Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients.
Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients.
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DOI：
10.7326/0003-4819-153-7-201010050-00005
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发表时间：
2010-10-05
影响因子：
39.2
通讯作者：
PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Investigators
中科院分区：
文献类型：
--
作者：
Rosenberg S;Elashoff MR;Beineke P;Daniels SE;Wingrove JA;Tingley WG;Sager PT;Sehnert AJ;Yau M;Kraus WE;Newby LK;Schwartz RS;Voros S;Ellis SG;Tahirkheli N;Waksman R;McPherson J;Lansky A;Winn ME;Schork NJ;Topol EJ;PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Investigators
在高危患者中诊断严重的冠状动脉疾病（CAD）可能具有挑战性，通常包括无创成像模式，最终是冠状动脉造影的金标准。以往的研究表明，外周血基因表达可以反映CAD的存在。验证先前开发的基于23个基因表达的分类器用于诊断非糖尿病患者的阻塞性CAD。冠状动脉造影前采集血样的多中心前瞻性试验。美国39个中心一项由526例临床上适合进行冠状动脉造影术的非糖尿病患者组成的独立验证队列。通过实时聚合酶链反应（RT-PCR）测量的分类器评分的受试者-操作者特征（ROC）分析，临床因素的加和性，以及患者疾病可能性与定量冠状动脉造影（QCA）定义的疾病状态的重新分类。阻塞性CAD定义为QCA确定的≥1支主要冠状动脉狭窄≥50%。总体ROC曲线面积（AUC）为0.70 ±0.02，（p<0.001）;分类器加入临床变量（Diamond-Forrester方法）（有分类器的AUC 0.72 vs无分类器的AUC 0.66，p = 0.003）。分类器通过Diamond-Forrester和扩展的临床模型改善了净重新分类（均p<0.001）。在对应于20%阻塞性CAD可能性（14.75）的评分阈值时，灵敏度和特异性分别为85%和43%，得出的净现值为83%，净现值为46%，33%的患者评分低于该阈值。该研究排除了慢性炎症性疾病、白色血细胞计数或心脏蛋白标志物升高和糖尿病患者。这种基于基因表达和人口统计学的非侵入性全血检测可能有助于评估无已知CAD的非糖尿病患者的阻塞性CAD。Pandex，Inc.
Diagnosis of significant coronary artery disease (CAD) in at risk patients can be challenging, typically including non-invasive imaging modalities and ultimately the gold standard of coronary angiography. Previous studies suggested that peripheral blood gene expression can reflect the presence of CAD. To validate a previously developed 23-gene expression-based classifier for diagnosis of obstructive CAD in non-diabetic patients. Multi-center prospective trial with blood samples drawn prior to coronary angiography. Thirty-nine US centers. An independent validation cohort of 526 non-diabetic patients clinically-indicated for coronary angiography None. Receiver-operator characteristics (ROC) analysis of classifier score measured by real-time polymerase chain reaction (RT-PCR), additivity to clinical factors, and reclassification of patient disease likelihood vs disease status defined by quantitative coronary angiography (QCA). Obstructive CAD defined as ≥50% stenosis in ≥1 major coronary artery by QCA. The overall ROC curve area (AUC) was 0.70 ±0.02, (p<0.001); the classifier added to clinical variables (Diamond-Forrester method) (AUC 0.72 with classifier vs 0.66 without, p = 0.003). Net reclassification was improved by the classifier over Diamond-Forrester and an expanded clinical model (both p<0.001). At a score threshold corresponding to 20% obstructive CAD likelihood (14.75), the sensitivity and specificity were 85% and 43%, yielding NPV of 83% and PPV 46%, with 33% of patient scores below this threshold. The study excluded patients with chronic inflammatory disorders, elevated white blood counts or cardiac protein markers, and diabetes. This non-invasive whole blood test, based on gene expression and demographics, may be useful for assessment of obstructive CAD in non-diabetic patients without known CAD. CardioDx, Inc.
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