TY - JOUR
T1 - Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis
T2 - A Single-Center Trial
AU - Burzotta, Francesco
AU - Leone, Antonio Maria
AU - Aurigemma, Cristina
AU - Zambrano, Aniello
AU - Zimbardo, Giuseppe
AU - Arioti, Manfredi
AU - Vergallo, Rocco
AU - De Maria, Giovanni Luigi
AU - Cerracchio, Emma
AU - Romagnoli, Enrico
AU - Trani, Carlo
AU - Crea, Filippo
N1 - Funding Information:
The FORZA trial was funded by academic grants (Bando Linea D. 1, Universit? Cattolica del Sacro Cuore, Rome, Italy). Drs. Burzotta, Trani, and Aurigemma have received speaking fees from Abbott, Medtronic, and Abiomed. Dr. Leone has received speaking honoraria from St. Jude Medical/Abbott, Medtronic, Abiomed, and Bracco Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 American College of Cardiology Foundation
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/1/13
Y1 - 2020/1/13
N2 - Objectives: The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial. Background: FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization. Methods: Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm2 or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months. Results: A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging. Conclusions: In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030)
AB - Objectives: The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial. Background: FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization. Methods: Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm2 or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months. Results: A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging. Conclusions: In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030)
KW - FFR
KW - fractional flow reserve
KW - OCT
KW - optical coherence tomography
KW - PCI
KW - percutaneous coronary interventions
KW - personalized medicine
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U2 - 10.1016/j.jcin.2019.09.034
DO - 10.1016/j.jcin.2019.09.034
M3 - Article
C2 - 31918942
AN - SCOPUS:85076845427
VL - 13
SP - 49
EP - 58
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 1
ER -