Javier Escaned1, Mauro Echavarría-Pinto2, Hector M Garcia-Garcia3, Tim P van de Hoef4, Ton de Vries5, Prashant Kaul6, Ganesh Raveendran7, John D Altman8, Howard I Kurz9, Johannes Brechtken10, Mark Tulli11, Clemens Von Birgelen12, Joel E Schneider13, Ahmed A Khashaba14, Allen Jeremias15, Jim Baucum16, Raul Moreno17, Martijn Meuwissen18, Gregory Mishkel19, Robert-Jan van Geuns3, Howard Levite20, Ramon Lopez-Palop21, Marc Mayhew22, Patrick W Serruys3, Habib Samady23, Jan J Piek4, Amir Lerman24. 1. Cardiovascular Institute, Hospital Clinico San Carlos and Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC), Madrid, Spain; Faculty of Medicine, Complutense University of Madrid, Spain. Electronic address: escaned@secardiologia.es. 2. Cardiovascular Institute, Hospital Clinico San Carlos and Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC), Madrid, Spain; Erasmus MC, Department of Cardiology, Rotterdam, the Netherlands. 3. Erasmus MC, Department of Cardiology, Rotterdam, the Netherlands. 4. AMC Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 5. Cardialysis BV, Rotterdam, the Netherlands. 6. University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. 7. Cardiovascular Division of the University of Minnesota, Minneapolis, Minnesota. 8. St. Anthony's Heart and Vascular Center and Colorado Heart and Vascular PC, Denver, Colorado. 9. Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri. 10. Regions Hospital, Saint Paul, Minnesota. 11. Cardiovascular Research of North Florida, Gainesville Florida. 12. Thoraxcentrum Twente, Department of Cardiology, Medisch Spectrum Twente, and Health Technology and Services Research, MIRA, University of Twente, Enschede, the Netherlands. 13. Wake Heart and Vascular Institute, Raleigh, North Carolina. 14. Al Dorrah Heart Care Hospital, Ain Shams University, Cairo, Egypt. 15. Stony Brook University Medical Center, Stony Brook, New York. 16. Greenville Memorial Hospital, Grenville, South Carolina. 17. Hospital Universitario la Paz, Madrid, Spain. 18. Department of Cardiology, Amphia Hospital, Breda, the Netherlands. 19. Prairie Heart Institute, St. John's Hospital, Springfield, Illinois. 20. AtlantiCare Regional Medical Center, Egg Harbor Township, New Jersey. 21. Hospital Universitario de San Juan de Alicante, Alicante, Spain. 22. Wellmont Holston Valley Medical Center, Kingsport, Tennessee. 23. Division of Cardiology, Department of Medicine, Andreas Gruentzig Cardiovascular Center, Emory University School of Medicine, Atlanta, Georgia. 24. Center for Coronary Physiology and Imaging, Division of Cardiovascular Diseases, and Department of Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota.
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 < 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. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).
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. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).
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