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Randomized Controlled Trial
. 2024 Dec 31;26(1):38-48.
doi: 10.1093/ehjci/jeae210.

Increased incidence of adverse events in diabetes mellitus patients with combined multiple vulnerable plaque features: new insights from the COMBINE OCT-FFR trial

David Del Val  1   2 , Balazs Berta  3   4 , Tomasz Roleder  5   6 , Krzysztof Malinowski  7 , Teresa Bastante  1   2 , Renicus S Hermanides  4 , Wojciech Wojakowski  5 , Enrico Fabris  8 , Javier Cuesta  1   2 , Giuseppe De Luca  9   10 , Fernando Rivero  1   2 , Fernando Alfonso  1   2 , Elvin Kedhi  5   11
Affiliations
Randomized Controlled Trial

Increased incidence of adverse events in diabetes mellitus patients with combined multiple vulnerable plaque features: new insights from the COMBINE OCT-FFR trial

David Del Val et al. Eur Heart J Cardiovasc Imaging. .

Abstract

Aims: To evaluate the individual as well as combined impact of optical coherence tomography-detected vulnerability features (OCT-VFs) in the prediction of major adverse cardiovascular events (MACEs) in non-ischaemic lesions in patients with diabetes mellitus (DM).

Methods and results: The COMBINE OCT-FFR (NCT02989740) was a prospective, double-blind, international, natural-history study that included patients with DM having ≥1 lesions with a fractional flow reserve > 0.80, undergoing systematic OCT assessment. Pre-specified OCT-VFs included thin-cap fibroatheroma (TCFA), reduced minimal lumen area (r-MLA), high plaque burden (h-PB), and complicated plaque (CP). The primary endpoint (MACE) was a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization, or hospitalization for unstable angina up to 5 years, analysed according to the presence of these OCT-VFs, both individually and in combination. TCFA, r-MLA, h-PB, and CP were identified in 98 (25.1%), 159 (40.8%), 56 (14.4%), and 116 (29.8%) patients, respectively. The primary endpoint rate increased progressively from 6.9% to 50.0% (HR = 10.10; 95% CI, 3.37-30.25, P < 0.001) in patients without OCT-VFs compared with those with concomitant h-PB, r-MLA, CP, and TCFA. Importantly, while TCFA, h-PB, r-MLA, and CP were individually associated with the primary endpoint, the presence of two or more OCT-VFs significantly increased the likelihood of adverse events at 5 years.

Conclusion: In patients with DM and non-ischaemic lesions, TCFA, h-PB, r-MLA, and CP were predictors of adverse events. However, the presence of two or more OCT-VFs significantly increased the likelihood of MACE at 5 years. Further studies are warranted to confirm these findings and their potential clinical implications in a randomized fashion.

Keywords: coronary artery disease; diabetes mellitus; optical coherence tomography; vulnerable plaque.

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Conflict of interest statement

Conflict of interest: E.K. reports personal lecture and advisory fees and institutional research grants from Abbott and Medtronic, outside the submitted work. W.W. reports personal fees from Abbott, outside the submitted work. R.S.H. reports that he has received speaker fees from Abbott, Amgen, and N.B.B. reports that the Research Department of Cardiology of Isala has received an institutional research grant provided by Bayer outside the scope of the present study. The other authors have no conflicts of interest to declare.

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