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

International Journal of Stroke : Official Journal of the International Stroke Society
Rachael L MacIsaacVISTA Endovascular collaboration

Abstract

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. 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. 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 ...Continue Reading

References

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Citations

Sep 8, 2016·Annals of Emergency Medicine·Joseph B MillerChristopher Lewandowski
May 4, 2018·International Journal of Stroke : Official Journal of the International Stroke Society·Else Charlotte SandsetUNKNOWN Blood pressure in Acute Stroke Collaboration Investigators
Nov 5, 2016·International Journal of Stroke : Official Journal of the International Stroke Society·Syed Ali RazaUNKNOWN Trevo2 study group
Jul 14, 2016·Stroke; a Journal of Cerebral Circulation·Kennedy R LeesUNKNOWN STAIR IX Collaborators
Feb 21, 2016·Stroke; a Journal of Cerebral Circulation·Kennedy R LeesJoseph P Broderick
Sep 9, 2016·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Jennifer AndresGuillermo Linares
Jul 7, 2020·Physiotherapy Theory and Practice·Kimberly B CastleEmily Warren
Apr 14, 2016·Stroke; a Journal of Cerebral Circulation·Steven J WarachUNKNOWN Stroke Imaging Research (STIR) and VISTA-Imaging Investigators
Mar 29, 2016·Current Treatment Options in Neurology·Hamed AsadiJohn Thornton
Nov 12, 2020·Journal of Cerebral Blood Flow and Metabolism : Official Journal of the International Society of Cerebral Blood Flow and Metabolism·Clemens J Sommer, Wolf-Rüdiger Schäbitz

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Software Mentioned

MR RESCUE
TREAT
ESCAPE
SWIFT PRIME
EXTEND
IA
SAS
THRACE
MNAR
VISTA

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