Outcomes With Drug-coated Balloon Versus Bare-metal Or Drug-eluting Stents For De Novo Coronary Lesions In Large Vessels:A Meta-analysis Of Randomized Clinical Trials

BACKGROUND:The drug-coated balloon(DCB)has unique advantages in coronary interventions due to its "intervention without implantation" feature,and DCB for in-stent restenosis is a Class I recommendation,Level A evidence in the 2018 European Society of Cardiology guidelines for myocardial revascularization.And several randomized trials have confirmed the efficacy of DCB in bifurcation lesions and small vessel lesions.However,the use of drug-coated balloon(DCB)for de novo coronary artery disease in large vessels have received limited study,and their clinical outcomes remains inconsistent.Objectives:To assess the efficacy and safety of DCB for large-vessel coronary artery disease compared with percutaneous coronary intervention(PCI)with the implantation of either bare-metal stents(BMS)or drug-eluting stents(DES).Methods:We searched studies in Pub Med,Embase,Cochrane Library,CNKI and Wan Fang databases before October 2021 by computer.All randomized controlled trials(RCTs)were included if they compared DCB with a control treatment(DES alone or BMS alone)in patients with coronary reference vessel diameter(RVD)≥2.5mm.The included studies are analyzed by Review Manager 5.3 software.Results:Seven randomized controlled trials with a total of 879 patients were included in this meta-analysis(441 in the DCB group and438 in the control group).Overall,DCB treatment was associated with a lower rate of TLR(RR: 0.30,95%CI: 0.12 to 0.73,P=0.008),less MACEs(RR: 0.22,95%CI: 0.11 to 0.46,P<0.0001),lower incidence of MI(RR: 0.18,95%CI: 0.04 to 0.83,P=0.03)and reduced LLL(MD:-0.23 mm,95%CI:-0.41 to-0.04 mm,P=0.02)compared with stenting group,the difference was statistically significant.And there was no significant difference between DCB and stenting group in terms of MLD(MD:-0.16 mm,95%CI:-0.39 to 0.07 mm,P=0.18),cardiac death(RR: 0.34,95%CI: 0.11 to 1.03,P=0.06)and binary restenosis(RR: 0.51,95%CI: 0.22 to1.16,p =0.11).However,DCB showed significantly smaller MLD compared with DES(MD=-0.27 mm,95% CI:-0.41～-0.13 mm,p=0.0001),with regard to LLL(MD=-0.12 mm,95%CI:-0.25～0.01 mm,P =0.07)and the incidence of TLR(RR=056,95%CI: 0.20-1.58,P=0.27),there was no difference between DCB and DES.And DCB showed significantly lower rate of TLR(RR=0.19,95% CI: 0.04～0.83,P=0:03),reduced LLL(MD=-1.00 mm,95%CI:-1.37～-0.63 mm,P= 0.07)and smaller MLD(MD=0.5mm,95%CI: 0.09～0.91 mm,P= 0.02).ConclusionsThe DCB-only strategy for large vessel coronary de novo lesions would be non-inferior to DES but superior to BMS in terms of efficacy and safety.Compared with BMS,DCB reduces the incidence of target lesions revascularization,reduces late lumen loss.Overall,this study demonstrates the feasibility and effectiveness of DCB for large vessel de novo coronary disease.