Chinese General Practice ›› 2024, Vol. 27 ›› Issue (33): 4125-4131.DOI: 10.12114/j.issn.1007-9572.2024.0071

• Original Research • Previous Articles     Next Articles

Effectiveness and Safety of Drug-coated Balloons in Treating De Novo Lesions in Large Coronary Vessels of Elderly Patients: a Cohort Study

  

  1. 1. Geriatric Medicine Center, Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, China
    2. Department of Hematology, Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, China
    3. Department of General Practice, Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, China
  • Received:2024-02-23 Revised:2024-07-11 Published:2024-11-20 Online:2024-08-08
  • Contact: CHEN Qiuyu, ZHANG Yue

药物涂层球囊治疗老年患者冠状动脉大血管原位病变的有效性和安全性:一项队列研究

  

  1. 1.010000 内蒙古自治区呼和浩特市,内蒙古医科大学附属医院老年医学中心
    2.010000 内蒙古自治区呼和浩特市,内蒙古医科大学附属医院血液科
    3.010000 内蒙古自治区呼和浩特市,内蒙古医科大学附属医院全科医学科
  • 通讯作者: 陈秋雨, 张越
  • 作者简介:

    作者贡献:

    贾高鹏提出主要研究目标,负责研究的构思与设计,研究的实施,撰写论文;曲泽、李桂梅、赵子豪、闫爽、陈秋雨进行数据的收集与整理,统计学处理,图、表的绘制与展示;皇甫卫忠、张越负责文章的质量控制与审查,对文章整体负责,监督管理。

  • 基金资助:
    内蒙古自然科学基金项目(2024LHMS08011); 内蒙古医科大学面上项目(YKD2022MS069); 内蒙古医科大学创客培育项目(101322024031)

Abstract:

Background

In recent years, with the aging of the population, the incidence of coronary artery large vessel disease in elderly patients has significantly increased. Drug-coated balloons (DCB), as an emerging treatment method, have attracted considerable attention due to their ability to effectively reduce the rate of restenosis. However, existing studies have largely focused on small vessel lesions, with limited data on the effectiveness in de novo large vessel lesions.

Objective

To explore the effectiveness of DCBs in treating de novo large coronary artery vessel lesions in elderly patients.

Methods

A retrospective selection of 128 elderly patients (>60 years) with coronary heart disease (CHD) who underwent percutaneous coronary intervention (PCI) at the Affiliated Hospital of Inner Mongolia Medical University in 2022 was conducted. Preoperative examinations and laboratory tests were completed. The patients were divided into DCB group (n=30), Drug-eluting stent (DES) group (n=64), and bioresorbable vascular scaffold (BVS) group (n=34) according to the PCI treatment plan. Coronary angiography (CAG) was performed preoperatively, immediately postoperatively, and during the 1-year follow-up to observe the reference vessel diameter (RVD), minimum lumen diameter (MLD), and further calculate the preoperative diameter stenosis (DS), immediate postoperative lumen gain (AG), residual diameter stenosis (RDS) at immediate postoperative and 1-year follow-up, and late lumen loss (LLL). During the follow-up period, patients were regularly followed up in outpatient clinics or by telephone, recording major adverse cardiovascular events (MACE) within the hospital and within one year after discharge. LASSO regression analysis was used to screen relevant variables, followed by multifactorial Logistic regression analysis to explore the influencing factors of MACE. The Kaplan-Meier method was used to draw the survival curve of patients with MACE, and the comparison of survival curves was made using the Log-rank test.

Results

There was no statistically significant difference in the baseline data of patients in the DCB, DES, and BVS groups (P>0.05). Immediately postoperatively, the MLD and AG in the BVS group were higher than those in the DCB and DES groups, and the RDS was lower than those in the DCB and DES groups (P<0.05). At 1-year postoperatively, the RDS in the DES group was lower than that in the DCB group (P<0.05). No MACE occurred in the hospital in all three groups. The median follow-up time was 478 (425, 538) days, with a total of 38 MACE. No myocardial infarction or cardiac death occurred during the follow-up period. Bleeding events: there were 0 cases in the DCB group, 3 cases in the DES group, and 3 cases in the BVS group, manifested as gum bleeding, assessed as mild bleeding. The Log-rank test showed no statistically significant difference in the survival rate of patients without MACE events among the three groups (P=0.580). LASSO regression analysis included low-density lipoprotein cholesterol (LDL-C) and history of interventional treatment in the analysis, and the results of multifactorial Logistic regression analysis showed that LDL-C (OR=12.204, 95%CI=3.403-43.768) and history of interventional treatment (OR=0.041, 95%CI=0.010-0.162) were influencing factors for the occurrence of MACE.

Conclusion

Compared with DES and BVS, there is no significant difference in the treatment of large vessel lesions in elderly CHD patients with DCB, and its effectiveness and safety are comparable to that of DES and BVS. DCB is a safe and effective method for treating large coronary artery vessel lesions in elderly patients, and increased LDL-C and a history of interventional treatment are influencing factors for the occurrence of MACE.

Key words: Coronary disease, Percutaneous coronary intervention, Coronary balloon angioplasties, Drug-coated balloon, Aged, Cohort studies

摘要:

背景

近年来,随着人口老龄化程度加深,老年患者冠状动脉大血管病变的发病率显著增加。药物涂层球囊(DCB)作为一种新兴治疗手段,因其能有效减少再狭窄发生率而备受关注。然而,现有研究多集中于小血管病变,对大血管原位病变的有效性数据较少。

目的

探讨DCB治疗老年患者冠状动脉大血管原位病变的效果。

方法

回顾性选取2022年就诊于内蒙古医科大学附属医院行经皮冠状动脉介入治疗(PCI)且年龄>60岁老年冠心病(CHD)患者128例为研究对象。完善术前检查化验。按照PCI治疗方案分为DCB组(n=30)、药物洗脱支架(DES)组(n=64)和生物可吸收支架(BVS)组(n=34)。术前、术后即刻及术后随访分别进行冠状动脉造影(CAG),观察术前靶血管参考直径(RVD),术前、术后即刻及术后1年随访观察最小管腔直径(MLD),进一步推算术前直径狭窄程度(DS)、术后即刻观察管腔获益(AG),术后即刻与术后随访1年残余直径狭窄程度(RDS)和晚期管腔丢失(LLL)。随访期间每月定期门诊或电话随访,记录患者院内及出院后1年内患者主要不良心血管事件(MACE)。采用LASSO回归分析筛选相关变量后,采用多因素Logistic回归分析探究MACE发生的影响因素。采用Kaplan-Meier法绘制患者发生MACE的生存曲线,生存曲线的比较采用Log-rank检验。

结果

DCB组、DES组和BVS组患者基线资料比较,差异无统计学意义(P>0.05)。术后即刻BVS组MLD、AG高于DCB组、DES组,RDS低于DCB组、DES组(P<0.05),术后1年DES组RDS低于DCB组(P<0.05)。3组患者院内均无MACE发生,术后中位随访时间为478(425,538)d,共发生38例MACE,随访期间3组均无心肌梗死与心源性死亡事件发生;出血事件:DCB组有0例,DES组有3例,BVS组有3例,表现为牙龈出血,经评估为轻度出血。Log-rank检验结果示3组患者无MACE存活率比较,差异无统计学意义(P=0.580)。LASSO回归分析筛选低密度脂蛋白胆固醇(LDL-C)、介入治疗史纳入多因素Logistic回归分析,结果示LDL-C(OR=12.204,95%CI=3.403~43.768)、介入治疗史(OR=0.041,95%CI=0.010~0.162)是患者发生MACE的影响因素。

结论

DCB治疗老年CHD患者大血管病变与DES和BVS比较无明显差异,有效性及安全性DES和BVS相当。DCB是治疗老年患者冠状动脉大血管病变安全、有效的方式,LDL-C升高和介入治疗史是MACE发生的影响因素。

关键词: 冠心病, 经皮冠状动脉介入治疗, 冠状动脉气囊血管成形术, 药物涂层球囊, 老年人, 队列研究