BACKGROUND: The overall analysis of the rivaroxaban versus warfarin in Japanese 
patients with atrial fibrillation (J-ROCKET AF) trial revealed that rivaroxaban 
was not inferior to warfarin with respect to the primary safety outcome. In 
addition, there was a strong trend for a reduction in the rate of 
stroke/systemic embolism with rivaroxaban compared with warfarin.
METHODS: In this subanalysis of the J-ROCKET AF trial, we investigated the 
consistency of safety and efficacy profile of rivaroxaban versus warfarin among 
the subgroups of patients with previous stroke, transient ischemic attack, or 
non-central nervous system systemic embolism (secondary prevention group) and 
those without (primary prevention group).
RESULTS: Patients in the secondary prevention group were 63.6% of the overall 
population of J-ROCKET AF. In the secondary prevention group, the rate of the 
principal safety outcome (% per year) was 17.02 in rivaroxaban-treated patients 
and 18.26 in warfarin-treated patients (hazard ratio [HR] 0.95; 95% confidence 
interval [CI] 0.70-1.29), while the rate of the primary efficacy endpoint was 
1.66 in rivaroxaban-treated patients and 3.25 in warfarin-treated patients (HR 
0.51; 95% CI 0.23-1.14). There were no significant interactions in the principal 
safety and the primary efficacy endpoints of rivaroxaban compared to warfarin 
between the primary and secondary prevention groups (P=.090 and .776 for both 
interactions, respectively).
CONCLUSIONS: The safety and efficacy profile of rivaroxaban compared with 
warfarin was consistent among patients in the primary prevention group and those 
in the secondary prevention group.