{"id":"d98b9b4ed094","type":"article","url":"https://hartvaat.nl/2021/12/01/thin-cap-fibroatheroom-voorspelt-events-bij-diabetes-met-normale-ffr-combine-oct/","title":"Thin-cap fibroatheroom voorspelt events bij diabetes met normale FFR: COMBINE OCT-FFR","title_en":"Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":[],"journal":"European heart journal","doi":"10.1093/eurheartj/ehab433","source_url":"https://doi.org/10.1093/eurheartj/ehab433","authors":["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"],"significance":7,"published":"2021-12-01","source_date":"2021-12-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:29:32Z","updated":"2026-07-03T13:28:39Z","licence":"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.","body_markdown":"COMBINE OCT-FFR trial die aantoonde dat thin-cap fibroatheroom events voorspelt bij diabetespatiënten met normale FFR.","abstract_original":"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."}