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

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. COMBINE OCT-FFR study was a prospective, double-blind, internat...

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Veröffentlicht in:European heart journal 2021-12, Vol.42 (45), p.4671-4679
Hauptverfasser: Kedhi, Elvin, Berta, Balazs, Roleder, Tomasz, Hermanides, Renicus S, Fabris, Enrico, IJsselmuiden, Alexander J J, Kauer, Floris, Alfonso, Fernando, von Birgelen, Clemens, Escaned, Javier, Camaro, Cyril, Kennedy, Mark W, Pereira, Bruno, Magro, Michael, Nef, Holger, Reith, Sebastian, Al Nooryani, Arif, Rivero, Fernando, Malinowski, Krzysztof, De Luca, Giuseppe, Garcia Garcia, Hector, Granada, Juan F, Wojakowski, Wojciech
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Sprache:eng
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Zusammenfassung: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. 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 
ISSN:0195-668X
1522-9645
DOI:10.1093/eurheartj/ehab433