Xu Xiaohan, Zhang Weijun, Zhou Yujie, Zhao Yingxin, Liu Yuyang, Shi Dongmei, Zhou Zhiming, Ma Hanying, Wang Zhijian, Yu Miao, Ma Qian, Gao Fei, Shen Hua, Zhang Jianwei
Department of Cardiology, Beijing An Zhen Hospital, Capital Medical University and Beijing Institute of Heart Lung and Blood Vessel Disease, Anzhenli Avenue, Chao Yang District, Beijing, 100029, China.
Clin Drug Investig. 2014 Apr;34(4):251-8. doi: 10.1007/s40261-014-0170-9.
Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %.
This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF.
At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P < 0.01). The E peak to A peak (E/A) ratio in trimetazidine-treated patients and in the control group decreased after 2 years; the E/A ratio in trimetazidine-treated patients was slightly better than that in the control group, without a significant difference (P = 0.170). There was no significant difference in event-free survival for the composite end point including death, myocardial infarction, cerebrovascular accident (P = 0.422) and subsequent revascularization (P = 0.073).
Adjunctive therapy with trimetazidine after DES implantation can have a beneficial effect on recurrent angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.
已证实曲美他嗪可改善缺血性心肌病糖尿病患者的心绞痛及左心室（LV）功能。本研究的目的是评估曲美他嗪对老年多支血管冠心病（CHD）合并糖尿病（DM）且左心室射血分数（LVEF）≥50%的患者在药物洗脱支架（DES）植入后复发性心绞痛及左心室结构的影响。
这是一项单中心、前瞻性、随机、双盲评估研究。2010年1月至2010年9月，招募了700例年龄≥65岁、在北京安贞医院接受冠状动脉造影的CHD合并DM患者，并在DES植入后前瞻性随机分组，在常规CHD治疗基础上加用曲美他嗪（每日3次，每次20mg）或安慰剂。主要终点是复发性心绞痛的发生率及各种超声心动图参数的测量值，包括LVEF。
在2年随访时，曲美他嗪组（n = 255）患者与对照组相比，心绞痛的发生率（P = 0.024）和严重程度、无症状心肌缺血（P = 0.009）及无心绞痛生存期（P = 0.011）均有显著改善。曲美他嗪治疗患者的左心室功能和结构在2年随访时相对稳定，而对照组（n = 255）则恶化，两组间有显著差异（所有P < 0.01）。曲美他嗪治疗患者和对照组的E峰与A峰（E/A）比值在2年后均下降；曲美他嗪治疗患者的E/A比值略优于对照组，但无显著差异（P = 0.170）。包括死亡、心肌梗死、脑血管意外（P = 0.422）及后续血运重建（P = 0.073）的复合终点的无事件生存期无显著差异。
DES植入后加用曲美他嗪治疗对老年多支血管CHD合并DM患者的复发性心绞痛以及左心室功能和结构有益。
