Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.,The New England Journal of Medicine

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Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2020-05-06 , DOI: 10.1056/nejmoa2001123
Pengfei Yang ₁ , Yongwei Zhang ₁ , Lei Zhang ₁ , Yongxin Zhang ₁ , Kilian M Treurniet ₁ , Wenhuo Chen ₁ , Ya Peng ₁ , Hongxing Han ₁ , Jiyue Wang ₁ , Shouchun Wang ₁ , Congguo Yin ₁ , Sheng Liu ₁ , Peng Wang ₁ , Qi Fang ₁ , Hongchao Shi ₁ , Jianhong Yang ₁ , Changming Wen ₁ , Conghui Li ₁ , Changchun Jiang ₁ , Jun Sun ₁ , Xincan Yue ₁ , Min Lou ₁ , Meng Zhang ₁ , Hansheng Shu ₁ , Dianjing Sun ₁ , Hui Liang ₁ , Tong Li ₁ , Fuqiang Guo ₁ , Kaifu Ke ₁ , Haicheng Yuan ₁ , Guoping Wang ₁ , Weimin Yang ₁ , Huaizhang Shi ₁ , Tianxiao Li ₁ , Zifu Li ₁ , Pengfei Xing ₁ , Ping Zhang ₁ , Yu Zhou ₁ , Hao Wang ₁ , Yi Xu ₁ , Qinghai Huang ₁ , Tao Wu ₁ , Rui Zhao ₁ , Qiang Li ₁ , Yibin Fang ₁ , Laixing Wang ₁ , Jianping Lu ₁ , Yansheng Li ₁ , Jianhui Fu ₁ , Xihua Zhong ₁ , Yongjun Wang ₁ , Longde Wang ₁ , Mayank Goyal ₁ , Diederik W J Dippel ₁ , Bo Hong ₁ , Benqiang Deng ₁ , Yvo B W E M Roos ₁ , Charles B L M Majoie ₁ , Jianmin Liu ₁ ,

Affiliation

From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).

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.).

更新日期：2020-05-06

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