Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.
Aged
Cerebral Hemorrhage
/ etiology
China
Combined Modality Therapy
Confidence Intervals
Endovascular Procedures
Female
Fibrinolytic Agents
/ adverse effects
Humans
Infusions, Intravenous
Male
Middle Aged
Reperfusion
/ methods
Stroke
/ drug therapy
Thrombectomy
/ adverse effects
Time-to-Treatment
Tissue Plasminogen Activator
/ adverse effects
Treatment Outcome
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
21 05 2020
21 05 2020
Historique:
pubmed:
7
5
2020
medline:
5
6
2020
entrez:
7
5
2020
Statut:
ppublish
Résumé
In acute ischemic stroke, there is uncertainty regarding the benefit and risk of administering intravenous alteplase before endovascular thrombectomy. 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. 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. 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.).
Sections du résumé
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.).
Identifiants
pubmed: 32374959
doi: 10.1056/NEJMoa2001123
doi:
Substances chimiques
Fibrinolytic Agents
0
Tissue Plasminogen Activator
EC 3.4.21.68
Banques de données
ClinicalTrials.gov
['NCT03469206']
Types de publication
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1981-1993Subventions
Organisme : National Health and Family Planning Commission of the People's Republic of China
ID : GN-2017R0001
Pays : International
Investigateurs
Manon Kappelhof
(M)
Natalie LeCouffe
(N)
Dongwei Dai
(D)
Kaijun Zhao
(K)
Yina Wu
(Y)
Ying Yu
(Y)
Chao Zou
(C)
Qian Zheng
(Q)
Nan Lv
(N)
Chuanchuan Wang
(C)
Pei Liu
(P)
Qiao Zuo
(Q)
Xiaoxi Zhang
(X)
Guoli Duan
(G)
Hongjian Zhang
(H)
Weilong Hua
(W)
He Li
(H)
Wenjin Yang
(W)
Hongjian Shen
(H)
Lei Chen
(L)
Xuan Zhu
(X)
Minmin Zhang
(M)
Xiongfeng Wu
(X)
Shiren Huang
(S)
Yi Jiang
(Y)
Fang Shen
(F)
Bing Tian
(B)
Yingying Zhang
(Y)
Tingyu Yi
(T)
Jie Cao
(J)
Qiyi Zhu
(Q)
Liyong Zhang
(L)
Mingchao Shi
(M)
Lin Jiang
(L)
Haibing Shi
(H)
Chenghua Xu
(C)
Xiaowei Hu
(X)
Feng Zhou
(F)
Yuefei Wu
(Y)
Jun Sun
(J)
Hui Li
(H)
Yu Fan
(Y)
Maohua Chen
(M)
Yuwei Ren
(Y)
Xuting Zhang
(X)
Shuhan Huang
(S)
Hao Wang
(H)
Zijun Wang
(Z)
Shu Yang
(S)
Xinmin Wu
(X)
Bo Xu
(B)
Yuyou Zhu
(Y)
Shuiping Wang
(S)
Guang Zhang
(G)
Zhaoshuo Li
(Z)
Zhi Yang
(Z)
Jinbo Huang
(J)
Liping Wei
(L)
Wenbo Li
(W)
Guangsen Cheng
(G)
Shengli Chen
(S)
Yongping Chen
(Y)
Chun Fang
(C)
Hao Feng
(H)
Anding Xu
(A)
Hongyu Qiao
(H)
Wanchao Shi
(W)
Futang Xie
(F)
Xin Xiang
(X)
Han Peng
(H)
Yun Xu
(Y)
Jingwei Li
(J)
Xiaoping Gao
(X)
Huan Zhang
(H)
Jie Yang
(J)
Xingguang Yang
(X)
Haibo Wang
(H)
Shuailing Yin
(S)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 Massachusetts Medical Society.