Center for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
Center for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
JACC Cardiovasc Imaging. 2021 Jul;14(7):1384-1393. doi: 10.1016/j.jcmg.2020.11.012. Epub 2021 Jan 13.
This study aimed to examine the concordance of coronary computed tomographic angiography (CCTA) assessment of coronary anatomy and invasive coronary angiography (ICA) as the reference standard in patients enrolled in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches).
Performance of CCTA compared with ICA has not been assessed in patients with very high burdens of stress-induced ischemia and a high likelihood of anatomically significant coronary artery disease (CAD). A blinded CCTA was performed after enrollment to exclude patients with left main (LM) disease or no obstructive CAD before randomization to an initial conservative or invasive strategy, the latter guided by ICA and optimal revascularization.
Rates of concordance were calculated on a per-patient basis in patients randomized to the invasive strategy. Anatomic significance was defined as ≥50% diameter stenosis (DS) for both modalities. Sensitivity analyses using a threshold of ≥70% DS for CCTA or considering only CCTA images of good-to-excellent quality were performed.
In 1,728 patients identified by CCTA as having no LM disease ≥50% and at least single-vessel CAD, ICA confirmed 97.1% without LM disease ≥50%, 92.2% with at least single-vessel CAD and no LM disease ≥50%, and only 4.9% without anatomically significant CAD. Results using a ≥70% DS threshold or only CCTA of good-to-excellent quality showed similar overall performance.
CCTA before randomization in ISCHEMIA demonstrated high concordance with subsequent ICA for identification of patients with angiographically significant disease without LM disease.
本研究旨在评估冠状动脉计算机断层扫描血管造影(CCTA)评估冠状动脉解剖结构与以有创冠状动脉造影(ICA)为参考标准在 ISCHEMIA 研究(比较医学和有创方法对健康效果的国际研究)中入组患者的一致性。
在应激诱导缺血负担非常高且存在高度可能存在有意义的冠状动脉疾病(CAD)的患者中,CCTA 与 ICA 的性能比较尚未得到评估。在入组后进行盲法 CCTA,排除左主干(LM)疾病或无阻塞性 CAD 的患者,然后随机分配至初始保守或有创策略,后者根据 ICA 和最佳血运重建指导。
在随机分配至有创策略的患者中,按患者计算一致性率。解剖学意义定义为两种方式均≥50%直径狭窄(DS)。进行了使用 CCTA 的阈值≥70% DS 或仅考虑 CCTA 图像质量良好至优秀的敏感性分析。
在通过 CCTA 确定无 LM 疾病≥50%且至少单支血管 CAD 的 1728 例患者中,ICA 确认无 LM 疾病≥50%的患者中 97.1%、至少单支血管 CAD 且无 LM 疾病≥50%的患者中 92.2%、且仅 4.9%无有意义 CAD。使用≥70% DS 阈值或仅 CCTA 质量良好至优秀的结果显示总体性能相似。
ISCHEMIA 中的随机化前 CCTA 显示出与随后的 ICA 高度一致,可识别无 LM 疾病但有血管造影显著疾病的患者。