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.

译文

背景:在房颤的长期抗凝治疗期间,治疗的临时中断(TIs)很常见,但是患者预后与TIs之间的关系尚未得到很好的研究。我们试图确定TI的原因,TI患者的特征以及TI患者中抗凝剂与预后之间的关系。
方法和结果:在利伐沙班每日一次中,口服,直接因子Xa抑制与维生素K拮抗剂预防房颤的中风和栓塞试验(ROCKET AF)进行了一项随机,双盲,双盲研究的利伐沙班和在因任何原因经历过TI(3-30天)的参与者中,报告了非瓣膜性房颤中的华法林,基线特征,治疗和预后,包括中风,非中枢神经系统全身性栓塞,死亡,心肌梗塞和出血。与TI相关的结局的风险期是从TI开始到恢复研究药物后的30天。在接受至少1剂研究药物的14236名参与者中,有4692名(33%)经历了TI。就基线临床特征而言,TI的参与者与整个ROCKET AF人群相似。 TI发生率中只有6%(n = 483)涉及桥接治疗。在风险期中,利伐沙班治疗和华法林治疗的参与者中风/全身性栓塞发生率相似(每30天0.30%比0.41%;危险比[置信区间] = 0.74 [0.36-1.50]; P = 0.40) 。在利伐沙班治疗和华法林治疗的受试者中,处于危险期的大出血风险也相似(每30天0.99%比0.79%;危险比[置信区间] = 1.26 [0.80-2.00]; P = 0.32) 。
结论:口服抗凝治疗的TI很常见,并且与利伐沙班或华法林治疗的患者发生中风的风险和出血的风险相似。需要进一步研究以确定需要抗凝TI的房颤患者的最佳治疗策略。
临床试验注册网址:http://www.clinicaltrials.gov。唯一标识符:NCT00403767。

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