Safety and efficacy of shockwave balloon compared to coronary rotational atherectomy in the treatment of chronic complete occlusion with severe calcification
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摘要: 目的 探讨冠状动脉冲击波球囊与冠状动脉旋磨在慢性完全闭塞合并重度钙化病变患者中应用的安全性与有效性，为临床决策提供参考。 方法 回顾性纳入行冠状动脉介入治疗的慢性完全闭塞合并重度钙化病变患者共88例，其中21例采用冲击波球囊技术(SB组)，67例采用冠状动脉旋磨(RA组)。比较两组患者一般情况、冠状动脉病变特点、治疗效果、术中并发症和3个月主要心血管不良事件。采用多因素logistic回归分析主要心血管不良事件的危险因素。 结果 两组患者一般临床情况、靶病变位置、病变长度、钙化角度等病变情况差异无统计学意义。两组钙化环断裂、支架成功释放、最终血流TIMI 3级等差异无统计学意义。SB组最大支架直径及获得管腔面积大于RA组(均P＜0.05)，两组术中并发症差异无统计学意义。PSM后，SB组最大支架直径及获得管腔面积大于RA组(均P＜0.05)，SB组与RA组3个月主要心血管不良事件差异无统计学意义。多因素logistic分析显示，支架最终残余狭窄>20%(OR=12.167，95%CI：1.447~102.319，P=0.021)和最终血流小于TIMI 3级(OR=24.333，95%CI：2.502~236.658，P=0.006)是主要心血管不良事件的独立危险因素。 结论 冲击波球囊与冠状动脉旋磨在慢性完全闭塞病变合并重度钙化中应用的安全性相当，都可成功断裂钙化环，冲击波球囊可获得更大管腔面积。Abstract: Objective To investigate the safety and efficacy of shockwave balloon therapy and coronary rotational atherectomy for patients with severe calcification in chronic total occlusion, and provide reference for clinical decision-making. Methods A retrospective analysis was conducted on 88 patients with chronic complete occlusion complicated with severe calcification who underwent coronary intervention. Among them, 21 patients were treated with shockwave balloon(SB group), while 67 patients received coronary rotational atherectomy(RA group). A comparison was made between the two groups in terms of general characteristics, coronary artery disease features, treatment efficacy, intraoperative complications, and major cardiovascular adverse events within 3 months. Multivariate logistic regression analysis was conducted to identify the risk factors for major cardiovascular adverse events. Results There were no statistically significant differences observed in the general clinical data, target lesion location, lesion length, and calcification angle between the two groups, as well as calcification ring rupture, successful stent deployment, and attainment of final blood flow at TIMI-3 level. The SB group exhibited significantly larger maximum stent diameter and lumen area compared to the RA group(both P < 0.05), while no significant variances were noted in intraoperative complications between the two groups. The maximum stent diameter and lumen area in the SB group were greater than those in the RA group after PSM(both P < 0.05). There was no statistically significant difference in major cardiovascular adverse events within 3 months between the two groups. Multivariate logistic analysis revealed that residual stent stenosis greater than 20%(OR=12.167, 95%CI: 1.447-102.319, P=0.021) and final blood flow less than TIMI grade 3(OR=24.333, 95%CI: 2.502-236.658, P=0.006) were independent risk factors for major cardiovascular adverse events. Conclusion The safety of shockwave balloon therapy and coronary rotational atherectomy in treating chronic complete occlusion with severe calcification is comparable, with both methods effectively disrupting calcified plaques. Additionally, shockwave balloon therapy has shown potential for achieving a larger lumen area.
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Key words:
- shockwave balloon /
- rotational atherectomy /
- chronic complete occlusion
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表 1 两组一般情况
Table 1. General characteristics
例(%), X±S 项目 PSM前 PSM后 SB组(21例) RA组(67例) t/χ2 P SB组(21例) RA组(18例) t/χ2 P 年龄/岁 61.9±5.1 62.0±4.4 -0.070 0.944 61.9±5.1 62.7±4.9 -0.473 0.639 男性 13(61.9) 46(68.7) 0.330 0.566 13(61.9) 10(55.6) 0.161 0.688 BMI/(kg/m2) 24.2±4.0 24.7±2.4 -0.671 0.504 24.2±4.0 23.9±2.2 0.299 0.766 高血压 11(52.4) 35(52.2) 0.000 0.991 11(52.4) 11(61.1) 0.300 0.584 糖尿病 8(38.1) 26(38.8) 0.003 0.953 8(38.1) 6(33.3) 0.096 0.757 高脂血症 13(61.9) 38(56.7) 0.177 0.674 13(61.9) 13(72.2) 0.464 0.496 既往PCI 8(38.1) 22(32.8) 0.197 0.657 8(38.1) 6(33.3) 0.096 0.757 吸烟 11(52.4) 35(52.2) 0.000 0.991 11(52.4) 11(61.1) 0.300 0.584 TC/(mmol/L) 5.5±0.8 5.5±0.9 0.100 0.921 5.5±0.8 5.6±0.9 -0.315 0.755 LDL-C/(mmol/L) 2.8±0.6 2.9±0.7 -0.541 0.590 2.8±0.6 2.6±0.6 1.240 0.223 血红蛋白/(g/L) 128.4±18.7 125.4±10.2 0.966 0.337 128.4±18.7 127.6±10.8 0.175 0.862 血小板/(×109/L) 200.7±39.8 212.4±27.9 -1.506 0.136 200.7±39.8 206.9±31.3 -0.536 0.595 LVEF/% 56.7±7.1 58.9±6.5 -1.374 0.173 56.7±7.1 60.3±6.9 -1.626 0.112 住院费用/万元 5.0±0.6 4.9±0.7 0.700 0.486 5.0±0.6 5.1±0.6 -0.292 0.772 
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表 2 病变特点及手术情况
Table 2. Angiographic and procedural characteristics
例(%), X±S 项目 PSM前 PSM后 SB组(21例) RA组(67例) t/χ2 P SB组(21例) RA组(18例) t/χ2 P 靶病变位置 0.291 0.590 0.559 0.455 左主干 0 0 0 0 前降支 13(61.9) 37(55.2) 13(61.9) 9(50.0) 右冠脉 8(38.1) 30(44.8) 8(38.1) 9(50.0) 回旋支 0 0 0 0 病变特点 参考管腔直径/mm 3.1±0.2 3.2±0.3 -1.298 0.198 3.1±0.2 3.2±0.2 -1.067 0.293 钙化角度/° 312.9±46.0 310.3±45.1 0.226 0.822 312.9±46.0 295.0±41.5 1.263 0.214 病变长度/mm 27.5±4.5 27.0±5.3 0.371 0.711 27.5±4.5 27.4±4.4 -0.133 0.895 支架内闭塞 5(23.8) 11(16.4) 0.587 0.443 5(23.8) 2(11.1) 1.016 0.303 5年以上独立术者 10(47.6) 48(71.6) 4.107 0.043 10(47.6) 9(50.0) 0.022 0.882 治疗效果 最大旋磨导管直径/mm 1.8±0.4 1.8±0.5 最大冲击波球囊直径/mm 2.8±0.4 2.8±0.4 钙化断裂 20(95.5) 61(91.0) 0.384 0.535 20(95.5) 17(94.4) 1.000 支架成功释放 20(95.2) 63(94.0) 1.000 20(95.2) 18(100.0) 0.490 平均支架个数 2.6±1.1 2.6±1.1 -0.194 0.847 2.6±1.1 2.1±1.2 1.409 0.167 支架长度/mm 39.8±11.1 41.5±9.7 -0.677 0.500 39.8±11.1 43.4±10.4 -1.048 0.302 最大支架直径/mm 3.2±0.3 3.0±0.4 2.329 0.022 3.2±0.3 2.9±0.3 2.881 0.007 最终TIMI 3级血流 19(90.5) 61(91.0) 0.006 0.937 19(90.5) 13(72.2) 0.215 最大获得管腔面积/mm2 8.4±1.0 7.7±1.1 2.485 0.015 8.4±1.0 7.4±1.0 3.239 0.003 术中并发症 1(4.8) 6(9.0) 0.384 0.535 1(4.8) 5(27.8) 0.077 冠脉穿孔/破裂 0 1(1.5) 1.000 0 1(5.6) 0.462 冠脉夹层 1(4.8) 2(3.0) 0.563 1(4.8) 2(11.1) 0.586 慢血流/无复流 0 3(4.5) 1.000 0 2(11.1) 0.206
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表 3 3个月MACE发生情况
Table 3. MACE within 3 months
例(%) 项目 SB组(21例) RA组(67例) P MACE 2(9.5) 4(6.0) 0.626 急性心肌梗死 1(4.8) 1(1.5) 0.422 支架内血栓 0 1(1.5) 1.000 靶血管再次血运重建 1(4.8) 2(3.0) 0.563 心源性死亡 0 0
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表 4 MACE危险因素的多因素logistic回归分析
Table 4. Risk factors of MACE analyzed by multivariate logistic regression analysis
项目 B SE Wald P OR 95%CI 支架最终残余狭窄>20% 2.499 1.086 5.289 0.021 12.167 1.447~102.319 最终血流小于TIMI 3级 3.192 1.161 7.563 0.006 24.333 2.502~236.658 常量 -3.597 0.717 25.191
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