摘要
目的通过对CREDITⅡ、Ⅲ研究中的糖尿病亚组资料进行分析,探讨第二代聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)在糖尿病患者中的有效性和安全性。方法入选了CREDITⅡ、Ⅲ研究中置入EXCEL2支架的所有患者。主要终点为24个月的靶病变失败,以心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建为复合终点。次要终点为患者相关复合终点,包括全因死亡、心肌梗死和血运重建。结果入选828例患者24个月随访率99.5%,糖尿病组与非糖尿病组比较,主要终点事件发生率(P>0.05)及次要终点发生率[全因死亡(2.5%比1.4%,P=0.290)、心肌梗死(7.5%比5.0%,P=0.215)、任何血运重建(5.0%比3.9%,P=0.533)以及支架内血栓形成(0.6%比0.5%,P=0.577)],差异均无统计学意义。结论 EXCEL2支架可降低糖尿病患者术后支架内再狭窄、靶病变血运重建率及支架内血栓形成风险,且不劣于非糖尿病患者。
Objective To invesgate the safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent（EXCEL2） stent in diabetic patients by a subgroup analysis of of the CREDIT Ⅱ and CREDIT Ⅲ trials. Methods All patients who were implanted with the EXCEL2 stent were enrolled in the CREDIT Ⅱ and CREDIT Ⅲ trials. The primary endpoint was target lesion failure at 24-month, defi ned as a composite of cardiac death, target vessel myocardial infarction（TV-MI） and target lesion revascularization（TLR）. The secondary endpoint was endpoints including all-cause death, all myocardial infarction（MI） or any revascularization.Results A total of 828 patients were included from the patients who were implanted with the EXCEL2 stent in the CREDIT II and CREDIT Ⅲ trials. 24-month follow-up rate was 99.5%. There was no significant difference in the primary endpoint（P〉0.05） and event rates of the secondary endpoints（P〉0.05） between the diabetic and non-diabetic group, which included all-cause death[diabetics（2.5%） vs. non-diabetics（1.4%）, P〉0.05], myocardial infarction（MI）（7.5% vs. 5.0%,P〉0.05）, all from of revascularization（5.0% vs. 3.9%,P〉0.05）, and stent thrombosis（0.6% vs. 0.4%,P〈0.05）.Conclusions EXCEL 2 stent met the objective performance goal on efficacy and safety, which can reduce make stent restenosis, target vessel revascularization,with 160 diabetic cases among them, and stent thrombosis in diabetic patients.
出处
《中国介入心脏病学杂志》
2018年第1期7-11,共5页
Chinese Journal of Interventional Cardiology
