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

被引：7

作者：

van den Berg, Lucie A. ^{[1
]}

Dijkgraaf, Marcel G. W. ^{[2
]}

Berkhemer, Olvert A. ^{[3
]}

Fransen, Puck S. S. ^{[4
]}

Beumer, Debbie ^{[5
]}

Lingsma, Hester ^{[6
]}

Majoie, Charles B. M. ^{[3
]}

Dippel, Diederik W. J. ^{[4
]}

van der Lugt, Aad J. ^{[7
]}

van Oostenbrugge, Robert J. ^{[5
]}

van Zwam, Wim H. ^{[8
]}

Roos, Yvo B. W. E. M. ^{[1
]}

机构：

[1] Acad Med Ctr, Dept Neurol, POB 22660, NL-1100 DD Amsterdam, Netherlands

[2] Acad Med Ctr, Clin Res Unit, POB 22660, NL-1100 DD Amsterdam, Netherlands

[3] Acad Med Ctr, Dept Radiol, POB 22660, NL-1100 DD Amsterdam, Netherlands

[4] Erasmus MC Univ Med Ctr Rotterdam, Dept Neurol, POB 2040, NL-3000 CA Rotterdam, Netherlands

[5] Maastricht Univ, Med Ctr, Dept Neurol, POB 5800, NL-6202 AZ Maastricht, Netherlands

[6] Erasmus MC Univ, Med Ctr, Dept Publ Hlth, Rotterdam, Netherlands

[7] Erasmus MC Univ, Med Ctr, Dept Radiol, POB 2040, NL-3000 CA Rotterdam, Netherlands

[8] Maastricht Univ, Med Ctr, Dept Radiol, POB 5800, NL-6202 AZ Maastricht, Netherlands

来源：

TRIALS | 2016年 / 17卷

关键词：

Intravenous thrombolysis; Endovascular treatment; Acute ischemic stroke; Randomized controlled trial; Mechanical thrombectomy; THROMBECTOMY; PROJECT; IMPACT; SCALE;

D O I：

10.1186/s13063-016-1669-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：7

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