Li Changling, Hu Yumeng, Jiang Jun, Dong Liang, Sun Yong, Tang Lijiang, Du Changqing, Yin Da, Jiang Wenbing, Leng Xiaochang, Jiang Fan, Pan Yibin, Jiang Xuejun, Zhou Zhong, Koo Bon-Kwon, Xiang Jianping, Wang Jian'an
Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
ArteryFlow Research and Development Center for Intelligent Diagnosis and Treatment of Cardiovascular and Cerebrovascular Diseases, ArteryFlow Technology Co, Ltd, Hangzhou, China.
JACC Cardiovasc Interv. 2024 Sep 9;17(17):1980-1992. doi: 10.1016/j.jcin.2024.06.027. Epub 2024 Aug 21.
AccuFFRct (ArteryFlow Technology) is a novel noninvasive method for calculating fractional flow reserve (FFR) from coronary computed tomography angiography (CCTA). The accuracy of AccuFFRct has not been adequately assessed.
This study sought to evaluate the diagnostic performance of AccuFFRct in detecting lesion-specific ischemia.
This prospective study enrolled 339 patients with 404 vessels. CCTA-derived FFR was calculated using an on-site computational fluid dynamics-based method and compared with invasive FFR. The performance of AccuFFRct was comprehensively analyzed in all lesions and subgroups, including "gray zone" lesions, various lesion classifications, clinical presentations, stenosis severities, and lesion locations.
Using FFR ≤0.80 as a reference standard, the overall diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for AccuFFRct were 90.6% (95% CI: 87.3%-93.3%), 90.9% (95% CI: 85.1%-94.9%), 90.4% (95% CI: 86.1%-93.8%), 85.3% (95% CI: 79.8%-89.5%), and 94.2% (95% CI: 90.8%-96.4%), respectively. Good correlation and agreement were found between the computed AccuFFRct and measured FFR. AccuFFRct showed superior discrimination ability to CCTA (AUC: 0.93 [95% CI: 0.89-0.95] vs 0.77 [95% CI: 0.72-0.81]; P < 0.001) and quantitative coronary angiography (AUC: 0.93 [95% CI: 0.89-0.95] vs 0.89 [95% CI: 0.85-0.92]; P = 0.048) for identifying functionally significant stenosis. Notably, AccuFFRct maintained high diagnostic accuracy across the spectrum of lesion classifications, clinical presentations, stenosis severities, lesion locations, and in the "gray zone". Furthermore, in the cohort with ≥70% stenosis, AccuFFRct could significantly reduce the rate of un-necessary invasive tests (33.1% vs 6.6%; P < 0.001).
The study confirms the potential of AccuFFRct as a noninvasive alternative to invasive FFR for detecting ischemia in coronary artery disease and to risk stratify patients. The results highlight AccuFFRct's robust diagnostic ability across a wide range of lesion classifications, clinical presentations, stenosis severities, lesion locations, and in the "gray zone". (Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography [ACCURATE-CT]; NCT04426396).
AccuFFRct(动脉血流技术)是一种用于从冠状动脉计算机断层扫描血管造影(CCTA)计算血流储备分数(FFR)的新型非侵入性方法。AccuFFRct的准确性尚未得到充分评估。
本研究旨在评估AccuFFRct在检测病变特异性缺血方面的诊断性能。
这项前瞻性研究纳入了339例患者的404条血管。使用基于现场计算流体动力学的方法计算CCTA衍生的FFR,并与有创FFR进行比较。在所有病变和亚组中全面分析AccuFFRct的性能,包括“灰色地带”病变、各种病变分类、临床表现、狭窄严重程度和病变位置。
以FFR≤0.80作为参考标准,AccuFFRct的总体诊断准确性、敏感性、特异性、阳性预测值和阴性预测值分别为90.6%(95%CI:87.3%-93.3%)、90.9%(95%CI:85.1%-94.9%)、90.4%(95%CI:86.1%-93.8%)、85.3%(95%CI:79.8%-89.5%)和94.2%(95%CI:90.8%-96.4%)。计算出的AccuFFRct与测量的FFR之间发现了良好的相关性和一致性。在识别功能性显著狭窄方面,AccuFFRct显示出比CCTA(AUC:0.93[95%CI:0.89-0.95]对0.77[95%CI:0.72-0.81];P<0.001)和定量冠状动脉造影(AUC:0.93[95%CI:0.89-0.95]对0.89[95%CI:0.85-0.92];P=0.048)更强的鉴别能力。值得注意的是,AccuFFRct在各种病变分类、临床表现、狭窄严重程度、病变位置以及“灰色地带”中均保持较高的诊断准确性。此外,在狭窄≥70%的队列中,AccuFFRct可显著降低不必要的有创检查率(33.1%对6.6%;P<0.001)。
该研究证实了AccuFFRct作为检测冠心病缺血及对患者进行风险分层的有创FFR的非侵入性替代方法的潜力。结果突出了AccuFFRct在广泛的病变分类、临床表现、狭窄严重程度、病变位置以及“灰色地带”中的强大诊断能力。(冠状动脉CT血管造影衍生的血流储备分数的诊断性能[ACCURATE-CT];NCT04426396)