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)
Bibliographical noteFunding Information:
This study was funded by Volcano Corporation. The sponsor of the study had no role in the study design, data acquisition, data analysis or writing of the manuscript. All analyses were independently performed by the core laboratory (Cardialysis). Dr. Escaned has had consultancies/been a speaker at educational events for Volcano Corporation and St. Jude Medical. Dr. Echavarría-Pinto has served as a speaker at educational events organized by Volcano Corporation and St. Jude Medical. Dr. van de Hoef has served as a speaker at educational events organized by Volcano Corporation, St. Jude Medical, and Boston Scientific. Dr. Kaul has served as a consultant to Cardiovascular Systems Inc. Dr. von Birgelen has served as a consultant to Abbott Vascular, Boston Scientific, and Medtronic (including lecture fees or travel expenses); has received travel expenses from Biotronik; has received lecture fees from Merck Sharp & Dohme; and his institution has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. Jeremias has served as a consultant to Volcano Corporation. Dr. Mishkel has served as a speaker/trainer for Volcano Therapeutics. Dr. Samady has received a research grant from Volcano Corporation and St. Jude Medical. Dr. Lerman has received an unrestricted grant from Volcano to support an NIH project. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2015 American College of Cardiology Foundation.
- coronary artery disease
- fractional flow reserve
- instantaneous wave-free ratio