药物涂层球囊在急性冠状动脉综合征伴高出血风险患者中的应用研究  

Safety and Efficacy of Drug-coated Balloons in Patients With Acute Coronary Syndrome Combined With High Bleeding Risk

作　　者：张浩渊 王徐乐[1] 卢文杰[1] 王玺[1] 单迎光[1] 朱永建 薛力旗 韩战营[1] 邱春光[1] ZHANG Haoyuan;WANG Xule;LU Wenjie;WANG Xi;SHAN Yingguang;ZHU Yongjian;XUE Liqi;HAN Zhanying;QIU Chunguang(Department of Cardiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院心内科,郑州450052

出　　处：《中国循环杂志》2023年第4期402-407,共6页Chinese Circulation Journal

基　　金：河南省医学科技攻关计划省部共建项目(SB201901027)。

摘　　要：目的:比较药物涂层球囊(DCB)与药物洗脱支架(DES)在急性冠状动脉综合征(ACS)伴高出血风险(HBR)患者中的安全性和有效性。方法:连续纳入2020年1月至2020年12月期间于郑州大学第一附属医院心内科接受单纯DCB或DES治疗且符合纳入及排除标准的ACS伴HBR患者共239例,分为DCB组(n=73)和DES组(n=166),收集两组患者的基线资料、手术资料并进行随访。研究的主要终点为净临床获益复合终点事件,包括心原性死亡、急性心肌梗死(AMI)、靶血管血运重建(TVR)、出血学术研究联合会(BARC)≥2型出血;次要终点为BARC≥1型出血、BARC≥3型出血和主要不良心血管事件(MACE,包括心原性死亡、AMI和TVR)。结果:两组在各基线资料指标方面的差异均无统计学意义(P均>0.05)。平均随访(20.5±3.9)个月,DCB组净临床获益复合终点事件的发生率(9.6%vs.21.7%,P=0.025)和发生风险(HR=0.44,95%CI:0.23~0.83,log-rank P=0.031)均明显低于DES组。DCB组BARC≥1型出血的发生率显著低于DES组(8.2%vs.22.9%,P=0.009),两组的MACE(6.8%vs.9.0%,P=0.727)和BARC≥3型出血(0%vs.4.8%,P=0.059)发生率差异均无统计学意义。结论:单纯DCB治疗ACS伴HBR患者安全、有效,且与DES相比可显著降低术后出血事件发生风险。Objectives:To compare the safety and efficacy of drug-coated balloon(DCB)with drug-eluting stent(DES)in patients with acute coronary syndrome(ACS)combined with high bleeding risk(HBR).Methods:A total of 239 consecutive patients with ACS and HBR who were treated with DCB alone or DES alone from January 2020 to December 2020 at the First Affiliated Hospital of Zhengzhou University and met the inclusion criteria were enrolled(including 73 in the DCB group and 166 in the DES group).Baseline data,procedural data,and follow-up data were compared between the two groups.The primary endpoint of the study was the composite endpoint of net clinical benefit,including cardiac death,acute myocardial infarction(AMI),target vessel revascularization(TVR),and Bleeding Academic Research Consortium(BARC)≥type 2 bleeding.Secondary endpoints were:BARC≥type 1 bleeding,BARC≥type 3 bleeding,and major adverse cardiovascular events(MACE,including cardiac death,AMI,and TVR).Results:There were no statistically significant differences in baseline information between the two groups.After a mean follow-up of(20.5±3.9)months,the incidence of net clinical benefit composite endpoint was significantly lower in the DCB group than in the DES group(9.6%vs.21.7%,P=0.025;HR=0.44,95%CI:0.23-0.83,log-rank P=0.031).The incidence of BARC≥type 1 bleeding was significantly lower in the DCB group than in the DES group(8.2%vs.22.9%,P=0.009).The incidences of MACE and BARC≥type 3 bleeding events were similar between the two groups(6.8%vs.9.0%,P=0.727;0%vs.4.8%,P=0.059).Conclusions:DCB alone is safe and effective in treating patients with ACS and HBR and can significantly reduce the risk of postoperative hemorrhagic events compared to DES.

关 键 词：药物涂层球囊 急性冠状动脉综合征 高出血风险 药物洗脱支架 

分 类 号：R54[医药卫生—心血管疾病]