药物涂层球囊与药物洗脱支架治疗STEMI有效性及安全性的Meta分析

Meta-analysis of Efficacy and Safety of Drug-coated Balloon and Drug-eluting Stent Treatment for STEMI

目的:探讨药物涂层球囊(DCB)对比药物洗脱支架(DES)对接受直接经皮冠状动脉介入治疗(PCI)的ST段抬高型心肌梗死(STEMI)病人的有效性及安全性。方法:计算机检索中国生物医学文献数据库(CBM)、中国知网期刊数据库(CNKI)、万方数据库、维普中文科技期刊数据库(VIP)、PubMed、the Cochrane Library、Web of Science、EMbase等数据库自建库至2022年9月20日的DCB对比DES治疗STEMI病人的随机对照试验。采用Stata 14、Stata 16及RevMan 5.3软件分析两组病人的心血管死亡事件发生率、再梗死发生率、靶病变血运重建发生率、主要心血管不良事件(MACE)发生率及靶病变晚期管腔丢失(LLL)。结果:最终纳入8项研究,涉及病人773例,均接受直接PCI治疗,其中试验组(应用DCB)383例,对照组(应用DES)390例。两组病人的心血管死亡发生率[OR=0.72,95%CI(0.20,2.52),Z=0.52,P=0.60]、再梗死发生率[OR=0.50,95%CI(0.21,1.19),Z=1.57,P=0.12]、靶病变血运重建发生率[OR=0.74,95%CI(0.34,1.61),Z=0.76,P=0.45]、MACE发生率[OR=0.68,95%CI(0.38,1.19),Z=1.36,P=0.17]差异均无统计学意义;与对照组比较,试验组病人靶病变晚期管腔丢失更低[MD=-0.16,95%CI(-0.25,-0.07),Z=3.35,P=0.0008],差异有统计学意义。结论:现有研究表明,在治疗STEMI方面,DCB的安全性及有效性并不劣于DES,DCB可以作为STEMI病人直接PCI的备选方案。

Objective:To analyse the efficacy and safety of drug-coated balloon(DCB)and drug-eluting stent(DES)in patients with ST-elevation myocardial infarction(STEMI)after primary percutaneous coronary intervention(PCI).Methods:The randomized controlled trials of DCB compared with DES in treatment of STEMI patients in Chinese Biomedical Literature Database(CBM),China National Knowledge Infrastructure(CNKI)database,Wanfang Data,Wipro Chinese Full-text Database of Scientific and Technological Journals(VIP),Pubmed,the Cochrane Library,Web of Science,and EMbase were retrieved by computer.The retrieving time was from database establishment to September 2022.Stata 14,Stata 16 and RevMan 5.3 software were used to compare the incidence of cardiovascular death,reinfarction,target-lesion revascularization(TLR),major adverse cardiovascular events(MACE),and late lumen loss(LLL)in two groups.Results:Eight RCTs included 773 patients with STEMI receiving primary PCI were analysed with 383 patients in the DCB group,while 390 patients in the DES group.There were no significant difference between two groups in the incidence of cardiovascular death[OR=0.72,95%CI(0.20,2.52),Z=0.52,P=0.60],reinfarction[OR=0.50,95%CI(0.21,1.19),Z=1.57,P=0.12],TLR[OR=0.74,95%CI(0.34,1.61),Z=0.76,P=0.45]and MACE incidence[OR=0.68,95%CI(0.38,1.19),Z=1.36,P=0.17].The LLL was lower in the DCB group[MD=-0.16,95%CI(-0.25,-0.07),Z=3.35,P=0.0008].Conclusion:For the treatment of STEMI,the safety and efficacy of DCB are not inferior to DES.DCB might provide an alternative option for the patients with STEMI receiving primary PCI.