Canadian Heart Research Centre and Terrence Donnelly Heart Centre, Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.
This study sought to report additional safety results 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).
The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin.
The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model.
The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk.
Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767).
本研究旨在报告 ROCKET AF（利伐沙班每日口服直接因子 Xa 抑制与维生素 K 拮抗剂预防心房颤动的卒中与栓塞试验）的其他安全性结果。
ROCKET AF 试验表明，利伐沙班和华法林在卒中/全身性栓塞和主要/非主要临床相关出血（主要安全性终点）方面的风险相似。
比较了利伐沙班与华法林的主要安全性和出血终点的风险，并在多变量模型中检查了与大出血相关的因素。
利伐沙班组和华法林组的主要安全性终点相似（14.9 与 14.5 例/100 患者-年；风险比：1.03；95%置信区间：0.96 至 1.11）。随着年龄的增长，大出血风险增加，但在每个年龄组（<65、65-74、≥75 岁）中，两种治疗方法之间无差异（p 交互=0.59）。与无大出血患者（n=13455）相比，有大出血患者（n=781）更可能年龄较大、当前/既往吸烟者、有既往胃肠道（GI）出血史、轻度贫血，估算的肌酐清除率较低，而更不可能为女性或有既往卒中/短暂性脑缺血发作史。年龄增加、基线舒张压（DBP）≥90mmHg、慢性阻塞性肺疾病或 GI 出血史、既往使用乙酰水杨酸和贫血与大出血风险独立相关；女性和 DBP<90mmHg 与较低的大出血风险相关。
利伐沙班和华法林在主要/非主要临床相关出血方面的风险相似。年龄、性别、DBP、既往 GI 出血史、既往使用乙酰水杨酸和贫血与大出血风险相关。（利伐沙班与华法林预防非瓣膜性心房颤动患者卒中和非中枢神经系统系统性栓塞的疗效和安全性研究：NCT00403767）。
