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
Rachael L MacIsaac, Pooja Khatri, Martin Bendszus, Serge Bracard, Joseph Broderick, Bruce Campbell, Alfonso Ciccone, Antoni Davalos, Stephen M Davis, Andrew Demchuk, Hans-Christoph Diener, Diederik Dippel, Geoffrey A Donnan, Jens Fiehler, David Fiorella, Mayank Goyal, Werner Hacke, Michael D Hill, Reza Jahan, Edward Jauch Show all
International Journal of Stroke | WILEY-BLACKWELL | Published : 2015
Awarded by DFG
Awarded by National Institute for Health Research
Awarded by Alberta Innovates
Dr MacIsaac: None. Dr Khatri received financial support to Department for research roles from Genentech (lead principal investigator [PI] of Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis [PRISMS] trial), Penumbra (neurology PI of Assess the Penumbra System in the Treatment of Acute Stroke [THERAPY] trial), and Biogen (Data and Safety Monitoring Board [DSMB] member). Dr Hacke is a steering committee member for Solitaire FR as Primary Treatment for Acute Ischemic Stroke (SWIFT-PRIME) and the Chair of Virtual International Stroke Trials Archive (VISTA)- Endovascular. Dr Fiehler received funding from DFG, SFB 936 Multisite Communication in the Brain and BMBF for Airchill Research Project. He received consultant/lecturer fees from Acandis, Bayer, Boehringer Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker. Dr Saver is an employee of the University of California (UC). UC Regents received funding for Dr Saver's services as a scientific consultant to Covidien, Stryker, BrainsGate, Pfizer, and St. Jude Medical. He is an unpaid site investigator in multicenter trials run by Lundbeck for which the UC Regents received payments for enrollment of subjects. He is also an unpaid consultant to Genentech for PRISMS trial. UC has patent rights in retrieval devices for stroke. Dr Diener received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from Abbott, Allergan, AstraZeneca, Bayer Vital, BMS, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi-Sankyo, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Knoll, Lilly, MSD, Medtronic, MindFrame, Neurobiological Technologies, Novartis, Novo-Nordisk, Paion, Parke-Davis, Pfizer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, Syngis, Talecris, Thrombogenics, WebMD Global, Wyeth, and Yamanouchi. He received financial support for research projects from AstraZeneca, GSK, Boehringer Ingelheim, Lundbeck, Novartis, Janssen-Cilag, Sanofi-Aventis, Syngis and Talecris. The department received research grants from DFG, BMBF, European Union, National Institutes of Health (NIH), Bertelsmann Foundation and Heinz-Nixdorf Foundation.He is also an editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerznews, and guidelines of the German Neurological Society; coeditor of Cephalalgia, editorial board of Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. Dr Bendszus is a PI of Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment [THRILL; uncompensated) and received consultant/lecture fees from Codman, Guerbet, Novartis, Vascular Dynamics, and Roche. Dr Bracard received grant from French Ministry of Health for Trial and Cost Effectiveness Evaluation of Intra-Arterial Thrombectomy in Acute Ischemic Stroke (THRACE). Dr Broderick received research monies to department from Genentech (PRISMS SC); travel to conference payment from Boerhinger Ingelheim. Dr Ciccone received consultant/lecture fees from Boehringer Ingelheim and Teva. Dr Davalos received honoraria from Medtronic. Dr Davis is a consultant to Boehringer Ingelheim and received travel grants from BMS Pfizer, Allergan, Covidien, and Ever Neuropharma.Dr Dippel received nominal unrestricted grants from AngioCare, Covidien/ev3, Medac/Lamepro, and Penumbra. Dr Fiorella royalties and consulting fees frome Codman/JnJ; consulting fees and research support from Penumbra; research support from Microvention/Terumo, Siemens Medical Imaging, and Sequent Medical; and consulting fees from ev3. Dr Goyal is a consultant to Covidien (educational engagements).Dr Hill received research grant from Hoffman La Roche, and he is a consultant to Merck (adjudication committee for clinical trial). Dr Jauch received research grants from Genentech (Executive Committee PRISMS Trial). Dr Jovin is a consultant to Silk Road Medical and an unpaid consultant to Covidien Vascular, and Stryker Neurovascular. Dr Liebeskind is a consultant to Stryker and Covidien and an employee of UC, which holds a patent on retriever devices for stroke, at the time of this work. Dr Majoie received payment for lecture to institution from Stryker. Dr Mocco is a PI of THERAPY, Perfusion Imaging Selection of Ischemic Stroke Patients for Endovascular Therapy (POSITIVE), Large Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy (LARGE), Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT) Trial, and Barrel Study; he is a consultant to Medina Medical, Edge Therapeutics, Pulsar, and Lazarus Effect; he is a science advisory board member for Codman Neurovascular; and he is an investor of Blockade Medical and Medina Medical. Dr Muir is an advisory board memebr for Covidien in 2011. Dr Nogueira received support from Covidien (Study of Tamoxifen and Raloxifene [STAR] Trial Angiographic Core Laboratory - significant), Penumbra (3D Separator Trial Executive Committee - no payment), and Rapid Medical (Stroke Trial DSMB - modest). Dr Siddiqui received financial interests from Hotspur, Intratech Medical, StimSox, Valor Medical, Blockade Medical, Lazarus Effect, Pulsar Vascular, and Medina Medical. He is a consultant to Codman & Shurtleff, Covidien Vascular Therapies, GuidePoint Global Consulting, Penumbra, Stryker, Pulsar Vascular, Microvention, Lazarus Effect, Blockade Medical, and Reverse Medical. He is a National Steering Committee member of Penumbra, 3D Separator trial; Covidien, for SWIFT-PRIME trial; MicroVention, for Pivotal Study of the FRED [Flow Redirection Intraluminal Device] Stent System in the Treatment of Intracranial Aneurysms (FRED) trial. He is also a member of speakers' bureaus for Codman & Shurtleff and an advisory board member for Codman & Shurtleff, Covidien Neurovascular, ICAVL, and Medina Medical, and he received honoraria from Abbott Vascular, Codman & Shurtleff, and Penumbra. Dr Thomalla is a neurological principal investigator of THRILL and received consultant/lecture fees from Bayer Healthcare, Bristol-Myers-Squibb/Pfizer, Boehringer Ingelheim, and Covidien. Dr Tomsick is a coprincipal investigator of the NIH-funded Interventional Management of Stroke (IMS) III trial. Dr Turk received research grants from Toshiba. He is a consultant to Penumbra, Stryker, Lazarus Effect, and Siemens, and he is a member of the speakers' Bureau for Penumbra. Dr White is an educational consultant to Codman and Microvention, and he received research grant from Microvention for Stroke: An Evaluation of Thrombectomy in the Aging Brain (STABILISE) Trial and travel support from Microvention. Dr Zaidat is a consultant/speaker for Penumbra, Stryker, and Covidien. Dr Lees plays a leadership role in VISTA, a DMC member for REVASCAT, and a scientific committee member for SITS and SITS-OPEN. He is also the president of ESO that receives sponsorship from companies.