Yamashita Yugo, Uozumi Ryuji, Hamatani Yasuhiro, Esato Masahiro, Chun Yeong-Hwa, Tsuji Hikari, Wada Hiromichi, Hasegawa Koji, Ogawa Hisashi, Abe Mitsuru, Morita Satoshi, Akao Masaharu
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine.
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine.
Circ J. 2017 Aug 25;81(9):1278-1285. doi: 10.1253/circj.CJ-16-1337. Epub 2017 Apr 19.
The current status and outcomes of direct oral anticoagulant (DOAC) use have not been widely evaluated in unselected patients with atrial fibrillation (AF) in the real world.
The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating medical institutions (n=80) in Fushimi, Kyoto, Japan. Follow-up data with oral anticoagulant (OAC) status were available for 3,731 patients by the end of November 2015. We evaluated OAC status and clinical outcomes according to OAC status. The number (incidence rate) of stroke/systemic embolism (SE) and major bleeding events during the median follow-up of 3.0 years was 224 (2.3%/year) and 177 (1.8%/year), respectively. After the release of DOAC, the prevalence of DOAC use increased gradually and steadily, and that of warfarin, DOAC and no OAC was 37%, 26% and 36%, respectively in 2015. On Cox proportional hazards modeling incorporating change in OAC status as a time-dependent covariate for stroke/SE and major bleeding events, use of DOAC compared with warfarin was not associated with stroke/SE events (HR, 0.95; 95% CI: 0.59-1.51, P=0.82) or major bleeding events (HR, 0.82; 95% CI: 0.50-1.36, P=0.45).
In real-world clinical practice, there were no significant differences in stroke/SE events or major bleeding events for DOAC compared with warfarin in patients with AF.
在现实世界中,未经过挑选的房颤(AF)患者使用直接口服抗凝剂(DOAC)的现状和结果尚未得到广泛评估。
伏见房颤登记研究是一项基于社区的前瞻性调查,对象为日本京都伏见地区参与研究的医疗机构(n = 80)中就诊的房颤患者。截至2015年11月底,3731例患者有口服抗凝剂(OAC)使用情况的随访数据。我们根据OAC使用情况评估了OAC状态和临床结局。在3.0年的中位随访期内,卒中/全身性栓塞(SE)和大出血事件的发生例数(发生率)分别为224例(2.3%/年)和177例(1.8%/年)。DOAC上市后,DOAC的使用比例逐渐稳步上升,2015年华法林、DOAC和未使用OAC的比例分别为37%、26%和36%。在将OAC状态变化作为卒中/SE和大出血事件的时间依赖性协变量纳入的Cox比例风险模型中,与华法林相比,使用DOAC与卒中/SE事件(HR,0.95;95%CI:0.59 - 1.51,P = 0.82)或大出血事件(HR,0.82;95%CI:0.50 - 1.36,P = 0.45)无关。
在现实世界的临床实践中,房颤患者使用DOAC与使用华法林相比,在卒中/SE事件或大出血事件方面无显著差异。