Vimalesvaran Kavitha, Dockrill Seth J, Gorog Diana A
Department of Cardiology, East and North Hertfordshire NHS Trust, Stevenage, Hertfordshire, UK.
School of Life and Medical Sciences, Postgraduate Medical School, University of Hertfordshire, Hertfordshire, UK.
Vasc Health Risk Manag. 2018 Jan 9;14:13-21. doi: 10.2147/VHRM.S134394. eCollection 2018.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and it leads to significant morbidity and mortality, predominantly from ischemic stroke. Vitamin K antagonists, mainly warfarin, have been used for decades to prevent ischemic stroke in AF, but their use is limited due to interactions with food and other drugs, as well as the requirement for regular monitoring of the international normalized ratio. Rivaroxaban, a direct factor Xa inhibitor and the most commonly used non-vitamin K oral anticoagulant, avoids many of these challenges and is being prescribed with increasing frequency for stroke prevention in non-valvular AF. Randomized controlled trial (RCT) 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) trial have shown rivaroxaban to be non-inferior to warfarin in preventing ischemic stroke and systemic embolism and to have comparable overall bleeding rates. Applicability of the RCT data to real-world practice can sometimes be limited by complex clinical scenarios or multiple comorbidities not adequately represented in the trials. Available real-world evidence in non-valvular AF patients with comorbidities - including renal impairment, acute coronary syndrome, diabetes mellitus, malignancy, or old age - supports the use of rivaroxaban as safe and effective in preventing ischemic stroke in these subgroups, though with some important considerations required to reduce bleeding risk. Patient perspectives on rivaroxaban use are also considered. Real-world evidence indicates superior rates of drug adherence with rivaroxaban when compared with vitamin K antagonists and with alternative non-vitamin K oral anticoagulants - perhaps, in part, due to its once-daily dosing regimen. Furthermore, self-reported quality of life scores are highest among patients compliant with rivaroxaban therapy. The generally high levels of patient satisfaction with rivaroxaban therapy contribute to overall favorable clinical outcomes.
心房颤动(AF)是最常见的持续性心律失常,会导致严重的发病率和死亡率,主要源于缺血性中风。维生素K拮抗剂,主要是华法林,已用于预防房颤患者的缺血性中风数十年,但由于其与食物和其他药物的相互作用,以及需要定期监测国际标准化比值,其应用受到限制。利伐沙班是一种直接的Xa因子抑制剂,也是最常用的非维生素K口服抗凝剂,避免了许多此类挑战,并且在非瓣膜性房颤的中风预防中处方频率越来越高。ROCKET-AF(利伐沙班每日一次口服直接Xa因子抑制与维生素K拮抗剂预防房颤中风和栓塞试验)试验的随机对照试验(RCT)数据表明,利伐沙班在预防缺血性中风和全身性栓塞方面不劣于华法林,且总体出血率相当。RCT数据在现实世界实践中的适用性有时可能会受到复杂临床情况或试验中未充分体现的多种合并症的限制。在患有合并症(包括肾功能损害、急性冠状动脉综合征、糖尿病、恶性肿瘤或老年)的非瓣膜性房颤患者中,现有的真实世界证据支持使用利伐沙班在这些亚组中预防缺血性中风是安全有效的,不过需要一些重要的考虑因素来降低出血风险。同时也考虑了患者对利伐沙班使用的观点。真实世界证据表明,与维生素K拮抗剂和其他非维生素K口服抗凝剂相比,利伐沙班的药物依从率更高——这可能部分归因于其每日一次的给药方案。此外,在依从利伐沙班治疗的患者中,自我报告的生活质量评分最高。患者对利伐沙班治疗的总体满意度较高有助于实现总体良好的临床结果。