@article{a6bab65feabe4e74abf5320bfb902fc2,
title = "Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: The RESOLVE study",
abstract = "Objectives This study sought to examine the diagnostic accuracy of the instantaneous wave-free ratio (iFR) and resting distal coronary artery pressure/aortic pressure (Pd/Pa) 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 Pd/Pa are nonhyperemic pressure-derived indices of the severity of stenosis with discordant reports regarding their accuracy with respect to FFR. Methods iFR, resting Pd/Pa, 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 Pd/Pa 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 ≤0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for PdPa was 0.92 (C statistic: 0.82 [95% confidence interval: 0.80 to 0.84]; overall accuracy: 81.5%), with no significant difference between these resting measures. iFR and PdPa had ≥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 PdPa with FFR demonstrated an overall accuracy of ∼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 PdPa might obviate the need for hyperemia in selected patients.",
keywords = "coronary physiology, fractional flow reserve, myocardial ischemia",
author = "Allen Jeremias and Akiko Maehara and Philippe G{\'e}n{\'e}reux and Asrress, {Kaleab N.} and Colin Berry and {De Bruyne}, Bernard and Davies, {Justin E.} and Javier Escaned and Fearon, {William F.} and Gould, {K. Lance} and Johnson, {Nils P.} and Kirtane, {Ajay J.} and Koo, {Bon Kwon} and Marques, {Koen M.} and Sukhjinder Nijjer and Oldroyd, {Keith G.} and Ricardo Petraco and Piek, {Jan J.} and Pijls, {Nico H.} and Simon Redwood and Maria Siebes and Spaan, {Jos A.E.} and {Van'T Veer}, Marcel and Mintz, {Gary S.} and Stone, {Gregg W.}",
note = "Funding Information: The present investigation was an international, multicenter, nonrandomized, retrospective, core laboratory–based analysis in patients with coronary artery disease undergoing physiological lesion assessment by FFR, iFR, and P d /P a . The principal investigators representing all of the published iFR/FFR comparative studies agreed to collaboratively participate in this effort, including the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study and registry (8,11) , VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice) (9) , and Johnson et al. (10) . In addition, 6 other study sites contributed unpublished data to the analysis. All studies included in this analysis were approved by the institutional review boards of the individual sites. Original raw phasic pressure waveforms from each patient were submitted digitally to the Physiology Core Laboratory at the Cardiovascular Research Foundation (New York, New York) for independent off-line analysis. In addition, selected baseline patient demographic and procedural data were supplied to the core laboratory. This study was an investigator-sponsored study by the Cardiovascular Research Foundation and was supported by funding from Volcano Corp. (San Diego, California). The funding source was uninvolved with the design of the protocol and the analysis and interpretation of the study results. ",
year = "2014",
month = apr,
day = "8",
doi = "10.1016/j.jacc.2013.09.060",
language = "English",
volume = "63",
pages = "1253--1261",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier Inc.",
number = "13",
}