使用高剂量冠状动脉内腺苷的瞬时无波比率与血流储备分数混合方法对中度冠状动脉病变进行特征性诊断的准确性：PALS（病变严重程度的实际评估）前瞻性研究结果

Diagnostic accuracy of a hybrid approach of instantaneous wave-free ratio and fractional flow reserve using high-dose intracoronary adenosine to characterize intermediate coronary lesions: Results of the PALS (Practical Assessment of Lesion Severity) prospective study.

作者信息

Rivero Fernando, Cuesta Javier, Bastante Teresa, Benedicto Amparo, García-Guimaraes Marcos, Fuentes-Ferrer Manuel, Alvarado Teresa, Alfonso Fernando

机构信息

Department of Cardiology, Hospital Universitario de la Princesa. IIS-IP. Universidad Autónoma de Madrid, Madrid, Spain.

Department of Preventive Medicine, Research Unit, Hospital Universitario Clínico San Carlos, Madrid, Spain.

出版信息

Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1070-1076. doi: 10.1002/ccd.27038. Epub 2017 May 22.

DOI:10.1002/ccd.27038

PMID:28544741

Abstract

OBJECTIVES

We sought to investigate the diagnostic accuracy of instantaneous wave-free ratio (iFR) and high-dose intracoronary adenosine fractional flow reserve (IC-FFR) compared with classical intravenous adenosine fractional flow reserve (IV-FFR) to assess coronary stenosis severity. The usefulness of two hybrid strategies combining iFR and high-dose IC-FFR was also evaluated.

BACKGROUND

Physiological assessment of intermediate coronary stenoses to guide revascularization is currently recommended.

METHODS

Consecutive real-world patients with angiographically intermediate coronary stenosis (40-80% diameter stenosis) were prospectively included in the PALS (Practical Assessment of Lesion Severity) study. In every target lesion iFR, high-dose IC-FFR and IV-FFR were systematically measured to assess the accuracy of an hybrid sequential approach combining iFR and IC-FFR.

RESULTS

A total of 106 patients with 121 intermediate coronary lesions were analyzed. Both, iFR and IC-FFR showed a significant correlation with IV-FFR (iFR: r = 0.60, 95%CI 0.48-0.70; IC-FFR: r = 0.88; 95%CI: 0.83-0.92). High-dose IC-FFR provided lower FFR values than IV-FFR (0.81 ± 0.08 vs. 0.82 ± 0.09, P = 0.25). Using a receiver-operating-characteristic curve an optimal iFR threshold of 0.91 for the screening test was identified. A sequential test strategy (initial iFR followed by IC-FFR only in lesions with iFR <0.91) yielded an excellent diagnostic accuracy (96.7%, 95%CI 96.7-99.1%) with a sensitivity, specificity, positive and negative predicted values of 100%, 94.7%, 91.8%, and 100%, respectively. A hybrid approach using the previously described iFR gray zone (0.85-0.94) also provided an excellent diagnostic accuracy (95%, 95%CI: 89.5-98.1%).

CONCLUSIONS

In patients with intermediate coronary lesions a hybrid strategy by using a sequential approach of iFR and high-dose IC-FFR, provided a very good diagnostic performance to identify physiologically significant stenoses. © 2017 Wiley Periodicals, Inc.

摘要

目的

我们试图研究瞬时无波比值（iFR）和高剂量冠状动脉内腺苷血流储备分数（IC-FFR）相较于传统静脉注射腺苷血流储备分数（IV-FFR）评估冠状动脉狭窄严重程度的诊断准确性。还评估了两种结合iFR和高剂量IC-FFR的混合策略的实用性。

背景

目前推荐对中度冠状动脉狭窄进行生理评估以指导血运重建。

方法

连续入选PALS（病变严重程度的实际评估）研究中的冠状动脉造影显示为中度狭窄（直径狭窄40%-80%）的真实世界患者。在每个靶病变中系统测量iFR、高剂量IC-FFR和IV-FFR，以评估结合iFR和IC-FFR的混合序贯方法的准确性。

结果

共分析了106例患者的121处中度冠状动脉病变。iFR和IC-FFR均与IV-FFR显著相关（iFR：r = 0.60，95%CI 0.48-0.70；IC-FFR：r = 0.88；95%CI：0.83-0.92）。高剂量IC-FFR的FFR值低于IV-FFR（0.81±0.08 vs. 0.82±0.09，P = 0.25）。使用受试者工作特征曲线确定筛查试验的最佳iFR阈值为0.91。序贯试验策略（初始iFR，仅在iFR<0.91的病变中进行IC-FFR）具有出色的诊断准确性（96.7%，95%CI 96.7-99.1%），敏感性、特异性、阳性预测值和阴性预测值分别为100%、94.7%、91.8%和100%。使用先前描述的iFR灰色区域（0.85-0.94）的混合方法也具有出色的诊断准确性（95%，95%CI：89.5-98.1%）。