TY - JOUR
T1 - Impact of core laboratory assessment on treatment decisions and clinical outcomes using combined fractional flow reserve and coronary flow reserve measurements – DEFINE-FLOW core laboratory sub-study
AU - van de Hoef, Tim P.
AU - Stegehuis, Valérie E.
AU - Madera-Cambero, Maribel I.
AU - van Royen, Niels
AU - van der Hoeven, Nina W.
AU - de Waard, Guus A.
AU - Meuwissen, Martijn
AU - Christiansen, Evald H.
AU - Eftekhari, Ashkan
AU - Niccoli, Giampaolo
AU - Lockie, Tim
AU - Matsuo, Hitoshi
AU - Nakayama, Masafumi
AU - Kakuta, Tsunekazu
AU - Tanaka, Nobuhiro
AU - Casadonte, Lorena
AU - Spaan, Jos A. E.
AU - Siebes, Maria
AU - Tijssen, Jan G. P.
AU - Escaned, Javier
AU - Piek, Jan J.
N1 - Funding Information: TvdH has received speaker fees and institutional research grants from Abbott and Philips. NvR has received speaker fees and institutional research grants from Abbott and Philips. JE is a speaker and consultant for Abbott, Boston Scientific, and Philips, and received personal fees from Philips, Boston Scientific, and Abbott/St. Jude Medical outside the submitted work. JJP has received support as consultant for Philips/Volcano, and has received institutional research grants from Philips. The other authors report no relationship with industry related to this work. Publisher Copyright: © 2023
PY - 2023/4/15
Y1 - 2023/4/15
N2 - Objective: The role of combined FFR/CFR measurements in decision-making on coronary revascularization remains unclear. DEFINE-FLOW prospectively assessed the relationship of FFR/CFR agreement with 2-year major adverse cardiac event (MACE) and target vessel failure (TVF) rates, and uniquely included core-laboratory analysis of all pressure and flow tracings. We aimed to document the impact of core-laboratory analysis on lesion classification, and the relationship between core-laboratory fractional flow reserve (FFR) and coronary flow reserve (CFR) values with clinical outcomes and angina burden during follow-up. Methods: In 398 vessels (348 patients) considered for intervention, ≥1 coronary pressure/flow tracing was approved by the core-laboratory. Revascularization was performed only when both FFR(≤0.80) and CFR(<2.0) were abnormal, all others were treated medically. Results: MACE was lowest for concordant normal FFR/CFR, but was not significantly different compared with either discordant group (low FFR/normal CFR: HR:1.63; 95%CI:0.61–4.40; P = 0.33; normal FFR/low CFR: HR:1.81; 95%CI:0.66–4.98; P = 0.25). Moreover, MACE did not differ between discordant groups treated medically and the concordant abnormal group undergoing revascularization (normal FFR/low CFR: HR:0.63; 95%CI:0.23–1.73;P = 0.37; normal FFR/low CFR: HR:0.70; 95%CI:0.22–2.21;P = 0.54). Similar findings applied to TVF. Conclusions: Patients with concordantly normal FFR/CFR have very low 2-year MACE and TVF rates. Throughout follow-up, there were no differences in event rates between patients in whom revascularization was deferred due to preserved CFR despite reduced FFR, and those in whom PCI was performed due to concordantly low FFR and CFR. These findings question the need for routine revascularization in vessels showing low FFR but preserved CFR. Clinical trial registration: http://ClinicalTrials.gov
AB - Objective: The role of combined FFR/CFR measurements in decision-making on coronary revascularization remains unclear. DEFINE-FLOW prospectively assessed the relationship of FFR/CFR agreement with 2-year major adverse cardiac event (MACE) and target vessel failure (TVF) rates, and uniquely included core-laboratory analysis of all pressure and flow tracings. We aimed to document the impact of core-laboratory analysis on lesion classification, and the relationship between core-laboratory fractional flow reserve (FFR) and coronary flow reserve (CFR) values with clinical outcomes and angina burden during follow-up. Methods: In 398 vessels (348 patients) considered for intervention, ≥1 coronary pressure/flow tracing was approved by the core-laboratory. Revascularization was performed only when both FFR(≤0.80) and CFR(<2.0) were abnormal, all others were treated medically. Results: MACE was lowest for concordant normal FFR/CFR, but was not significantly different compared with either discordant group (low FFR/normal CFR: HR:1.63; 95%CI:0.61–4.40; P = 0.33; normal FFR/low CFR: HR:1.81; 95%CI:0.66–4.98; P = 0.25). Moreover, MACE did not differ between discordant groups treated medically and the concordant abnormal group undergoing revascularization (normal FFR/low CFR: HR:0.63; 95%CI:0.23–1.73;P = 0.37; normal FFR/low CFR: HR:0.70; 95%CI:0.22–2.21;P = 0.54). Similar findings applied to TVF. Conclusions: Patients with concordantly normal FFR/CFR have very low 2-year MACE and TVF rates. Throughout follow-up, there were no differences in event rates between patients in whom revascularization was deferred due to preserved CFR despite reduced FFR, and those in whom PCI was performed due to concordantly low FFR and CFR. These findings question the need for routine revascularization in vessels showing low FFR but preserved CFR. Clinical trial registration: http://ClinicalTrials.gov
KW - Coronary flow reserve
KW - Fractional flow reserve
KW - Percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85148730577&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ijcard.2023.01.009
DO - https://doi.org/10.1016/j.ijcard.2023.01.009
M3 - Article
C2 - 36640965
SN - 0167-5273
VL - 377
SP - 9
EP - 16
JO - International journal of cardiology
JF - International journal of cardiology
ER -