorrhage (ICH), remain a concern.Unlike VKAs, DOACs historically lacked effective reversal agents, posing challenges in emergency bleeding management.3 Andexanet alfa, a recombinant modified factor Xa, was approved by the United States Food and Drug Administration in 2018 to reverse anticoagulation from apixaban in cases of major bleeding.3,4 Although promising, its use is limited by high cost and concerns about thromboembolic risks, with limited real-world data from regions such as Saudi Arabia.This case series presents the experience of using andexanet alfa to reverse factor Xa inhibitorassociated ICH in two patients, evaluating hemostatic effectiveness, safety, and clinical outcomes.A retrospective data collection was conducted in the emergency department of King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia, from October to December 2024.Patients with life-threatening bleeding who received andexanet alfa for factor Xa inhibitor reversal were identified from institutional medical records and included in documenting this case series.Individuals under 18 years of age who received prothrombin complex concentrate concurrently with other anticoagulants, such as warfarin, and those with incomplete medical records were excluded.Data on demographic details, medical history, functional status before and after the injury, complications, surgical intervention, and length of hospital stay
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Mohammad Saleh Aldeeb (2026) conducted a case report in Factor Xa inhibitor-associated Intracranial Hemorrhage (n=2). Andexanet alfa was evaluated on Hemostatic effectiveness, safety, and clinical outcomes. A retrospective case series evaluated the use of andexanet alfa for reversing factor Xa inhibitor-associated intracranial hemorrhage in 2 patients, with no outcome data reported in the abstract.
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