单中心、大样本冠心病合并糖尿病患者置入第一代和第二代药物洗脱支架远期预后的影响研究

Second-generation drug-eluting stents versus first-generation drug-eluting stents in patients with diabetes mellitus: a single-center study

目的探讨冠心病合并糖尿病患者置入第一和第二代药物洗脱支架(DES)对远期预后的影响。方法连续纳入阜外医院2013年1月至2013年12月2013例冠心病合并糖尿病,并置入第一、第二代DES的患者,PCI术后随访2年,比较随访期间置入不同类型DES的远期预后。结果 2013例患者中置人第一代DES的患者仅有151例,置入第二代DES的患者有1862例。置入第二代DES的糖尿病患者冠状动脉靶病变个数、支架置入个数以及B2或C型病变的比例明显高于置入第一代DES的患者。两组患者其他的临床特点(人口学特点、危险因素、既往病史、用药情况以及其他的冠状动脉情况)比较无统计学意义。2年随访结果显示,置入第一代DES与第二代DES的糖尿病患者,全因死亡、心源性死亡、心肌梗死、靶病变血运重建、靶血管血运重建、支架内血栓、脑卒中等主要不良心脑血管事件以及出血的发生率两组间均没有显著性差异(P>0.05)。COX回归分析显示,置入不同类型的DES并不是冠心病合并糖尿病患者不良临床预后的独立危险因素(HR=1.058,95%CI:0.589-1.904,P=0.849)。倾向性评分调整后,上述趋势没有变化。多因素COX分析显示:年龄、女性、B2或C型病变是不良临床预后的独立危险因素。结论冠心病合并糖尿病患者置入一二代DES,术后2年随访期间的有效性和安全性无明显差异。置人不同类型的DES并不是冠心病合并糖尿病患者不良临床预后的独立危险因素。传统危险因素(高龄、女性)以及冠脉复杂病变(B2型或C型病变等)是影响不良临床预后的独立危险因素。

Objective To evaluate the efficacy and safety of first-generation(G1)and second-generation drug-eluting stent(G2-DES)in patients with diabetes mellitus(DM)in a high-volume cardiovascular center in China.Methods 2013 cases of coronary heart disease(CHD)with DM who had exclusively Gl-DES or G2-DES implantation in Fuwai Hospital from January 2013 to December 2013 were consecutively selected during the follow-up period.The follow-up period was 2 years.Results In the 2013 patients,151 were placed in the Gl-DES,and 1862 were placed in the G2-DES.The number of coronary target lesions,the number of stent implantation and the proportion of B2 or C type lesionswere higher in the G2-DES group than those in the Gl-DES group.The other clinical features of the two groups(demographic characteristics,risk factors,past medical history,medication and other coronary arteries conditions)were no significant difference.The incidence of death,cardiac death,myocardial infarction(MI),target lesion revascularization(TLR),target vessel revascularization(TVR),stent thrombosis,and bleeding was no difference in two groups(P>0.05).COX regression analysis showed that different types of DES was not an independent risk factor for prognosis in patients with DM(HR 1.058,95%CI:0.589-1.904,P-0.849).After adjustment for propensity score,the above trend did not change.Multivariate COX analysis showed that age,female,B2 or C lesions were independent risk factors for clinical outcmes.Conclusion The safety and efficacy of Gl-DES and G2-DES were similar in CHD patients with DM during 2 year-follow-up period.Different types of DES was not an independent risk factor for clincal outcomes in patients with DM;traditional risk factors(old age,female)and complex coronary artery lesions(B2 or C lesions)were independent risk factors for clinical outcomes.