Efficacy and safety of drug-coated balloon in patients with coronary artery disease and diabetic
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摘要: 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。Abstract: 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 122 patients with diabetes mellitus complicated with coronary artery macrovascular disease admitted to department of Cardiology, The Fifth Affiliated Hospital of Zhengzhou University from October 2019 to 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 6 months after surgery, respectively. We observed the minimum lumen diameter(MLD), residual stenosis, lumen increase, and late lumen(LLL) loss in 2 groups. The target lesion revascularization rate(TLR), major adverse cardiovascular events(MACE) and bleeding events were followed up 6 months 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.
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图 1 两组术后无MACE生存曲线
Figure 1. Survival curves of the two groups without MACE after surgery
表 1 两组基线资料比较
Table 1. Comparison of baseline data between the two groups
X±S 项目 DES组(65例) DCB组(57例) χ2/t P 男/例(%) 53(81.5) 43/75.4 0.674 0.412 年龄/岁 69.4±6.1 68.5±9.6 0.676 0.500 糖尿病病程/年 7.5±2.5 7.2±2.4 0.665 0.512 心绞痛分型/例(%) 稳定型心绞痛 48(73.8) 41(71.9) 0.057 0.812 不稳定型心绞痛 17(24.6) 16(28.1) 0.187 0.665 既往史/例(%) 心肌梗死史 8(12.3) 9(15.8) 0.307 0.580 介入史 6(9.2) 6(10.5) 0.057 0.811 高血压史 44(67.7) 35(61.4) 0.526 0.468 高脂血症史 55(84.6) 45(78.9) 0.660 0.417 吸烟史 31(47.7) 25(43.9) 0.180 0.672 酗酒史 27(41.5) 26(46.4) 0.292 0.589 左心室射血分数/% 56.9±5.8 56.8±6.0 0.115 0.909 血清肌酐/(μmol·L-1) 95.2±11.1 94.0±14.4 0.503 0.616 糖化血红蛋白/% 6.62±0.62 6.51±0.68 0.928 0.355 冠脉病变情况/例(%) 单支病变 15(23.1) 11(19.3) 0.259 0.611 双支病变 23(35.4) 16(28.1) 0.747 0.387 3支病变 27(41.5) 30(52.6) 1.501 0.220 病变血管位置/例(%) 左前降支 44(65.7) 34(58.6) 0.659 0.414 左回旋支 11(16.4) 6(10.3) 0.967 0.323 右冠脉 12(17.9) 18(31.0) 2.932 0.087 药物应用/例(%) 阿司匹林 65(100.0) 57(100.0) - - 氯吡格雷 42(64.6) 32(56.1) 0.914 O.339 替格瑞洛 23(35.4) 25(43.9) 0.914 0.339 他汀类药物 65(100.0) 57(100.0) - - β受体阻滞剂/例(%) 62(92.5) 51(87.9) 0.760 0.383 ACEI/ARB/例(%) 40(59.7) 32(55.2) 0.261 0.609 
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表 2 两组造影术前及术后资料的比较
Table 2. Comparison of pre-and post-operative data between the two groups
X±S 项目 DES组(65例) DCB组(57例) t P 术前 病变血管参考直径/mm 3.35±0.34 3.30±0.24 1.070 0.287 最小管腔直径/mm 0.62±0.19 0.61±0.10 0.315 0.753 管腔狭窄率/% 81.9±4.2 81.5±3.4 0.576 0.566 术后即刻 最小管腔直径/mm 3.26±0.35 2.82±0.22 8.409 < 0.001 管腔残余狭窄率/% 2.8±1.4 14.5±5.0 -18.143 < 0.001 管腔获得/mm 2.64±0.22 2.21±0.26 10.083 < 0.001 术后6个月 最小管腔直径/mm 2.89±0.29 2.80±0.22 1.964 0.054 管腔残余狭窄率/% 13.7±1.8 14.9±4.9 -1.855 0.066 晚期管腔丢失/mm 0.37±0.10 0.01±0.04 26.604 < 0.001
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表 3 两组术后6个月随访资料的比较
Table 3. Comparison of 6-month follow-up data between the two groups
例(%) 项目 DES组(65例) DCB组(57例) P 院内事件 急性缺血事件 2(3.1) 0(0) 0.535 靶血管/支架内血栓 0(0) 0(0) - 死亡 0(0) 0(0) - 随访事件 再狭窄 6(9.0) 4(6.9) 0.926 靶病变血运重建 4(6.0) 2(3.4) 0.812 心肌梗死 0(0) 0(0) - 死亡 0(0) 0(0) - 累计MACE 6(9.2) 2(3.5) 0.364 出血事件 15(23.1) 5(8.8) 0.033
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