Multicenter Core Laboratory Comparison of the Instantaneous Wave-Free Ratio and Resting P-d/P-a With Fractional Flow Reserve

作者：Jeremias, Allen^*; Maehara, Akiko; Genereux, Philippe; Asrress, Kaleab N.; Berry, Colin; De Bruyne, Bernard; Davies, Justin E.; Escaned, Javier; Fearon, William F.; Gould, K. Lance; Johnson, Nils P.; Kirtane, Ajay J.; Koo, Bon-Kwon; Marques, Koen M.; Nijjer, Sukhjinder; Oldroyd, Keith G.; Petraco, Ricardo; Piek, Jan J.; Pijls, Nico H.; Redwood, Simon; Siebes, Maria; Spaan, Jos A. E.; van 't Veer, Marcel; Mintz, Gary S.; Stone, Gregg W.

来源：Journal of the American College of Cardiology, 2014, 63(13): 1253-1261.

DOI：10.1016/j.jacc.2013.09.060

• coronary physiology
• fractional flow reserve myocardial ischemia

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 <= 0.80 was 0.90 (C statistic: 0.81 [95% confidence interval: 0.79 to 0.83]; overall accuracy: 80.4%) and for P-d/P-a 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 P-d/P-a 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 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.

• 出版日期2014-4-8