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血管内取栓术联合和不联合阿替普酶静脉溶栓治疗急性缺血性卒中的比较研究
Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke


Pengfei Yang ... 心脑血管疾病 • 2020.05.21
相关阅读
• 急性缺血性卒中取栓术前可否免除溶栓治疗 • 缺血性卒中血栓切除术前使用替奈普酶和阿替普酶的比较 • 取栓术前溶栓治疗——溶栓还是相信DIRECT-MT

述评译文

血管内取栓术治疗脑部大血管急性闭塞前可否不使用阿替普酶——一项非劣效性试验的推论

 

Thomas W Leung,Lee Quo Wei

香港中文大学内科及药物治疗学系神经科

 

与单独采用阿替普酶静脉溶栓相比,血管内取栓术(EVT)对于卒中发病后6小时内的颈内动脉颅内段或大脑中动脉急性闭塞患者有明显益处1-5。一项荟萃分析综合了5项随机对照试验(RCT)的个体数据,结果发现EVT组有46.0%的患者在90日时达到功能独立(改良Rankin评分[mRS],0~2分),而对照组仅为26.5%。要使mRS降低≥1分,需要治疗的患者数量(NNT)仅为2.6 6

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摘要


背景

对于急性缺血性卒中,患者接受血管内取栓术前给予静脉阿替普酶溶栓的疗效与风险尚不明确。

 

方法

中国41家学术型三级医院开展了一项临床研究,目的是对血管内取栓术联合或不联合阿替普酶静脉溶栓治疗急性缺血性卒中进行疗效评估。本研究将发病在4.5小时以内的前循环急性大血管闭塞性缺血性卒中患者,按照1∶1的比例随机分配至直接取栓组(单独血管内取栓术)和联合治疗组(取栓术前启动阿替普酶静脉溶栓,阿替普酶按照0.9 mg/kg剂量给予)。研究采用非劣效性设计。主要结局是两组术后90日的改良Rankin量表评分的整体分布情况,采用校正共同比值比评估(95%置信区间[CI]下限是否≥0.8)。此外,还对包括死亡和缺血区域再灌注情况等的多个次要结局进行了评估。

 

结果

研究共筛选了1,586例患者,其中656例符合入排标准纳入研究。327例被随机分配至直接取栓组,329例被随机分配至联合治疗组。主要结局的分析结果显示,单独血管内取栓术不劣于阿替普酶静脉溶栓联合血管内取栓术(校正共同比值比,1.07;95% CI,0.81~1.40;非劣效性P=0.04)。但直接取栓组在取栓术前成功再灌注的比例(2.4% vs. 7.0%)和总体成功再灌注的比例(79.4% vs. 84.5%)低于联合治疗组。直接取栓组组和联合治疗组的90日死亡率分别为17.7%和18.8%。

 

结论

对于中国发病4.5小时以内的急性前循环大血管闭塞性缺血性卒中患者,基于20%的可信界值,单独采用血管内取栓术的功能性结局不劣于阿替普酶静脉溶栓联合血管内取栓术(研究由中华人民共和国国家卫生健康委员会卒中防治工程委员会和吴阶平医学基金会资助, DIRECT-MT试验在 ClinicalTrials.gov注册号为NCT03469206)。





作者信息

Pengfei Yang, M.D., Yongwei Zhang, M.D., Lei Zhang, M.D., Yongxin Zhang, M.D., Kilian M. Treurniet, M.D., Wenhuo Chen, M.D., Ya Peng, M.D., Hongxing Han, M.D., Jiyue Wang, M.D., Shouchun Wang, M.D., Congguo Yin, M.D., Sheng Liu, M.D., Peng Wang, M.D., Qi Fang, M.D., Hongchao Shi, M.D., Jianhong Yang, M.D., Changming Wen, M.D., Conghui Li, M.D., Changchun Jiang, M.D., Jun Sun, M.D., Xincan Yue, M.D., Min Lou, M.D., Meng Zhang, M.D., Hansheng Shu, M.D., Dianjing Sun, M.D., Hui Liang, M.D., Tong Li, M.D., Fuqiang Guo, M.D., Kaifu Ke, M.D., Haicheng Yuan, M.D., Guoping Wang, M.D., Weimin Yang, M.D., Huaizhang Shi, M.D., Tianxiao Li, M.D., Zifu Li, M.D., Pengfei Xing, M.D., Ping Zhang, M.D., Yu Zhou, M.D., Hao Wang, M.D., Yi Xu, M.D., Qinghai Huang, M.D., Tao Wu, M.D., Rui Zhao, M.D., Qiang Li, M.D., Yibin Fang, M.D., Laixing Wang, M.D., Jianping Lu, M.D., Yansheng Li, M.D., Jianhui Fu, M.D., Xihua Zhong, Ph.D., Yongjun Wang, M.D., Longde Wang, M.D., Mayank Goyal, M.D., Ph.D., Diederik W.J. Dippel, M.D., Ph.D., Bo Hong, M.D., Benqiang Deng, M.D., Yvo B.W.E.M. Roos, M.D., Ph.D., Charles B.L.M. Majoie, M.D., Ph.D., and Jianmin Liu, M.D., for the DIRECT-MT Investigators*
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.). Address reprint requests to Dr. J. Liu at the Department of Neurosurgery, Changhai Hospital, 168 Changhai Rd., Shanghai 200433, China, or at direct_mt@163.com. *A complete list of the DIRECT-MT Investigators is provided in the Supplementary Appendix, available at NEJM.org. Drs. P. Yang and Yongwei Zhang and Drs. Majoie and J. Liu contributed equally to this article.

 

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