Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke

被引：623

作者：

Yang, Pengfei ^{[1
]}

Zhang, Yongwei ^{[2
]}

Zhang, Lei ^{[1
]}

Zhang, Yongxin ^{[1
]}

Treurniet, Kilian M. ^{[38
]}

Chen, Wenhuo ^{[7
]}

Peng, Ya ^{[8
]}

Han, Hongxing ^{[9
]}

Wang, Jiyue ^{[10
]}

Wang, Shouchun ^{[11
]}

Yin, Congguo ^{[12
]}

Liu, Sheng ^{[14
]}

Wang, Peng ^{[16
]}

Fang, Qi ^{[17
]}

Shi, Hongchao ^{[15
]}

Yang, Jianhong ^{[18
]}

Wen, Changming ^{[19
]}

Li, Conghui ^{[20
]}

Jiang, Changchun ^{[21
]}

Sun, Jun ^{[22
]}

Yue, Xincan ^{[23
]}

Lou, Min ^{[13
]}

Zhang, Meng ^{[24
]}

Shu, Hansheng ^{[25
]}

Sun, Dianjing ^{[26
]}

Liang, Hui ^{[27
]}

Li, Tong ^{[28
]}

Guo, Fuqiang ^{[29
]}

Ke, Kaifu ^{[30
]}

Yuan, Haicheng ^{[31
]}

Wang, Guoping ^{[32
]}

Yang, Weimin ^{[33
]}

Shi, Huaizhang ^{[34
]}

Li, Tianxiao ^{[35
]}

Li, Zifu ^{[1
]}

Xing, Pengfei ^{[2
]}

Zhang, Ping ^{[2
]}

Zhou, Yu ^{[1
]}

Wang, Hao ^{[9
]}

Xu, Yi ^{[1
]}

Huang, Qinghai ^{[1
]}

Wu, Tao ^{[2
]}

Zhao, Rui ^{[1
]}

Li, Qiang ^{[1
]}

Fang, Yibin ^{[1
]}

Wang, Laixing ^{[1
]}

Lu, Jianping ^{[3
]}

Li, Yansheng ^{[4
]}

Fu, Jianhui ^{[5
]}

Zhong, Xihua ^{[6
]}

机构：

[1] Naval Med Univ, Changhai Hosp, Dept Neurosurg, Shanghai, Peoples R China

[2] Naval Med Univ, Changhai Hosp, Dept Neurol, Shanghai, Peoples R China

[3] Naval Med Univ, Changhai Hosp, Dept Radiol, Shanghai, Peoples R China

[4] Shanghai Jiao Tong Univ, Renji Hosp, Dept Neurol, Shanghai, Peoples R China

[5] Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai, Peoples R China

[6] Shanghai KNOWLANDS MedPharm Consulting, Data Stat Ctr, Shanghai, Peoples R China

[7] Fujian Med Univ, Zhangzhou Affiliated Hosp, Dept Neurol, Zhangzhou, Peoples R China

[8] Soochow Univ, Affiliated Hosp 3, Dept Neurosurg, Changzhou, Jiangsu, Peoples R China

[9] Qingdao Univ, Linyi Peoples Hosp, Dept Neurol, Linyi, Shandong, Peoples R China

[10] Shandong First Med Univ, Liaocheng Peoples Hosp, Dept Neurosurg, Liaocheng, Shandong, Peoples R China

[11] Jilin Univ, Affiliated Hosp 1, Dept Neurol, Changchun, Peoples R China

[12] Zhejiang Univ, Peoples Hosp 1, Dept Neurol, Hangzhou, Peoples R China

[13] Zhejiang Univ, Affiliated Hosp 2, Dept Neurol, Hangzhou, Peoples R China

[14] Nanjing Med Univ, Jiangsu Prov Peoples Hosp, Dept Radiol, Nanjing, Peoples R China

[15] Nanjing Med Univ, Nanjing First Hosp, Dept Neurol, Nanjing, Peoples R China

[16] Wenzhou Med Univ, Taizhou Peoples Hosp 1, Dept Neurol, Taizhou, Peoples R China

[17] Soochow Univ, Affiliated Hosp 1, Dept Neurol, Suzhou, Peoples R China

[18] Zhejiang Univ, Ningbo Hosp, Dept Neurol, Ningbo, Peoples R China

[19] Xinxiang Med Univ, Nanyang Cent Hosp, Dept Neurol, Nanyang, Peoples R China

[20] Hebei Med Univ, Hosp 1, Dept Neurosurg, Shijiazhuang, Hebei, Peoples R China

[21] Inner Mongolia Med Univ, Baotou Cent Hosp, Dept Neurol, Baotou, Peoples R China

[22] Wenzhou Med Univ, Wenzhou Cent Hosp, Dept Neurosurg, Wenzhou, Peoples R China

[23] Henan Univ, Zhoukou Cent Hosp, Dept Neurosurg, Zhoukou, Peoples R China

[24] Army Med Univ, Daping Hosp, Dept Neurol, Chongqing, Peoples R China

[25] Bengbu Med Univ, Affiliated Hosp 2, Dept Neurosurg, Bengbu, Peoples R China

[26] Shandong First Med Univ, Yantaishan Hosp, Dept Radiol, Yantai, Peoples R China

[27] Shandong First Med Univ, Yantaishan Hosp, Dept Neurol, Yantai, Peoples R China

[28] Guangxi Med Univ, Affiliated Hosp 3, Dept Neurol, Nanning, Peoples R China

[29] Univ Elect Sci & Technol China, Sichuan Prov Hosp, Dept Neurol, Chengdu, Peoples R China

[30] Nantong Univ, Affiliated Hosp, Dept Neurol, Nantong, Peoples R China

[31] Qingdao Univ, Qingdao Cent Hosp, Dept Neurol, Qingdao, Peoples R China

[32] Univ Sci & Technol China, Affiliated Hosp 1, Dept Neurol, Hefei, Peoples R China

[33] Anhui Med Univ, Affiliated Hosp 1, Dept Neurol, Hefei, Peoples R China

[34] Harbin Med Univ, Affiliated Hosp 1, Dept Neurosurg, Harbin, Peoples R China

[35] Zhengzhou Univ, Henan Prov Peoples Hosp, Dept Radiol, Zhengzhou, Peoples R China

[36] Capital Med Univ, Tiantan Hosp, Dept Neurol, Beijing, Peoples R China

[37] Beijing Univ, Sch Publ Hlth, Beijing, Peoples R China

[38] Univ Amsterdam, Med Ctr, Dept Radiol & Nucl Med, Amsterdam, Netherlands

[39] Univ Amsterdam, Med Ctr, Dept Neurol, Amsterdam, Netherlands

[40] Erasmus MC, Univ Med Ctr, Dept Neurol, Rotterdam, Netherlands

[41] Univ Calgary, Dept Radiol, Calgary, AB, Canada

[42] Univ Calgary, Dept Clin Neurosci, Calgary, AB, Canada

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2020年 / 382卷 / 21期

关键词：

ISCHEMIC-STROKE; MECHANICAL THROMBECTOMY; THROMBOLYSIS; RECANALIZATION; REPERFUSION; PREDICTORS; ADJUSTMENT; OUTCOMES; THERAPY;

D O I：

10.1056/NEJMoa2001123

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background In acute ischemic stroke, there is uncertainty regarding the benefit and risk of administering intravenous alteplase before endovascular thrombectomy. Methods We conducted a trial at 41 academic tertiary care centers in China to evaluate endovascular thrombectomy with or without intravenous alteplase in patients with acute ischemic stroke. Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation were randomly assigned in a 1:1 ratio to undergo endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset (combination-therapy group). The primary analysis for noninferiority assessed the between-group difference in the distribution of the modified Rankin scale scores (range, 0 [no symptoms] to 6 [death]) at 90 days on the basis of a lower boundary of the 95% confidence interval of the adjusted common odds ratio equal to or larger than 0.8. We assessed various secondary outcomes, including death and reperfusion of the ischemic area. Results Of 1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group. Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P=0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%). Mortality at 90 days was 17.7% in the thrombectomy-alone group and 18.8% in the combination-therapy group. Conclusions In Chinese patients with acute ischemic stroke from large-vessel occlusion, endovascular thrombectomy alone was noninferior with regard to functional outcome, within a 20% margin of confidence, to endovascular thrombectomy preceded by intravenous alteplase administered within 4.5 hours after symptom onset. (Funded by the Stroke Prevention Project of the National Health Commission of the People's Republic of China and the Wu Jieping Medical Foundation; DIRECT-MT ClinicalTrials.gov number, NCT03469206.)

引用

页码：1981 / 1993

页数：13

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