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替卡格雷联合阿司匹林治疗急性缺血性中风或短

2020-07-18 18:48      点击:

本期文章:《新英格兰医学杂志》:Vol.383 No.3

美国德克萨斯大学奥斯汀分校S. Claiborne Johnston团队比较了替卡格雷联合阿司匹林与阿司匹林单用治疗急性缺血性中风或短暂性脑缺血发作的效果。2020年7月16日,该论文发表在《新英格兰医学杂志》上。

有研究评估了使用氯吡格雷和阿司匹林预防缺血性中风或短暂性脑缺血发作(TIA)后再次中风的效果。先前的试验表明,替卡格雷在预防中风或TIA后的心血管事件或死亡方面并不优于阿司匹林。但替卡格雷和阿司匹林联合使用对预防中风的作用尚未明确。

研究组进行了一项随机、安慰剂对照、双盲试验,招募了11016例轻中度急性非心脏栓塞性缺血性中风患者,美国国立卫生研究院卒中量表(NIHSS)得分为5分及以下(0-42分,得分较高表示中风越严重),或未进行溶栓或血栓切除术的TIA。患者在症状发作后24小时内,以1:1随机分组,其中5523例接受30天的替卡格雷联合阿司匹林的治疗方案,5493例接受匹配的安慰剂联合阿司匹林的治疗方案。

替卡格雷-阿司匹林组中有303例患者(5.5%)在30天内发生中风和死亡的综合结局,阿司匹林组有362例(6.6%),风险比为0.83,差异显著。替卡格雷-阿司匹林组中有276例患者(5.0%)发生缺血性卒中,显著低于阿司匹林组(345例,6.3%),风险比为0.79。两组之间的残疾发生率没有显著差异。替卡格雷-阿司匹林组中有28例患者(0.5%)发生严重出血,显著高于阿司匹林组(7例,0.1%)。

总之,在未接受静脉或血管内溶栓治疗的轻中度急性非心脏栓塞性缺血性卒中或TIA患者中,替卡格雷-阿司匹林治疗30天内发生中风或死亡的综合风险低于单独使用阿司匹林,但两组间残疾发生率没有显著差异。替卡格雷的严重出血率更高。

附:英文原文

Title: Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA

Author: S. Claiborne Johnston, M.D., Ph.D.,, Pierre Amarenco, M.D.,, Hans Denison, M.D., Ph.D.,, Scott R. Evans, Ph.D.,, Anders Himmelmann, M.D., Ph.D.,, Stefan James, M.D., Ph.D.,, Mikael Knutsson, Ph.D.,, Per Ladenvall, M.D., Ph.D.,, Carlos A. Molina, M.D., Ph.D.,, and Yongjun Wang, M.D.

Issue&Volume: 2020-07-15

Abstract: 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.

DOI: 10.1056/NEJMoa1916870

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1916870

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