Background and Purpose- Patients with transient ischemic attack (TIA) and minor ischemic stroke are at risk for early recurrent cerebral ischemia. Anticoagulants are associated with reduced recurrence but also increased hemorrhagic transformation (HT). The safety of the novel oral anticoagulant dabigatran in acute stroke has not been evaluated. Methods- DATAS II (Dabigatran Treatment of Acute Stroke II) was a phase II prospective, randomized open label, blinded end point trial. Patients with noncardioembolic stroke/transient ischemic attack (National Institutes of Health Stroke Scale score, ≤9; infarct volume, ≤25 mL) were randomized to dabigatran or aspirin. Magnetic resonance imaging was performed before randomization and repeated at day 30. Imaging end points were ascertained centrally by readers blinded to treatment. The primary end point was symptomatic HT within 37 days of randomization. Results- A total of 305 patients, mean age 66.59±13.21 years, were randomized to dabigatran or aspirin a mean of 42.00±17.31 hours after symptom onset. The qualifying event was a transient ischemic attack in 21%, and ischemic stroke in 79% of patients. Median National Institutes of Health Stroke Scale (interquartile range) was 1 (0-2), and mean infarct volume 3.2±6.5 mL. No symptomatic HT occurred. Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]). Baseline infarct volume predicted incident HT (odds ratio, 1.07 [95% CI, 1.03-1.12]; P=0.0026). Incident covert infarcts on day 30 imaging occurred in 9/142 (6.3%) of dabigatran-assigned and 14/142 (9.8%) of aspirin-assigned patients (relative risk, 0.62 [95% CI, 0.26, 1.48]). Conclusions- Dabigatran was associated with a risk of HT similar to aspirin in acute minor noncardioembolic ischemic stroke/transient ischemic attack. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02295826.

中文翻译：

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达比加群治疗急性非心脏栓塞性缺血性中风。

背景和目的-短暂性脑缺血发作（TIA）和轻度缺血性中风的患者有早期复发性脑缺血的风险。抗凝剂与减少复发有关，但也增加出血转化（HT）。尚未评估新型口服抗凝剂达比加群在急性卒中中的安全性。方法-DATAS II（达比加群治疗急性卒中II）是一项II期前瞻性，随机开放标签，盲点试验。非心脏栓塞性卒中/短暂性脑缺血发作（美国国立卫生研究院卒中量表评分，≤9；梗塞体积，≤25mL）患者被随机分配至达比加群或阿司匹林。在随机分组之前进行磁共振成像，并在第30天重复进行。成像终点由对治疗不知情的读者集中确定。主要终点为随机分组后37天内的症状性HT。结果-305例平均发病年龄为42.00±17.31小时的患者，平均年龄66.59±13.21岁，被随机分配至达比加群或阿司匹林。合格事件为21％的短暂性脑缺血发作和79％的患者为缺血性中风。美国国立卫生研究院中风量表（四分位间距）为1（0-2），平均梗塞体积为3.2±6.5 mL。无症状性HT发生。在达比加群分配的患者中，无症状的上皮HT发生率为11/142（7.8％），在阿司匹林分配的患者中为5/142（3.5％）（相对危险度为2.301 [95％CI，0.778-6.802]）。基线梗塞体积可预测事件HT（优势比，1.07 [95％CI，1.03-1.12]； P = 0.0026）。在第30天成像时发生的事件隐性梗塞发生在达比加群分配的9/142（6.3％）和14/142（9。分配给阿司匹林的患者中占8％（相对危险度为0.62 [95％CI，0.26，1.48]）。结论：达比加群在急性轻度非心脏栓塞性缺血性卒中/短暂性脑缺血发作中与阿司匹林相似，具有HT风险。注册网址：https：//www.clinicaltrials.gov；唯一标识符：NCT02295826。