Incidence and predictors of recurrent in-stent restenosis after drug-coated balloon angioplasty
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摘要: 目的 本研究旨在探讨药物涂层球囊(DCB)扩张术后反复支架内再狭窄(RISR)的发生率和预测因素。方法 本项回顾性研究纳入2018年9月—2021年9月于郑州大学第一附属医院成功单纯应用DCB治疗支架内再狭窄(ISR)病变的患者，症状复发时再次住院复查冠状动脉(冠脉)造影，根据有无再次ISR分为RISR组和非RISR组，比较两组术时基本资料和实验室检验结果、术时及复查时的手术资料等；根据有无RISR，将有统计学差异的基线变量纳入多因素logistic回归分析中进一步分析。结果 共136例患者(147例ISR病变)被纳入研究，其中126例原支架为药物洗脱支架(DES)，21例为裸金属支架(BMS)。经过(13.6±8.5)个月的随访后，147例ISR病变中52例(35.4%)发生了RISR，DES发生RISR 41例(32.5%)，BMS发生RISR 11例(52.4%)。RISR组患者术前陈旧性心肌梗死率、红细胞分布宽度(RDW)、高密度脂蛋白胆固醇、术前管腔直径狭窄率、支架内慢性完全闭塞病变率、切割球囊使用率均高于非RISR组，总胆红素低于非RISR组，差异均有统计学意义(P < 0.05)。多因素分析结果显示高RDW、高术前管腔狭窄率、术中应用切割球囊是DCB扩张术治疗ISR后期发生RISR独立影响因素。结论 约1/3的ISR患者在DCB扩张术后1年左右出现RISR。基线RDW高值，较高的术前管腔狭窄率以及术中使用切割球囊是RISR发生的独立影响因素
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关键词:
- 冠状动脉粥样硬化性心脏病 /
- 药物涂层球囊 /
- 支架内再狭窄 /
- 反复支架内再狭窄 /
- 经皮冠状动脉介入术
Abstract: Objective To investigate the incidence and predictors of recurrent in-stent restenosis(RISR) after drug-coated balloon(DCB) angioplasty.Methods This retrospective study included patients who underwent successful DCB treatment for ISR lesions at the First Affiliated Hospital of Zhengzhou University from September 2018 to September 2021 and were rehospitalized due to recurrent symptoms. The patients were divided into the recurrent in-stent restenosis group(RISR group) and the non-recurrent in-stent restenosis group(non-RISR group) based on the presence or absence of recurrent ISR. Basic data, laboratory test results, data during baseline procedure and review between two groups were compared. Multivariate logistic regression analysis was performed to identify predictors of RISR based on the statistically significant baseline variables.Results A total of 136 patients(147 cases of ISR lesions) were enrolled in the study, of which 126 were drug-eluting stents(DES) and 21 were bare metal stents(BMS). After 13.6±8.5 months of follow-up, 35.4%(52 cases) of the 147 ISR lesions developed RISR, and the incidence of RISR in DES was 32.5%(41 cases) and BMS was 52.4%(11 cases). Compared with non-RISR group, the rate of old myocardial infarction before procedure, the red blood cell distribution width(RDW), and high-density lipoprotein cholesterol, the rate of luminal diameter stenosis before procedure, the rate of chronic total occlusive lesions in the stent, the utilization rate of cutting balloons were higher in the RISR group and the total bilirubin was lower, and the differences were statistically significant(P < 0.05). Multivariate analysis showed that high RDW, high rate of luminal stenosis before procedure, and use of cutting balloons during procedure were independently associated with RISR after DCB angioplasty in the treatment of ISR in the late stage.Conclusion About 1/3 of ISR patients develop RISR approximately 1 year after DCB angioplasty. High RDW at baseline, high rates of luminal stenosis before procedure, and the use of cutting balloon during procedure were independent predictors of RISR. -
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表 1 基本资料及术后服药史
Table 1. Basic data and medications after procedure
例(%), X±S, M(P25, P75) 项目 非RISR组(95例) RISR组(52例) P 男性 65(68.4) 29(55.8) 0.127 年龄/岁 60.8±10.6 63.0±13.4 0.263 吸烟 41(43.1) 25(48.1) 0.566 饮酒 49(51.6) 28(53.8) 0.701 糖尿病 37(38.9) 23(44.2) 0.533 高血压 49(51.6) 31(59.6) 0.350 脑梗死病史 10(10.5) 10(19.2) 0.141 陈旧性心肌梗死 4(4.21) 10(19.2) 0.003 新发心肌梗死 27(28.4) 19(36.5) 0.310 首次PCI至ISR间隔时间/月 12.0(10.00，46.00) 21.5(8.25，94.75) 0.363 靶血管部位 LM 3(3.16) 2(3.85) 0.826 LAD 46(48.4) 24(46.2) 0.792 LCX 21(22.1) 6(11.5) 0.114 RCA 25(26.3) 20(38.5) 0.127 原支架 裸金属支架 10(10.5) 11(21.2) 0.078 总数目/个 1.80±0.81 1.79±0.83 0.935 总长度/mm 49.7±29.1 44.3±24.6 0.253 内径/mm 3.00(2.75，3.50) 3.03(2.75，3.50) 0.679 术后服药史 阿司匹林+氯吡格雷 41(43.2) 21(40.4) 0.745 阿司匹林+替格瑞洛 54(56.8) 31(59.6) 0.745 β受体阻滞剂 74(77.9) 34(65.4) 0.100 硝酸酯类 39(41.1) 20(38.5) 0.390 CCB 30(31.6) 16(30.8) 0.919 ACEI/ARB/ARNI 55(57.9) 24(46.2) 0.172 注：CCB：钙离子通道拮抗剂；ACEI/ARB/ARNI：血管紧张素转换酶抑制剂/血管紧张素受体拮抗剂/血管紧张素受体脑啡肽酶抑制剂。 
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表 2 术前实验室检验结果
Table 2. Laboratory parameters before procedure
X±S, M(P25, P75) 项目 非RISR组(95例) RISR组(52例) P HbA1c/% 6.74±1.23 6.72±1.26 0.919 Fib/(g/L) 3.24±1.52 3.39±1.34 0.537 D-二聚体/(mg/L) 0.09(0.05，0.19) 0.12(0.06，0.26) 0.337 TBiL/(μmol/L) 10.0±4.06 8.52±3.05 0.021 UA/(μmol/L) 307.7±80.1 314.3±99.2 0.663 GFR/[mL·min-1·(1.73m2)-1] 87.9±23.0 82.6±24.3 0.194 NLR 2.33(1.58，3.13) 2.37(1.78，3.74) 0.378 PLR 125.8(92.9，148.5) 115.7(85.3，181.2) 0.703 RDW/% 13.6±1.23 14.6±2.62 0.011 PDW/% 16.6±0.62 16.5±1.07 0.630 TC/(mmol/L) 3.27±0.85 3.36±0.84 0.541 TG/(mmol/L) 1.47±0.97 1.23±0.82 0.141 HDL-C/(mmol/L) 0.99±0.22 1.11±0.35 0.027 LDL-C/(mmol/L) 1.87±0.72 1.89±0.70 0.862 Lp(a)/(mg/dL) 20.0(6.3，30.0) 20.0(12.8，30.0) 0.066
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表 3 术中手术相关资料及复查结果
Table 3. Data during procedure and review results
例(%), X±S 项目 非RISR组(95例) RISR组(52例) P 术前 参考血管直径/mm 2.66±0.48 2.59±0.44 0.395 最小管腔直径/mm 0.81±0.55 0.48±0.48 < 0.001 直径狭窄率/% 69.60±19.90 81.60±17.00 < 0.001 支架内慢性完全闭塞 5(5.3) 11(21.2) 0.003 预扩球囊 应用棘突球囊 46(48.4) 25(48.1) 0.968 应用切割球囊 17(17.9) 19(36.5) 0.012 预扩张术后 最小管腔直径/mm 1.95±0.45 1.79±0.50 0.053 直径狭窄率/% 20.60±12.20 31.00±14.50 0.061 DCB DCB长度/mm 24.6±8.44 27.1±8.87 0.096 DCB直径/mm 3.15±0.43 3.16±0.50 0.831 DCB释放压力/atm 9.18±1.85 9.19±2.05 0.968 DCB维持时间/s 58.40±7.20 58.60±4.68 0.865 DCB术后 最小管腔直径/mm 2.10±0.43 1.95±0.46 0.050 直径狭窄率/% 20.70±12.20 24.60±13.90 0.078 即刻管腔增益/% 48.80±21.90 56.90±21.70 0.034 随访时 随访时间/月 13.4±8.88 14.0±7.79 0.708 参考血管直径/mm 2.72±0.50 2.54±0.47 0.027 最小管腔直径/mm 1.92±0.53 0.61±0.49 < 0.001 直径狭窄率/% 30.10±11.80 76.20±18.20 < 0.001 晚期管腔丢失/mm 0.28±0.33 1.33±0.60 < 0.001 再次TLR 0 42(80.8) - 再次PCI使用DCB 0 25(48.1) - 再次PCI使用DES 0 12(23.1) - 通过CABG再治疗 0 5(9.6) -
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表 4 DCB扩张术后RISR的多因素logistic回归分析
Table 4. Multivariate logistic regression analysis of RISR after DCB angioplasty
自变量 OR(95%CI) P RDW 1.346(1.013~1.790) 0.041 术前管腔直径狭窄率 1.046(1.006~1.089) 0.025 应用切割球囊 3.570(1.401~9.094) 0.008
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