Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion.
Humans
Administration, Intravenous
Arterial Occlusive Diseases
/ complications
Basilar Artery
/ drug effects
Brain Ischemia
/ drug therapy
Endovascular Procedures
/ adverse effects
Fibrinolytic Agents
/ administration & dosage
Intracranial Hemorrhages
/ chemically induced
Prospective Studies
Quality of Life
Stroke
/ drug therapy
Thrombectomy
/ adverse effects
Thrombolytic Therapy
/ adverse effects
Treatment Outcome
Recovery of Function
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:
13 10 2022
13 10 2022
Historique:
entrez:
14
10
2022
pubmed:
15
10
2022
medline:
19
10
2022
Statut:
ppublish
Résumé
Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited. We conducted a multicenter, prospective, randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications. Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval [CI], 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation. In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).
Sections du résumé
BACKGROUND
Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited.
METHODS
We conducted a multicenter, prospective, randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications.
RESULTS
Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval [CI], 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation.
CONCLUSIONS
In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).
Identifiants
pubmed: 36239644
doi: 10.1056/NEJMoa2206317
doi:
Substances chimiques
Fibrinolytic Agents
0
Banques de données
ClinicalTrials.gov
['NCT04751708']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1361-1372Investigateurs
Wei Hu
(W)
Xinfeng Liu
(X)
Guoping Wang
(G)
Raul G Nogueira
(RG)
Adnan I Qureshi
(AI)
Blaise W Baxter
(BW)
Gelin Xu
(G)
Xiaoyan Yan
(X)
Feng Gao
(F)
Liqun Jiao
(L)
Sen Qun
(S)
Zi Wang
(Z)
Juan Chen
(J)
Ruidong Ye
(R)
Yongwei Zhang
(Y)
Cangjun Wu
(C)
Rui Li
(R)
Chuanqing Fang
(C)
Kexue Deng
(K)
Shuya Yuan
(S)
Menglong Zheng
(M)
Hongbing Chen
(H)
Guang Zhang
(G)
Wei Bao
(W)
Hongxing Han
(H)
Guangxiong Yuan
(G)
Changming Wen
(C)
Peiyang Zhou
(P)
Wenhuo Chen
(W)
Guoyong Zeng
(G)
Hui Xu
(H)
Yuwen Li
(Y)
Zhengfei Ma
(Z)
Chuanqing Yu
(C)
Junfeng Su
(J)
Zhiming Zhou
(Z)
Zhongjun Chen
(Z)
Geng Liao
(G)
Yaxuan Sun
(Y)
Youquan Ren
(Y)
Hui Zhang
(H)
Jie Chen
(J)
Xincan Yue
(X)
Xiuyao Ma
(X)
GuoDong Xiao
(G)
Li Wang
(L)
Rui Liu
(R)
Weimin Yang
(W)
Wenhua Liu
(W)
Yong Liu
(Y)
Fuqiang Guo
(F)
Xueli Cai
(X)
Bo Yin
(B)
Jinglun Li
(J)
Pu Fang
(P)
Chunyun Shen
(C)
Chuyuan Ni
(C)
Hui Wang
(H)
Liang Liu
(L)
Kai Li
(K)
Tao Cui
(T)
Hao Wang
(H)
Jun Gao
(J)
Tingyu Yi
(T)
Youmeng Wang
(Y)
Tao Wang
(T)
Xueying Shi
(X)
Zhihua Cao
(Z)
Chen Long
(C)
Li Chen
(L)
Chi Zhang
(C)
Gichao Zhai
(G)
Xia Zhang
(X)
Xiushan Liang
(X)
Qingsong Li
(Q)
Yuhan Meng
(Y)
Jianbo Tao
(J)
Zhenzhu Zhu
(Z)
Yuedong Cheng
(Y)
Meng Zhang
(M)
Tong Zhou
(T)
Jing Wang
(J)
Yali Zhang
(Y)
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