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 RedwoodMaria Siebes, Jos A.E. Spaan, Marcel Van'T Veer, Gary S. Mintz, Gregg W. Stone

Research output: Contribution to journalArticle

179 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1253-1261
Number of pages9
JournalJournal of the American College of Cardiology
Volume63
Issue number13
DOIs
StatePublished - Apr 8 2014
Externally publishedYes

Fingerprint

Accidental Falls
Confidence Intervals
Pressure
Coronary Stenosis
Hyperemia
ROC Curve
Multicenter Studies
Coronary Vessels
Arterial Pressure
Pathologic Constriction
Outcome Assessment (Health Care)
Clinical Studies

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Jeremias, Allen ; Maehara, Akiko ; Généreux, 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. / Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve : The RESOLVE study. In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 13. pp. 1253-1261.
@article{059ee9e2a24f499e9dbd4bbb301f6177,
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.",
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.}",
year = "2014",
month = "4",
day = "8",
doi = "10.1016/j.jacc.2013.09.060",
language = "English (US)",
volume = "63",
pages = "1253--1261",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "13",

}

Jeremias, A, Maehara, A, Généreux, P, Asrress, KN, Berry, C, De Bruyne, B, Davies, JE, Escaned, J, Fearon, WF, Gould, KL, Johnson, NP, Kirtane, AJ, Koo, BK, Marques, KM, Nijjer, S, Oldroyd, KG, Petraco, R, Piek, JJ, Pijls, NH, Redwood, S, Siebes, M, Spaan, JAE, Van'T Veer, M, Mintz, GS & Stone, GW 2014, 'Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: The RESOLVE study', Journal of the American College of Cardiology, vol. 63, no. 13, pp. 1253-1261. https://doi.org/10.1016/j.jacc.2013.09.060

Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve : The RESOLVE study. / Jeremias, Allen; Maehara, Akiko; Généreux, 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.

In: Journal of the American College of Cardiology, Vol. 63, No. 13, 08.04.2014, p. 1253-1261.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve

T2 - The RESOLVE study

AU - Jeremias, Allen

AU - Maehara, Akiko

AU - Généreux, Philippe

AU - Asrress, Kaleab N.

AU - Berry, Colin

AU - De Bruyne, Bernard

AU - Davies, Justin E.

AU - Escaned, Javier

AU - Fearon, William F.

AU - Gould, K. Lance

AU - Johnson, Nils P.

AU - Kirtane, Ajay J.

AU - Koo, Bon Kwon

AU - Marques, Koen M.

AU - Nijjer, Sukhjinder

AU - Oldroyd, Keith G.

AU - Petraco, Ricardo

AU - Piek, Jan J.

AU - Pijls, Nico H.

AU - Redwood, Simon

AU - Siebes, Maria

AU - Spaan, Jos A.E.

AU - Van'T Veer, Marcel

AU - Mintz, Gary S.

AU - Stone, Gregg W.

PY - 2014/4/8

Y1 - 2014/4/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84892403148&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84892403148&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2013.09.060

DO - 10.1016/j.jacc.2013.09.060

M3 - Article

C2 - 24211503

AN - SCOPUS:84892403148

VL - 63

SP - 1253

EP - 1261

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 13

ER -