A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
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DOI：
10.1056/nejmoa1411587
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发表时间：
2015-01-01
影响因子：
158.5
通讯作者：
Dippel, D. W. J.
中科院分区：
文献类型：
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作者：
Berkhemer, O. A.;Fransen, P. S. S.;Dippel, D. W. J.
研究背景对于近端颅内动脉闭塞引起的急性缺血性卒中患者，动脉内治疗对急诊血运重建非常有效。然而，一个有益的影响功能outcome.METHODSWe随机分配的患者动脉内治疗加常规护理或常规护理单独的证据是缺乏。合格患者的大脑前循环近端动脉闭塞经血管成像证实，可在症状发作后6小时内进行动脉内治疗。主要结局是90天时的改良兰金量表评分;该分类量表测量功能结局，评分范围为0（无症状）至6（死亡）。治疗效果用有序逻辑回归作为常见优势比进行评估，并根据预先设定的预后因素进行调整。调整后的普通比值比测量动脉内治疗与单独常规治疗相比导致改良兰金评分降低的可能性（变化分析）。我们在荷兰的16个医疗中心招募了500名患者（233名分配到动脉内治疗，267名分配到单独常规治疗）。平均年龄为65岁（范围：23 - 96岁），445例患者（89.0%）在随机化前接受静脉阿替普酶治疗。在233例分配接受动脉内治疗的患者中，190例（81.5%）使用了可回收支架。调整后的常见优势比为1.67（95%置信区间[CI]，1.21至2.30）。功能独立率（改良兰金评分，0 - 2）的绝对差异为13.5个百分点（95% CI，5.9 - 21.2），支持干预（32.6% vs. 19.1%）。死亡率或症状性脑出血的发生率无显著差异。CONCLUSIONSIn患者急性缺血性卒中引起的近端颅内闭塞的前循环，动脉内治疗中风发作后6小时内是有效和安全的。（由荷兰心脏基金会和其他机构资助; MR CLEAN荷兰试验注册编号NTR 1804和当前对照试验编号ISRCTN 10888758。
BACKGROUNDIn patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking.METHODSWe randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis).RESULTSWe enrolled 500 patients at 16 medical centers in the Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage.CONCLUSIONSIn patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.)