Department of Cardiology, Henri Mondor Hospital and University of Paris Est Créteil, Créteil, France.
Am J Cardiol. 2013 Feb 15;111(4):471-8. doi: 10.1016/j.amjcard.2012.10.029. Epub 2012 Dec 19.
Computed tomographic coronary angiography (CTCA) has been proposed as a noninvasive test for significant coronary artery disease (CAD), but only limited data are available from prospective multicenter trials. The goal of this study was to establish the diagnostic accuracy of CTCA compared to coronary angiography (CA) in a large population of symptomatic patients with clinical indications for coronary imaging. This national, multicenter study was designed to prospectively evaluate stable patients able to undergo CTCA followed by conventional CA. Data from CTCA and CA were analyzed in a blinded fashion at central core laboratories. The main outcome was the evaluation of patient-, vessel-, and segment-based diagnostic performance of CTCA to detect or rule out significant CAD (≥50% luminal diameter reduction). Of 757 patients enrolled, 746 (mean age 61 ± 12 years, 71% men) were analyzed. They underwent CTCA followed by CA 1.7 ± 0.8 days later using a 64-detector scanner. The prevalence of significant CAD in native coronary vessels by CA was 54%. The rate of nonassessable segments by CTCA was 6%. In a patient-based analysis, sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of CTCA were 91%, 50%, 68%, 83%, 1.82, and 0.18, respectively. The strongest predictors of false-negative results on CTCA were high estimated pretest probability of CAD (odds ratio [OR] 1.97, p <0.001), male gender (OR 1.5, p <0.002), diabetes (OR 1.5, p <0.0001), and age (OR 1.2, p <0.0001). In conclusion, in this large multicenter study, CTCA identified significant CAD with high sensitivity. However, in routine clinical practice, each patient should be individually evaluated, and the pretest probability of obstructive CAD should be taken into account when deciding which method, CTCA or CA, to use to diagnose its presence and severity.
计算机断层扫描冠状动脉造影术(CTCA)已被提议作为一种非侵入性的方法来检测严重的冠状动脉疾病(CAD),但只有有限的前瞻性多中心试验数据可用。本研究的目的是在有冠状动脉成像临床指征的症状性患者的大人群中,确立 CTCA 与冠状动脉造影(CA)相比的诊断准确性。这项全国性、多中心研究旨在前瞻性评估能够进行 CTCA 并随后进行常规 CA 的稳定患者。在中心核心实验室以盲法分析 CTCA 和 CA 的数据。主要结果是评估 CTCA 在检测或排除有意义的 CAD(≥50%管腔直径狭窄)的患者、血管和节段的诊断性能。在纳入的 757 例患者中,746 例(平均年龄 61±12 岁,71%为男性)进行了分析。他们接受 CTCA 检查,然后在 1.7±0.8 天后使用 64 探测器扫描仪进行 CA。通过 CA 评估的原生冠状动脉中存在严重 CAD 的患病率为 54%。CTCA 不可评估的节段率为 6%。在基于患者的分析中,CTCA 的敏感性、特异性、阳性和阴性预测值以及阳性和阴性似然比分别为 91%、50%、68%、83%、1.82 和 0.18。CTCA 假阴性结果的最强预测因素是 CAD 的高估计术前概率(比值比 [OR] 1.97,p<0.001)、男性(OR 1.5,p<0.002)、糖尿病(OR 1.5,p<0.0001)和年龄(OR 1.2,p<0.0001)。总之,在这项大型多中心研究中,CTCA 以高敏感性识别出严重 CAD。然而,在常规临床实践中,应单独评估每位患者,并在决定使用 CTCA 或 CA 来诊断其存在和严重程度时考虑阻塞性 CAD 的术前概率。