Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke

Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke
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DOI:
10.1056/nejmoa1415061
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发表时间:
2015-06-11
影响因子:
158.5
通讯作者:
Jahan, Reza
Jahan, Reza
中科院分区:
医学1区
文献类型:
--
作者:
Saver, Jeffrey L.;Goyal, Mayank;Jahan, Reza

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背景在急性缺血性卒中患者中,仅静脉注射组织型纤溶酶原激活剂(t-PA)的患者中,只有不到40%的患者恢复了功能独立。我们随机将符合条件的接受或已经接受t-PA静脉注射的中风患者随机分为两组,一组继续接受t-PA治疗,另一组在症状出现后6小时内使用支架取栓器进行血管内取栓术(干预组)。患者已确认近端前颅内循环闭塞,且无大的缺血核心病变。主要结果是90天后全球残疾的严重程度,通过改良的Rankin量表(分数从0[无症状]到6[死亡])进行评估。结果由于疗效原因,研究提前停止。在39个中心,196名患者接受了随机分组(每组98名患者)。干预组从显影合格到腹股沟穿刺术的中位时间为57分钟,手术结束时再通率为88%。血栓摘除加支架取回器加静脉注射t-PA在90天内降低了改良的朗肯评分范围内的残疾(P<0.001)。干预组的功能独立性(改良朗金量表评分,0~2分)高于对照组(60%比35%,P<0.001)。在90天死亡率(9%比12%,P=0.50)和症状性颅内出血(0%比3%,P=0.12)方面,两组之间没有显著差异。结论在急性缺血性卒中患者中,由于近端前循环闭塞而接受t-PA静脉注射的患者,在发病后6小时内取栓加支架取回器可改善90天的功能预后。
BACKGROUNDAmong patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.METHODSWe randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]).RESULTSThe study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P< 0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P< 0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P = 0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P = 0.12).CONCLUSIONSIn patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days.