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日本有和无冠状动脉疾病的心房颤动患者的不良临床事件-来自 SAKURA AF 注册研究的结果。

Adverse clinical events in Japanese atrial fibrillation patients with and without coronary artery disease-findings from the SAKURA AF Registry.

机构信息

Division of Cardiology, Nihon University Itabashi Hospital, Tokyo, Japan.

Department of Cardiology, Nihon University Hospital, Tokyo, Japan.

出版信息

Curr Med Res Opin. 2019 Dec;35(12):2053-2062. doi: 10.1080/03007995.2019.1650014. Epub 2019 Sep 6.

Abstract

Although atrial fibrillation (AF) and coronary artery disease (CAD) are increasing in prevalence in Japan, real-world data regarding clinical outcomes in Japanese AF patients with CAD are limited. The SAKURA AF Registry is a prospective multi-center registry created to investigate outcomes of oral anticoagulant (OAC) use in Japanese AF patients. A study was conducted involving 3237 enrollees from 63 Tokyo-area institutions who were followed up for a median of 39.3 months. Clinical adverse events were compared between the patients accompanied with ( = 312) and without CAD ( = 2925). The incidence of cardiovascular events and all-cause mortality rates were significantly higher among patients with CAD than among those without CAD (5.98 vs 2.52 events per 100 patient-years, respectively,  < 0.001; 3.27 vs 1.94 deaths per 100 patient-years, respectively,  = 0.012), but there was no difference in strokes/transient ischemic attacks or systemic embolisms (1.70 vs 1.34). After a multivariate adjustment, CAD remained a risk factor for cardiovascular events (hazard ratio [HR] = 1.57, 95% confidence interval [CI] = 1.08-2.25,  = 0.018). Among CAD patients, the propensity score-adjusted risk for major bleeding was significantly decreased among direct oral anticoagulant (DOAC) users in comparison to that among warfarin users (HR = 0.29, 95% CI = 0.07-0.94,  = 0.04), but other adverse clinical events did not differ significantly between these two groups. CAD did not appear to be a major determinant of strokes/TIAs, major bleeding, or all-cause mortality, but appeared to increase the risk of cardiovascular events in Japanese AF patients. The risk of major bleeding in CAD patients appeared to decrease when a DOAC rather than warfarin was administered. The data suggested that patients with AF and concomitant CAD require careful management and follow-up to reduce cardiovascular risks, and DOACs may be a better choice over warfarin when considering the risk of major bleeding.

摘要

尽管心房颤动 (AF) 和冠状动脉疾病 (CAD) 在日本的发病率不断上升,但有关日本 CAD 合并 AF 患者临床结局的真实世界数据有限。SAKURA AF 注册研究是一项前瞻性多中心注册研究,旨在调查日本 AF 患者口服抗凝剂 (OAC) 应用的结局。该研究共纳入了来自东京地区 63 家机构的 3237 名参与者,中位随访时间为 39.3 个月。比较了伴有 CAD(n=312)和无 CAD(n=2925)患者的临床不良事件。CAD 患者的心血管事件和全因死亡率均显著高于无 CAD 患者(分别为每 100 患者年 5.98 次和 2.52 次,均<0.001;分别为每 100 患者年 3.27 次和 1.94 次,均=0.012),但卒中和短暂性脑缺血发作或全身性栓塞无差异(分别为 1.70 次和 1.34 次)。多变量调整后,CAD 仍然是心血管事件的危险因素(风险比 [HR] = 1.57,95%置信区间 [CI] = 1.08-2.25,均<0.018)。在 CAD 患者中,与华法林相比,直接口服抗凝剂(DOAC)使用者的大出血风险显著降低(HR = 0.29,95% CI = 0.07-0.94,均=0.04),但两组其他不良临床事件无显著差异。CAD 似乎不是卒中和 TIA、大出血或全因死亡率的主要决定因素,但似乎会增加日本 AF 患者心血管事件的风险。CAD 患者使用 DOAC 而非华法林时,大出血风险似乎降低。数据表明,合并 CAD 的 AF 患者需要进行仔细的管理和随访,以降低心血管风险,在考虑大出血风险时,DOAC 可能优于华法林。

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