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Published in: Trials 1/2016

Open Access 01-12-2016 | Update

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

Authors: Lucie A. van den Berg, Marcel G. W. Dijkgraaf, Olvert A. Berkhemer, Puck S. S. Fransen, Debbie Beumer, Hester Lingsma, Charles B. M. Majoie, Diederik W. J. Dippel, Aad J. van der Lugt, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B. W. E. M. Roos, for the MR CLEAN invesigators

Published in: Trials | Issue 1/2016

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Abstract

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).
Appendix
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Metadata
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
Authors
Lucie A. van den Berg
Marcel G. W. Dijkgraaf
Olvert A. Berkhemer
Puck S. S. Fransen
Debbie Beumer
Hester Lingsma
Charles B. M. Majoie
Diederik W. J. Dippel
Aad J. van der Lugt
Robert J. van Oostenbrugge
Wim H. van Zwam
Yvo B. W. E. M. Roos
for the MR CLEAN invesigators
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1669-6

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