From the Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.W., S.W., M.-B.V., B.K.A., E.N.H., C.F.M., L.N.A., J.K.S., S.D.K., M.M., A.K., C.J.T., L.R.K., L.J., J.F.L., H.E.B., E.H.C., N.R.H.); Med-X Research Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T., Y.Z.); Department of Cardiology, Hospitalsenheden Vest, Regionshospitalet Herning, Denmark (L.N., M.B.); Department of Cardiology, Hospitalsenheden Midt, Regionshospitalet Silkeborg, Denmark (J.K.J.); and Department of Radiology, Leiden University Medical Center, The Netherlands (J.H.C.R.).
Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.
Quantitative flow ratio (QFR) is a novel diagnostic modality for functional testing of coronary artery stenosis without the use of pressure wires and induction of hyperemia. QFR is based on computation of standard invasive coronary angiographic imaging. The purpose of WIFI II (Wire-Free Functional Imaging II) was to evaluate the feasibility and diagnostic performance of QFR in unselected consecutive patients.
WIFI II was a predefined substudy to the Dan-NICAD study (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease), referring 362 consecutive patients with suspected coronary artery disease on coronary computed tomographic angiography for diagnostic invasive coronary angiography. Fractional flow reserve (FFR) was measured in all segments with 30% to 90% diameter stenosis. Blinded observers calculated QFR (Medis Medical Imaging bv, The Netherlands) for comparison with FFR. FFR was measured in 292 lesions from 191 patients. Ten (5%) and 9 patients (5%) were excluded because of FFR and angiographic core laboratory criteria, respectively. QFR was successfully computed in 240 out of 255 lesions (94%) with a mean diameter stenosis of 50±12%. Mean difference between FFR and QFR was 0.01±0.08. QFR correctly classified 83% of the lesions using FFR with cutoff at 0.80 as reference standard. The area under the receiver operating characteristic curve was 0.86 (95% confidence interval, 0.81-0.91) with a sensitivity, specificity, negative predictive value, and positive predictive value of 77%, 86%, 75%, and 87%, respectively. A QFR-FFR hybrid approach based on the present results enables wire-free and adenosine-free procedures in 68% of cases.
Functional lesion evaluation by QFR assessment showed good agreement and diagnostic accuracy compared with FFR. Studies comparing clinical outcome after QFR- and FFR-based diagnostic strategies are required.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02264717.
定量血流比（QFR）是一种新型的诊断方式，可在不使用压力导丝和诱导充血的情况下对冠状动脉狭窄进行功能检测。QFR 基于标准的有创冠状动脉造影成像计算得出。WIFI II（Wire-Free Functional Imaging II）的目的是评估 QFR 在未经选择的连续患者中的可行性和诊断性能。
WIFI II 是 Dan-NICAD 研究（丹麦冠状动脉疾病无创诊断检测研究）的预设子研究，该研究对 362 例经冠状动脉计算机断层扫描血管造影检查怀疑患有冠状动脉疾病的连续患者进行了诊断性有创冠状动脉造影检查。所有狭窄程度在 30%至 90%之间的节段均进行了血流储备分数（FFR）测量。盲法观察者计算了 QFR（荷兰 Medis Medical Imaging bv）并与 FFR 进行比较。FFR 测量了 191 例患者中的 292 个病变。由于 FFR 和血管造影核心实验室标准，10 例（5%）和 9 例（5%）患者被排除在外。255 个病变中有 240 个（94%）成功计算了 QFR，平均狭窄程度为 50±12%。FFR 和 QFR 之间的平均差异为 0.01±0.08。使用 FFR 截断值为 0.80 作为参考标准，QFR 正确分类了 83%的病变。受试者工作特征曲线下面积为 0.86（95%置信区间为 0.81-0.91），灵敏度、特异性、阴性预测值和阳性预测值分别为 77%、86%、75%和 87%。基于目前结果的 QFR-FFR 混合方法可使 68%的病例实现无导丝和无腺苷的程序。
与 FFR 相比，通过 QFR 评估进行功能病变评估显示出良好的一致性和诊断准确性。需要进行比较 QFR 和 FFR 基于诊断策略的临床结果的研究。
网址：https://www.clinicaltrials.gov。唯一标识符：NCT02264717。
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