Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE optical coherence tomography (OCT)–fractional flow reserve (FFR) trial
Main findingResult — go to the resultHazard ratio 4.65 95% CI 1.99–10.89Authors' conclusion
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.
Study context
- Population
- Diabetes mellitus (DM) patients with ≥1 FFR-negative lesion after revascularization of FFR-positive lesions390 with ≥1 FFR-negative lesion
- Participants
- 550 patients
- Exposure
- Thin-cap fibroatheroma (TCFA)-positive vs TCFA-negative in FFR-negative lesions
- TCFA-positiven = 98
- TCFA-negativen = 292reference
- Outcome
- Composite of:
- Cardiac mortality
- Target vessel MI
- Clinically driven target lesion revascularization
- Unstable angina requiring hospitalization
- Follow-up
- 18 months
Methodological detailsdouble-blind, international
- Double-blind
- International
Main finding
As reported in the abstract
Hazard ratio
4.65
95% CI 1.99–10.89
P < 0.001
By group
TCFA-positive vs TCFA-negative
HR 4.65 (95% CI 1.99–10.89); P < 0.001
Observational data: associations, not effects.
Further findings
Predictors of major adverse clinical events (MACE) (Cox multivariable analysis)
- TCFA strongest predictor of MACE, HR
- 5.12 (95% CI 2.12-12.34; P < 0.001)
- Multivariable analysis
Original publication
Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT–FFR trial. Eur Heart J. Published 29 July 2021. doi:10.
Summarised from the published abstract; every number is checked against it