The influencing factors of coronary artery dissection caused by drug balloons under intravascular ultrasound
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摘要: 目的 探究在血管内超声(intravascular ultrasound，IVUS)辅助下药物涂层球囊(drug-coated balloon，DCB)处理冠状动脉(冠脉)原位病变出现冠脉夹层的影响因素。 方法 收集2020年1月—2021年6月于郑州大学第一附属医院在IVUS辅助下DCB处理冠脉原位病变患者的临床资料及影像资料进行回顾性分析。根据IVUS下是否观察到冠脉夹层，分为夹层组和无夹层组，使用logistic回归分析夹层的影响因素。 结果 共纳入患者99例，其中夹层组较非夹层组有更长的药物球囊长度(30.33 mm vs 22.17 mm，P＜0.05)，更大的预扩球囊直径/IVUS下病变部位直径(0.92 vs 0.81，P＜0.05)和药物球囊直径/IVUS下病变部位直径(0.95 vs 0.88，P＜0.05)，更低的左心室射血分数(58.23% vs 62.15%，P＜0.05)，更小的管腔面积(2.74 mm2 vs 3.61 mm2，P＜0.05)和平均管腔中膜面积(11.53 mm2 vs 16.79 mm2，P＜0.05)。多因素logistic回归分析结果显示，最小管腔面积(OR=0.498，95%CI：0.270~0.919，P=0.026)、平均管腔中膜面积(OR=0.854，95%CI：0.732~0.997，P=0.046)、药物球囊长度(OR=1.084，95%CI：1.003~1.171，P=0.041)、最大预扩球囊直径/IVUS下病变部位直径(OR=166.968，95%CI：1.712~16 286.265，P=0.029)是夹层发生的影响因素。 结论 药物球囊长度、最大预扩球囊直径/IVUS下病变部位直径是DCB处理原位病变冠脉夹层发生的独立危险因素，病变部位最小管腔面积、平均管腔中膜面积是DCB处理原位病变冠脉夹层发生的保护因素。Abstract: Objective To explore the influencing factors of coronary artery dissection in the treatment of de novo coronary artery disease with drug-coated balloons under intravascular ultrasound(IVUS) guidance. Methods Clinical and imaging data of patients treated with DCB for de novo coronary artery disease under IVUS guidance at the First Affiliated Hospital of Zhengzhou University from January 2020 to June 2021 were retrospectively analyzed. According to the presence or absence of coronary artery dissection observed under IVUS, the patients were divided into the dissection group and non-dissection group, and multiple logistic regression analysis was used to analyze the influencing factors of dissection. Results A total of 99 patients were included. Compared with the non-dissection group, the dissection group had a greater drug balloon length(30.33 mm vs 22.17 mm, P < 0.05), bigger pre-dilation balloon diameter/lesion site diameter under IVUS(0.92 vs 0.81, P < 0.05), and bigger drug balloon diameter/lesion site diameter under IVUS(0.95 vs 0.88, P < 0.05). In addition, the dissection group had a lower left ventricular ejection fraction(58.23% vs 62.15%, P < 0.05), smaller lumen area(2.74 mm2 vs 3.61 mm2, P < 0.05), and smaller average external elastic membrane cross-sectional area(11.53 mm2 vs 16.79 mm2, P < 0.05). The results of multiple logistic regression analysis showed that minimum lumen area(OR=0.498, 95%CI 0.270-0.919, P=0.026), average external elastic membrane cross-sectional area(OR=0.854, 95%CI 0.732-0.997, P=0.046), drug-coated balloon length(OR=1.084, 95%CI 1.003-1.171, P=0.041), and the ratio of the maximum pre-dilation balloon diameter to the diameter of the lesion site under IVUS(OR=166.968, 95%CI 1.712-16 286.265, P=0.029) were associated with the occurrence of dissection. Conclusion The length of the drug-coated balloon and the ratio of the maximum pre-dilation balloon diameter to the diameter of the lesion site under IVUS are independent risk factors for dissection in treating de novo coronary artery disease with the drug-coated balloon. The minimum lumen area and average external elastic membrane area of the lesion site are protective factors for dissection in treating de novo coronary artery disease with drug-coated balloon.
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表 1 患者基础资料
Table 1. General data
例(%), X±S, M(Q1, Q3) 项目 非夹层组(47例) 夹层组(52例) t/χ2 P 女性 16(34.0) 15(28.8) 0.31 0.578 年龄/岁 55.83±11.02 59.85±12.28 -1.705 0.091 HbA1c /% 6.19±0.94 6.25±1.25 -0.297 0.767 LDL-C/(mmol/L) 2.17±0.78 1.94±0.73 1.539 0.127 TC/(mmol/L) 3.74±0.97 3.57±1.02 0.845 0.400 TG/(mmol/L) 1.49(1.00，1.90) 1.45(0.90，2.00) -0.582 0.561 GFR/(mL/min) 94.87±19.99 86.12±26.79 1.826 0.071 LVEF/% 62.15±5.96 58.23±9.65 2.455 0.016 pro-BNP/(pg/mL) 107.26(57.20，510.00) 255.30(79.30，721.10) -1.78 0.075 术前cTn/(ng/mL) 0.012(0.000，0.100) 0.013(0.000，0.100) -1.307 0.191 术前CK-MB/(U/L) 16.00(12.00，20.90) 15.65(9.80，20.20) -0.501 0.616 术前CK(U/L) 73.00(48.00，102.00) 74.00(46.10，97.80) -0.427 0.669 FPG/(mmol/L) 5.30(4.70，6.30) 4.84(4.50，6.10) -1.535 0.125 肌酐/(μmol/L) 70.00(54.00，84.00) 77.00(67.00，94.80) -1.878 0.060 高血压分级 1.222 0.776 1 9(19.15) 8(15.38) 2 3(6.38) 6(11.54) 3 15(31.91) 14(26.92) 吸烟 5(10.64) 12(23.08) 2.685 0.101 糖尿病 13(27.66) 12(23.08) 0.275 0.600 高脂血症 1(2.12) 13(27.66) 0.09 0.764 陈旧性脑梗死 9(19.15) 8(15.38) 0.246 0.62 陈旧性心肌梗死 3(6.38) 7(13.46) 1.362 0.324 PCI史 9(19.15) 9(17.31) 0.056 0.813 CABG史 1(2.13) 0 1.118 0.475 SAP 0 2(3.85) 1.826 0.496 UA 39(82.98) 37(71.15) 1.935 0.164 Non-STEMI 6(12.77) 8(15.38) 0.139 0.709 STEMI 2(4.26) 3(5.77) 0.118 1.000 HbA1c：糖化血红蛋白；LDL-C：低密度脂蛋白胆固醇；TC：总胆固醇；TG：三酰甘油；pro-BNP：脑钠肽前体；cTn：心肌肌钙蛋白；CK-MB：肌酸激酶同工酶；CK：肌酸激酶；FPG：空腹血糖；CABG：冠脉旁路移植；SAP：稳定性心绞痛；UA：不稳定性心绞痛；Non-STEMI：非ST段抬高型心肌梗死；STEMI：ST段抬高型心肌梗死。 
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表 2 手术资料
Table 2. Surgery data
例(%), X±S 项目 无夹层组(47例) 夹层组(52例) t/χ2 P 预扩球囊直径/mm 2.63±0.54 2.67±0.46 -0.381 0.704 预扩球囊长度/mm 14.23±4.82 14.04±4.03 0.22 0.827 预扩球囊压力/atm 10.79±2.65 11.15±2.48 -0.71 0.479 药物球囊直径/mm 2.85±0.49 2.74±0.43 1.137 0.258 药物球囊长度/mm 22.17±6.93 30.33±8.21 -5.31 ＜0.001 药物球囊压力/atm 8.38±2.31 7.90±2.18 1.062 0.291 棘突球囊 25(53.19) 25(53.19) 0.258 0.689 切割球囊 21(44.68) 22(42.30) 0.057 0.841
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表 3 CAG资料
Table 3. CAG data
X±S 项目 无夹层组(47例) 夹层组(52例) t P 病变长度/mm 20.09±9.18 23.49±10.00 -1.76 0.082 远端参考血管直径/mm 2.98±0.79 2.70±0.67 1.869 0.065 近端参考血管直径/mm 3.57±0.68 3.36±0.77 1.483 0.141 DCB前造影狭窄程度/% 86.17±9.90 86.63±10.51 -0.226 0.822 DCB后造影狭窄程度/% 17.02±8.05 15.38±6.99 1.082 0.282
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表 4 IVUS资料
Table 4. IVUS data
例(%), X±S 项目 无夹层组(47例) 夹层组(52例) t/z/χ2 P 病变部位MLA/mm2 3.61±1.20 2.74±0.83 4.162 ＜0.001 病变部位长度/mm 19.88±8.62 23.19±11.40 -1.641 0.104 病变部位斑块负荷/% 71.81±10.87 73.42±7.26 -0.86 0.393 病变部位EEM/mm2 13.50±4.64 12.36±4.79 1.204 0.232 平均EEM/mm2 16.79±5.52 11.53±3.34 5.666 ＜0.001 病变部位斑块性质 1.791 0.408 低回声 14(29.79) 13(25.00) 等回声 23(48.94) 32(61.54) 高回声 10(21.28) 7(13.46) 偏心/向心斑块 0.137 0.712 偏心 35(74.47) 37(71.15) 向心 12(25.53) 15(28.85) 正负重构 13.024 0.001 无重构 6(12.77) 9(17.31) 正性重构 6(12.77) 22(42.31) 负性重构 35(74.47) 21(40.38) 最大预扩球囊直径/IVUS病变部位直径 0.81±0.15 0.92±0.12 -4.049 ＜0.001 药物球囊直径/IVUS病变部位直径 0.88±0.13 0.95±0.13 -2.81 0.006 DCB长度/IVUS病变长度 1.27±0.55 1.51±0.53 -2.237 0.028
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表 5 单因素logistic回归分析结果
Table 5. Univariate logistic regression analysis results
变量 β SE P OR(95%CI) LVEF -0.07 0.032 0.029 0.932(0.875~0.993) 药物球囊长度 0.133 0.031 0 1.142(1.075~1.213) 病变部位MLA -0.86 0.239 0 0.423(0.26~0.676) 平均EEM -0.312 0.072 0 0.732(0.635~0.843) 预扩球囊直径/IVUS病变部位直径 6.042 1.727 0 420.833(14.273~12 408.419) 药物球囊直径/IVUS病变部位直径 4.574 1.751 0.009 96.945(3.134~2 999.198) DCB长度/IVUS病变长度 0.864 0.403 0.032 2.374(1.077~5.231) 正性重构 0.894 0.7 0.202 2.444(0.620~9.637) 负性重构 -0.916 0.595 0.124 0.400(0.125~1.284)
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表 6 多因素logistic回归分析结果
Table 6. Multivariate logistic regression analysis results
变量 β SE P OR(95%CI) LVEF -0.037 0.041 0.365 0.963(0.888~1.045) 药物球囊长度 0.08 0.039 0.041 1.084(1.003~1.171) 病变部位MLA -0.697 0.312 0.026 0.498(0.270~0.919) 平均EEM -0.157 0.079 0.046 0.854(0.732~0.997) 预扩球囊直径/IVUS病变部位直径 5.118 2.337 0.029 166.968(1.712~16 286.265) 药物球囊长度/IVUS病变长度 0.96 0.575 0.095 2.612(0.847~8.056) 正性重构 0.617 0.961 0.521 1.853(0.282~12.184) 负性重构 -1.024 0.805 0.204 0.359(0.074~1.741)
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