Optical Coherence Tomography Measures Predicting Fractional Flow Reserve: The OMEF Study
Presenter
Rocco Vergallo, M.D., Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Rocco Vergallo, M.D.1, Francesco Burzotta, MD, PhD2, Tsunekazu Kakuta3, Tomasz Pawlowski, MD4, Antonio Maria Leone5, Gennaro Sardella, M.D.6, Pierfrancesco Agostoni, M.D.7, Jonathan Hill, M.B.B.S.8, Adrian P Banning9, Tomasz Roleder10, Anouar Belkacemi7, Giovanni L De Maria9 and Carlo Trani, MD2, (1)Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy, (2)Catholic University of the Sacred Heart, Roma RM, Italy, (3)Tsuchiura Kyodo General Hospital, Tsuchiura, Japan, (4)CSK MSWiA, WARSAW, Warsaw, Poland, (5)Catholic University of the Sacred Heart, Rome, Italy, (6)Policlinico Umberto I, Roma, Italy, (7)University Medical Center Utrecht, Antwerp, Belgium, (8)King's College Hospital, London, United Kingdom, (9)Oxford Heart Center, Oxford University Hospitals, Oxford, United Kingdom, (10)Medical University of Silesia in Katowice, Katowice, Poland
Keywords: Imaging & Physiology
Background:
Optical coherence tomography (OCT) allows to carefully characterize coronary plaque morphology and lumen dimensions. Such anatomic features may influence coronary flow but the value of OCT in predicting fractional flow reserve (FFR) has not been established. This study aimed: 1) to evaluate whether OCT parameters may predict FFR values and 2) to assess if OCT parameters may predict clinical outcome in patients with negative FFR.
Methods:
We designed a multicenter, international, study using individual patient's level data pooled analysis (ClinicalTrial.gov: NCT03573388). Stable or unstable patients who underwent both FFR and OCT of the same coronary lesion were enrolled. Primary outcome measures were OCT parameters predicting an FFR <0.80, including mean lumen area (MLA), percentage area stenosis (%AS), and presence of plaque thrombus/rupture. Secondary outcome was the incidence of Major Adverse Cardiac Events (MACE) in patients not undergoing revascularization based on negative FFR (≥0.80). MACEs were defined as the composite of cardiac death, spontaneous myocardial infarction (MI), and target lesion revascularization.
Results:
A total of 502 coronary lesions in 489 patients were included. A significant correlation was observed between OCT-MLA and FFR values (R=0.525, p<0.001), and between OCT-%AS and FFR values (R=-0.482, p<0.001), while plaque thrombus/rupture did not differ significantly. At ROC analysis, an OCT-MLA <2.0 mm
2 showed a good discriminative power to predict an FFR<0.80 (AUC 0.80), as well as an OCT %AS >73% (AUC 0.73). When considering proximal coronary segments only, the best OCT cut-off values predicting an FFR<0.80 were MLA <3.1 mm
2 (AUC 0.82), and %AS >61% (AUC 0.84). Among 105 patients who had not undergone revascularization based on negative FFR and had completed the clinical follow up, 11 (10.5%) had MACE. Median follow-up time was 6 years (IQR: 2.3-8.3). Patients with MLA <2.0 mm
2 showed a non-significantly higher incidence of MACE than those with MLA ≥2.0 mm
2 (16.7% vs. 9.2%, p=0.139).
Conclusions:
OCT parameters may predict FFR values. An OCT MLA <2.0 mm
2 (<3.1 mm
2 for proximal segments), showed a good predictive value for the identification of FFR<0.80.