A collaborative sequential meta-analysis of individual patient data from randomized trials of endovascular therapy and tPA vs. tPA alone for acute ischemic stroke: ThRombEctomy And tPA (TREAT) analysis: statistical analysis plan for a sequential meta-analysis performed within the VISTA-Endovascular collaboration

被引：14

作者：

MacIsaac, Rachael L. ^{[1
]}

Khatri, Pooja ^{[2
]}

Bendszus, Martin ^{[3
]}

Bracard, Serge ^{[4
]}

Broderick, Joseph ^{[2
]}

Campbell, Bruce ^{[5
]}

Ciccone, Alfonso ^{[6
]}

Davalos, Antoni ^{[7
]}

Davis, Stephen M. ^{[8
]}

Demchuk, Andrew ^{[9
]}

Diener, Hans-Christoph ^{[10
]}

Dippel, Diederik ^{[11
]}

Donnan, Geoffrey A. ^{[12
]}

Fiehler, Jens ^{[13
]}

Fiorella, David ^{[14
]}

Goyal, Mayank ^{[15
]}

Hacke, Werner ^{[16
]}

Hill, Michael D. ^{[17
]}

Jahan, Reza ^{[18
]}

Jauch, Edward ^{[19
]}

Jovin, Tudor ^{[20
]}

Kidwell, Chelsea S. ^{[21
,22
]}

Liebeskind, David ^{[23
]}

Majoie, Charles B. ^{[24
]}

Ouriques Martins, Sheila Cristina ^{[25
]}

Mitchell, Peter ^{[26
,27
]}

Mocco, J. ^{[28
]}

Muir, Keith W. ^{[29
,30
]}

Nogueira, Raul ^{[31
]}

Saver, Jeffrey L. ^{[32
]}

Schonewille, Wouter J. ^{[33
]}

Siddiqui, Adnan H. ^{[34
]}

Thomalla, Goetz ^{[35
]}

Tomsick, Thomas A. ^{[2
]}

Turk, Aquilla S. ^{[36
]}

White, Philip ^{[37
]}

Zaidat, Osama ^{[38
]}

Lees, Kennedy R. ^{[1
]}

机构：

[1] Univ Glasgow, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland

[2] Univ Cincinnati, Cincinnati, OH USA

[3] Univ Heidelberg Hosp, Heidelberg, Germany

[4] CHRU Nancy, Nancy, France

[5] Royal Melbourne Hosp, Parkville, Vic 3050, Australia

[6] Azienda Osped Carlo Poma Mantova, Dept Cardiothorac Vasc, Mantua, Italy

[7] Hosp Univ Germans Trias i Pujol, Dept Neurol, Barcelona, Spain

[8] Royal Melbourne Hosp, Dept Neurol, Parkville, Vic 3050, Australia

[9] Univ Calgary, Calgary, AB, Canada

[10] Univ Hosp Essen, Dept Neurol, Essen, Germany

[11] Erasmus MC, Dept Neurol, Rotterdam, Netherlands

[12] Univ Melbourne, Florey Inst Neurosci & Mental Hlth, Parkville, Vic 3052, Australia

[13] Univ Med Ctr Hamburg Eppendorf, Dept Neuroradiol, Hamburg, Germany

[14] SUNY Stony Brook, Stony Brook, NY 11794 USA

[15] Hotchkiss Brain Inst, Calgary, AB, Canada

[16] Heidelberg Univ, Dept Neurol, Heidelberg, Germany

[17] Univ Calgary, Dept Clin Neurosci, Calgary, AB, Canada

[18] Univ Calif Los Angeles, Dept Radiol, Los Angeles, CA USA

[19] Med Univ S Carolina, Dept Neurosci, Charleston, SC 29425 USA

[20] Univ Pittsburgh, Dept Neurol, UPMC, Stroke Inst, Pittsburgh, PA 15260 USA

[21] Univ Arizona, Dept Neurol, Tucson, AZ USA

[22] Univ Arizona, Dept Med Imaging, Tucson, AZ USA

[23] Univ Calif Los Angeles, Stroke Ctr, Los Angeles, CA USA

[24] Univ Amsterdam, Acad Med Ctr, Dept Neurol, NL-1105 AZ Amsterdam, Netherlands

[25] Hosp Clin Porto Alegre, Dept Neurol, Porto Alegre, RS, Brazil

[26] Univ Melbourne, Melbourne Hlth, Melbourne, Vic, Australia

[27] Royal Melbourne Subject, Melbourne, Vic, Australia

[28] Mt Sinai Hosp, New York, NY 10029 USA

[29] Univ Glasgow, Inst Neurosci & Psychol, Ctr Stroke & Brain Imaging Res, Glasgow, Lanark, Scotland

[30] So Gen Hosp, Inst Neurol Sci, Glasgow G51 4TF, Lanark, Scotland

[31] Massachusetts Gen Hosp, Boston, MA 02114 USA

[32] Univ Calif Los Angeles, Dept Neurol, Los Angeles, CA 90024 USA

[33] St Antonius Hosp, Dept Neurol, Utrecht, Netherlands

[34] SUNY Buffalo, Buffalo, NY 14260 USA

[35] Univ Med Ctr Hamburg Eppendorf, Dept Neurol, Hamburg, Germany

[36] Med Univ S Carolina, Charleston, SC 29425 USA

[37] Newcastle Univ, Inst Neurosci, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England

[38] Med Coll Wisconsin, Milwaukee, WI 53226 USA

来源：

INTERNATIONAL JOURNAL OF STROKE | 2015年 / 10卷

基金：

美国国家卫生研究院;

关键词：

acute; endovascular; ischemic stroke; meta-analysis; protocols; treatment; CUMULATIVE METAANALYSIS; IMAGING SELECTION; CLINICAL-TRIALS; END-POINTS; REVASCULARIZATION; DEVICE; IMPLEMENTATION; THROMBOLYSIS; ALTEPLASE; SWIFT;

D O I：

10.1111/ijs.12622

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

RationaleEndovascular treatment has been shown to restore blood flow effectively. Second-generation medical devices such as stent retrievers are now showing overwhelming efficacy in clinical trials, particularly in conjunction with intravenous recombinant tissue plasminogen activator. Aims and DesignThis statistical analysis plan utilizing a novel, sequential approach describes a prospective, individual patient data analysis of endovascular therapy in conjunction with intravenous recombinant tissue plasminogen activator agreed upon by the Thrombectomy and Tissue Plasminogen Activator Collaborative Group. Study OutcomesThis protocol will specify the primary outcome for efficacy, as favorable' outcome defined by the ordinal distribution of the modified Rankin Scale measured at three-months poststroke, but with modified Rankin Scales 5 and 6 collapsed into a single category. The primary analysis will aim to answer the questions: what is the treatment effect of endovascular therapy with intravenous recombinant tissue plasminogen activator compared to intravenous tissue plasminogen activator alone on full scale modified Rankin Scale at 3 months?' and to what extent do key patient characteristics influence the treatment effect of endovascular therapy?'. Key secondary outcomes include effect of endovascular therapy on death within 90 days; analyses of modified Rankin Scale using dichotomized methods; and effects of endovascular therapy on symptomatic intracranial hemorrhage. Several secondary analyses will be considered as well as expanding patient cohorts to intravenous recombinant tissue plasminogen activator-ineligible patients, should data allow. DiscussionThis collaborative meta-analysis of individual participant data from randomized trials of endovascular therapy vs. control in conjunction with intravenous thrombolysis will demonstrate the efficacy and generalizability of endovascular therapy with intravenous thrombolysis as a concomitant medication.

引用

页码：136 / 144

页数：9

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