随机对照比较药物球囊与普通球囊用于冠脉分叉病变的临床效果研究

发布时间：2018-09-10 11:22

【摘要】：研究背景及目的:经皮冠状动脉介入治疗(PCI)已成为当今冠心病主要的治疗手段,随着介入器械以及介入技术的不断改进和提高,现代PCI治疗的适应证越来越宽。过去认为治疗困难甚至是禁忌症的病变类型现在可以很安全地进行治疗。然而分叉病变的介入治疗依旧充满挑战、治疗效果仍不甚理想。药物涂层球囊(DCB)作为近年来出现的一项新技术,为冠心病带来了新的介入治疗理念。其应用于小血管病变及分叉病变中的效果也初显优势,但目前就其进行的临床研究相对较少、且其中多数为小样本量研究,其临床证据还需进一步加强。本文通过于我院进行的随机对照比较药物球囊与普通球囊应用于冠脉分叉病变患者的临床试验,通过对比分析,评价药物球囊应用于分叉病变治疗中的安全性和有效性。为DCB应用于分叉病变、分支小血管病变积累更多临床依据,并旨在探索更加简洁、有效的分叉病变介入治疗方法。研究方法:入选2015年3月至2015年12月期间就诊于吉林大学第一医院心血管内科、诊断为冠状动脉粥样硬化性心脏病并通过行冠状动脉造影检查证实为真性分叉病变,术式拟采用单支架术、仅于病变主支置入药物洗脱支架(DES),分支不考虑支架置入、拟单纯与主支行对吻扩张的病人共40例。随机将其分为试验组及对照组各20例,其分支处理分别采用药物涂层球囊(DCB)和普通球囊经60S扩张治疗后与主支行对吻扩张。并于术后270±30天行冠状动脉造影随访。收集两组患者的基本临床资料、PCI术相关资料进行基线资料比较。采用定量冠状动脉造影(QCA)比较并统计分析分支靶血管随访复查时较术后即刻狭窄程度差异。研究结果:1、试验组和对照组患者的定量资料比较:两组患者的年龄、手术时间,术前MV直径、术前MV狭窄程度、术前SB直径、术前SB狭窄程度、MV/SB夹角、术后即刻SB狭窄程度等基线资料在两组间比较,差异无统计学意义(P均0.05)。术后随访复查SB狭窄程度,试验组20.00(20.00-30.00)VS对照组35.00(22.5.-50.00),差异在两组间比较有统计学意义(P=0.009)。2、试验组和对照组患者的定性资料比较:两组患者的性别、吸烟史,有无高血压、糖尿病、高血脂病史,狭窄的病变部位、分叉病变类型等基线资料在两组间比较,差异无统计学意义(P均0.05)。3、试验组和对照组患者SB随访复查狭窄程度定性资料比较:将试验组和对照组患者SB随访复查狭窄程度较术后即刻SB狭窄程度变化转化为定性资料,随访时狭窄程度较前加重定义为“进展”,随访时狭窄程度较前无变化定义为“维持”,随访时狭窄程度较前减轻定义为“好转”。三组间进行比较、其差异有统计学意义(P=0.001)。三组间两两比较,其中进展组VS维持组、进展组VS好转组,复查狭窄程度变化、其差异有统计学意义(p0.016)。维持组VS好转组,复查狭窄程度变化、其差异无统计学意义(p0.016)。结论:1、分叉病变行单支架术后行对吻扩张是一种操作简单、可行、成功率高的冠脉介入治疗技术,在冠脉分叉病变中可以常规采用;2、分叉病变行单支架术后行对吻扩张,药物涂层球囊应用于分支血管较普通球囊远期临床疗效好。有助于减少分支血管的再狭窄率;3、分叉病变采用药物洗脱支架联合药物涂层球囊行单支架术后对吻扩张,似乎是一种更加有效的分叉病变治疗方法。
[Abstract]:BACKGROUND AND OBJECTIVE: Percutaneous coronary intervention (PCI) has become the main treatment for coronary heart disease. With the continuous improvement of interventional instruments and techniques, the indications of modern PCI are becoming wider and wider. However, interventional therapy for bifurcation lesions is still challenging, and the therapeutic effect is still not satisfactory. Drug-coated balloon (DCB), as a new technology emerging in recent years, has brought a new concept of interventional therapy for coronary heart disease. In this paper, the safety and efficacy of drug balloon in the treatment of bifurcation lesions were evaluated by comparing the randomized controlled clinical trials of drug balloon and common balloon in patients with coronary bifurcation lesions. Methods: From March 2015 to December 2015, the patients were admitted to the Department of Cardiovascular Medicine of the First Hospital of Jilin University. They were diagnosed as coronary atherosclerotic heart disease and passed the examination. A total of 40 patients were randomly divided into experimental group and control group, 20 patients in each group were treated with drug-eluting stent (DES) and 20 patients in each group. After 60S dilatation of balloon (DCB) and common balloon, the patients were followed up with coronary angiography (CA) at 270 65 Results: 1. There was no significant difference in the baseline data of age, operation time, MV diameter before operation, MV stenosis degree before operation, SB diameter before operation, SB stenosis degree before operation, MV / SB angle, SB stenosis degree immediately after operation between the two groups (P After follow-up, the degree of SB stenosis was reexamined in the experimental group (20.00-30.00) and the control group (35.00-22.5-50.00). The difference was statistically significant between the two groups (P = 0.009). The qualitative data of the experimental group and the control group were compared: gender, smoking history, hypertension, diabetes mellitus, hyperlipidemia history, stenosis lesion site. There was no significant difference between the two groups in baseline data, such as the type of bifurcation lesions (P 0.05). 3. Comparison of qualitative data of stenosis degree in SB follow-up between the experimental group and the control group: The change of stenosis degree in SB follow-up between the experimental group and the control group was translated into qualitative data, and the stenosis degree was higher at follow-up. Pre-aggravation was defined as "progression", stenosis was defined as "maintenance" at follow-up, and stenosis was defined as "improvement" at follow-up. The difference was statistically significant (p0.016). There was no significant difference in the degree of stenosis between the maintenance group and the VS improvement group (p0.016). Conclusion: 1. It is a simple, feasible and high success rate coronary interventional therapy technique for bifurcation lesions. 2. Bifurcation lesions can be routinely used. Drug-eluting stent combined with drug-eluting stent balloon for kiss dilatation seems to be a more effective treatment for bifurcation lesions. Law.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4

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