Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Department of Radiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
J Diabetes. 2022 Aug;14(8):524-531. doi: 10.1111/1753-0407.13300. Epub 2022 Aug 5.
Previously, in the ESCAPE study, a randomized controlled trial, we found that 12 months of cilostazol administration significantly decreased coronary artery stenosis and the noncalcified plaque component compared with aspirin. The goal of the current study was to evaluate the effect of cilostazol treatment on cardiovascular events up to 7 years after the end of the original study.
After the end of the ESCAPE study with patients with type 2 diabetes mellitus (T2DM) and mild to moderate coronary artery stenosis, we decided to extend the ESCAPE study to investigate the long-term effect of cilostazol and aspirin, named the ESCAPE-extension study. The study participants had been investigated for cardiovascular events for up to 7 years, bringing the total follow-up time to a median of 5.2 years (interquartile range 3.6-6.7 years). Adverse events were also investigated.
Among 100 participants from the original study, 88 were included in this extension study. Cilostazol treatment reduced the incidence of cardiovascular events in the patients with T2DM when compared with aspirin for a 5.2-year median follow-up (hazard ratio 0.24; 95% CI, 0.07-0.83). The cardiovascular benefit of cilostazol therapy was maintained along with age, sex, systolic blood pressure, low-density lipoprotein cholesterol, and coronary artery calcium score. No serious adverse events in the cilostazol group were noted in the follow-up period.
In this ESCAPE-extension study, cilostazol treatment proved its efficacy in reducing cardiovascular events compared with aspirin in diabetic patients with subclinical coronary artery disease, suggesting the beneficial role of cilostazol in the primary prevention of cardiovascular disease.
此前，在 ESCAPE 研究（一项随机对照试验）中，我们发现与阿司匹林相比，12 个月的西洛他唑给药可显著减少冠状动脉狭窄和无钙化斑块成分。本研究的目的是评估西洛他唑治疗对原始研究结束后 7 年内心血管事件的影响。
在 ESCAPE 研究结束后（该研究纳入了 2 型糖尿病（T2DM）和轻度至中度冠状动脉狭窄的患者），我们决定延长 ESCAPE 研究以研究西洛他唑和阿司匹林的长期效果，命名为 ESCAPE-延伸研究。研究参与者接受了长达 7 年的心血管事件调查，总随访时间中位数为 5.2 年（四分位距 3.6-6.7 年）。还调查了不良事件。
在原始研究的 100 名参与者中，有 88 名纳入了该延伸研究。在中位随访 5.2 年期间，与阿司匹林相比，西洛他唑治疗降低了 T2DM 患者的心血管事件发生率（风险比 0.24；95%CI，0.07-0.83）。随着年龄、性别、收缩压、低密度脂蛋白胆固醇和冠状动脉钙评分的变化，西洛他唑治疗的心血管获益得以维持。在随访期间，西洛他唑组未出现严重不良事件。
在这项 ESCAPE-延伸研究中，与阿司匹林相比，西洛他唑治疗在亚临床冠状动脉疾病的糖尿病患者中证明了其减少心血管事件的疗效，表明西洛他唑在心血管疾病的一级预防中具有有益作用。
