Watanabe Tetsu, Miyamoto Takuya, Miyasita Takehiko, Shishido Tetsuro, Arimoto Takanori, Takahashi Hiroki, Nishiyama Satoshi, Hirono Osamu, Matsui Motoyuki, Sugawara Shigeo, Ikeno Eiichiro, Miyawaki Hiroshi, Akira Fukao, Kubota Isao
Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.
J Cardiol. 2014 Sep;64(3):236-9. doi: 10.1016/j.jjcc.2013.12.008. Epub 2014 Feb 3.
Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) can significantly reduce coronary artery disease in both primary and secondary prevention. A recent study showed that aggressive lipid-lowering therapy with strong statins could achieve coronary artery plaque regression, as evaluated with gray-scale intravascular ultrasound (IVUS). However, it is unknown whether coronary plaque regression and stabilization are reinforced when eicosapentaenoic acid (EPA) is used with a strong statin.
We aim to assess patients with stable angina or acute coronary syndrome who had undergone successful percutaneous coronary intervention (PCI) with integrated backscatter IVUS (IB-IVUS) guidance. They will be randomly allocated to receive pitavastatin (4mg), or pitavastatin (4mg) plus EPA (1800mg), and prospectively followed for 6-8 months.
The primary endpoint will be changes in tissue characteristics in coronary plaques, evaluated by IB-IVUS, and secondary endpoints will include absolute changes in coronary plaque volume, serum lipid levels, and inflammatory markers. The safety profile will also be evaluated.
The combination therapy of EPA and pitavastatin for regression of coronary plaque evaluated by IB-IVUS (CHERRY) study will be the first multicenter study using IB-IVUS to investigate the effects of combination therapy with pitavastatin and EPA on coronary plaque volume and tissue characteristics.
许多临床试验表明，3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂（他汀类药物）在一级和二级预防中均可显著降低冠状动脉疾病的发生。最近一项研究显示，使用强效他汀类药物进行积极的降脂治疗可实现冠状动脉斑块消退，这是通过灰阶血管内超声（IVUS）评估得出的。然而，当二十碳五烯酸（EPA）与强效他汀类药物联用时，冠状动脉斑块的消退和稳定是否会增强尚不清楚。
我们旨在评估在集成背向散射IVUS（IB-IVUS）引导下成功接受经皮冠状动脉介入治疗（PCI）的稳定型心绞痛或急性冠状动脉综合征患者。他们将被随机分配接受匹伐他汀（4mg），或匹伐他汀（4mg）加EPA（1800mg），并进行为期6至8个月的前瞻性随访。
主要终点将是通过IB-IVUS评估的冠状动脉斑块组织特征的变化，次要终点将包括冠状动脉斑块体积、血脂水平和炎症标志物的绝对变化。还将评估安全性。
EPA与匹伐他汀联合治疗对冠状动脉斑块消退的IB-IVUS评估（CHERRY）研究将是第一项使用IB-IVUS研究匹伐他汀与EPA联合治疗对冠状动脉斑块体积和组织特征影响的多中心研究。
