Safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL 2) stent in diabetic patients:A Subgroup analysis of the CREDIT Ⅱ and CREDIT Ⅲ trials / 中国介入心脏病学杂志

ABSTRACT

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 CREDITⅡand CREDIT Ⅲ trials. Methods All patients who were implanted with the EXCEL2 stent were enrolled in the CREDITⅡand 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 effcacy and safety, which can reduce make stent restenosis, target vessel revascularization ,with 160 diabetic cases among them, and stent thrombosis in diabetic patients.