PCI术中应用药物涂层球囊对冠心病不稳定性心绞痛患者的临床疗效

doi:10.3760/cma.j.issn.1007-1245.2024.01.012

摘要/Abstract

摘要：

目的　探讨经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI）术中应用药物涂层球囊对冠心病不稳定性心绞痛患者的临床疗效。方法　选取2019年8月至2022年6月徐州仁慈医院收治的97例行PCI的冠心病不稳定性心绞痛患者，依据治疗方法不同分为对照组和观察组。对照组48例，男25例，女23例，年龄（61.58±4.15）岁，采用支架植入治疗。观察组49例，男26例，女23例，年龄（61.65±4.22）岁，采用药物涂层球囊扩张治疗。均随访12个月。比较两组心功能、参考血管直径（RVD）、最小管腔直径（MLD）、晚期管腔丢失、生活质量以及不良心血管事件总发生率情况。采用t检验、χ²检验进行统计分析。结果　术前对照组射血分数（EF）、心排出量（CO）及心脏指数（CI）分别为（75.24±7.31）%、（2.63±0.60）L/min、（4.08±0.71）L/（min•m²），观察组分别为（74.85±7.26）%、（2.57±0.61）L/min、（3.37±0.71）L/（min•m²）；术后对照组EF、CO及CI分别为（86.03±10.17）%、（4.61±0.79）L/min、（4.08±0.71）L/（min•m²），观察组分别为（86.64±10.23）%、（4.52±0.76）L/min、（4.15±0.67）L/（min•m²）。术前两组心功能对比差异无统计学意义（P>0.05）；术后两组EF、CO及CI均高于术前，与同组术前比较差异均有统计学意义（均P<0.05），但术后两组比较差异均无统计学意义（均P>0.05）。术后即刻对照组RVD、MLD分别为（2.57±0.29）mm、（0.57±0.14）mm，观察组分别为（2.53±0.26）mm、（0.59±0.12）mm；术后12个月对照组RVD、MLD分别为（2.68±1.09）mm、（2.03±0.33）mm，观察组分别为（2.73±1.12）mm、（1.98±0.34）mm。两组RVD、MLD比较，差异无统计学意义（P>0.05）；术后12个月两组MLD均高于术前（均P<0.05），但两组RVD、MLD比较，差异无统计学意义（P>0.05）。术后12个月两组晚期管腔丢失为（0.32±0.20）mm，对照组为（0.36±0.22）mm，差异无统计学意义（t=-0.937，P=0.351）。术前两组生活质量评分比较，差异无统计学意义（P>0.05）；术后12个月两组生理功能、躯体疼痛、生理职能、活力、社会功能、总体健康、情感职能及精神健康评分升高，且观察组生理功能、总体健康及精神健康评分高于对照组（均P<0.05）；术后12个月，两组不良心血管事件总发生率［12.24%（6/49）比8.33%（4/48）］比较，差异无统计学意义（P>0.05）。结论　应用药物涂层球囊治疗冠心病不稳定性心绞痛效果与支架植入效果、安全性相当，药物涂层球囊治疗后患者生活质量更高。

关键词:

冠心病, 经皮冠状动脉介入治疗, 药物涂层球囊, 不稳定性心绞痛, 心功能, 不良心血管事件

Abstract:

Objective　To investigate the clinical efficacy of drug-coated balloons in percutaneous coronary intervention (PCI) for patients with unstable angina pectoris caused by coronary heart disease. Methods　Ninety-seven patients with unstable angina pectoris caused by coronary heart disease who underwent percutaneous coronary intervention in Xuzhou Renci Hospital from August 2019 to June 2022 were selected and divided into a control group (48 cases) and an observation group (49 cases) according to the treatment methods. There were 25 males and 23 females in the control group; they were (61.58±4.15) years old. There were 26 males and 23 females in the observation group; they were (61.65±4.22) years old. The control group took stent implantation treatment, and the observation group drug-coated balloon dilation treatment. Both groups were followed up for 12 months. The cardiac function, reference vessel diameters (RVD), minimum lumen diameters (MLD), late stage luminal loss, quality of life, and overall incidences of adverse cardiovascular events were compared between the two groups. t and χ² tests were applied.Results　Before the surgery, the ejection fraction (EF), cardiac output (CO), and cardiac index (CI) in control group were (75.24±7.31) %, (2.63±0.60) L/min and (4.08±0.71) L/ (min•m²), and those in the observation group (74.85±7.26) %, (2.57±0.61) L/min, and (3.37±0.71) L/(min•m²); after the surgery, the EF, CO, and CI in the control group were (86.03±10.17) %, (4.61±0.79) L/min and (4.08±0.71) L/(min•m²), and those in the observation group (86.64±10.23) %, (4.52±0.76) L/min, and (4.15±0.67) L/(min•m²); there were no statistical differences in the cardiac function between the two groups before the surgery (all P>0.05); the EF, CO, and CI increased after the surgery in both groups, with statistical differences between before and after the surgery in both groups (all P<0.05), but no between the two groups after the surgery (all P>0.05). Immediately after surgery, the RVD and MLD in the control group were (2.57±0.29) mm and (0.57±0.14) mm, and those in the observation group were (2.53±0.26) mm and (0.59±0.12) mm, respectively. Twelve months after the surgery, the RVD and MLD in the control group were (2.68±1.09) mm and (2.03±0.33) mm, and those in the observation group were (2.73±1.12) mm and (1.98±0.34) mm, respectively; immediately and 12 months after the surgery, there were no statistical differences in RVD and MLD between the two groups (all P>0.05); twelve months after the surgery, the MLD increased in both groups (both P<0.05), but there were no statistical differences in RVD and MLD between the two groups. Twelve months after the surgery, the late stage luminal loss in the observation group was (0.32±0.20) mm, while that in the control group was (0.36±0.22) mm, with no statistical difference (t=-0.937, P=0.351). There was no statistical difference in the quality of life score between the two groups before the surgery (P>0.05). Twelve months after the surgery, the scores of physiological function, physical pain, physiological function, vitality, social function, overall health, emotional function, and mental health increased in both groups, and the scores of physiological function, overall health, and mental health in the observation group were higher than those in the control group (all P<0.05). Twelve months after the surgery, there was no statistical difference in the total incidence of adverse cardiovascular events between the two groups [12.24% (6/49) vs. 8.33% (4/48); P>0.05]. Conclusion　The application of drug-coated balloons in the treatment of patients with unstable angina pectoris caused by coronary heart disease is equivalent to the stent implantation in effectiveness and safety, but the patients' quality of life after drug-coated balloon treatment is higher.

Key words:

Coronary heart disease, Percutaneous coronary intervention, Drug-coated balloons, Unstable angina pectoris, Cardiac function, , Adverse cardiovascular events

叶凤翔刘栋涛范子晨.

PCI术中应用药物涂层球囊对冠心病不稳定性心绞痛患者的临床疗效 [J]. 国际医药卫生导报, 2024, 30(1): 57-62.

Ye Fengxiang, Liu Dongtao, Fan Zichen.

Clinical efficacy of drug-coated balloons in percutaneous coronary intervention for patients with unstable angina pectoris caused by coronary heart disease [J]. International Medicine and Health Guidance News, 2024, 30(1): 57-62.

参考文献

[1] Zhang LM, DU TH, Niu LL, et al. Network Meta-analysis of Chinese patent medicine in treatment of unstable angina pectoris[J]. Zhongguo Zhong Yao Za Zhi, 2021,46(3):703-711. DOI: 10.19540/j.cnki.cjcmm.20201103.502.
[2] Roos A, Edgren G, Holzmann MJ. Unstable angina pectoris with myocardial injury versus myocardial infarction in the era of high-sensitivity cardiac troponin[J]. Am J Cardiol, 2022,169:32-41. DOI: 10.1016/j.amjcard.2021.12.044.
[3] Bhatt DL, Lopes RD, Harrington RA. Diagnosis and treatment of acute coronary syndromes: a review[J]. JAMA, 2022,327(7):662-675. DOI: 10.1001/jama. 2022.0358.
[4] Makover ME, Shapiro MD, Toth PP. There is urgent need to treat atherosclerotic cardiovascular disease risk earlier, more intensively, and with greater precision: a review of current practice and recommendations for improved effectiveness[J]. Am J Prev Cardiol, 2022,12:100371. DOI: 10.1016/j.ajpc.2022.100371.
[5] Puelacher C, Gugala M, Adamson PD, et al. Incidence and outcomes of unstable angina compared with non-ST-elevation myocardial infarction[J]. Heart, 2019,105(18):1423-1431. DOI: 10.1136/heartjnl-2018- 314305.
[6] Stone GW, Maehara A, Ali ZA, et al. Percutaneous coronary intervention for vulnerable coronary atherosclerotic plaque[J]. J Am Coll Cardiol, 2020,76(20):2289-2301. DOI: 10.1016/j.jacc.2020.09.547.
[7] Wininger KL. Percutaneous transluminal coronary angioplasty: history, current techniques, and future directions[J]. Radiol Technol, 2022,94(1):35-45.
[8] 陈韵岱.药物涂层球囊在冠心病介入治疗中的应用现状[J].中国心血管杂志,2020,25(2):101-103.DOI:10.3969/j.issn.1007-5410.2020.02.001.
[9] «药物涂层球囊临床应用中国专家共识»专家组.药物涂层球囊临床应用中国专家共识[J].中国介入心脏病学杂志,2016,24(2):61-67.DOI:10.3969/j.issn.1004-8812. 2016.02.001.
[10] 中华医学会心血管病学分会,中华心血管病杂志编辑委员会.非ST段抬高型急性冠状动脉综合征诊断和治疗指南(2016)[J].中华心血管病杂志,2017,45(5):359-376.DOI:10.3760/cma.j.issn.0253-3758.2017.05.003.
[11] 中国医师协会急诊医师分会,国家卫健委能力建设与继续教育中心急诊学专家委员会,中国医疗保健国际交流促进会急诊急救分会.急性冠脉综合征急诊快速诊治指南(2019)[J].中国急救医学,2019,39(4):301-308.DOI:10.3969/j.issn.1002-1949.2019.04.001.
[12] Kristensen AMD, Pareek M, Kragholm KH, et al. Unstable angina as a component of primary composite endpoints in clinical cardiovascular trials: pros and cons[J]. Cardiology, 2022,147(3):235-247. DOI: 10.1159/000524948.
[13] Fladseth K, Wilsgaard T, Lindekleiv H, et al. Outcomes after coronary angiography for unstable angina compared to stable angina, myocardial infarction and an asymptomatic general population[J]. Int J Cardiol Heart Vasc, 2022,42:101099. DOI: 10.1016/j.ijcha.2022.101099.
[14] Su Q, Zhang L, Qi Z, et al. The mechanism of inflammatory factors and soluble vascular cell adhesion molecule-1 regulated by nuclear transcription factor NF-κB in unstable angina pectoris[J]. J Immunol Res, 2022,2022:6137219. DOI: 10.1155/2022/6137219.
[15] Goyal A, Zeltser R. Unstable Angina[M].Treasure Island (FL): StatPearls Publishing, 2023.
[16] Yerasi C, Case BC, Forrestal BJ, et al. Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review[J]. J Am Coll Cardiol, 2020,75(9):1061-1073. DOI: 10.1016/j.jacc.2019.12.046.
[17] Chowdhury MM, Singh K, Albaghdadi MS, et al. Paclitaxel drug-coated balloon angioplasty suppresses progression and inflammation of experimental atherosclerosis in rabbits[J]. JACC Basic Transl Sci, 2020,5(7):685-695. DOI: 10.1016/j.jacbts.2020.04.007.
[18] 李英肖,宋学莲,吕彩霞,等.药物涂层球囊与药物洗脱支架治疗异质性支架内再狭窄的临床疗效分析[J].实用医学杂志,2021,37(5):637-642.DOI:10.3969/j.issn.1006-5725. 2021.05.016.