依维莫司药物洗脱支架在女性患者中的安全性和有效性:SEEDS多中心注册研究亚组分析

Safety and efficacy of everolimus-eluting stent in women: subgroup analysis of multicenter registry SEEDS study

目的本文通过对SEEDS研究中的性别亚组资料进行分析,探讨依维莫司药物洗脱支架(DES)在不同性别患者中的有效性和安全性。方法选取2010年6月至2011年12月入选SEEDS试验的1900例患者,其中男性患者1408例(男性组),女性患者492例(女性组)。主要终点包括:12个月临床随访心源性死亡、Q波或非Q波心肌梗死、缺血驱动的靶血管再次血运重建复合终点。结果与男性患者相比,女性患者的年龄更大,糖尿病、高血压及高血脂的发生率更高,小血管病变的比例更高。虽然两组患者的基线治疗差异有统计学意义,但主要终点事件的发生率差异无统计学意义[6.39%(男)比4.67%(女),P=0.166]。女性患者靶血管再次血运重建的发生率相对于男性患者有降低趋势[2.84%(男)比1.42%(女),P=0.081]。结论依维莫司DES在女性患者中具有良好的安全性和有效性。

Objective To invesgate the safety and efficacy of everolimus-eluting stent in women by a subgroup analysis of multicenter registry SEEDS study. Methods 1900 patients were enrolled from June2010 to December 2011 in the SEEDS trial. Among them,1408 were male patients and 492 were female patients. The primary endpoint was ischaemia-driven target vessel failure（ TVF）,defined as the composite of cardiac death, target vessel myocardial infarction（ TVMI）, and ischaemia-driven target vessel revascularisation（ TVR）. Results Female patients were older,and have higher percentage of co-morbidity of diabetes,hypertension and hyperlipidemia than male patients. Small vessel disease was more prevalent in female patients. There was no significant difference in primary endpoints between two groups despite of baseline difference（ male vs female,6. 39% vs. 4. 67%,P = 0. 166）. There was a trend that female patients have less revascularization compare to male patients（ male vs. female,2. 84% vs. 1. 42%,P =0. 081）. Conclusions Everolimus-eluting stent has optimal safety and efficacy of in women.