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Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance

Abstract 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,...

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Published in:JACC. Cardiovascular interventions 2015-05, Vol.8 (6), p.824-833
Main Authors: Escaned, Javier, MD, PhD, Echavarría-Pinto, Mauro, MD, Garcia-Garcia, Hector M., MD, PhD, van de Hoef, Tim P., MD, de Vries, Ton, MA, Kaul, Prashant, MD, Raveendran, Ganesh, MD, Altman, John D., MD, Kurz, Howard I., MD, Brechtken, Johannes, MD, Tulli, Mark, MD, Von Birgelen, Clemens, MD, PhD, Schneider, Joel E., MD, Khashaba, Ahmed A., MD, Jeremias, Allen, MD, Baucum, Jim, MD, Moreno, Raul, MD, Meuwissen, Martijn, MD, PhD, Mishkel, Gregory, MD, van Geuns, Robert-Jan, MD, PhD, Levite, Howard, MD, Lopez-Palop, Ramon, MD, Mayhew, Marc, MD, Serruys, Patrick W., MD, PhD, Samady, Habib, MD, Piek, Jan J., MD, PhD, Lerman, Amir, MD
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Language:English
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Summary:Abstract 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 
ISSN:1936-8798
1876-7605
DOI:10.1016/j.jcin.2015.01.029