Background:Direct oral anticoagulants have become a standard therapy for non-valvular atrial fibrillation (NVAF). However, little is known about their effectiveness/safety when prescribed by general practitioners to treat high-risk populations such as the elderly, those who are frail or have cognitive dysfunction.

Methods and Results:In this multicenter, prospective study, a total of 5,717 NVAF patients (mean age 73.9 years) receiving rivaroxaban were registered by general practitioners, with a maximum 3-year follow up (mean 2.0±0.5 years). The primary endpoint was a composite of stroke and systemic embolism (SE). The annual incidence (per 100 person-years) of stroke/SE was 1.23% and for major bleeding, it was 0.63%. Multivariate analyses identified age ≥75 years (hazard ratio [HR]; 2.67, P<0.001) and history of ischemic stroke (HR; 1.89, P=0.005) as significant risk factors of stroke/SE, with history of major bleeding (HR; 14.9, P<0.001) and warfarin use (HR; 2.15, P=0.002) as risk factors for major bleeding events. Neither cognitive dysfunction, defined by the receipt of anti-dementia medications, nor frailty, evaluated by the classification of the Japanese Long-term Care Insurance system, correlated with stroke/SE or major bleeding events.

Conclusions:The low incidence of adverse events, including stroke/SE and bleeding, in patients prescribed rivaroxaban by general practitioners supports its use as a safe and efficacious treatment in the standard clinical care of high-risk patient populations.

背景：直接口服抗凝剂已成为非瓣膜性心房颤动（NVAF）的标准疗法。然而，当全科医生开具处方用于治疗高危人群（如老年人、体弱者或认知功能障碍者）时，它们的有效性/安全性知之甚少。

方法和结果：在这项多中心、前瞻性研究中，共有 5,717 名接受利伐沙班的 NVAF 患者（平均年龄 73.9 岁）由全科医生登记，最长随访时间为 3 年（平均 2.0±0.5 年）。主要终点是中风和全身性栓塞（SE）的复合终点。卒中/SE 的年发病率（每 100 人年）为 1.23%，大出血为 0.63%。多变量分析确定年龄≥75 岁（风险比 [HR]；2.67，P<0.001）和缺血性卒中史（HR；1.89，P=0.005）是卒中/SE 的重要危险因素，有大出血史（HR ; 14.9, P<0.001) 和使用华法林 (HR; 2.15, P=0.002) 作为大出血事件的危险因素。既不是认知功能障碍，也不是由接受抗痴呆药物定义的，也不是虚弱，

结论：在全科医生开具利伐沙班处方的患者中，不良事件（包括卒中/SE 和出血）的发生率较低，支持在高危患者人群的标准临床护理中将其用作安全有效的治疗方法。