Endovascular therapy after intravenous t-PA versus t-PA alone for stroke.
Endovascular therapy after intravenous t-PA versus t-PA alone for stroke.
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DOI：
10.1056/nejmoa1214300
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发表时间：
2013-03-07
期刊：
影响因子：
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通讯作者：
Interventional Management of Stroke (IMS) III Investigators
中科院分区：
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作者：
Broderick JP;Palesch YY;Demchuk AM;Yeatts SD;Khatri P;Hill MD;Jauch EC;Jovin TG;Yan B;Silver FL;von Kummer R;Molina CA;Demaerschalk BM;Budzik R;Clark WM;Zaidat OO;Malisch TW;Goyal M;Schonewille WJ;Mazighi M;Engelter ST;Anderson C;Spilker J;Carrozzella J;Ryckborst KJ;Janis LS;Martin RH;Foster LD;Tomsick TA;Interventional Management of Stroke (IMS) III Investigators
中至重度急性缺血性卒中患者在静脉注射组织型纤溶酶原激活剂（t-PA）后，越来越多地采用血管内治疗，但联合治疗是否比单独静脉注射t-PA更有效尚不确定。我们随机分配在症状出现后3小时内接受静脉注射t-PA的符合条件的患者，以2:1的比例接受额外的血管内治疗或单独静脉注射t-PA。主要结局指标是90天的修正Rankin量表评分为2分或更低（表明功能独立性）（评分范围从0到6，得分越高表明残疾程度越严重）。在656名参与者接受随机分组（434名患者接受血管内治疗，222名患者单独接受静脉注射t-PA）后，由于无效，研究提前停止。90天改良Rankin评分为2或更低的受试者比例根据治疗没有显著差异(血管内治疗40.8%，静脉注射t-PA 38.7%；绝对调整差，1.5个百分点；95%置信区间[CI]， - 6.1至9.1，调整为美国国立卫生研究院卒中量表[NIHSS]评分[8-19，表示中度卒中，或≥20，表示严重卒中])，NIHSS评分为20或更高（6.8个百分点，95% CI, - 4.4至18.1）和评分为19或更低（- 1.0个百分点，95% CI, - 10.8至8.8）的预定义亚组患者之间也没有显著差异。血管内治疗组和静脉注射t-PA组的90天死亡率相似（分别为19.1%和21.6%,P = 0.52）， t-PA开始后30小时内出现症状性脑出血的患者比例相似（分别为6.2%和5.9%,P = 0.83）。该试验显示了相似的安全性结果，与单独静脉注射t-PA相比，静脉注射t-PA后血管内治疗的功能独立性无显著差异。（由美国国立卫生研究院和其他机构资助；ClinicalTrials.gov号码，NCT00359424。）
Endovascular therapy is increasingly used after the administration of intravenous tissue plasminogen activator (t-PA) for patients with moderate-to-severe acute ischemic stroke, but whether a combined approach is more effective than intravenous t-PA alone is uncertain. We randomly assigned eligible patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2:1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The study was stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone). The proportion of participants with a modified Rankin score of 2 or less at 90 days did not differ significantly according to treatment (40.8% with endovascular therapy and 38.7% with intravenous t-PA; absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], −6.1 to 9.1, with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8–19, indicating moderately severe stroke, or ≥20, indicating severe stroke]), nor were there significant differences for the predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, −4.4 to 18.1) and those with a score of 19 or lower (−1.0 percentage point; 95% CI, −10.8 to 8.8). Findings in the endovascular-therapy and intravenous t-PA groups were similar for mortality at 90 days (19.1% and 21.6%, respectively; P = 0.52) and the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; P = 0.83). The trial showed similar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00359424.)