Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke The DIAS-4 Trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke)

被引：41

作者：

von Kummer, Ruediger ^{[1
]}

Mori, Etsuro ^{[2
]}

Truelsen, Thomas ^{[3
]}

Jensen, Jens-Kristian S. ^{[3
]}

Gronning, Bjorn A. ^{[3
]}

Fiebach, Jochen B. ^{[4
]}

Lovblad, Karl-Olof ^{[5
]}

Pedraza, Salvador ^{[6
]}

Romero, Javier M. ^{[7
]}

Chabriat, Hugues ^{[8
,9
]}

Chang, Ku-Chou ^{[10
]}

Davalos, Antoni ^{[11
]}

Ford, Gary A. ^{[12
,13
]}

Grotta, James ^{[14
]}

Kaste, Markku ^{[15
]}

Schwamm, Lee H. ^{[16
,17
]}

Shuaib, Ashfaq ^{[18
]}

Albers, Gregory W. ^{[19
]}

机构：

[1] Tech Univ Dresden, Univ Klinikum Carl Gustav Carus, Dresden, Germany

[2] Tohoku Univ, Grad Sch Med, Sendai, Miyagi, Japan

[3] H Lundbeck & Co AS, Valby, Denmark

[4] Charite, Ctr Stroke Res Berlin, Berlin, Germany

[5] Univ Geneva, CH-1211 Geneva 4, Switzerland

[6] UDG, Hosp Dr Josep Trueta, C IDIBGI, Girona, Spain

[7] Harvard Med Sch, Dept Radiol, Boston, MA USA

[8] Univ Paris 07, Hop Lariboisiere, AP HP, Dept Neurol, Paris, France

[9] DHU NeuroVasc, INSERM, U1161, Paris, France

[10] Chang Gung Univ, Kaohsiung Chang Gung Mem Hosp, Dept Neurol, Taoyuan, Taiwan

[11] Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Dept Neurosci, Barcelona, Spain

[12] Oxford Univ Hosp, Oxford, England

[13] Univ Oxford, Div Med Sci, Oxford OX1 2JD, England

[14] Mem Hermann Hosp, Houston, TX USA

[15] Univ Helsinki, Helsinki Univ Hosp, Dept Neurol, Clin Neurosci, FIN-00014 Helsinki, Finland

[16] Harvard Med Sch, Massachusetts Gen Hosp, Dept Neurol, Boston, MA USA

[17] Harvard Med Sch, Massachusetts Gen Hosp, Stroke Serv, Boston, MA USA

[18] Univ Alberta, Edmonton, AB, Canada

[19] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA

来源：

STROKE | 2016年 / 47卷 / 12期

关键词：

brain ischemia; cerebral arteries; goals; intracranial hemorrhage; stroke; ONSET; THROMBECTOMY;

D O I：

10.1161/STROKEAHA.116.013715

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background and Purpose-The DIAS-3 trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke [phase 3]) did not demonstrate a significant clinical benefit of desmoteplase administered 3 to 9 hours after stroke in patients with major artery occlusion. We present the results of the prematurely terminated DIAS-4 trial together with a post hoc pooled analysis of the concomitant DIAS-3, DIAS-4, and DIAS-J (Japan) trials to better understand the potential risks and benefits of intravenous desmoteplase for the treatment of ischemic stroke in an extended time window. Methods-Ischemic stroke patients with occlusion/high-grade stenosis in major cerebral arteries were randomly assigned to intravenous treatment with desmoteplase (90 mu g/kg) or placebo. The primary outcome was modified Rankin Scale (mRS) score of 0 to 2 at day 90. Safety assessments included mortality, symptomatic intracranial hemorrhage, and other serious adverse events. Results-In DIAS-4, 52 of 124 (41.9%) desmoteplase-treated and 46 of 128 (35.9%) placebo-treated patients achieved an mRS score of 0 to 2 (odds ratio, 1.45; 95% confidence interval, 0.79; 2.64; P=0.23) with equal mortality, frequency of symptomatic intracranial hemorrhage, and other serious adverse events in both the treatment arms. In the pooled analysis, mRS score of 0 to 2 was achieved by 184 of 376 (48.9%) desmoteplase-treated versus 171 of 381 (44.9%) placebo-treated patients (odds ratio, 1.33; 95% confidence interval, 0.95; 1.85; P=0.096). Treatment with desmoteplase was safe and increased the recanalization rate (107/217 [49.3%] versus 85/222 [38.3%]; odds ratio, 1.59; 95% confidence interval, 1.08-2.35; P=0.019). Recanalization was associated with favorable outcomes (mRS 0-2) at day 90 in both the treatment arms. Conclusions-Late treatment with intravenous 90 mu g/kg desmoteplase is safe, increases arterial recanalization, but does not significantly improve functional outcome at 3 months.

引用

页码：2880 / 2887

页数：8

共 13 条

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