Management of Major Bleeding Events in Patients Treated With Rivaroxaban vs. Warfarin: Results From the ROCKET AF Trial

Study Questions:

What are the outcomes of bleeding events in patients anticoagulated with rivaroxaban?


In the ROCKET AF trial, the efficacy and safety of dose-adjusted warfarin and rivaroxaban (15-20 mg/day depending on creatinine clearance) were compared in randomized fashion in 14,143 patients with atrial fibrillation (AF). In this post-hoc analysis, the outcomes of major bleeding events in the two study arms were compared.


A major bleeding event occurred in 5.5% of patients, with no significant difference between the two groups. Compared to warfarin, rivaroxaban more often was associated with gastrointestinal bleeding (38.1% vs. 25.7%) and less often with intracranial bleeding (12.8% vs. 20.5%). Patients received a median of 2 units of packed red blood cells in both study arms. Fresh frozen plasma was used 57% less frequently in the rivaroxaban than the warfarin group. Vitamin K and prothrombin complex concentrate were administered less often in the rivaroxaban group (7.4% and 0.9%, respectively) than in the warfarin group (13.2% and 2.2%, respectively). The prevalence of the composite outcome of stroke, embolism, myocardial infarction, and all-cause death after a major bleed was similar in the rivaroxaban (24.8%) and warfarin (29.9%) groups.


The investigators concluded that outcomes after bleeding events are not worse in patients anticoagulated with rivaroxaban compared to warfarin.


Despite the advantages of a factor Xa inhibitor over warfarin, some physicians and patients have avoided these agents because of the lack of a specific antidote if a bleeding event occurs. This study provides reassuring evidence that safety is not compromised by the use of rivaroxaban.

Clinical Topics: Anticoagulation Management, Dyslipidemia, Lipid Metabolism, Novel Agents

Keywords: Vitamin K, Myocardial Infarction, Stroke, Morpholines, Thiophenes, Prothrombin, Fibrinolytic Agents, Blood Coagulation, Intracranial Hemorrhages, Factor Xa, Embolism, Pregnancy, Prolonged

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