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

on behalf of the VISTA Endovascular collaboration1

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Rationale: Endovascular 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 Design: This 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 Outcomes: This 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. Discussion: This 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.

Original languageEnglish (US)
Pages (from-to)136-144
Number of pages9
JournalInternational Journal of Stroke
Volume10
Issue numberA100
DOIs
StatePublished - Oct 1 2015

Fingerprint

Thrombectomy
Meta-Analysis
Stroke
Tissue Plasminogen Activator
Therapeutics
Intracranial Hemorrhages
Stents
Outcome Assessment (Health Care)
Clinical Trials
Equipment and Supplies

Keywords

  • Acute
  • Endovascular
  • Ischemic stroke
  • Meta-analysis
  • Protocols
  • Treatment

ASJC Scopus subject areas

  • Neurology

Cite this

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title = "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",
abstract = "Rationale: Endovascular 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 Design: This 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 Outcomes: This 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. Discussion: This 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.",
keywords = "Acute, Endovascular, Ischemic stroke, Meta-analysis, Protocols, Treatment",
author = "{on behalf of the VISTA Endovascular collaboration1} and Macisaac, {Rachael L.} and Pooja Khatri and Martin Bendszus and Serge Bracard and Joseph Broderick and Bruce Campbell and Alfonso Ciccone and Antoni D{\'a}valos and Davis, {Stephen M.} and Andrew Demchuk and Diener, {Hans Christoph} and Diederik Dippel and Donnan, {Geoffrey A.} and Jens Fiehler and David Fiorella and Mayank Goyal and Werner Hacke and Hill, {Michael D.} and Reza Jahan and Edward Jauch and Tudor Jovin and Stella Kidwell and David Liebeskind and Majoie, {Charles B.} and Martins, {Sheila Cristina Ouriques} and Peter Mitchell and J. Mocco and Muir, {Keith W.} and Raul Nogueira and Saver, {Jeffrey L.} and Schonewille, {Wouter J.} and Siddiqui, {Adnan H.} and G{\"o}tz Thomalla and Tomsick, {Thomas A.} and Turk, {Aquilla S.} and Philip White and Osama Zaidat and Lees, {Kennedy R.}",
year = "2015",
month = "10",
day = "1",
doi = "10.1111/ijs.12622",
language = "English (US)",
volume = "10",
pages = "136--144",
journal = "International Journal of Stroke",
issn = "1747-4930",
publisher = "Wiley-Blackwell",
number = "A100",

}

TY - JOUR

T1 - A collaborative sequential meta-analysis of individual patient data from randomized trials of endovascular therapy and tPA vs. tPA alone for acute ischemic stroke

T2 - ThRombEctomy And tPA (TREAT) analysis: Statistical analysis plan for a sequential meta-analysis performed within the VISTA-Endovascular collaboration

AU - on behalf of the VISTA Endovascular collaboration1

AU - Macisaac, Rachael L.

AU - Khatri, Pooja

AU - Bendszus, Martin

AU - Bracard, Serge

AU - Broderick, Joseph

AU - Campbell, Bruce

AU - Ciccone, Alfonso

AU - Dávalos, Antoni

AU - Davis, Stephen M.

AU - Demchuk, Andrew

AU - Diener, Hans Christoph

AU - Dippel, Diederik

AU - Donnan, Geoffrey A.

AU - Fiehler, Jens

AU - Fiorella, David

AU - Goyal, Mayank

AU - Hacke, Werner

AU - Hill, Michael D.

AU - Jahan, Reza

AU - Jauch, Edward

AU - Jovin, Tudor

AU - Kidwell, Stella

AU - Liebeskind, David

AU - Majoie, Charles B.

AU - Martins, Sheila Cristina Ouriques

AU - Mitchell, Peter

AU - Mocco, J.

AU - Muir, Keith W.

AU - Nogueira, Raul

AU - Saver, Jeffrey L.

AU - Schonewille, Wouter J.

AU - Siddiqui, Adnan H.

AU - Thomalla, Götz

AU - Tomsick, Thomas A.

AU - Turk, Aquilla S.

AU - White, Philip

AU - Zaidat, Osama

AU - Lees, Kennedy R.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Rationale: Endovascular 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 Design: This 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 Outcomes: This 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. Discussion: This 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.

AB - Rationale: Endovascular 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 Design: This 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 Outcomes: This 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. Discussion: This 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.

KW - Acute

KW - Endovascular

KW - Ischemic stroke

KW - Meta-analysis

KW - Protocols

KW - Treatment

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U2 - 10.1111/ijs.12622

DO - 10.1111/ijs.12622

M3 - Article

VL - 10

SP - 136

EP - 144

JO - International Journal of Stroke

JF - International Journal of Stroke

SN - 1747-4930

IS - A100

ER -