Rivaroxaban for Atrial Fibrillation

Posted by Graham McMahon • September 9th, 2011

In the ROCKET-AF trial, 14,264 patients with atrial fibrillation were randomly assigned to receive either rivaroxaban or warfarin. In a perprotocol, as-treated analysis, rivaroxaban was noninferior to warfarin with respect to the primary end point of stroke or systemic embolism.    

The use of vitamin K antagonists is highly effective for stroke prevention in patients with nonvalvular atrial fibrillation and is recommended for persons at increased risk. However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice.            

Clinical Pearls

 What are the pharmacologic properties of rivaroxaban?            

Rivaroxaban is a direct factor Xa inhibitor that may provide more consistent and predictable anticoagulation than warfarin. It is taken once daily by mouth and does not require dose-adjustment.     

 As compared to warfarin, what was the efficacy of rivaroxaban in preventing stroke or systemic embolism among patients with atrial fibrillation in this study?               

According to the results of this study, in patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism.       

Table 2. Primary End Point of Stroke or Systemic Embolism.        

Morning Report Questions

Q: What bleeding events were more common in the rivaroxaban group as compared to the warfarin group in this study?  

A: Major bleeding from a gastrointestinal site was more common in the rivaroxaban group, with 224 bleeding events (3.2%), as compared with 154 events in the warfarin group (2.2%, P<0.001).            

Q: What bleeding events were less common in the rivaroxaban group as compared to the warfarin group in this study?  

A: Rates of intracranial hemorrhage were significantly lower in the rivaroxaban group than in the warfarin group (0.5% vs. 0.7% per year; hazard ratio, 0.67; 95% CI, 0.47 to 0.93; P=0.02).

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