Department of Preventive Medicine and Public Health Faculty of Medicine Fukuoka University Fukuoka Japan.
Department of Research Planning and Information Management Fukuoka Institute of Health and Environmental Sciences Fukuoka Japan.
J Am Heart Assoc. 2020 Mar 3;9(5):e014574. doi: 10.1161/JAHA.119.014574. Epub 2020 Feb 28.
Background This large-scale observational study on negative events in a real-world setting investigated Japanese patients with atrial fibrillation who were not on anticoagulants. This study aims to evaluate the incidence of ischemic stroke and bleeding events (intracranial hemorrhage, gastrointestinal bleeding, others) based on CHA2DS2-VASc scores in Japanese patients with atrial fibrillation who were not anticoagulated. Methods and Results We used health checkups and insurance claim data from a Japanese insurance organization. Altogether, 9733 atrial fibrillation patients were not prescribed anticoagulation during their follow-up periods. Patients' risk levels were defined by their CHA2DS2-VASc scores (range 0-≥3): Men with scores of 0, 1, or ≥2 and women with scores of 1, 2, or ≥3 were considered at low, intermediate, or high risk, respectively. Cox proportional hazards model was used to assess the association between the CHA2DS2-VASc-determined risk and the incidence of ischemic stroke and intracranial, gastrointestinal, and other bleeding. The mean 2.5-year follow-up revealed 143 ischemic strokes and 332 bleeding events. Annual event rates were 0.58% for ischemic stroke and 1.17% for total bleeding events. Annual incidence of ischemic stroke increased with elevated predicted risks based on CHA2DS2-VASc scores: 0.18% for low-risk, 0.44% intermediate-risk, and 1.29% high-risk groups (<0.001 for trend). Annual incidences of total bleeding also increased with elevated predicted risks: 0.51% for low-risk, 1.28% intermediate-risk, and 2.02% high-risk groups (<0.001 for trend). Conclusions Risks of ischemic stroke and bleeding events were high, particularly among those with high CHA2DS2-VASc scores.
这项在真实环境下对负面事件进行的大规模观察性研究，调查了未使用抗凝剂的日本房颤患者。本研究旨在评估未接受抗凝治疗的日本房颤患者，根据 CHA2DS2-VASc 评分，发生缺血性卒中和出血事件（颅内出血、胃肠道出血、其他）的发生率。
我们使用了来自一家日本保险公司的健康检查和保险理赔数据。共有 9733 例房颤患者在随访期间未开具抗凝药物。患者的风险水平由 CHA2DS2-VASc 评分确定（范围 0-≥3）：评分 0、1 或≥2 的男性和评分 1、2 或≥3 的女性分别被认为处于低、中或高风险。Cox 比例风险模型用于评估 CHA2DS2-VASc 确定的风险与缺血性卒中和颅内、胃肠道和其他出血发生率之间的关联。平均 2.5 年的随访显示，有 143 例缺血性卒中和 332 例出血事件。缺血性卒中和总出血的年发生率分别为 0.58%和 1.17%。基于 CHA2DS2-VASc 评分的预测风险升高，缺血性卒中的年发生率也随之增加：低危组为 0.18%，中危组为 0.44%，高危组为 1.29%（趋势<0.001）。总出血的年发生率也随着预测风险的升高而增加：低危组为 0.51%，中危组为 1.28%，高危组为 2.02%（趋势<0.001）。
缺血性卒中和出血事件的风险较高，尤其是 CHA2DS2-VASc 评分较高的患者。
