近日，上海长海医院刘建民团队取得新进展。他们比较了有或没有静脉溶栓的血管内血栓切除术治疗急性中风的疗效。该研究于2020年5月6日发表于《新英格兰医学杂志》上。

对于急性缺血性中风，在血管内血栓切除术前静脉输注阿替普酶的益处和风险尚不确定。

研究组在中国41个三级医疗中心进行了一项试验，以评估急性缺血性卒中患者在血管内血栓切除术前静脉注射或不注射阿替普酶的效果。共招募了656名前循环大血管闭塞引起的急性缺血性中风患者，将其按1：1随机分配，327名接受血管内血栓切除术（单独血栓切除术），329名先静脉内输注阿替普酶再行血管内血栓切除术（联合治疗组）。

治疗90天后，单独血栓切除术组的改良Rankin量表得分不逊于联合治疗组，但血栓切除术前再灌注和总再灌注的成功率分别为2.4%和79.4%，均低于联合治疗组（7.0%和84.5%）。单独血栓切除术组的90天死亡率为17.7％，联合治疗组为18.8％。

总之，对于因大血管闭塞而导致急性缺血性中风的患者，与症状发作后4.5小时内静脉输注阿替普酶的血管内血栓切除术相比，单独血管内血栓切除术在功能预后方面并不逊色，置信度为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