血管内血栓切除术联合或不联合静脉内阿替普酶治疗急性脑卒中。
Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.
机构信息
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.).
出版信息
N Engl J Med. 2020 May 21;382(21):1981-1993. doi: 10.1056/NEJMoa2001123. Epub 2020 May 6.
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.).
背景
在急性缺血性脑卒中患者中，静脉内使用阿替普酶溶栓联合血管内取栓与单纯血管内取栓的获益和风险尚不确定。
方法
我们在中国 41 家学术性三级护理中心进行了一项试验，以评估急性缺血性脑卒中患者接受单纯血管内取栓与血管内取栓联合静脉内阿替普酶溶栓治疗的效果。前循环大血管闭塞的急性缺血性脑卒中患者以 1:1 的比例随机分为两组，分别接受单纯血管内取栓（取栓组）或在症状发作后 4.5 小时内给予 0.9 mg/kg 体重的静脉内阿替普酶溶栓治疗（联合治疗组）。主要非劣效性分析基于调整后的共同比值比的 95%置信区间下限等于或大于 0.8，评估了 90 天时改良 Rankin 量表（0 分[无症状]至 6 分[死亡]）分布的组间差异。我们评估了包括死亡和缺血区再灌注在内的各种次要结局。
结果
在筛选的 1586 名患者中，有 656 名入组，其中 327 名患者被分配至取栓组，329 名患者被分配至联合治疗组。单纯血管内取栓在主要结局方面不劣于静脉内阿替普酶溶栓联合血管内取栓（调整后的共同比值比，1.07；95%置信区间，0.81 至 1.40；非劣效性 P=0.04），但血管内取栓前成功再灌注的患者比例（2.4% vs. 7.0%）和整体成功再灌注的患者比例（79.4% vs. 84.5%）较低。取栓组 90 天时的死亡率为 17.7%，联合治疗组为 18.8%。
结论
在接受血管内取栓治疗的中国急性缺血性脑卒中患者中，在 90 天时，与血管内取栓联合静脉内阿替普酶溶栓相比，单纯血管内取栓在功能结局方面的非劣效性置信区间上限为 20%。（由中华人民共和国国家卫生健康委员会卒中预防项目和吴阶平医学基金会资助；DIRECT-MT ClinicalTrials.gov 编号，NCT03469206。）
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