Safety and efficacy of drug-coated balloon following rotational atherectomy for severe coronary artery calcification
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摘要: 目的 探索冠状动脉(冠脉)旋磨术(RA)联合药物涂层球囊(DCB)治疗严重冠脉钙化病变的疗效。方法 连续入选2018年5月—2021年7月就诊于郑州大学第一附属医院因冠脉严重钙化行RA的患者318例，根据不同治疗方案分为RA/DCB组(57例)和RA/药物洗脱支架(DES)组(261例)。比较两组一般临床资料、冠脉病变特征、术中并发症、院内不良事件、随访期间主要心脑血管不良事件(MACCE)发生率。结果 两组基线临床资料、术中并发症、院内不良事件均差异无统计学意义。RA/DES组较多合并左主干病变、分叉病变、弥漫性病变等复杂解剖类型(均P < 0.05)。随访期间RA/DES组MACCE(18.77% vs.12.28%)及靶病变血运重建(13.79% vs.7.02%)发生率较RA/DCB组升高，但差异无统计学意义。多因素Cox回归分析显示，分叉病变(HR=2.284，95%CI：1.063~4.908，P＝0.034)、植入物总长度(HR=1.023，95%CI：1.005~1.047，P＝0.014)、SNYTAX评分(HR：1.047，95%CI：1.013~1.082，P＝0.006)是RA-PCI术后远期MACCE发生的危险影响因素。结论 RA联合DCB可对部分适合的钙化病变进行安全有效的治疗。Abstract: Objective To assess the safety and efficacy of drug-coated balloons(DCB) following rotational atherectomy(RA) for coronary artery calcification.Methods A retrospective analysis was performed on 318 consecutive patients with severe coronary artery calcification who underwent RA-assisted PCI at the First Affiliated Hospital of Zhengzhou University from May 2018 to July 2021. Among them, 57 patients(RA/DCB group) were treated with drug-coated balloon(DCB), and 261 patients(RA/DES group) were treated with drug-eluting stent(DES). Clinical baseline data, lesions' characteristics, intraoperative complications, in-hospital adverse events, and major adverse cardiovascular and cerebrovascular events(MACCE) throughout the follow-up were compared between the two groups.Results The baseline clinical data, intra-operative complications, and in-hospital adverse events were not significantly different between the two groups. The anatomical categories included left main coronary disease, bifurcation disease, and multivessel disease in the RA/DES group were more complex and. MACCE(18.77% vs 12.28%) and target lesion revascularization(13.79% vs 7.02%) occurred more frequently in the RA/DES group than those in the RA/DCB group, but there was no statistically significant difference. Multivariate Cox regression analysis showed that bifurcation lesions(HR=2.284, 95%CI: 1.063-4.908, P＝0.034)、total length of DCB/DES(HR=1.023, 95%CI: 1.005-1.047, P＝0.014), and SNYTAX score(HR=1.047, 95%CI: 1.013-1.082, P＝0.006) were independent risk factors of long-term outcomes in patients with severe coronary artery calcification treated with RA.Conclusion Combined application of RA and DCB can safely and effectively treat some appropriate coronary artery calcification.
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表 1 两组基线临床资料比较
Table 1. Baseline characteristics
例(%), M(P25, P75), X±S 项目 RA/DES组(261例) RA/DCB组(57例) t/χ2/Z P 年龄/岁 65.64±7.99 66.68±9.13 0.803 0.424 男性 154(59.00) 30(52.63) 0.779 0.377 高血压 170(65.13) 38(66.67) 0.049 0.826 糖尿病 96(36.78) 24(42.11) 0.564 0.453 房颤 12(4.59) 2(3.51) 0.000 0.995 脑卒中病史 63(24.14) 15(26.32) 0.120 0.729 肾功能不全 29(11.11) 4(7.02) 0.460 0.498 高脂血症 61(23.37) 7(12.28) 3.423 0.064 心肌梗死病史 42(16.09) 11(19.29) 0.346 0.556 冠心病家族史 72(27.59) 17(29.82) 0.116 0.733 吸烟史 78(29.89) 14(24.56) 0.645 0.422 PCI史 29(11.11) 12(21.05) 4.068 0.044 CABG史 3(1.15) 0(0.00) 0.003 0.954 实验室检查 LVEF/% 62(60.00，64.00) 63(60.00，65.00) 1.084 0.278 血红蛋白/(g·L-1) 125.43±17.45 124.56±17.32 0.342 0.733 HbA1c/% 6.10(5.60，7.07) 6.10(5.70，7.19) 0.174 0.862 eGFR/[mL·min-1·(1.73 m2)-1] 89.00(78.00，96.00) 87.00(76.50，96.00) 0.005 0.966 TC/(mmol·L-1) 3.38(2.95，4.04) 3.29(2.69，3.75) 1.941 0.052 TG/(mmol·L-1) 1.28(0.92，1.78) 1.08(0.83，1.39) 2.348 0.019 HDL-C/(mmol·L-1) 1.19(1.01，1.39) 1.29(1.04，1.54) 1.277 0.202 LDL-C/(mmol·L-1) 1.94(1.51，2.48) 1.78(1.26，2.12) 2.244 0.025 SYNTAX评分 25(19，33) 25(17，30) 1.236 0.217 
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表 2 两组病变特征及术中情况比较
Table 2. Lesion characteristics and surgical data
处(%), M(P25, P75), X±S 项目 RA/DES组(274处) RA/DCB组(58处) χ2/Z P 手术入路 0.547 0.460 桡动脉 220(80.29) 49(84.48) 股动脉 54(19.71) 9(15.52) 指引导管 0.194 0.659 6F 141(51.46) 28(48.28) 7F 133(48.54) 30(51.72) 靶血管 24.610 < 0.001 LM 67(24.45) 1(1.72) LAD 152(55.47) 42(72.41) LCX 13(4.74) 7(12.07) RCA 42(15.33) 8(13.79) CTO病变 25(9.12) 6(10.34) 0.084 0.772 分叉病变 51(18.61) 2(3.45) 7.114 0.008 三支病变 119(43.43) 20(34.48) 1.575 0.210 IVUS/OCT指导 106(38.69) 34(58.62) 7.800 0.005 临时起搏器 18(6.57) 2(3.45) 0.365 0.546 IABP辅助 10(3.65) 1(1.72) 0.116 0.733 旋磨头数量/枚 1.29±0.53 1.17±0.43 1.589 0.112 最大磨头直径/mm 1.54±0.16 1.60±0.19 2.502 0.012 磨头直径/参考血管直径 0.52±0.06 0.61±0.09 7.063 < 0.001 植入物数量/枚 2.17±0.79 1.57±0.65 5.406 < 0.001 植入物直径/mm 2.99±0.34 2.68±0.38 5.695 < 0.001 植入物总长度/mm 52.16±20.76 42.60±17.42 3.521 < 0.001 注：CTO：冠脉慢性完全闭塞病变；LCX：左回旋支；RCA：右冠脉。
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表 3 两组术中并发症、院内不良事件及远期随访结果比较
Table 3. Intraoperative complications, in-hospital adverse events and long-term follow-up results
例(%) 项目 RA/DES组(261例) RA/DCB组(57例) χ2 P 术中并发症 22(8.43) 5(8.77) 0.007 0.933 慢血流/无复流 16(6.13) 2(3.51) 0.211 0.646 穿孔/心包压塞 2(0.77) 0(0.00) 0.000 1.000 旋磨头嵌 1(0.38) 1(1.75) 0.068 0.794 导丝断裂 2(0.77) 1(1.75) 0.000 1.000 低血压 1(0.38) 1(1.75) 0.068 0.794 院内MACCE 7(2.68) 0(0.00) 0.566 0.452 全因死亡 4(1.53) 0(0.00) 0.081 0.776 非致死性心肌梗死 2(0.77) 0(0.00) 0.000 1.000 脑卒中 1(0.38) 0(0.00) 0.000 1.000 远期随访MACCE 49(18.77) 7(12.28) 1.359 0.244 全因死亡 4(1.53) 1(1.75) 0.000 1.000 非致死性心肌梗死 3(1.15) 0(0.00) 0.003 0.954 靶病变血运重建 36(13.79) 4(7.02) 1.386 0.239 脑卒中 6(2.29) 2(3.51) 0.004 0.951
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表 4 单因素及多因素Cox回归分析
Table 4. Univariate and multivariate Cox regression analysis
项目 单因素分析 多因素分析 HR(95%CI) P HR(95%CI) P CABG史 0.188(0.046~0.775) 0.021 1.136(0.206~6.265) 0.884 总胆固醇 1.398(1.043~1.873) 0.025 1.300(0.961~1.759) 0.089 左主干病变 0.504(0.290~0.877) 0.015 0.740(0.338~1.620) 0.451 三支病变 0.482(0.282~0.825) 0.008 1.118(0.597~2.095) 0.728 分叉病变 0.392(0.222~0.694) 0.001 2.284(1.063~4.908) 0.034 植入物数量 1.431(1.037~1.974) 0.029 0.807(0.491~1.327) 0.398 植入物总长度 1.021(1.009~1.034) 0.001 1.023(1.005~1.047) 0.014 SNYTAX评分 1.065(1.038~1.093) 0.001 1.047(1.013~1.082) 0.006
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