Hausleiter Jörg, Meyer Tanja, Hadamitzky Martin, Zankl Maria, Gerein Pia, Dörrler Katharina, Kastrati Adnan, Martinoff Stefan, Schömig Albert
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Klinik an der TU München, Munich, Germany.
Eur Heart J. 2007 Dec;28(24):3034-41. doi: 10.1093/eurheartj/ehm150. Epub 2007 May 31.
Non-invasive coronary angiography by multislice spiral computed tomography (MSCT) is a promising method for the diagnosis of coronary artery disease (CAD). However, the clinical role of this method has not been established for specific patient cohorts. Therefore, the objective of the current prospective, blinded study was to investigate the diagnostic value of coronary MSCT angiography in patients with an intermediate pre-test probability for having CAD when compared with invasive angiography.
A total of 243 patients with an intermediate pre-test probability for having CAD were asked to undergo coronary 16- or 64-slice CT angiography before planned invasive angiography from 12 September 2003 to 13 July 2005. The primary end point was defined as the diagnostic accuracy in the detection of significant coronary stenosis (> or =50% lumen diameter reduction) on a per-patient and an 'intention-to-diagnose'-based analysis. Secondary end points comprised per-artery and per segment-based analyses as well as the comparison of diagnostic accuracy of 16- vs. 64-slice MSCT angiography. Of 243 enrolled patients, 129 and 114 patients were studied by 16- and 64-slice CT angiography, respectively. The overall sensitivity, negative predictive value, and specificity for CAD detection by MSCT were 99% (95% CI, 94-99%), 99% (95% CI, 94-99%), and 75% (95% CI, 67-82%), respectively. On a per-segment basis, the use of 64-slice CT was associated with significantly less inconclusive segments (7.4 vs. 11.3%, P < 0.01), resulting in a trend to an improved specificity (92 vs. 88%, P = 0.09).
In patients with an intermediate pre-test probability for having CAD this large, prospective trial demonstrates that non-invasive coronary CT angiography is a very sensitive method for CAD detection. Furthermore, this method allows ruling out CAD very reliably and safely. Finally, 64-slice CT appears to be superior for CAD detection when compared with 16-slice CT.
多层螺旋计算机断层扫描(MSCT)进行无创冠状动脉造影是诊断冠状动脉疾病(CAD)的一种很有前景的方法。然而,该方法在特定患者群体中的临床作用尚未确立。因此,当前这项前瞻性、盲法研究的目的是,将冠状动脉MSCT血管造影与有创血管造影相比较,研究其在CAD预测试概率为中等的患者中的诊断价值。
从2003年9月12日至2005年7月13日,共有243例CAD预测试概率为中等的患者在计划进行有创血管造影前接受了冠状动脉16层或64层CT血管造影。主要终点定义为基于每位患者以及“意向性诊断”分析检测显著冠状动脉狭窄(管腔直径减少≥50%)的诊断准确性。次要终点包括基于每条动脉和每个节段的分析,以及16层与64层MSCT血管造影诊断准确性的比较。在243例入组患者中,分别有129例和114例患者接受了16层和64层CT血管造影研究。MSCT检测CAD的总体敏感性、阴性预测值和特异性分别为99%(95%CI,94 - 99%)、99%(95%CI,94 - 99%)和75%(95%CI,67 - 82%)。在每个节段的基础上,使用64层CT时不确定节段明显更少(7.4%对11.3%,P < 0.01),导致特异性有提高的趋势(92%对88%,P = 0.09)。
在这项针对CAD预测试概率为中等的患者的大型前瞻性试验中表明,无创冠状动脉CT血管造影是检测CAD的一种非常敏感的方法。此外,该方法能够非常可靠且安全地排除CAD。最后,与16层CT相比,64层CT在CAD检测方面似乎更具优势。