Dataset Information

Optical Coherence Tomography Measures Predicting Fractional Flow Reserve: The OMEF Study.

ABSTRACT:

Background

Optical coherence tomography (OCT) allows to carefully characterize coronary plaque morphology and lumen dimensions. We sought to evaluate the value of OCT in predicting fractional flow reserve (FFR).

Methods

We performed a multicenter, international, pooled analysis of individual patient-level data from published studies assessing FFR and OCT on the same vessel. Data from stable or unstable patients who underwent both FFR and OCT of the same coronary artery were collected through a dedicated database. Predefined OCT parameters were minimum lumen area (MLA), percentage area stenosis (%AS), and presence of thrombus or plaque rupture. Primary end point was FFR ≤0.80. Secondary outcome was the incidence of major adverse cardiac events in patients not undergoing revascularization based on negative FFR (>0.80).

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 < .001), and between OCT-%AS and FFR values (R = -0.482; P < .001). In Receiver operating characteristic analysis, MLA <2.0 mm² showed a good discriminative power to predict an FFR ≤0.80 (AUC, 0.80), whereas %AS >73% showed a moderate discriminative power (AUC, 0.73). When considering proximal coronary segments, the best OCT cutoff values predicting an FFR ≤0.80 were MLA <3.1 mm² (AUC, 0.82), and %AS >61% (AUC, 0.84). In patients with a negative FFR not revascularized, the combination of lower MLA and higher %AS had a trend toward worse outcome (which was statistically significant in the analysis restricted to proximal vessels).

Conclusions

OCT lumen measures (MLA, %AS) may predict FFR, and different cutoffs are needed for proximal vessels.

SUBMITTER: Vergallo R

PROVIDER: S-EPMC11307753 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Optical Coherence Tomography Measures Predicting Fractional Flow Reserve: The OMEF Study.

Vergallo Rocco R Lombardi Marco M Kakuta Tsunekazu T Pawlowski Tomasz T Leone Antonio Maria AM Sardella Gennaro G Agostoni Pierfrancesco P Hill Jonathan M JM De Maria Giovanni Luigi GL Banning Adrian P AP Roleder Tomasz T Belkacemi Anouar A Trani Carlo C Burzotta Francesco F

Journal of the Society for Cardiovascular Angiography & Interventions 20240209 4

<h4>Background</h4>Optical coherence tomography (OCT) allows to carefully characterize coronary plaque morphology and lumen dimensions. We sought to evaluate the value of OCT in predicting fractional flow reserve (FFR).<h4>Methods</h4>We performed a multicenter, international, pooled analysis of individual patient-level data from published studies assessing FFR and OCT on the same vessel. Data from stable or unstable patients who underwent both FFR and OCT of the same coronary artery were collec ...[more]

PMID: 39130179

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Project description:Background Fractional flow reserve (FFR) and optical coherence tomography (OCT) may help both in assessment and in percutaneous coronary intervention optimization of angiographically intermediate coronary lesions. We designed a prospective trial comparing the clinical and economic outcomes associated with FFR or OCT in angiographically intermediate coronary lesions. Methods and Results Three hundred fifty patients with angiographically intermediate coronary lesions (n=446) were randomized to FFR or OCT guidance. In the FFR arm, percutaneous coronary intervention was performed if FFR was ≤0.80 aiming for a postprocedure FFR >0.90. In the OCT arm, percutaneous coronary intervention was performed if percentage of area stenosis was ≥75% or 50% to 75% with minimal lumen area <2.5 mm2 or plaque ulceration. Costs, angina frequency, and major adverse cardiac events were assessed at 1 month and at 13 months. We present early data at 1 month consistent with a prespecified analysis of secondary end points. Patients randomized to FFR, as compared with OCT, were significantly more commonly managed with medical therapy alone (67.7% versus 41.1%; P<0.001), required less contrast media (245±137 versus 280±129 mL; P=0.004), and exhibited a lower occurrence of contrast-induced acute kidney injury (1.7% versus 8.6%; P=0.034). At 1 month, in comparison to FFR, OCT was associated with increased total costs (2831±1288 versus 4292±3844 euros/patient; P<0.001) whereas occurrence of major adverse cardiac events or significant angina was similar. Conclusions In patients with angiographically intermediate coronary lesions, a functional guidance by FFR, as compared with OCT, increased the rate of patients treated with medical therapy alone. This translated into a significant reduction in administered contrast, contrast-induced acute kidney injury, and total costs at 1 month with FFR. Clinical Trial Registration URL: http://www.clinicaltrialsgov. Unique identifier: NCT01824030.

Project description:BackgroundCoronary computed tomography angiography-derived fractional flow reserve (FFRCT) is a per-vessel index reflecting cumulative hemodynamic burden while coronary events occur in focal lesions.ObjectivesThe authors sought to evaluate the additive prognostic value of the local gradient of FFRCT (FFRCT gradient) in addition to FFRCT to predict future coronary events.MethodsThe current study included 245 patients (634 vessels) who underwent coronary computed tomography angiography within 6 to 36 months before the index angiography, of which 209 vessels had future coronary events and 425 vessels did not. Future coronary events were defined as a composite of vessel-specific myocardial infarction or urgent revascularization during a mean interval of 1.5 years. Pre-existing disease patterns were classified according to FFRCT of ≤0.80 and FFRCT gradient of ≥0.025/mm.ResultsBoth FFRCT (per 0.01 decrease; adjusted HR: 1.040; 95% CI: 1.029-1.051; P < 0.001) and FFRCT gradient (per 0.01 increase; adjusted HR: 1.144; 95% CI: 1.101-1.190; P < 0.001) were significantly associated with the risk of future coronary events. Lesions with FFRCT gradient of ≥0.025/mm showed significantly higher risk of future coronary events than those with FFRCT gradient of <0.025/mm in both the FFRCT >0.80 (49.2% vs 30.1%; HR: 2.069; 95% CI: 1.265-3.385; P = 0.004) and FFRCT ≤0.80 groups (60.9% vs 38.3%; HR: 1.988; 95% CI: 1.317-2.999; P =0 .001). Adding FFRCT gradient into the model with FFRCT alone showed significantly increased predictability of future coronary events (global chi-square: 45.8 vs 39.9; P = 0.015).ConclusionsPatients with high FFRCT gradient showed increased risk of future coronary events irrespective of FFRCT. Integrating both FFRCT and FFRCT gradient showed incremental predictability of future coronary events compared with FFRCT alone. (Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization [DESTINY Study]; NCT04794868).

Project description:BackgroundThe management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions.Methods/designPatients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale.DiscussionThe FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques.Trial registrationClinicaltrials.gov NCT01824030.

Dataset Information

Optical Coherence Tomography Measures Predicting Fractional Flow Reserve: The OMEF Study.

Background

Methods

Results

Conclusions

Publications

Optical Coherence Tomography Measures Predicting Fractional Flow Reserve: The OMEF Study.

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