European heart journal. Cardiovascular Imaging · 2024
Increased incidence of adverse events in diabetes mellitus patients with combined multiple vulnerable plaque features: new insights from the COMBINE OCT-FFR trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Del Val David, Berta Balazs, Roleder Tomasz, Malinowski Krzysztof, Bastante Teresa, Hermanides Renicus S, Wojakowski Wojciech, Fabris Enrico, Cuesta Javier, De Luca Giuseppe, Rivero Fernando, Alfonso Fernando, Kedhi Elvin
Аннотация
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.
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.