Systemic Embolic Events in Atrial Fibrillation: An Individual Patient Data Meta-analysis of 71 683 Participants Randomized to NOAC Versus Warfarin.

Although non-vitamin K antagonist oral anticoagulants prevent ischemic stroke (IS), their efficacy in SEE and the clinical characteristics of patients who experience SEE remain poorly understood.

尽管非维生素K拮抗剂口服抗凝药可以预防缺血性中风（IS），但其在全身性栓塞事件（SEE）中的疗效以及经历SEE的患者的临床特征仍然不为人所了解。

Methods

We analyzed individual patient data from 4 pivotal randomized trials enrolling patients between 2005 and 2010 comparing non-vitamin K antagonist oral anticoagulants versus warfarin in atrial fibrillation.

我们分析了2005年至2010年间4项关键的随机试验中的个别患者数据，这些试验比较了非维生素K拮抗剂口服抗凝药与华法林在心房颤动中的应用。

We characterized the incidence, clinical features, management, and outcomes of clinically overt SEE and compared results in these patients with patients who had an IS.

我们描述了临床明显的视网膜血管事件（SEE）的发生率、临床特征、管理方式和结果，并将这些患者的发现与有缺血性中风（IS）的患者进行了比较。

Results

Among 71 683 patients, 188 experienced SEE (26 with concurrent IS), yielding an annualized event rate of 0.13% per patient-year, compared with 1.25% per patient-year for IS (n=1797).

在71,683名患者中，有188名经历了系统性栓塞事件（SEE），其中26例伴有同时发生的缺血性卒中（IS），导致每患者年0.13%的年化事件率，相比之下，IS的每患者年事件率为1.25%（n=1797）。

Among 171 patients with SEE as their first event, median age was 75 years (interquartile range, 68-80), 49.7% were female, and mean±SD CHA2DS2-VASc score was 4.7±1.5.

在171名以SEE为首次事件的患者中，中位年龄为75岁（四分位数范围，68-80岁），49.7%为女性，平均±标准差CHA2DS2-VASc评分为4.7±1.5。

Compared with IS, patients with SEE had higher rates of peripheral arterial disease (PAD, 16.5% versus 5.4%; P<0.001), previous myocardial infarction (24% versus 17%; P=0.02), previous vitamin K antagonist exposure (57% versus 46%; P=0.007), worse renal function (median creatinine clearance 58 versus 62 mL/min; P=0.02), and higher incidenceof nonparoxysmal atrial fibrillation (86% versus 80%; P=0.047).

与IS相比，SEE患者外周动脉疾病(PAD)的发生率更高（16.5%对比5.4%；P<0.001），既往心肌梗死的发生率更高（24%对比17%；P=0.02），既往维生素K拮抗剂暴露率更高（57%对比46%；P=0.007），肾功能更差（中位肌酐清除率58对比62 mL/min；P=0.02），以及非阵发性房颤的发生率更高（86%对比80%；P=0.047）。

Interventions (surgical or percutaneous) were performed in 62 patients (31%) with SEE.

在62名（31%）SEE患者中进行了干预措施（外科或经皮）。

Standard-dose non-vitamin K antagonist oral anticoagulants reduced the risk of SEE by 29% compared with warfarin over a median follow-up of 25.2 months (interquartile range, 17.5-32.0; hazard ratio, 0.71 [95% CI, 0.51-0.99]; P=0.04).

标准剂量的非维生素K拮抗剂口服抗凝药与华法林相比，在中位随访25.2个月（四分位数范围，17.5-32.0；风险比，0.71 [95% 置信区间，0.51-0.99]；P=0.04）时，降低了29%的SEE风险。

Thirty-day mortality after SEE was similar to IS (18% versus 17%), and SEE was associated with a nearly 3-fold increased risk of long-term mortality compared with patients without SEE or IS (hazard ratio, 2.85 [95% CI, 2.11-3.85]).

SEE后的30天死亡率与IS相似（18%对比17%），与没有SEE或IS的患者相比，SEE与长期死亡风险几乎增加了3倍（风险比，2.85 [95% 置信区间，2.11-3.85]）。

Independent predictors of SEE included peripheral artery disease, smoking, nonparoxysmal atrial fibrillation, female sex, previous myocardial infarction, previous stroke or transient ischemic attack, vitamin K antagonist experience, and renal dysfunction.

SEE的独立预测因素包括外周动脉疾病、吸烟、非阵发性房颤、女性性别、既往心肌梗死、既往中风或短暂性脑缺血发作、维生素K拮抗剂使用经验以及肾功能不全。

Conclusions

In this large individual patient data meta-analysis, non-vitamin K antagonist oral anticoagulants significantly reduced the risk of SEE compared with warfarin.

在这项大型患者个体数据的荟萃分析中，非维生素K拮抗剂口服抗凝药与华法林相比显著降低了SEE的风险。

Although SEEs were approximately one-tenth as frequent as IS, they were associated with comparable mortality and substantial morbidity.

尽管SEEs的发生频率大约是IS的十分之一，但它们与相似的死亡率和显著的发病率相关。