OBJECTIVES: The purpose of this study was to understand the possible risk of 
discontinuation in the context of clinical care.
BACKGROUND: Rivaroxaban is noninferior to warfarin for preventing stroke in 
atrial fibrillation patients. Concerns exist regarding possible increased risk 
of stroke and non-central nervous system (CNS) thromboembolic events early after 
discontinuation of rivaroxaban.
METHODS: We undertook a post-hoc analysis of data from the ROCKET AF 
(Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin 
K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation, 
n = 14,624) for stroke or non-CNS embolism within 30 days after temporary 
interruptions of 3 days or more, early permanent study drug discontinuation, and 
end-of-study transition to open-label therapy.
RESULTS: Stroke and non-CNS embolism occurred at similar rates after temporary 
interruptions (rivaroxaban: n = 9, warfarin: n = 8, 6.20 vs. 5.05/100 
patient-years, hazard ratio [HR]: 1.28, 95% confidence interval [CI]: 0.49 to 
3.31, p = 0.62) and after early permanent discontinuation (rivaroxaban: n = 42, 
warfarin: n = 36, 25.60 vs. 23.28/100 patient-years, HR: 1.10, 95% CI: 0.71 to 
1.72, p = 0.66). Patients transitioning to open-label therapy at the end of the 
study had more strokes with rivaroxaban (n = 22) versus warfarin (n = 6, 6.42 
vs. 1.73/100 patient-years, HR: 3.72, 95% CI: 1.51 to 9.16, p = 0.0044) and took 
longer to reach a therapeutic international normalized ratio with rivaroxaban 
versus warfarin. All thrombotic events within 30 days of any study drug 
cessation (including stroke, non-CNS embolism, myocardial infarction, and 
vascular death) were similar between groups (HR: 1.02, 95% CI: 0.83 to 1.26, p = 
0.85).
CONCLUSIONS: In atrial fibrillation patients who temporarily or permanently 
discontinued anticoagulation, the risk of stroke or non-CNS embolism was similar 
with rivaroxaban or warfarin. An increased risk of stroke and non-CNS embolism 
was observed in rivaroxaban-treated patients compared with warfarin-treated 
patients after the end of the study, underscoring the importance of therapeutic 
anticoagulation coverage during such a transition.