目的:评估OCT检测到的易损性特征(OCT-VFs)在预测糖尿病(DM)患者非缺血性病变的主要不良心血管事件(MACE)中的个体以及联合影响。
结果:COMBINEOCT-FFR(NCT02989740)是一个前瞻性的,双盲,国际,纳入有≥1个病灶且血流储备分数>0.80的DM患者的自然史研究,接受系统OCT评估.预先指定的OCT-VF包括TCFA,r-MLA,h-PB,和CP。主要终点(MACE)是心脏死亡率的复合,靶血管心肌梗死,临床驱动的靶病变血运重建或不稳定型心绞痛住院长达5年,根据这些OCT-VF的存在进行分析,无论是单独还是组合。TCFA,r-MLA,h-PB和CP在98例(25.1%)中被鉴定出来,159(40.8%),56(14.4%),116名(29.8%)患者,分别。与伴有h-PB的患者相比,无OCT-VFs的患者的主要终点发生率从6.9%逐渐增加至50.0%(HR=10.10;95CI,3.37至30.25,p<0.001),r-MLA,CP,和TCFA。重要的是,而TCFA,h-PB,r-MLA和CP分别与主要终点相关,两个或两个以上OCT-VFs的存在显著增加了5年时发生不良事件的可能性.
结论:在患有DM和非缺血性病变的患者中,TCFA,h-PB,r-MLA和CP是不良事件的预测因子。然而,两个或两个以上OCT-VFs的存在显著增加了5年时发生MACE的可能性.需要进一步的研究以随机方式证实这些发现及其潜在的临床意义。
OBJECTIVE: To evaluate the individual as well as combined impact of OCT-detected vulnerability features (OCT-VFs) in the prediction of major adverse cardiovascular events (MACE) in non-ischemic lesions in patients with diabetes mellitus (DM).
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 TCFA, r-MLA, h-PB, and 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, analyzed 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 to 30.25, p<0.001) in patients without OCT-VFs compared to 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.
CONCLUSIONS: In patients with DM and non-ischemic 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.