Subscribe/Learn More > Clinical Research | December 2013 Factors Associated with Major Bleeding Events: Insights from the Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) ONLINE FIRST
Clinical Trials Thursday, January 9th, 2014JACC: December 2013
Objectives – To report additional safety results from the Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF).
Background ROCKET AF demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin.
Methods The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared and factors associated with major bleeding were examined in a multivariable model.
Results The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events per 100 patient-years; hazard ratio [HR] 1.03 [0.96, 1.11]). Major bleeding risk increased with age but there were no differences between treatments in each age category (<65, 65-74, ≥75 years; Pinteraction=0.59). Compared to those without (n=13,455), patients with a major bleed (n=781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, a lower calculated creatinine clearance, and less likely to be female or have a prior stroke/TIA. Read more
