替格瑞洛联合阿司匹林或单用阿司匹林治疗急性缺血性卒中或短暂性脑缺血发作
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替格瑞洛联合阿司匹林或单用阿司匹林治疗急性缺血性卒中或短暂性脑缺血发作
翻译：冯玉蓉 编辑：冯玉蓉 审校：曹莹
背景：已有试验评估了氯吡格雷和阿司匹林在预防缺血性卒中或短暂性脑缺血发作(TIA)后的作用。曾有研究报道，替格瑞洛在预防卒中或TIA后的血管事件或死亡方面并不优于阿司匹林。目前替格瑞洛联合阿司匹林预防卒中的效果尚未得到充分研究。
方法：我们进行了一项随机、安慰剂对照、双盲试验，研究对象为美国国立卫生研究院卒中量表（NIHSS）评分为5分或以下（范围为0至42分，得分越高表示卒中越严重）的轻度至中度急性非心源性缺血性卒中患者，或TIA患者，以及未进行溶栓治疗或血栓切除术的患者。患者在症状出现后24小时内，按照1:1的比例，接受30天的治疗方案：替格瑞洛（180mg负荷剂量，然后90 mg每天两次）+阿司匹林（第一天300~325mg，然后每天75~100mg）；或相对应的安慰剂+阿司匹林。主要观察指标是30天内卒中或死亡的综合结果。次要观察指标是30天内首次继发缺血性卒中和残疾发生率。主要安全指标是严重出血。
结果：共有11016名患者参与了随机分组（替格瑞洛-阿司匹林组为5523例，阿司匹林组为5493例）。替格瑞洛-阿司匹林组发生主要结局事件303例（5.5%），阿司匹林组发生362例（6.6%）（危险比0.83；95%CI 0.71～0.96；P=0.02）。替格瑞洛-阿司匹林组发生缺血性卒中276例（5.0%），阿司匹林组发生345例（6.3%）（危险比0.79；95%CI 0.68～0.93；P=0.004）。两组间残疾发生率无显著差异。替格瑞洛-阿司匹林组发生严重出血28例（0.5%），阿司匹林组发生7例（0.1%）（P=0.001）。
结论：未接受静脉或血管内溶栓治疗的轻度至中度急性非心源性缺血性卒中（NIHSS评分≤5）或TIA的患者，替格瑞洛-阿司匹林组30天内卒中或死亡的综合风险低于单独使用阿司匹林组，但两组间残疾发生率无显著差异。使用替格瑞洛更容易出现严重出血。
原始文献来源：Johnston SC, Amarenco P, Denison H, et al. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA[J]. N. Engl. J. Med. 2020 07 16;383(3).
Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA
Abstract
BACKGROUND Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied.
METHODS We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding.
RESULTS A total of 11,016 patients underwent randomization (5523 in the ticagrelor–aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor–aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor–aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P=0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor–aspirin group and in 7 patients (0.1%) in the aspirin group (P=0.001).
CONCLUSIONS Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor–aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor.
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