Value of intravenous thrombolysis in endovascular treatment for large-vessel anterior circulation stroke: individual participant data meta-analysis of six randomised trials

被引：106

作者：

Majoie, Charles B. ^{[1
,31
]}

Cavalcante, Fabiano ^{[1
]}

Gralla, Jan ^{[3
]}

Yang, Pengfei ^{[4
,5
]}

Kaesmacher, Johannes ^{[3
]}

Treurniet, Kilian M. ^{[1
,6
]}

Kappelhof, Manon ^{[1
]}

Yan, Bernard ^{[7
]}

Suzuki, Kentaro ^{[9
]}

Zhang, Yongwei ^{[4
]}

Li, Fengli ^{[11
]}

Morimoto, Masafumi ^{[12
]}

Zhang, Lei ^{[4
,19
]}

Miao, Zhongrong ^{[13
]}

Rinkel, Leon A. ^{[2
]}

Huang, Jiacheng ^{[11
]}

Otsuka, Toshiaki ^{[10
]}

Wang, Shouchun ^{[14
]}

Davis, Stephen ^{[7
]}

Cognard, Christophe ^{[15
]}

Hong, Bo ^{[16
]}

Coutinho, Jonathan M. ^{[2
]}

Song, Jiaxing ^{[11
]}

Chen, Wenhuo ^{[17
]}

Emmer, Bart J. ^{[1
]}

Eker, Omer ^{[18
]}

Zhang, Liyong

Dobrocky, Tomas ^{[3
]}

Nguyen, Huy-Thang ^{[20
]}

Bush, Steven ^{[8
]}

Peng, Ya ^{[21
]}

Lecouffe, Natalie E. ^{[2
]}

Takeuchi, Masataka ^{[22
]}

Han, Hongxing ^{[23
]}

Matsumaru, Yuji ^{[24
]}

Strbian, Daniel ^{[25
]}

Lingsma, Hester F. ^{[26
]}

Nieboer, Daan ^{[26
]}

Yang, Qingwu ^{[11
]}

Meinel, Thomas ^{[27
]}

Mitchell, Peter ^{[8
]}

Kimura, Kazumi ^{[9
]}

Zi, Wenjie ^{[11
]}

Nogueira, Raul G. ^{[28
,29
]}

Liu, Jianmin ^{[4
,5
]}

Roos, Yvo B. ^{[2
]}

Fischer, Urs ^{[27
,30
]}

机构：

[1] Vrije Univ Amsterdam Med Ctr, Dept Radiol & Nucl Med, Amsterdam Neurosci, Amsterdam, Netherlands

[2] Univ Amsterdam, Dept Neurol, Amsterdam Univ, Amsterdam Neurosci,Med Ctr, Amsterdam, Netherlands

[3] Univ Bern, Univ Inst Diagnost & Intervent Neuroradiol, Univ Hosp Bern, Inselspital, Bern, Switzerland

[4] Naval Med Univ, Changhai Hosp, Neurovasc Ctr, Shanghai, Peoples R China

[5] Univ Shanghai Sci & Technol, Oriental Pan Vasc Devices Innovat Coll, Shanghai, Peoples R China

[6] Haaglanden Med Ctr, Dept Radiol, The Hague, Netherlands

[7] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Parkville, Vic, Australia

[8] Univ Melbourne, Royal Melbourne Hosp, Dept Radiol, Parkville, Vic, Australia

[9] Nippon Med Sch, Dept Neurol, Tokyo, Japan

[10] Nippon Med Sch, Dept Hyg & Publ Hlth, Tokyo, Japan

[11] Army Med Univ, Mil Med Univ 3, Xinqiao Hosp, Affiliated Hosp 2, Chongqing, Peoples R China

[12] Yokohama Shintoshi Neurosurg Hosp, Dept Neurosurg, Yokohama, Japan

[13] Beijing Tiantan Hosp, Dept Intervent Neuroradiol, Beijing, Peoples R China

[14] Jilin Univ, Dept Neurosurg, Affiliated Hosp 1, Changchun, Peoples R China

[15] Ctr Hosp Univ Toulouse, Dept Diagnost & Therapeut Neuroradiol, Toulouse, France

[16] Shanghai Jiao Tong Univ, Shanghai Gen Hosp, Clin Ctr Neurosci, Dept Neurovasc Intervent,Sch Med, Shanghai, Peoples R China

[17] Fujian Med Univ, Dept Nephrol, Zhangzhou Affiliated Hosp, Zhangzhou, Peoples R China

[18] Hosp Civils Lyon, Dept Neuroradiol, Lyon, France

[19] Shandong First Med Univ, Liaocheng Peoples Hosp, Dept Neurosurg, Liaocheng, Peoples R China

[20] Peoples Hosp, Ho Chi Minh, Vietnam

[21] Soochow Univ, Dept Nephrol, Affiliated Hosp 3, Changzhou 213000, Peoples R China

[22] Seisho Hosp, Dept Neurosurg, Odawara, Kanagawa, Japan

[23] Qingdao Univ, Linyi Peoples Hosp, Dept Neurol, Linyi, Peoples R China

[24] Univ Tsukuba, Fac Med, Dept Neurosurg, Div Stroke Prevent & Treatment, Ibaraki, Japan

[25] Univ Helsinki, Helsinki Univ Hosp, Dept Neurol, Helsinki, Finland

[26] Erasmus MC, Dept Publ Hlth, Rotterdam, Netherlands

[27] Univ Bern, Bern Univ Hosp, Stroke Res Ctr Bern, Dept Neurol, Bern, Switzerland

[28] Univ Pittsburgh, UPMC Stroke Inst, Dept Neurol, Sch Med, Pittsburgh, PA USA

[29] Univ Pittsburgh, Dept Neurosurg, Sch Med, Pittsburgh, PA USA

[30] Univ Hosp Basel, Univ Basel, Dept Neurol, Basel, Switzerland

[31] Univ Amsterdam, Dept Radiol & Nucl Med, Univ Amsterdam, Amsterdam Neurosci,Med Ctr, NL-1105 AZ Amsterdam, Netherlands

来源：

LANCET | 2023年 / 402卷 / 10406期

关键词：

ACUTE ISCHEMIC-STROKE; MECHANICAL THROMBECTOMY; ALTEPLASE; REPERFUSION; GUIDELINES; MANAGEMENT; OCCLUSION;

D O I：

10.1016/S0140-6736(23)01142-X

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Intravenous thrombolysis is recommended before endovascular treatment, but its value has been questioned in patients who are admitted directly to centres capable of endovascular treatment. Existing randomised controlled trials have indicated non -inferiority of endovascular treatment alone or have been statistically inconclusive. We formed the Improving Reperfusion Strategies in Acute Ischaemic Stroke collaboration to assess non -inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment. Methods We conducted a systematic review and individual participant data meta -analysis to establish non -inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment. We searched PubMed and MEDLINE with the terms "stroke", "endovascular treatment", "intravenous thrombolysis", and synonyms for articles published from database inception to March 9, 2023. We included randomised controlled trials on the topic of interest, without language restrictions. Authors of the identified trials agreed to take part, and individual participant data were provided by the principal investigators of the respective trials and collated centrally by the collaborators. Our primary outcome was the 90 -day modified Rankin Scale (mRS) score. Non -inferiority of endovascular treatment alone was assessed using a lower boundary of 0 center dot 82 for the 95% CI around the adjusted common odds ratio (acOR) for shift towards improved outcome (analogous to 5% absolute difference in functional independence) with ordinal regression. We used mixed -effects models for all analyses. This study is registered with PROSPERO, CRD42023411986. Findings We identified 1081 studies, and six studies (n=2313; 1153 participants randomly assigned to receive endovascular treatment alone and 1160 randomly assigned to receive intravenous thrombolysis and endovascular treatment) were eligible for analysis. The risk of bias of the included studies was low to moderate. Variability between studies was small, and mainly related to the choice and dose of the thrombolytic drug and country of execution. The median mRS score at 90 days was 3 (IQR 1-5) for participants who received endovascular treatment alone and 2 (1-4) for participants who received intravenous thrombolysis plus endovascular treatment (acOR 0 center dot 89, 95% CI 0 center dot 76-1 center dot 04). Any intracranial haemorrhage (0 center dot 82, 0 center dot 68-0 center dot 99) occurred less frequently with endovascular treatment alone than with intravenous thrombolysis plus endovascular treatment. Symptomatic intracranial haemorrhage and mortality rates did not differ significantly. Interpretation We did not establish non -inferiority of endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment in patients presenting directly at endovascular treatment centres. Further research could focus on cost-effectiveness analysis and on individualised decisions when patient characteristics, medication shortages, or delays are expected to offset a potential benefit of administering intravenous thrombolysis before endovascular treatment. Funding Stryker and Amsterdam University Medical Centers, University of Amsterdam. Copyright (c) 2023 Elsevier Ltd. All rights reserved.

引用

页码：965 / 974

页数：10

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共 33 条

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de Kort, Paul L. M. ;

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