Valérie E Stegehuis1, Gilbert W M Wijntjens1, Tim P van de Hoef1, Lorena Casadonte2, Richard L Kirkeeide3, Maria Siebes2, Jos A E Spaan2, K Lance Gould3, Nils P Johnson3, Jan J Piek4. 1. Amsterdam UMC-location AMC, Department of Cardiology, University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands. 2. Amsterdam UMC-location AMC, Department of Biomedical Engineering and Physics, Amsterdam, the Netherlands. 3. Weatherhead PET Imaging Center, Division of Cardiology, Department of Medicine, McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, TX. 4. Amsterdam UMC-location AMC, Department of Cardiology, University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands. Electronic address: j.j.piek@amc.uva.nl.
Abstract
BACKGROUND: It remains uncertain if invasive coronary physiology beyond fractional flow reserve (FFR) can refine lesion selection for revascularization or provide additional prognostic value. Coronary flow reserve (CFR) equals the ratio of hyperemic to baseline flow velocity and has a wealth of invasive and noninvasive data supporting its validity. Because of fundamental physiologic relationships, binary classification of FFR and CFR disagrees in approximately 30%-40% of cases. Optimal management of these discordant cases requires further study. AIM: The aim of the study was to determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of major adverse cardiac events. Secondary end points include repeatability of FFR and CFR, angina burden, and the percentage of successful FFR/CFR measurements which will not be excluded by the core laboratory. METHODS: This prospective, nonblinded, nonrandomized, and multicenter study enrolled 455 subjects from 12 sites in Europe and Japan. Patients underwent physiologic lesion assessment using the 0.014" Philips Volcano ComboWire XT that provides simultaneous pressure and Doppler velocity sensors. Intermediate coronary lesions received only medical treatment unless both FFR (≤0.8) and CFR (<2.0) were below thresholds. The primary outcome is a 24-month composite of death from any cause, myocardial infarction, and revascularization. CONCLUSION: The DEFINE-FLOW study will determine the prognostic value of invasive CFR assessment when measured simultaneously with FFR, with a special emphasis on discordant classifications. Our hypothesis is that lesions with an intact CFR ≥ 2.0 but reduced FFR ≤ 0.8 will have a 2-year outcome with medical treatment similar to lesions with FFR> 0.80 and CFR ≥ 2.0. Enrollment has been completed, and final follow-up will occur in November 2019.
BACKGROUND: It remains uncertain if invasive coronary physiology beyond fractional flow reserve (FFR) can refine lesion selection for revascularization or provide additional prognostic value. Coronary flow reserve (CFR) equals the ratio of hyperemic to baseline flow velocity and has a wealth of invasive and noninvasive data supporting its validity. Because of fundamental physiologic relationships, binary classification of FFR and CFR disagrees in approximately 30%-40% of cases. Optimal management of these discordant cases requires further study. AIM: The aim of the study was to determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of major adverse cardiac events. Secondary end points include repeatability of FFR and CFR, angina burden, and the percentage of successful FFR/CFR measurements which will not be excluded by the core laboratory. METHODS: This prospective, nonblinded, nonrandomized, and multicenter study enrolled 455 subjects from 12 sites in Europe and Japan. Patients underwent physiologic lesion assessment using the 0.014" Philips Volcano ComboWire XT that provides simultaneous pressure and Doppler velocity sensors. Intermediate coronary lesions received only medical treatment unless both FFR (≤0.8) and CFR (<2.0) were below thresholds. The primary outcome is a 24-month composite of death from any cause, myocardial infarction, and revascularization. CONCLUSION: The DEFINE-FLOW study will determine the prognostic value of invasive CFR assessment when measured simultaneously with FFR, with a special emphasis on discordant classifications. Our hypothesis is that lesions with an intact CFR ≥ 2.0 but reduced FFR ≤ 0.8 will have a 2-year outcome with medical treatment similar to lesions with FFR> 0.80 and CFR ≥ 2.0. Enrollment has been completed, and final follow-up will occur in November 2019.
Authors: Tadashi Murai; Valérie E Stegehuis; Tim P van de Hoef; Gilbert W M Wijntjens; Masahiro Hoshino; Yoshihisa Kanaji; Tomoyo Sugiyama; Rikuta Hamaya; Sukhjinder S Nijjer; Guus A de Waard; Mauro Echavarria-Pinto; Paul Knaapen; Martijn Meuwissen; Justin E Davies; Niels van Royen; Javier Escaned; Maria Siebes; Richard L Kirkeeide; K Lance Gould; Nils P Johnson; Jan J Piek; Tsunekazu Kakuta Journal: J Am Heart Assoc Date: 2020-07-14 Impact factor: 5.501
Authors: Ashkan Eftekhari; Jelmer Westra; Valérie Stegehuis; Niels Ramsing Holm; Tim P van de Hoef; Richard L Kirkeeide; Jan J Piek; K Lance Gould; Nils P Johnson; Evald Høj Christiansen Journal: Open Heart Date: 2022-04
Authors: Valerie Stegehuis; Jelmer Westra; Coen Boerhout; Martin Sejr-Hansen; Ashkan Eftekhari; Hernan Mejía-Renteria; Maribel Cambero-Madera; Niels Van Royen; Hitoshi Matsuo; Masafumi Nakayama; Maria Siebes; Evald Høj Christiansen; Tim Van de Hoef; Jan Piek Journal: Diagnostics (Basel) Date: 2022-07-21