Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT–FFR trial
Why the study?
The study aimed to evaluate the impact of OCT-detected thin-cap fibroatheroma on clinical outcomes in diabetes mellitus patients with FFR-negative lesions.
Does the presence of OCT-detected thin-cap fibroatheroma predict adverse clinical events in diabetic patients with FFR-negative lesions?
Population
390 DM patients with ≥1 FFR-negative lesions (from 550 enrolled)
Comparison
TCFA-positive vs TCFA-negative lesions
Design
Prospective, double-blind, international natural history study
Follow-up
18 months
Authors
Discussion
Loading...
Member takes
Implication
OCT-detected TCFA signals higher MACE risk in diabetic FFR-negative lesions; hypothesis-generating and requires prospective validation before practice change.
Structured PICO
Does the presence of OCT-detected thin-cap fibroatheroma predict adverse clinical events in diabetic patients with FFR-negative lesions?
P
Population
390 diabetes mellitus patients with ≥1 FFR-negative lesions (from a total of 550 enrolled patients), international.
I
Intervention
Presence of ≥1 OCT-detected thin-cap fibroatheroma (TCFA) lesion (TCFA-positive, n=98)
C
Comparator
Absence of OCT-detected thin-cap fibroatheroma (TCFA-negative, n=292)
O
Outcome
Composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 monthscomposite
In diabetic patients with FFR-negative lesions, the presence of OCT-detected thin-cap fibroatheroma is associated with a nearly five-fold higher rate of major adverse clinical events at 18 months, despite the absence of ischemia.
Cite This Study
Kedhi et al. (2021) studied this question.