# Thin-cap fibroatheroom voorspelt events bij diabetes met normale FFR: COMBINE OCT-FFR

*geplaatst 2021-12-01 · Preventie · European heart journal · doi 10.1093/eurheartj/ehab433 · https://hartvaat.nl/2021/12/01/thin-cap-fibroatheroom-voorspelt-events-bij-diabetes-met-normale-ffr-combine-oct/*

COMBINE OCT-FFR trial die aantoonde dat thin-cap fibroatheroom events voorspelt bij diabetespatiënten met normale FFR.

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

The COMBINE OCT-FFR trial demonstrated that thin-cap fibroatheroma detected by OCT in diabetic patients with normal FFR predicts future cardiovascular events, supporting imaging-based vulnerable plaque identification for risk stratification beyond physiological assessment.

## Abstract (original, from the publication)

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. 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). 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.

Auteurs: Elvin Kedhi, Balazs Berta, Tomasz Roleder, Renicus S Hermanides, Enrico Fabris, Alexander J J IJsselmuiden, Floris Kauer, Fernando Alfonso, Clemens von Birgelen, Javier Escaned, Cyril Camaro, Mark W Kennedy, Bruno Pereira, Michael Magro, Holger Nef, Sebastian Reith, Arif Al Nooryani, Fernando Rivero, Krzysztof Malinowski, Giuseppe De Luca, Hector Garcia Garcia, Juan F Granada, Wojciech Wojakowski

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehab433. Bijgewerkt 2026-07-03T13:28:39Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.