Clinical Outcomes and Management Associated With Major Bleeding in Patients With Atrial Fibrillation Treated With Apixaban or Warfarin: Insights From the ARISTOTLE Trial | Journal Scan

Study Questions:

How do outcomes compare after major bleeding events in patients anticoagulated with apixaban or warfarin?


This was a post-hoc analysis of a randomized trial in which 18,201 patients with atrial fibrillation were anticoagulated with either apixaban or warfarin. Major bleeding was defined as a ≥2 g/dl drop in hemoglobin level, transfusion of ≥2 units of packed red cells, or a fatal bleed.


A major bleed occurred in 848 patients (4.7%). Thirty-day mortality in these patients was 14.9%. Among 176 patients with an intracranial hemorrhage (ICH), 30-day mortality was 43.2%, compared to 9.2% among the 695 patients with a major non-ICH bleed. The risk of death, ischemic stroke, or myocardial infarction was increased by a factor of 12 after a major non-ICH bleed, and by a factor of 122 after an ICH. There was no significant difference in outcomes after a major bleed between patients treated with apixaban versus warfarin.


The authors concluded that the risk of death, ischemic stroke, and myocardial infarction is increased to a similar extent after a major bleed in patients anticoagulated with apixaban or warfarin.


The ARISTOTLE trial demonstrated that treatment with apixaban is associated with a lower risk of major bleeding and approximately a 10% reduction in mortality compared to warfarin. However, a lingering concern among patients and their physicians has been the lack of an immediate antidote for apixaban. This study provides reassurance that negative outcomes are not more likely in patients who suffer a major bleed while anticoagulated with apixaban as compared to warfarin.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, Hemoglobins, Hemorrhage, Intracranial Hemorrhages, Myocardial Infarction, Pyrazoles, Pyridones, Stroke, Warfarin

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