切割球囊与半顺应性球囊用于冠状动脉分叉病变预扩张的比较

Efficacy of cutting balloon versus semi-compliant balloon for predilation of coronary bifurcation lesions

背景:目前冠状动脉分叉病变治疗尚无高效统一的最佳方案,较多采用主支植入药物洗脱支架、分支用药物涂层球囊扩张的简单策略,但单纯直接的药物涂层球囊扩张不能克服血管壁弹性回缩难题,远期仍存在分支丢失的风险。目的:比较切割球囊与半顺应性球囊用于冠状动脉分叉病变预扩张的疗效和安全性。方法:选择2016年8月至2018年5月焦作市人民医院收治的冠状动脉分叉病变患者110例,其中男83例,女27例,年龄18-88岁,按照分层区组随机化原则分为观察组(n=55)和对照组(n=55)。两组均进行经皮冠状动脉介入治疗,观察组主支采用切割球囊预扩张后植入药物洗脱支架,分支采用切割球囊预扩张后行药物涂层球囊扩张;对照组主支采用半顺应性球囊预扩张后植入药物洗脱支架,分支采用半顺应性球囊预扩张后行药物涂层球囊扩张。术后即刻造影,判定主支、分支的前向血流TIMI分级及有无血管夹层发生;术前、术后即刻、术后6个月、12个月应用冠状动脉造影定量分析主支及分支血管参考直径、最小内径及狭窄程度;记录两组术后12个月内的主要心血管不良事件。研究已获得焦作市人民医院道德伦理委员会审核批准。结果与结论:(1)术后即刻造影,观察组主支、分支的前向血流TIMI 3级达标率高于对照组(P=0.007,0.015),主支、分支的血管夹层发生率低于对照组(P=0.023,0.012),主支、分支的紧急靶血管重建率低于对照组(P=0.006,0.026);(2)观察组术后即刻、6个月及12个月的冠状动脉保持成功率高于对照组(P均<0.001);(3)术后即刻、6个月及12个月,观察组的主支、分支最小内径均大于对照组(P均<0.01),主支、分支内径狭窄程度均小于对照组(P均<0.05);(4)术后12个月内,观察组的主支、分支靶血管再狭窄率低于对照组(P=0.038,0.043),主要心血管不良事件发生率低于对照组(P=0.025);(5)结果表明,在适用主支病变植入药物洗脱支架、分支病变植入药物涂层球囊治疗冠状动脉分叉病变中,切割球囊预扩张较半顺应性球囊预扩张更加安全、有效,并能降低靶血管再狭窄率及主要心血管不良事件发生率。

BACKGROUND:There is no efficient and unified optimal scheme for treating coronary bifurcation diseases.Simple strategies such as drug-eluting stent implantation in the main branch and drug-coated balloon dilation in the sub-branches are mostly adopted.However,direct drug-coated balloon dilation cannot overcome the problem of elastic retraction of vascular wall,and there is still a risk of branch loss in the long term.OBJECTIVE:To investigate the efficacy and safety of a cutting balloon versus a semi-compliant balloon for predilation of coronary bifurcation lesions.METHODS:From August 2016 to May 2018,110 patients with coronary bifurcation lesions admitted at Jiaozuo People’s Hospital were selected,including 83 males and 27 females,aged 18-88 years.The patients were randomized into observation and control groups(n=55/group)and received percutaneous coronary intervention.The main branch in the observation group was predilated by a cutting balloon prior to drug-eluting stent implantation,and the sub-branches were predilated by a cutting balloon prior to drug-coated balloon dilation.The main branch in the control group was predilated by a semi-compliant balloon prior to drug-eluting stent implantation,and the sub-branches were predilated by a semi-compliant balloon prior to drug-coated balloon dilation.Immediate postoperative angiography was performed to determine the forward blood flow TIMI grading of main branches and sub-branches and whether vascular dissection occurred.Coronary angiography quantitative analysis was used to detect the reference diameter,minimum inner diameter and stenosis degree of main and sub-branches before,immediately,6 and 12 months after surgery.Major cardiovascular adverse events within 12 months after surgery were recorded in both groups.The study was approved by the Ethics Committee of Jiaozuo People’s Hospital.RESULTS AND CONCLUSION:(1)Immediate postoperative angiography showed that the TIMI level 3 rate of the main branches and sub-branches in the observation group was higher than that in the control group(P=0.007,0.015),the incidence of vascular dissection was lower than that in the control group(P=0.023,0.012),and the emergency target vessel reconstruction rate was lower than that in the control group(P=0.006,0.026).(2)The success rate of coronary artery maintenance immediately and at 6 and 12 months after surgery in the observation group was higher than that in the control group(all P<0.001).(3)The minimum inner diameter of main branches and sub-branches in the observation group was larger than that in the control group immediately and at 6 and 12 months after surgery(all P<0.01).The degree of inner diameter stenosis was smaller than that in the control group(all P<0.01).(4)The target vessel restenosis rate of main branch and sub-branches in the observation group was lower than that in the control group within 12 months after surgery(P=0.038,0.043).The incidence of major cardiovascular adverse events was lower than that in the control group(P=0.025).(5)These results indicate that in coronary bifurcation lesions,drug-eluting stent implantation is suitable for main branch lesions and drug coated balloon is suitable for sub-branch lesion.Cutting balloon predilation is safer and more effective than semi-compliant balloon predilation.Cutting balloon predilation can also reduce the rate of target restenosis and the incidence of major cardiovascular adverse events.