Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial

Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial
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DOI:
10.1136/jnis.2009.001388
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发表时间:
2010-03-01
影响因子:
4.8
通讯作者:
Sterzi, R.
Sterzi, R.
中科院分区:
医学1区
文献类型:
--
作者:
Ciccone, A.;Valvassori, L.;Sterzi, R.

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目的比较动脉溶栓(IAT)与标准静脉溶栓(IVT)治疗急性缺血性脑卒中的可行性、安全性和初步疗效。患者在发病后3小时内随机接受静脉注射阿替普酶(根据现行欧洲标签)或动脉内注射阿替普酶(最高0.9 mg/kg,最高90 mg),在60分钟内进入血栓,必要时进行机械性血块破裂和/或取出。本研究的目的是确定90天时有利结局的比例。安全性终点包括症状性颅内出血(SICH)、死亡和其他严重不良事件。从卒中发作到开始治疗的中位时间,IAT为3小时15分钟,IVT为2小时35分钟(P
Objective To assess the feasibility, safety and preliminary efficacy of intra-arterial thrombolysis (IAT) compared with standard intravenous thrombolysis (IVT) for acute ischemic stroke.Methods Eligible patients with ischemic stroke, who were devoid of contraindications, started IVT within 3 h or IAT as soon as possible within 6 h. Patients were randomized within 3 h of onset to receive either intravenous alteplase, in accordance with the current European labeling, or up to 0.9 mg/kg intra-arterial alteplase (maximum 90 mg), over 60 min into the thrombus, if necessary with mechanical clot disruption and/or retrieval. The purpose of the study was to determine the proportion of favorable outcome at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (SICH), death and other serious adverse events.Results 54 patients (25 IAT) were enrolled. Median time from stroke onset to start to treatment was 3 h 15 min for IAT and 2 h 35 min for IVT (p