基于冠状动脉造影的计算流体动力学衍生的血流储备分数的诊断准确性：ACCURATE研究
Diagnostic Accuracy of Computational Fluid Dynamics-Based Fractional Flow Reserve Derived From Coronary Angiography: The ACCURATE Study.
作者信息
Jiang Jun, Hu Yumeng, Li Changling, Dong Liang, Xu Jian, Tang Lijiang, Jiang Wenbing, Du Changqing, Jiang Xuejun, Lyu Yongnan, Leng Xiaochang, Li Chengguang, Koo Bon-Kwon, Xiang Jianping, Ge Junbo, Wang Jian'an
机构信息
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.
出版信息
J Am Heart Assoc. 2025 Jan 7;14(1):e035672. doi: 10.1161/JAHA.124.035672. Epub 2024 Dec 24.
BACKGROUND
Although fractional flow reserve (FFR) is the contemporary standard to detect hemodynamically significant coronary stenosis, it remains underused for the need of pressure wire and hyperemic stimulus. Coronary angiography-derived FFR could break through these barriers. The aim of this study was to assess the feasibility and performance of a novel diagnostic modality deriving FFR from invasive coronary angiography (AccuFFRangio) for coronary physiological assessment.
METHODS AND RESULTS
The ACCURATE (Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease) study was a prospective, multicenter study conducted at 5 centers. Patients who had at least 1 lesion with a diameter stenosis of 30% to 90% were eligible. AccuFFRangio was measured on site in real time and compared with invasive FFR measurements in a blinded fashion. Primary end point was the diagnostic accuracy of AccuFFRangio in identifying functional relevant lesions. Between November 2020 and June 2021, pairwise analyses of AccuFFRangio and FFR were performed in 304 coronary arteries. AccuFFRangio showed good correlation (=0.89; <0.001) and agreement (mean difference: 0.01±0.06) with FFR. The diagnostic accuracy was 95.07% (95% CI, 91.99%-97.21%), which were significantly exceeded the prespecified target value (<0.001). The sensitivity, specificity, and area under the receiver operating characteristic curve of 95.83% (95% CI, 89.67%-98.85%), 94.71% (95% CI, 90.73%-97.33%), and 0.972 (95% CI, 0.947-0.988), respectively.
CONCLUSIONS
AccuFFRangio derived from coronary angiography alone has high diagnostic accuracy, sensitivity, and specificity compared with FFR. AccuFFRangio bears the potential for increasing the adoption of functional assessment of coronary artery stenosis and improving the use of physiological guided decision-making.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04814550.
背景
尽管血流储备分数（FFR）是检测具有血流动力学意义的冠状动脉狭窄的当代标准，但由于需要压力导丝和充血刺激，其使用仍然不足。冠状动脉造影衍生的FFR可以突破这些障碍。本研究的目的是评估一种从有创冠状动脉造影（AccuFFRangio）得出FFR的新型诊断方法用于冠状动脉生理评估的可行性和性能。
方法与结果
ACCURATE（用于冠状动脉疾病功能评估的造影衍生血流储备分数）研究是一项在5个中心进行的前瞻性多中心研究。有至少1处直径狭窄30%至90%病变的患者符合条件。AccuFFRangio在现场实时测量，并与有创FFR测量结果进行盲法比较。主要终点是AccuFFRangio识别功能相关病变的诊断准确性。在2020年11月至2021年6月期间，对304条冠状动脉进行了AccuFFRangio和FFR的配对分析。AccuFFRangio与FFR显示出良好的相关性（=0.89；<0.001）和一致性（平均差异：0.01±0.06）。诊断准确性为95.07%（95%CI，91.99%-97.21%），显著超过预定目标值（<0.001）。受试者工作特征曲线下面积的敏感性、特异性分别为95.83%（95%CI，89.67%-98.85%）、94.71%（95%CI，90.73%-97.33%）和0.972（95%CI，0.947-0.988）。
结论
仅从冠状动脉造影得出的AccuFFRangio与FFR相比具有较高的诊断准确性、敏感性和特异性。AccuFFRangio具有增加冠状动脉狭窄功能评估的采用率和改善生理指导决策应用的潜力。
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