Carag Michael R, Arora Rohit R
1Department of Medicine, School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY; and 2Department of Medicine, Chief of Medicine (NCVA), James Lovell Federal Health Care Center, North Chicago, IL.
Am J Ther. 2014 Sep-Oct;21(5):412-8. doi: 10.1097/MJT.0b013e3182491d8b.
Atrial fibrillation (AF), the most common form of cardiac arrhythmia, is a major risk factor for cardioembolic stroke. Dose-adjusted warfarin has been the gold standard for stroke prophylaxis in moderate- to high-risk patients with AF. However, the use of warfarin therapy is greatly limited by its narrow therapeutic window, numerous dietary restrictions, and drug-drug interactions, and an increased risk of hemorrhage. As a result, great emphasis has been placed on developing a new anticoagulant agent with fewer risks and limitations. Current data suggest that the oral direct factor Xa inhibitor rivaroxaban is a safe and effective alternative to warfarin. Furthermore, rivaroxaban does not require routine coagulation monitoring, which may improve patient compliance to anticoagulant therapy. The ROCKET AF trial demonstrated that 20-mg oral rivaroxaban taken once daily was noninferior to dose-adjusted warfarin in the prevention of stroke and non-central nervous system systemic embolism and had a comparable risk of bleeding. Based primarily on the ROCKET AF trial results, the US Food and Drug Administration recently approved the use of rivaroxaban for stroke prophylaxis in patients with nonvalvular AF. However, additional postmarketing studies on its safety and cost effectiveness are needed before it can be widely accepted as a sound alternative to warfarin.
心房颤动（AF）是最常见的心律失常形式，是心源性栓塞性中风的主要危险因素。剂量调整后的华法林一直是中高危心房颤动患者预防中风的金标准。然而，华法林治疗的应用因治疗窗窄、众多饮食限制、药物相互作用以及出血风险增加而受到极大限制。因此，人们一直非常重视开发一种风险和局限性更小的新型抗凝剂。目前的数据表明，口服直接因子Xa抑制剂利伐沙班是华法林的一种安全有效的替代品。此外，利伐沙班不需要常规凝血监测，这可能会提高患者对抗凝治疗的依从性。ROCKET AF试验表明，每日一次口服20毫克利伐沙班在预防中风和非中枢神经系统系统性栓塞方面不劣于剂量调整后的华法林，且出血风险相当。主要基于ROCKET AF试验结果，美国食品药品监督管理局最近批准利伐沙班用于非瓣膜性心房颤动患者的中风预防。然而，在它能够被广泛接受为华法林的合理替代品之前，还需要进行更多关于其安全性和成本效益的上市后研究。
