Comparison Of Drug-eluting Balloon Versus Drug-eluting Stent For Treatment Of Coronary Artery Disease:A Meta-analysis Of Randomized Controlled Trials

Background:Drug-eluting stents(DES)have been shown to be superior to bare metal stents(BMS)in the treatment of coronary artery disease(CAD).In particular,the emergence of second generation DES has significantly reduced the incidence of restenosis,but in complex lesion subsets,the long-term safety outcomes and persistent restenosis remain concern.The unpredictable risk of delayed stent thrombosis(ST)after DES implantation results in delayed healing of blood vessel,allergic reactions caused by drugs,polymer coatings or both,and impaired vascular endothelial function,which limits the use of DES.In recent years,drug-eluting balloon(DEB)has represented a new treatment for coronary artery disease.DEB has evolved to maintain benefits and eliminate or reduce potential limitations of DES.DEB provides stent-free,rapid and uniform delivery of anti-proliferating drugs to the vascular wall,thereby reducing intimal hyperplasia.DEB plays an important role in the treatment of various types of coronary artery disease,especially in diseases that are not suitable for stent implantation or difficult to operate,such as in-stent restenosis,small vessel disease,bifurcation disease and so on.Objective:DEB has significant value for treating CAD.However,the merits of using DEB versus DES to treat CAD remain controversial.Herein,we conducted a meta-analysis to compare the safety and efficacy of DEB and DES for treatment of CAD.Methods:We searched MEDLINE,EMBASE,and CENTRAL databases for eligible trials comparing DEB with DES for treatment of CAD.We also considered published review articles,editorials,and internet-based sources of information to assess potential information on trials of interest.The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses(PRISMA)guidelines for meta-analyses of randomized trials.The primary endpoint was major adverse cardiac events(MACE);the secondary endpoints included in-lesion late lumen loss(LLL),binary restenosis(BR),myocardial infarction(MI),target lesion revascularization(TLR)and mortality.Results:Twenty-three trials with a total of 2,712 patients were included.There were no significant differences in the primary endpoint of MACE between the DEB and DES groups(Risk Ratio(RR)1.19;95% confidence interval(CI)(0.87,1.63);P=0.27),or in the clinical outcomes of each of MACE's components,including TLR,MI and mortality.However,efficacy was significantly different between the DEB and DES groups,especially when we compared DEB to second-generation DES: in-lesion LLL(Mean Difference(MD)0.11;(0.01,0.22);P=0.03);binary restenosis(RR 1.46;(1.00,2.13);P=0.05).DES was more efficacious in treating de novo coronary diseases,but DES exhibited equivalent efficacy in the treatment of ISR compared to DEB.Analysis of long-term follow-up showed no significant difference between DEB and DES when considering MACE,MI,mortality,and TLR.Conclusions:DEB is equivalent to DES in terms of safety for managing CAD,and DEB may be considered as an alternative choice for treatment of CAD.