Daniels Susan E, Beineke Philip, Rhees Brian, McPherson John A, Kraus William E, Thomas Gregory S, Rosenberg Steven
CardioDx, Inc., 600 Saginaw Drive, Redwood City, CA, USA.
J Cardiovasc Transl Res. 2014 Oct;7(7):615-22. doi: 10.1007/s12265-014-9583-3. Epub 2014 Aug 14.
A gene expression score (GES) for obstructive coronary artery disease (CAD) has been validated in two multicenter studies. Receiver-operating characteristics (ROC) analysis of the GES on an expanded Personalized Risk Evaluation and Diagnosis in the Coronary Tree (PREDICT) cohort (NCT no. 00500617) with CAD defined by quantitative coronary angiography (QCA) or clinical reads yielded similar performance (area under the curve (AUC)=0.70, N=1,502) to the original validation cohort (AUC=0.70, N=526). Analysis of 138 non-Caucasian and 1,364 Caucasian patients showed very similar performance (AUCs=0.72 vs. 0.70). To assess analytic stability, stored samples of the original validation cohort (N=526) was re-tested after 5 years, and the mean score changed from 20.3 to 19.8 after 5 years (N=501, 95 %). To assess patient scores over time, GES was determined on samples from 173 Coronary Obstruction Detection by Molecular Personalized Gene Expression (COMPASS) study (NCT no. 01117506) patients at approximately 1 year post-enrollment. Mean scores increased slightly from 15.9 to 17.3, corresponding to a 2.5 % increase in obstructive CAD likelihood. Changes in cardiovascular medications did not show a significant change in GES.
一种用于阻塞性冠状动脉疾病（CAD）的基因表达评分（GES）已在两项多中心研究中得到验证。在一项扩大的冠状动脉树个性化风险评估与诊断（PREDICT）队列（NCT编号：00500617）中，采用定量冠状动脉造影（QCA）或临床诊断来定义CAD，对GES进行的受试者操作特征（ROC）分析得出的性能（曲线下面积（AUC）=0.70，N=1502）与原始验证队列（AUC=0.70，N=526）相似。对138名非白种人和1364名白种人患者的分析显示性能非常相似（AUC分别为0.72和0.70）。为评估分析稳定性，对原始验证队列（N=526）储存的样本在5年后重新进行检测，5年后平均评分从20.3变为19.8（N=501，95%）。为评估患者随时间的评分，在分子个性化基因表达冠状动脉阻塞检测（COMPASS）研究（NCT编号：01117506）中，对173名患者入组后约1年时采集的样本测定GES。平均评分从15.9略有增加至17.3，对应阻塞性CAD可能性增加2.5%。心血管药物的变化未显示GES有显著变化。
