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Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study

BACKGROUND: MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves...

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Autores principales: van den Berg, Lucie A., Dijkgraaf, Marcel G. W., Berkhemer, Olvert A., Fransen, Puck S. S., Beumer, Debbie, Lingsma, Hester, Majoie, Charles B. M., Dippel, Diederik W. J., van der Lugt, Aad J., van Oostenbrugge, Robert J., van Zwam, Wim H., Roos, Yvo B. W. E. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5120535/
https://www.ncbi.nlm.nih.gov/pubmed/27876083
http://dx.doi.org/10.1186/s13063-016-1669-6
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author van den Berg, Lucie A.
Dijkgraaf, Marcel G. W.
Berkhemer, Olvert A.
Fransen, Puck S. S.
Beumer, Debbie
Lingsma, Hester
Majoie, Charles B. M.
Dippel, Diederik W. J.
van der Lugt, Aad J.
van Oostenbrugge, Robert J.
van Zwam, Wim H.
Roos, Yvo B. W. E. M.
author_facet van den Berg, Lucie A.
Dijkgraaf, Marcel G. W.
Berkhemer, Olvert A.
Fransen, Puck S. S.
Beumer, Debbie
Lingsma, Hester
Majoie, Charles B. M.
Dippel, Diederik W. J.
van der Lugt, Aad J.
van Oostenbrugge, Robert J.
van Zwam, Wim H.
Roos, Yvo B. W. E. M.
author_sort van den Berg, Lucie A.
collection PubMed
description BACKGROUND: MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up. METHODS: MR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years. The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up. DISCUSSION: The results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness. TRIAL REGISTRATION: NTR1804. Registered on 7 May 2009; ISRCTN10888758. Registered on 24 July 2012 (main MR CLEAN trial); NTR5073. Registered on 26 February 2015 (extended follow-up study).
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spelling pubmed-51205352016-11-28 Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study van den Berg, Lucie A. Dijkgraaf, Marcel G. W. Berkhemer, Olvert A. Fransen, Puck S. S. Beumer, Debbie Lingsma, Hester Majoie, Charles B. M. Dippel, Diederik W. J. van der Lugt, Aad J. van Oostenbrugge, Robert J. van Zwam, Wim H. Roos, Yvo B. W. E. M. Trials Update BACKGROUND: MR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up. METHODS: MR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years. The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up. DISCUSSION: The results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness. TRIAL REGISTRATION: NTR1804. Registered on 7 May 2009; ISRCTN10888758. Registered on 24 July 2012 (main MR CLEAN trial); NTR5073. Registered on 26 February 2015 (extended follow-up study). BioMed Central 2016-11-22 /pmc/articles/PMC5120535/ /pubmed/27876083 http://dx.doi.org/10.1186/s13063-016-1669-6 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Update
van den Berg, Lucie A.
Dijkgraaf, Marcel G. W.
Berkhemer, Olvert A.
Fransen, Puck S. S.
Beumer, Debbie
Lingsma, Hester
Majoie, Charles B. M.
Dippel, Diederik W. J.
van der Lugt, Aad J.
van Oostenbrugge, Robert J.
van Zwam, Wim H.
Roos, Yvo B. W. E. M.
Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title_full Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title_fullStr Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title_full_unstemmed Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title_short Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
title_sort two-year clinical follow-up of the multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the netherlands (mr clean): design and statistical analysis plan of the extended follow-up study
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5120535/
https://www.ncbi.nlm.nih.gov/pubmed/27876083
http://dx.doi.org/10.1186/s13063-016-1669-6
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