药物涂层球囊治疗糖尿病患者冠状动脉大血管原位病变的疗效与安全性分析

Efficacy and safety of drug-coated balloon in patients with coronary artery disease and diabetic

目的:比较药物涂层球囊(DCB)与药物洗脱支架(DES)在糖尿病患者冠状动脉(冠脉)大血管原位病变的应用效果。方法:回顾性分析郑州大学第五附属医院心血管内科2019年10月—2020年10月收治糖尿病伴冠状动脉大血管病变患者122例,按手术方式分为DCB组和DES组。术前、术后即刻及术后6个月分别进行选择性定量冠脉造影,观察两组患者靶病变最小管腔直径、管腔残余狭窄率、管腔增加及晚期管腔丢失等指标。术后随访两组6个月的靶病变血运重建率、主要不良心血管事件(MACE)及出血事件。结果:术后即刻靶血管最小管腔直径、管腔残余狭窄率及管腔即刻获得,DES组分别为(3.26±0.35)mm、(2.8±1.4)%、(2.64±0.22)mm,DCB组分别为(2.82±0.22)mm、(14.5±5.0)%、(2.21±0.26)mm,差异有统计学意义(P<0.001)。DCB组靶血管晚期管腔丢失小于DES组,差异有统计学意义(P<0.001)。随访期间,DCB组靶病变血运重建率及MACE发生率分别为3.4%、3.5%,DES组靶病变血运重建率及MACE发生率分别为6.0%、9.2%;两组比较差异均无统计学意义(P>0.05)。随访期间DCB组和DES组出血事件发生率分别为8.8%和23.1%,差异有统计学意义(P<0.001)。两组无MACE生存Kaplan Meier曲线无统计学差异(P=0.216)。结论:DCB治疗糖尿病患者冠脉大血管原位病变安全有效。

Objective:To compare the efficacy of drug-coated balloon(DCB)and drug-eluting stent(DES)in the treatment of orthotopic lesions of coronary artery great vessels in diabetic patients.Methods:A retrospective analysis was performed on 122patients with diabetes mellitus complicated with coronary artery macrovascular disease admitted to department of Cardiology,The Fifth Affiliated Hospital of Zhengzhou University from October 2019to October 2020.They were divided into DCB group and DES group according to surgical methods.Selective quantitative coronary angiography was performed before surgery,immediately after surgery,and 6months after surgery,respectively.We observed the minimum lumen diameter(MLD),residual stenosis,lumen increase,and late lumen(LLL)loss in 2groups.The target lesion revascularization rate(TLR),major adverse cardiovascular events(MACE)and bleeding events were followed up 6months after operation.Results:Immediately after surgery,MLD of target vessel,residual stenosis and lumen were(3.26±0.35)mm,(2.8±1.4)%,(2.64±0.22)mm in DES group and(2.82±0.22)mm,(14.5±5.0)%,(2.21±0.26)mm in DCB group,respectively.The difference was statistically significant(P<0.001).The LLL of target vessels in DCB group was lower than that in DES group(P<0.001).During follow-up,the rate of TLR and incidence of MACE in DCB group were 3.4%and 3.5%,respectively.The incidence of TLR and MACE in DES group were 6.0%and 9.2%,respectively.There was no statistical significance between the two groups(P>0.05).During follow-up,the incidence of bleeding events in DCB group and DES group was 8.8%and 23.1%,respectively,with statistical significance(P<0.001).Kaplan Meier curves of MACE-free survival were no different between the two groups(P=0.216).Conclusion:DCB is safe and effective in the treatment of orthotopic lesions of large coronary vessels in diabetic patients.