Multicenter Core Laboratory Comparison of the Instantaneous Wave-Free Ratio and Resting Pd/Pa With Fractional Flow Reserve

Multicenter Core Laboratory Comparison of the Instantaneous Wave-Free Ratio and Resting Pd/Pa With Fractional Flow Reserve
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DOI:
10.1016/j.jacc.2013.09.060
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发表时间:
2014-04-08
影响因子:
24
通讯作者:
Stone, Gregg W.
Stone, Gregg W.
中科院分区:
医学1区
文献类型:
--
作者:
Jeremias, Allen;Maehara, Akiko;Stone, Gregg W.

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在一项以实验室为基础的多中心合作研究中,本研究旨在检验瞬时无波比(iFR)和静息远端冠状动脉压/主动脉压(P-d/P-a)对充血分数血流储备(FFR)的诊断准确性。FFR是衡量冠状动脉狭窄严重程度的指标,已在3项前瞻性随机试验中得到临床验证。iFR和P-d/P-a是非充血压力衍生的狭窄严重程度指标,其相对于FFR的准确性报道不一致。方法测定15个临床站点1768例患者的iFR、静息P-d/P-a和FFR。一个独立的生理学核心实验室对所有原始数据进行盲法离线分析。主要目的是确定特定的iFR和P-d/P-a阈值,预测缺血性与非缺血性FFR的准确度为>= 90%(基于FFR切割点0.80),以及超过这些阈值的患者比例。结果在1974例提交的病变中,381例(19.3%)因采集不理想而被排除,留下1593例进行最终分析。在接受者操作特征分析中,预测FFR阳性或阴性FFR的最佳iFR切点准确率为90%,分别为64.9%(62.6%至67.3%)和48.3%(45.6%至50.5%)的病变。这项综合的核心实验室分析比较了iFR和P-d/P-a与FFR,结果表明,对于两个非充血指标,iFR和P-d/P-a的总体准确性接近80%,在一部分病变中可以提高到>= 90%。需要进行临床结果研究,以确定使用iFR或P-d/P-a是否可以在选定的患者中消除充血的需要。(C) 2014年由美国心脏病学会基金会发布
Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal coronary artery pressure/aortic pressure (P-d/P-a) with respect to hyperemic fractional flow reserve (FFR) in a core laboratory-based multicenter collaborative study.Background FFR is an index of the severity of coronary stenosis that has been clinically validated in 3 prospective randomized trials. iFR and P-d/P-a are nonhyperemic pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR.Methods iFR, resting P-d/P-a, and FFR were measured in 1,768 patients from 15 clinical sites. An independent physiology core laboratory performed blinded off-line analysis of all raw data. The primary objectives were to determine specific iFR and P-d/P-a thresholds with >= 90% accuracy in predicting ischemic versus nonischemic FFR (on the basis of an FFR cut point of 0.80) and the proportion of patients falling beyond those thresholds.Results Of 1,974 submitted lesions, 381 (19.3%) were excluded because of suboptimal acquisition, leaving 1,593 for final analysis. On receiver-operating characteristic analysis, the optimal iFR cut point for FFR = 90% accuracy to predict a positive or negative FFR in 64.9% (62.6% to 67.3%) and 48.3% (45.6% to 50.5%) of lesions, respectively.Conclusions This comprehensive core laboratory analysis comparing iFR and P-d/P-a with FFR demonstrated an overall accuracy of similar to 80% for both nonhyperemic indices, which can be improved to >= 90% in a subset of lesions. Clinical outcome studies are required to determine whether the use of iFR or P-d/P-a might obviate the need for hyperemia in selected patients. (C) 2014 by the American College of Cardiology Foundation