title: Drug-eluting balloons for de novo coronary artery disease: a meta-analysis of angiographic and clinical data.
abstract: OBJECTIVE
  To evaluate the effectiveness of drug-eluting balloons (DEBs) in the treatment of de novo coronary artery disease by performing a meta-analysis of randomized controlled trials (RCTs).
  
  
  BACKGROUND
  Current evidence regarding the success of DEBs is insufficient to formulate formal recommendations.
  
  
  METHODS
  Seven RCTs were ultimately included. The primary angiographic endpoint was in-segment diameter stenosis, compared by measuring weighted mean difference (WMD). The primary clinical endpoint was incidence of major adverse cardiovascular events (MACEs) during a 1-year follow-up, compared by measuring pooled risk ratio (RR).
  
  
  RESULTS
  For de novo native coronary lesions intervention, DEB plus bare metal stent (BMS) was not superior to BMS alone in both primary angiographic and clinical endpoints (in-segment diameter stenosis: WMD, -2.59% [95% confidence interval (CI): -9.13% to 3.94%]; MACEs: RR, 0.83 [95%CI: 0.48-1.46]), and DEB with/without BMS was associated with worse outcomes when compared with DES alone (in-segment diameter stenosis: WMD, 10.64% [95%CI: 2.41-18.87%]; MACEs: RR, 1.54 [95%CI: 0.91-2.61]). Subgroup analysis showed that DEB plus BMS significantly increased the risk of MACEs for simple de novo coronary lesions intervention when compared with DES alone (RR, 1.87 [95%CI: 1.33-2.63]).
  
  
  CONCLUSIONS
  Current data does not support the use of DEBs for de novo coronary lesions, especially for simple coronary lesions.
authors.affiliation: Department of Cardiology, RenJi Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People's Republic of China.
authors.forename: Tuo
authors.initials: T
authors.lastname: Zhang
authors.forename: Shiqun
authors.initials: S
authors.lastname: Sun
authors.forename: Linghong
authors.initials: L
authors.lastname: Shen
authors.forename: Ben
authors.initials: B
authors.lastname: He
mesh_terms: D006328:Cardiac Catheterization / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D006801:Humans; D008670:Metals; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals
keywords: de novo coronary artery disease; drug-eluting balloon; percutaneous coronary intervention