Diabetics with thin-cap fibroatheroma on OCT at high CV risk despite negative FFR: Study

A group of European researchers conducted a study 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.

The study named OMBINE OCT-FFR was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesion (target lesions) were classified into 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.

The results of the study are as follows:

• Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesion. 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.
• The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE)

Thus, the researchers concluded that among Diabetes mellitus 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 Diabetes mellitus patients.

Reference:

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT–FFR trial by Kedhi, E et. al published in the European Heart Journal.

https://doi.org/10.1093/eurheartj/ehab433