Ikeda Takanori, Atarashi Hirotsugu, Inoue Hiroshi, Uchiyama Shinichiro, Kitazono Takanari, Yamashita Takeshi, Shimizu Wataru, Kamouchi Masahiro, Kaikita Koichi, Fukuda Koji, Origasa Hideki, Sakuma Ichiro, Saku Keijiro, Okumura Yasuo, Nakamura Yuichiro, Morimoto Hideo, Matsumoto Naoki, Tsuchida Akihito, Ako Junya, Sugishita Nobuyoshi, Shimizu Shogo, Shimokawa Hiroaki
Department of Cardiovascular Medicine, Toho University Faculty of Medicine.
Tohoku J Exp Med. 2016 Dec;240(4):259-268. doi: 10.1620/tjem.240.259.
The use of rivaroxaban, a factor Xa inhibitor, has been increasing for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) in Japan. We conducted the nationwide multicenter study, termed as the EXPAND Study, to address its effectiveness and safety in the real-world practice of patients with non-valvular AF in Japan. The EXPAND Study is a prospective, non-interventional, observational cohort study to evaluate the effectiveness and safety of rivaroxaban in non-valvular AF patients in a real-world clinical practice. A total of 7,178 patients with non-valvular AF were enrolled in 684 medical institutes between November 20, 2012 and June 30, 2014. As for the baseline demographic and clinical characteristics of 7,164 patients, the proportion of female patients was 32.2%, and those of patients with creatinine clearance < 50 mL/min and non-paroxysmal (persistent or permanent) AF were 21.8% and 55.1%, respectively. The proportions of patients complicated with hypertension, congestive heart failure, diabetes mellitus, and a history of ischemic stroke were 70.9%, 25.9%, 24.3%, and 20.2%, respectively. The proportions of patients with a CHADS score ≤ 1 and a CHADS-VASc score ≤ 1 were 37.3% and 13.6%, respectively. They were followed up until March 31, 2016 for a mean follow-up period of approximately 2.5 years. The findings of the EXPAND Study will help to establish an appropriate treatment with rivaroxaban for Japanese patients with non-valvular AF.
在日本，用于预防非瓣膜性心房颤动（AF）患者缺血性卒中和全身性栓塞的Xa因子抑制剂利伐沙班的使用量一直在增加。我们开展了一项名为EXPAND研究的全国性多中心研究，以探讨其在日本非瓣膜性AF患者的实际临床应用中的有效性和安全性。EXPAND研究是一项前瞻性、非干预性、观察性队列研究，旨在评估利伐沙班在非瓣膜性AF患者实际临床应用中的有效性和安全性。在2012年11月20日至2014年6月30日期间，共有7178例非瓣膜性AF患者被纳入684家医疗机构。关于7164例患者的基线人口统计学和临床特征，女性患者比例为32.2%，肌酐清除率<50 mL/min的患者比例和非阵发性（持续性或永久性）AF患者比例分别为21.8%和55.1%。合并高血压、充血性心力衰竭、糖尿病和缺血性卒中病史的患者比例分别为70.9%、25.9%、24.3%和20.2%。CHADS评分≤1和CHADS-VASc评分≤1的患者比例分别为37.3%和13.6%。对他们进行随访至2016年3月31日，平均随访期约为2.5年。EXPAND研究的结果将有助于为日本非瓣膜性AF患者确立合适的利伐沙班治疗方案。
