Key result
The presence of OCT-detected thin-cap fibroatheroma in FFR-negative lesions was associated with a higher risk of adverse cardiovascular events (21.4% vs 8.2%; HR 2.89, 95% CI 1.61-5.20; p<0.001).
Why the study?
The long-term prognostic implications of FFR-negative lesions hosting vulnerable plaques remained unsettled.
Does the presence of OCT-detected thin-cap fibroatheroma increase the risk of adverse cardiovascular events in diabetic patients with FFR-negative lesions?
Cohort (n=390)
Double-blind
Yes
Does the presence of OCT-detected thin-cap fibroatheroma increase the risk of adverse cardiovascular events in diabetic patients with FFR-negative lesions?
Hazard Ratio: 2.89 (95% CI 1.61–5.2)
Absolute Event Rate: 21.4% vs 8.2%
p-value: p=<0.001
In diabetic patients with FFR-negative lesions, the presence of OCT-detected thin-cap fibroatheroma is associated with a nearly 3-fold increased risk of adverse cardiovascular events over 5 years.
BACKGROUND: The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled. AIMS: The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population. METHODS: COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years. RESULTS: Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001). CONCLUSIONS: OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up. CLINICALTRIALS: gov: NCT02989740.
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Fabris et al. (2023) conducted a cohort in Diabetes mellitus with ≥1 FFR-negative lesion (n=390). OCT-detected thin-cap fibroatheroma (TCFA-positive) vs. Absence of TCFA (TCFA-negative) was evaluated on Composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation (HR 2.89, 95% CI 1.61-5.20, p=<0.001). The presence of OCT-detected thin-cap fibroatheroma in FFR-negative lesions was associated with a higher risk of adverse cardiovascular events (21.4% vs 8.2%; HR 2.89, 95% CI 1.61-5.20; p<0.001).
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