Abstract 17236: Intracranial Hemorrhage in Patients With Atrial Fibrillation in the ARISTOTLE Trial: Clinical Characteristics and Associated Outcomes

Abstract

Background: Intracranial hemorrhage (ICH) is associated with poor outcomes in patients with atrial fibrillation (AF) treated with oral anticoagulation. Little is known about clinical characteristics and factors associated with ICH and subsequent outcomes in patients receiving apixaban. Methods: The ARISTOTLE trial randomized 18,201 patients with AF and risk of stroke to warfarin or apixaban. All ICH events were identified and adjudicated by a central committee blinded to the study treatment assignment. ICH events were analyzed in patients receiving at least one dose of study drug (N=18,140). Multivariable cox regression models were developed to identify factors associated with ICH. Results: There were 174 (1.0%) ICH events. Of those, 111 (67.7%) were intracerebral hemorrhage, 50 (30.7%) subdural hematomas, and 25 (15.3%) subarachnoid hemorrhage. Patients with ICH were older and had higher CHADS 2 score than patients without ICH. Computed tomography was used in 95.2% of patients for the diagnosis of ICH. The majority of ICH cases were spontaneous (71.7%) and 91.4% of patients with ICH presented with some type of neurological deficit. Most (72%) of the patients received conservative treatment and 21% underwent surgical intervention; 71 (40.8%) patients died in hospital. The mean modified Rankin score at discharge of survivors was ≥4 in 23 (22%) patients. Apixaban was superior to warfarin in causing less ICH, including as categorized by each ICH location. Factors associated with ICH were older age, warfarin randomized treatment assignment, prior stroke, geographic region of the world, and use of aspirin at randomization (Table). Conclusion: ICH is uncommon in patients with AF who are treated with oral anticoagulant and is associated with very high mortality. Apixaban is superior to warfarin in causing less ICH, irrespective of the location and other risk factors for ICH.