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目的:评价冠心病合并糖尿病患者植入新型雷帕霉素洗脱钴铬合金支架(CoCr-SES)的长期疗效和安全性。方法:以一项前瞻性、多中心注册研究中植入CoCr-SES的1 045例糖尿病患者为研究对象,随访该组患者的死亡、心肌梗死(MI)、血运重建和血栓(ST)等事件的发生率。主要终点事件定义为由心血管死亡、非致死性MI和靶血管血运重建(TVR)组成的主要不良心血管事件(MACE),临床随访时间为3年。结果:在3年随访时,1 045例合并有糖尿病的冠心病患者中,主要不良心血管事件(major advere cardiavsacalar event,MACE)发生率为10.0%,包括41例(3.92%)心血管死亡、38例(3.63%)非致死性MI和25例(2.39%)靶血管血运重建。3年内ST的发生率为1.1%,包括7例(0.7%)早期ST和4例(0.4%)晚期ST。结论:冠心病合并糖尿病患者植入CoCr-SES后的3年期MACE及ST的发生率均较低,为国产CoCr-SES在冠心病合并糖尿病患者中的应用提供了有效的证据。(临床试验注册号:NCT00868829)
OBJECTIVE: To evaluate the long-term efficacy and safety of implanting a novel rapamycin-eluting cobalt-chromium alloy stent (CoCr-SES) in patients with coronary heart disease complicated with diabetes mellitus. METHODS: A total of 1,045 diabetic patients with CoCr-SES implanted in a prospective, multicenter registry were enrolled in this study. Mortality, MI, revascularization, and thrombosis (ST) were followed up Incident rate. The primary endpoint was defined as the major adverse cardiovascular event (MACE) consisting of cardiovascular death, nonfatal MI, and target revascularization (TVR) with a clinical follow-up of 3 years. Results: At 3 years of follow-up, the incidence of major advere cardiavacalar event (MACE) in 1045 patients with diabetes mellitus was 10.0%, including 41 (3.92%) cardiovascular deaths, 38 (3.63%) non-fatal MI and 25 (2.39%) target revascularization. The incidence of ST in 3 years was 1.1%, including 7 cases (0.7%) of early ST and 4 cases (0.4%) of late ST. CONCLUSIONS: The incidence of 3-year MACE and ST in patients with coronary heart disease complicated with diabetes mellitus is low after the implantation of CoCr-SES, which provides valid evidence for the application of domestic CoCr-SES in patients with coronary heart disease complicated with diabetes. (Clinical trial registration number: NCT00868829)