Outcomes of Temporary Interruption of Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation: Results from ROCKET AF.
Circulation. 2014 Feb 19;
Authors: Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC, on behalf of the ROCKET AF Investigators
BACKGROUND: During long-term anticoagulation in atrial fibrillation, temporary interruptions(TI) of therapy are common, but the relationship between patient outcomes and TI has not been well studied. We aimed 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 ROCKET AF trial, a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in non-valvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-CNS systemic embolism, death, MI, 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 one dose of study drug, 4692(33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regards to baseline clinical characteristics. Only 6%(n=483) of TI incidences involved bridging therapy. Stroke/SE rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% vs. 0.41% per 30-days; HR(CI) = 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% vs. 0.79% per 30 days; HR(CI) = 1.26 (0.80, 2.00), P=0.32).
CONCLUSIONS: TI of oral anticoagulation is common and 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 AF patients requiring TI of anticoagulation.
CLINICAL TRIAL REGISTRATION INFORMATION: www.ClinicalTrials.gov. Identifier: NCT00403767.
PMID: 24552831 [PubMed - as supplied by publisher]