Low molecular-weight heparin versus aspirin in patients with acute ischaemic stroke and atrial fibrillation: a double-blind randomised study
Low molecular-weight heparin versus aspirin in patients with acute ischaemic stroke and atrial fibrillation: a double-blind randomised study
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DOI：
10.1016/s0140-6736(00)02085-7
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发表时间：
2000-04-08
期刊：
影响因子：
168.9
通讯作者：
Sandset, PM
中科院分区：
文献类型：
--
作者：
Berge, E;Abdelnoor, M;Sandset, PM
背景急性缺血性卒中伴房颤患者早期卒中复发的风险增加，肝素抗凝治疗被广泛提倡，尽管缺乏风险和获益平衡的数据。方法肝素治疗急性栓塞性卒中试验（HAEST）是一项多中心、随机、双盲、双模拟试验，旨在评价低分子肝素的疗效应用低分子肝素（LMWH，达肝素100 IU/kg，皮下注射，每日2次）或阿司匹林（160 mg，每日1次）治疗449例急性缺血性卒中伴房颤患者。主要目的是测试在中风发作后30小时内开始LMWH治疗，在前14天内预防复发性卒中的作用上级于阿司匹林。结果在前14天内复发性缺血性卒中的频率为19/244（8.5%），而阿司匹林组为17/225（7.5%）（比值比=1.13，95% CI 0.57-2.24）。前14天内的次要事件也显示达肝素与阿司匹林相比无获益：症状性脑出血6/224与4/225;症状性和无症状性脑出血26/224与32/225;前48小时内症状进展24/224与17/225;死亡21/224与16/225。在14天或3 months.Interpretation的功能结果或死亡没有显着差异-目前的数据没有提供任何证据表明，低分子肝素是上级阿司匹林治疗急性缺血性中风房颤患者。然而，这项研究不能排除任何一种试验药物的作用较小但仍然值得的可能性。
Background Patients with acute ischaemic stroke and atrial fibrillation have an increased risk of early stroke recurrence, and anticoagulant treatment with heparins has ben widely advocated, despite missing data on the balance of risk and benefit.Methods Heparin in Acute Embolic Stroke Trial (HAEST) was a multicentre, randomised, double-blind, and double-dummy trial on the effect of low-molecular-weight heparin (LMWH, dalteparin 100 IU/kg subcutaneously twice a day) or aspirin (160 mg every day) for the treatment of 449 patients with acute ischaemic stroke and atrial fibrillation. The primary aim was to test whether treatment with LMWH, started within 30 h of stroke onset, is superior to aspirin for the prevention of recurrent stroke during the first 14 days.Findings The frequency of recurrent ischaemic stroke during the first 14 days was 19/244 (8.5%) in dalteparin-allocated patients versus 17/225 (7.5%) in aspirin-allocated patients (odds ratio=1.13, 95% CI 0.57-2.24). The secondary events during the first 14 days also revealed no benefit of dalteparin compared with aspirin: symptomatic cerebral haemorrhage 6/224 versus 4/225; symptomatic and asymptomatic cerebral haemorrhage 26/224 versus 32/225; progression of symptoms within the first 48 hours 24/224 versus 17/225; and death 21/224 versus 16/225. There were no significant differences in functional outcome or death at 14 days or 3 months.Interpretation The present data do not provide any evidence that LMWH is superior to aspirin for the treatment of acute ischaemic stroke in patients with atrial fibrillation. However, the study could not exclude the possibility of smaller, but still worthwhile, effects of either of the trial drugs.