BACKGROUND: During long-term anticoagulation in atrial fibrillation, temporary 
interruptions (TIs) of therapy are common, but the relationship between patient 
outcomes and TIs has not been well studied. We sought to determine reasons for 
TI, the characteristics of patients undergoing TI, and the relationship between 
anticoagulant and outcomes among patients with TI.
METHODS AND RESULTS: In 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), a randomized, double-blind, 
double-dummy study of rivaroxaban and warfarin in nonvalvular atrial 
fibrillation, baseline characteristics, management, and outcomes, including 
stroke, non-central nervous system systemic embolism, death, myocardial 
infarction, and bleeding, were reported in participants who experienced TI (3-30 
days) for any reason. The at-risk period for outcomes associated with TI was 
from TI start to 30 days after resumption of study drug. In 14 236 participants 
who received at least 1 dose of study drug, 4692 (33%) experienced TI. 
Participants with TI were similar to the overall ROCKET AF population in regard 
to baseline clinical characteristics. Only 6% (n=483) of TI incidences involved 
bridging therapy. Stroke/systemic embolism rates during the at-risk period were 
similar in rivaroxaban-treated and warfarin-treated participants (0.30% versus 
0.41% per 30 days; hazard ratio [confidence interval]=0.74 [0.36-1.50]; P=0.40). 
Risk of major bleeding during the at-risk period was also similar in 
rivaroxaban-treated and warfarin-treated participants (0.99% versus 0.79% per 30 
days; hazard ratio [confidence interval]=1.26 [0.80-2.00]; P=0.32).
CONCLUSIONS: TI of oral anticoagulation is common and is associated with 
substantial stroke risks and bleeding risks that were similar among patients 
treated with rivaroxaban or warfarin. Further investigation is needed to 
determine the optimal management strategy in patients with atrial fibrillation 
requiring TI of anticoagulation.
CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique 
identifier: NCT00403767.