Miyazaki Sakiko, Miyauchi Katsumi, Hayashi Hidemori, Tanaka Ryota, Nojiri Shuko, Miyazaki Tadashi, Sumiyoshi Masataka, Suwa Satoru, Nakazato Yuji, Urabe Takao, Hattori Nobutaka, Daida Hiroyuki
Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Cardiology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
J Cardiol. 2018 Jun;71(6):590-596. doi: 10.1016/j.jjcc.2017.10.021. Epub 2018 Mar 2.
The management of atrial fibrillation (AF) has evolved with the development of direct oral anticoagulants (DOACs), but data on their clinical effectiveness and safety outside clinical trial settings are limited.
The RAFFINE registry is an observational, multicenter, prospective registry of Japanese patients with AF, designed to follow clinical events over 3 years. Patient enrollment was conducted from 2013 to 2015 at university hospitals, general hospitals, and private clinics to ensure inclusion of a broad spectrum of representative AF patients. The primary outcome events in this study will be ischemic stroke, systemic embolism, and major bleeding.
We enrolled 3901 ambulatory patients with AF from 4 university hospitals and 50 general hospitals/clinics in Japan. The mean patient age was 72.6 years and 68.5% were male. The type of AF was paroxysmal in 37.8%, persistent in 9.3%, and permanent in 51.7%. Major coexisting diseases were hypertension (72.7%), diabetes mellitus (30.3%), congestive heart failure (23.8%), history of ischemic stroke or transient ischemic attack (15.1%), and coronary artery disease (13.7%). Of the entire cohort, 44.6% were treated with warfarin and 43.0% were treated with DOACs. The prescription of DOACs exceeded that of warfarin in the general hospitals and clinics. Risk scores such as CHADS score, CHADS-VASc score, and HAS-BLED score were higher in patients at university hospitals than in patients at general hospitals or clinics.
The RAFFINE registry at baseline described the current status of anticoagulation therapy in Japan and long-term follow-up data will identify how outcomes vary between stratified groups in patients with AF in the DOAC era (UMIN Clinical Trials Registry UMIN000009617).
随着直接口服抗凝剂（DOACs）的发展，心房颤动（AF）的管理方式不断演变，但关于其在临床试验环境之外的临床有效性和安全性的数据有限。
RAFFINE注册研究是一项针对日本AF患者的观察性、多中心、前瞻性注册研究，旨在对临床事件进行3年的随访。2013年至2015年期间，在大学医院、综合医院和私人诊所进行患者招募，以确保纳入广泛的代表性AF患者。本研究的主要结局事件为缺血性卒中、全身性栓塞和大出血。
我们从日本的4所大学医院和50所综合医院/诊所招募了3901例非卧床AF患者。患者的平均年龄为72.6岁，68.5%为男性。AF类型为阵发性的占37.8%，持续性的占9.3%，永久性的占51.7%。主要并存疾病包括高血压（72.7%）、糖尿病（30.3%）、充血性心力衰竭（23.8%）、缺血性卒中或短暂性脑缺血发作史（15.1%）以及冠状动脉疾病（13.7%）。在整个队列中，44.6%接受华法林治疗，43.0%接受DOACs治疗。在综合医院和诊所中，DOACs的处方量超过了华法林。大学医院患者的CHADS评分、CHADS-VASc评分和HAS-BLED评分等风险评分高于综合医院或诊所的患者。
RAFFINE注册研究在基线时描述了日本抗凝治疗的现状，长期随访数据将确定在DOAC时代AF患者分层组之间的结局如何不同（UMIN临床试验注册中心UMIN000009617）。
