Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

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Citation: European Heart Journal. 42(45):4671-4679, 2021 12 01.PMID: 34345911Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Coronary Artery Disease | *Diabetes Mellitus | *Fractional Flow Reserve, Myocardial | *Plaque, Atherosclerotic | Coronary Angiography | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Vessels/dg [Diagnostic Imaging] | Humans | Plaque, Atherosclerotic/dg [Diagnostic Imaging] | Predictive Value of Tests | Prospective Studies | Tomography, Optical CoherenceYear: 2021ISSN:
  • 0195-668X
Name of journal: European heart journalAbstract: AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions.CONCLUSIONS: Among DM patients with >=1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients. Copyright Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author(s) 2021. For permissions, please email: [email protected] AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with >=1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of >=1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had >=1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001).All authors: Al Nooryani A, Alfonso F, Berta B, Camaro C, De Luca G, Escaned J, Fabris E, Garcia Garcia H, Granada JF, Hermanides RS, IJsselmuiden AJJ, Kauer F, Kedhi E, Kennedy MW, Magro M, Malinowski K, Nef H, Pereira B, Reith S, Rivero F, Roleder T, von Birgelen C, Wojakowski WOriginally published: European Heart Journal. 2021 Jul 29Fiscal year: FY2022Fiscal year of original publication: FY2022Digital Object Identifier: Date added to catalog: 2021-11-01
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Journal Article MedStar Authors Catalog Article 34345911 Available 34345911

AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions.

CONCLUSIONS: Among DM patients with >=1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients. Copyright Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author(s) 2021. For permissions, please email: [email protected].

METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with >=1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of >=1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had >=1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001).

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