Clinical and Imaging Data at 5 Days as a Surrogate for 90-Day Outcome in Ischemic Stroke

Clinical and Imaging Data at 5 Days as a Surrogate for 90-Day Outcome in Ischemic Stroke
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DOI：
10.1161/strokeaha.108.528976
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发表时间：
2009-04-01
期刊：
STROKE
影响因子：
8.3
通讯作者：
Wagner, Douglas P.
Wagner, Douglas P.
中科院分区：
医学1区
文献类型：
--
作者：
Johnston, Karen C.;Barrett, Kevin M.;Wagner, Douglas P.

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背景和目的-一种简单、易于测量的替代结局指标用于急性缺血性卒中治疗的早期治疗试验将受到高度重视。我们假设，第5天NIH中风量表评分（NIHSS）和第5天弥散加权成像（DWI）的体积预测临床结果优于单独和可以被视为一个可能的替代结果在早期阶段急性中风trials. Methods的前瞻性急性中风准确预测（ASAP）试验包括一个预先指定的亚组评估早期结果。Logistic回归分析用于评估改良兰金（m兰金）为0或1的预测。结果-共有204例受试者完成了子研究，116例（57%）在3个月时结局良好。第5天NIHSS预测3个月优良预后的ROC曲线下面积（AUC）为0.84，DWI体积预测3个月优良预后的ROC曲线下面积为0.76，多变量模型预测3个月优良预后的ROC曲线下面积为0.84。在我们的数据集中，DWI体积在预测3个月结局时没有增加临床相关信息。需要验证这些结果。（中风。2009;40：1332-1333）。
Background and Purpose-A simple, easily measured surrogate outcome measure for use in early treatment trials for acute ischemic stroke therapies would be highly valued. We hypothesized that day-5 NIH stroke scale score (NIHSS) and day-5 diffusion weighted imaging (DWI) volume would predict clinical outcome better than either alone and could be considered as a possible surrogate outcome in early phase acute stroke trials.Methods-The prospective Acute Stroke Accurate Prediction (ASAP) trial included a prespecified subgroup evaluated for early outcome. Logistic regression analysis was used to assess the prediction of modified Rankin (mRankin) of 0 or 1.Results-A total of 204 subjects completed the substudy, and 116 (57%) had excellent outcome at 3 months. The area under the ROC curve (AUC) for day-5 NIHSS predicting 3-month excellent outcome was 0.84; for DWI volume predicting outcome was 0.76, and for the multivariable model combining both was 0.84.Conclusions-The results of the early outcome substudy of the ASAP trial suggest that early stroke severity and infarct volume measures are predictive of 3-month excellent outcome. In our data set the DWI volume does not add clinically relevant information in predicting 3-month outcome. Validation of these results is required. (Stroke. 2009;40:1332-1333.)