Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study
Allen Jeremias, Akiko Maehara, Philippe Généreux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F Fearon, K Lance Gould, Nils P Johnson, Ajay J Kirtane, Bon-Kwon Koo, Koen M Marques, Sukhjinder Nijjer, Keith G Oldroyd, Ricardo Petraco, Jan J Piek, Nico H Pijls, Simon Redwood, Maria Siebes, Jos A E Spaan, Marcel van 't Veer, Gary S Mintz, Gregg W Stone, Allen Jeremias, Akiko Maehara, Philippe Généreux, Kaleab N Asrress, Colin Berry, Bernard De Bruyne, Justin E Davies, Javier Escaned, William F Fearon, K Lance Gould, Nils P Johnson, Ajay J Kirtane, Bon-Kwon Koo, Koen M Marques, Sukhjinder Nijjer, Keith G Oldroyd, Ricardo Petraco, Jan J Piek, Nico H Pijls, Simon Redwood, Maria Siebes, Jos A E Spaan, Marcel van 't Veer, Gary S Mintz, Gregg W Stone
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 Pd/Pa 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 Pd/Pa 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 Pd/Pa 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 Pd/Pa might obviate the need for hyperemia in selected patients.
Keywords: coronary physiology; fractional flow reserve; myocardial ischemia.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed