Author/Authors :
Jeremias، نويسنده , , Allen and Maehara، نويسنده , , Akiko and Généreux، نويسنده , , Philippe and Asrress، نويسنده , , Kaleab N. and Berry، نويسنده , , Colin and De Bruyne، نويسنده , , Bernard and Davies، نويسنده , , Justin E. and Escaned، نويسنده , , Javier and Fearon، نويسنده , , William F. and Gould، نويسنده , , K. Lance and Johnson، نويسنده , , Nils P. and Kirtane، نويسنده , , Ajay J. and Koo، نويسنده , , Bon-Kwon and Marques، نويسنده , , Koen M. and Nijjer، نويسنده , , Sukhjinder and Oldroyd، نويسنده , , Keith G. and Petraco، نويسنده , , Ricardo and Piek، نويسنده , , Jan J. and Pijls، نويسنده , , Nico H. and Redwood، نويسنده , , Simon and Siebes، نويسنده , , Maria and Spaan، نويسنده , , Jos A.E. and van ʹt Veer، نويسنده , , Marcel and Mintz، نويسنده , , Gary S. and Stone، نويسنده , , Gregg W.، نويسنده ,
Abstract :
Objectives
tudy 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.
ound
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.
s
esting 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.
s
74 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.
sions
omprehensive 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.