Efficacy Of Drug-coated Balloons Approaches For De Novo Coronary Artery Disease: A Bayesian Network Meta-analysis

Background and objective: The de novo coronary lesions refer to a series of primary lesions without coronary intervention and are the most common type of coronary atherosclerotic heart disease.Stents implantation has currently become the main treatment method for coronary de novo lesions,mainly including bare-metal stents（BMS）,drug-eluting stents（DES）and bioabsorbable stents.However,such as stent thrombosis,stent restenosis and stent rupture may occur after stent implantation.Therefore,the most ideal way of cardiac interventional therapy is to achieve without implantation after interventional therapy,to reduce a series of complications caused by stent implantation.Drug-coated balloon（DCB）is mainly recommended for the treatment of in-stent restenosis in clinical practice,and a large number of clinical trials have confirmed the effectiveness for the de novo coronary lesions,including DCB+BMS and DCB only regimens.Therefore,this network meta-analysis was conducted to compare stents and DCB regiments based on a Bayesian network model to evaluate the efficacy of DCB in the treatment of de novo coronary artery lesions.Method: Pub Med,EMBASE and Cochrane Library databases were retrieved to include the relevant randomized controlled trials that compared DCB approaches and stents implantation in patients with de novo coronary artery diseases.The primary outcome was major adverse cardiac events（MACE）.The clinical outcomes included target lesion revascularization（TLR）,all-cause death and myocardial infarction.The angiographic outcomes consisted of in-segment late lumen loss（LLL）and binary restenosis.The odds risk（OR）and 95% confidence intervals（CI）for dichotomous data,mean differences for continuous data were calculated in the Bayesian network frame.Results: A total of 26 randomized controlled trials and 4664 patients were included in this study.The DCB only strategy was comparable with the efficacy of MACE,clinical outcomes and binary restenosis compared with DES.In addition,this strategy can also significantly reduce the in-segment LLL compared with the first-generation（MD-0.29,-0.49 to-0.12）and the second-generation DES（MD-0.15,-0.27 to-0.026）.However,the subgroup analysis suggested that DCB only was associated with higher in-segment LLL than DES（MD 0.33,0.14 to 0.51）in patients with acute coronary syndrome.Compared with DES,the DCB+ BMS strategy had similar incidence of myocardial infarction and all-cause death,but higher incidence of MACE,TLR and angiographic outcomes.In addition,although the DCB+BMS was associated with similar incidence of myocardial infarction and all-cause death than BMS,with lower incidence of MACE,TLR and angiographic outcomes.Conclusion: The DCB only is associated with similar efficacy and lower risk of LLL compared with DES.In addition,the DCB+ BMS strategy is superior to BMS alone but inferior to DES.