Yasaka Masahiro, Umeyama Michiaki, Kataoka Hirohide, Inoue Hiroshi
National Hospital Organization Kyushu Medical Center, 1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan.
Bristol-Myers Squibb K.K., Tokyo, Japan.
J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105034. doi: 10.1016/j.jstrokecerebrovasdis.2020.105034. Epub 2020 Jun 24.
Data on independent risk factors for stroke recurrence in Japanese patients with nonvalvular atrial fibrillation are limited.
We performed a subgroup analysis of a postmarketing surveillance study of apixaban (STroke prevention ANticoagulant Drug Apixaban Real-world Data study) in Japanese patients with nonvalvular atrial fibrillation receiving oral apixaban (5 mg/2.5 mg twice daily) in routine clinical practice. Patients were categorized into primary and secondary prevention groups based on the absence or presence of a history of ischemic stroke/transient ischemic attack, respectively.
Patients in the secondary prevention group (1101 of 6306 patients [17.5%] analyzed; mean observation period, 15.7 months) had a higher risk of ischemic stroke or hemorrhage than those in the primary prevention group. The incidence rates of major (3.92%/year vs 2.06%/year), intracranial (1.87%/year vs 0.55%/year), and cerebral (1.14%/year vs 0.37%/year) hemorrhage and effectiveness outcomes (ischemic stroke/systemic embolism/transient ischemic attack, 3.25%/year vs 0.57%/year) were significantly higher (all P < 0.001) in the secondary prevention group than in the primary prevention group. Multivariate analysis identified no independent risk factors in the secondary prevention group, while prior major bleeding, alcohol abuse, advanced age, male sex, lower body weight, higher serum creatinine, and antiplatelet drug use were identified as risk factors for major hemorrhage, and advanced age and antiplatelet drug use for effectiveness outcomes in the primary prevention group.
Among Japanese patients with nonvalvular atrial fibrillation who received apixaban, presence of a history of ischemic stroke/transient ischemic attack was associated with higher incidence rates of hemorrhage and thromboembolic events.
关于日本非瓣膜性心房颤动患者中风复发独立危险因素的数据有限。
我们对阿哌沙班的上市后监测研究（预防中风抗凝药物阿哌沙班真实世界数据研究）进行了亚组分析，该研究针对日本非瓣膜性心房颤动患者在常规临床实践中接受口服阿哌沙班（5毫克/2.5毫克，每日两次）的情况。根据是否有缺血性中风/短暂性脑缺血发作病史，患者分别被分为一级预防组和二级预防组。
二级预防组的患者（在分析的6306例患者中有1101例[17.5%]；平均观察期为15.7个月）比一级预防组的患者发生缺血性中风或出血的风险更高。二级预防组的大出血（3.92%/年对2.06%/年）、颅内出血（1.87%/年对0.55%/年）、脑内出血（1.14%/年对0.37%/年）以及有效性结局（缺血性中风/全身性栓塞/短暂性脑缺血发作，3.25%/年对0.57%/年）的发生率均显著高于一级预防组（所有P<0.001）。多变量分析未在二级预防组中确定独立危险因素，而在一级预防组中，既往大出血、酗酒、高龄、男性、体重较低、血清肌酐较高以及使用抗血小板药物被确定为大出血的危险因素，高龄和使用抗血小板药物被确定为有效性结局的危险因素。
在接受阿哌沙班治疗的日本非瓣膜性心房颤动患者中，有缺血性中风/短暂性脑缺血发作病史与出血和血栓栓塞事件的发生率较高相关。
