單獨血管內血栓清除術治療急性中風不遜於靜脈溶栓後血管內血栓切除術
作者：
小柯機器人發布時間：2020/5/9 20:41:21
近日，上海長海醫院劉建民團隊取得新進展。他們比較了有或沒有靜脈溶栓的血管內血栓切除術治療急性中風的療效。該研究於2020年5月6日發表於《新英格蘭醫學雜誌》上。
對於急性缺血性中風，在血管內血栓切除術前靜脈輸注阿替普酶的益處和風險尚不確定。
研究組在中國41個三級醫療中心進行了一項試驗，以評估急性缺血性卒中患者在血管內血栓切除術前靜脈注射或不注射阿替普酶的效果。共招募了656名前循環大血管閉塞引起的急性缺血性中風患者，將其按1：1隨機分配，327名接受血管內血栓切除術（單獨血栓切除術），329名先靜脈內輸注阿替普酶再行血管內血栓切除術（聯合治療組）。
治療90天後，單獨血栓切除術組的改良Rankin量表得分不遜於聯合治療組，但血栓切除術前再灌注和總再灌注的成功率分別為2.4%和79.4%，均低於聯合治療組（7.0%和84.5%）。單獨血栓切除術組的90天死亡率為17.7％，聯合治療組為18.8％。
總之，對於因大血管閉塞而導致急性缺血性中風的患者，與症狀發作後4.5小時內靜脈輸注阿替普酶的血管內血栓切除術相比，單獨血管內血栓切除術在功能預後方面並不遜色，置信度為20％。
附：英文原文
Title: Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke
Author: 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.
Issue&Volume: 2020-05-06
Abstract: Abstract
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.
DOI: 10.1056/NEJMoa2001123
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2001123