Application of drug-coated balloon in the treatment of coronary true bifurcation lesions
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摘要: 目的 探讨药物包被球囊(DCB)治疗冠状动脉真性分叉病变的疗效及安全性。方法 回顾性纳入于我院接受介入治疗的真性分叉病变患者，根据手术策略将其分为药物洗脱支架组(DES组，158例)和DCB组(98例)。主要观察终点为2年靶病变血运重建，次要观察终点为主要不良心血管事件(包括心源性死亡、靶血管血运重建、靶血管心肌梗死和支架内血栓)。结果 DCB组靶病变血运重建和主要不良心血管事件发生率均显著低于DES组(3.1% vs. 11.4%，log-rank P=0.019；5.1% vs. 13.9%，log-rank P=0.029)。两组均无支架内血栓和靶血管心肌梗死发生。结论 DCB治疗冠状动脉真性分叉病变疗效明确，安全可行。Abstract: Objective To investigate the efficacy and safety of drug-coated balloon(DCB) in treating the true bifurcation lesions of coronary arteries.Methods Patients with true bifurcation disease who received interventional therapy in our hospital were retrospectively enrolled. According to the interventional therapy strategy, all enrolled patients were divided into the drug-eluting stent(DES) group(n=158) and the DCB group(n=98). The primary endpoint was the 2-year target-lesion revascularization, and the secondary endpoint was major adverse cardiovascular events(including cardiac death, target-vessel revascularization, target-vessel myocardial infarction, and stent thrombosis).Results The incidences of target lesion revascularization and major adverse cardiovascular events in the DCB group were significantly lower than those in the DES group(3.1% vs. 11.4%, log-rank P=0.019; 5.1% vs. 13.9%, log-rank P=0.029). No stent thrombosis and target vessel myocardial infarction occurred in both groups.Conclusion DCB is safe and feasible for treating the true bifurcation of the coronary artery.
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Key words:
- drug-coated balloon /
- drug-eluting stent /
- true bifurcation lesion
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表 1 临床资料比较
Table 1. General clinical data
例(%), X±S 项目 DCB组(98例) DES组(158例) P 年龄/岁 60.1±10.4 60.4±9.1 0.772 男性 70(71.4) 118(74.7) 0.567 高血压 52(53.1) 81(51.3) 0.780 2型糖尿病 29(29.6) 51(32.3) 0.652 高脂血症 36(36.7) 56(35.4) 0.834 吸烟史 38(38.8) 63(39.9) 0.861 冠心病家族史 6(6.1) 13(8.2) 0.532 既往PCI史 11(11.2) 30(19.0) 0.100 既往心肌梗死史 5(5.1) 17(10.8) 0.116 既往冠脉旁路移植史 1(1.0) 2(1.3) 1.000 临床表现 0.559 稳定型心绞痛 57(58.2) 86(54.4) 不稳定型心绞痛 41(41.8) 72(45.6) LVEF/% 60.2±6.3 59.8±6.6 0.605 HbA1c/% 6.4±1.2 6.4±1.2 0.904 GFR/[mL·min-1·(1.73 m2)-1] 94.7±12.2 94.7±36.3 0.882 LDL-C/(mmol·L-1) 2.3±0.8 2.1±0.8 0.197 BNP/(pg·mL-1) 682.2±1530.5 507.0±740.9 0.223 CRP/(mg·L-1) 5.9±11.3 3.8±7.2 0.066 注：高脂血症：总胆固醇＞5.18 mmol/L或LDL-C＞2.37 mmol/L或甘油三酯＞1.7 mmol/L。 
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表 2 DCB组与DES组病变特点比较
Table 2. Comparison of the pathological characteristics
例(%), X±S 项目 DCB组(98例) DES组(158例) P 靶病变 0.655 前降支/对角支 76(77.6) 115(72.8) 回旋支/钝圆支 16(16.3) 33(20.9) 右冠/后降支 6(6.1) 10(6.3) Medina分型 0.092 1.1.1 82(83.7) 129(81.6) 1.0.1 10(10.2) 26(16.5) 0.1.1 6(6.1) 3(1.9) 主支病变特点 慢性完全闭塞病变 13(13.3) 12(7.6) 0.137 长弥漫病变 21(21.4) 45(28.5) 0.210 重度钙化病变 4(4.1) 8(5.1) 1.000 多支血管病变 62(63.3) 111(70.3) 0.246 主支血管参考直径/mm 3.1±0.4 3.2±0.5 0.447 主支病变长度/mm 21.3±11.6 31.3±11.3 0.843 主支狭窄程度/% 87.2±5.9 87.3±6.0 0.953 边支血管参考直径/mm 2.3±0.3 2.6±0.2 ＜0.001 边支病变长度/mm 9.5±4.1 16.4±6.3 ＜0.001 边支狭窄程度/% 82.6±8.3 83.0±8.3 0.905
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表 3 DCB组与DES组手术资料比较
Table 3. Comparison of the surgical data
例(%), M(P25, P75) 项目 DCB组(98例) DES组(158例) P 手术入路 0.267 经桡动脉 92(93.9) 142(89.9) 经股动脉 6(6.1) 16(10.1) 主支预处理 半顺应性球囊 94(95.9) 150(94.9) 1.000 切割球囊 16(16.3) 31(19.6) 0.508 双导丝球囊 9(9.2) 13(8.2) 0.791 棘突球囊 16(16.3) 31(19.6) 0.508 旋磨 2(2.0) 6(3.8) 0.714 主支植入器械直径 主支支架直径/mm 3.0(2.75，3.5) 3.0(2.75，3.0) 0.158 主支支架长度/mm 24.0(20.0，29.0) 25.0(20.0，33.0) 0.200 边支拘禁球囊技术 48(49.0) 82(51.9) 0.650 rewire边支开口支架网眼 69(70.4) 102(64.6) 0.334 边支预处理 半顺应性球囊 66(67.3) 120(75.9) 0.133 切割球囊 17(17.3) 2(1.3) 0.000 棘突球囊 7(7.1) 10(6.3) 0.799 边支植入器械直径/mm 2.1(2.0，2.5) 2.5(2.5，2.5) ＜0.001 边支植入器械长度/mm 17.0(15.0，20.2) 22.0(18.0，25.7) 0.023 DCB组 先边支应用球囊 36(36.7) 先主支应用支架 62(63.3) 边支应用DCB后夹层 A、B型夹层 2(2.0) C型及以上 3(3.1) 补救性支架 3(3.1) DES组术式 Provisional T 74(46.8) Crush 66(41.8) Culotte 14(8.9) T-stenting 4(2.5) 最终对吻技术 69(70.4) 121(76.6) 0.272 近段优化技术 69(70.4) 121(76.6) 0.272
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表 4 DCB组与DES组术后2年临床随访结果
Table 4. Comparison of 2-year follow-up data after surgery
例(%) 项目 DCB组
(98例)DES组
(158例)log-rank P P TLR 3(3.1) 18(11.4) 0.019 0.018 MACEs 5(5.1) 22(13.9) 0.029 0.027 心源性死亡 1(1.0) 2(1.3) 0.864 0.859 TVR 4(4.1) 20(12.7) 0.024 0.022
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表 5 不同术式2年随访临床结果比较
Table 5. Comparison of clinical results of 2 years follow-up with different surgical methods
例(%) 项目 先边支DCB 先主支DES Crush Culotte 总计 P TLR 1(20.0) 2(25.0) 9(31.0) 1(20.0) 13 0.888 MACEs 2(40.0) 3(37.5) 10(34.5) 2(40.0) 17 心源性死亡 1(20.0) 0(0.0) 1(3.4) 0(0.0) 2 TVR 1(20.0) 3(37.5) 9(31.0) 2(40.0) 15 总计 5(100) 8(100) 29(100) 5(100) 47
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