TY - JOUR
T1 - Prospective assessment of the diagnostic accuracy of instantaneous wave-free ratio to assess coronary stenosis relevance
T2 - Results of ADVISE II international, multicenter study (ADenosine vasodilator independent stenosis evaluation II)
AU - Escaned, Javier
AU - Echavarría-Pinto, Mauro
AU - Garcia-Garcia, Hector M.
AU - Van De Hoef, Tim P.
AU - De Vries, Ton
AU - Kaul, Prashant
AU - Raveendran, Ganesh
AU - Altman, John D.
AU - Kurz, Howard I.
AU - Brechtken, Johannes
AU - Tulli, Mark
AU - Von Birgelen, Clemens
AU - Schneider, Joel E.
AU - Khashaba, Ahmed A.
AU - Jeremias, Allen
AU - Baucum, Jim
AU - Moreno, Raul
AU - Meuwissen, Martijn
AU - Mishkel, Gregory
AU - Van Geuns, Robert Jan
AU - Levite, Howard
AU - Lopez-Palop, Ramon
AU - Mayhew, Marc
AU - Serruys, Patrick W.
AU - Samady, Habib
AU - Piek, Jan J.
AU - Lerman, Amir
N1 - Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/5/1
Y1 - 2015/5/1
N2 - Objectives The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) 0.80, in a prospective, independent, controlled, core laboratory-based environment. Background Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons. Methods A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report. Results The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≥0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses. Conclusions The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach.
AB - Objectives The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) 0.80, in a prospective, independent, controlled, core laboratory-based environment. Background Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons. Methods A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report. Results The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≥0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses. Conclusions The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach.
KW - adenosine
KW - coronary artery disease
KW - fractional flow reserve
KW - instantaneous wave-free ratio
KW - physiology
KW - vasodilation
UR - http://www.scopus.com/inward/record.url?scp=84929573959&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2015.01.029
DO - 10.1016/j.jcin.2015.01.029
M3 - Article
C2 - 25999106
AN - SCOPUS:84929573959
SN - 1936-8798
VL - 8
SP - 824
EP - 833
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 6
ER -