title: Comparison of drug-eluting balloon versus drug-eluting stent treatment of drug-eluting stent in-stent restenosis: A meta-analysis of available evidence.
abstract: BACKGROUND
  In-stent restenosis (ISR) remains an important concern despite the recent advances in the drug-eluting stent (DES) technology. The introduction of drug-eluting balloons (DEB) offers a good solution to such problem.
  
  
  OBJECTIVE
  We performed a meta-analysis to assess the clinical efficiency and safety of DEB compared with DES in patients with DES-ISR.
  
  
  METHODS
  A systematic search was conducted and all randomized and observational studies which compared DEB with DES in patients with DES-ISR were included. The primary outcome measure-major adverse cardiovascular events (MACE)-as well as individual events as target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI), cardiac death (CD) and all-cause mortality, were analyzed.
  
  
  RESULTS
  Three randomized and 4 observational studies were included with a total of 2052 patients. MACE (relative risk [RR]=1.00, 95% confidence interval (CI) 0.68 to 1.46, P=0.99), TLR (RR=1.15 [CI 0.79 to 1.68], P=0.44), ST (RR=0.37[0.10 to 1.34], P=0.13), MI (RR=0.97 [0.49 to 1.91], P=0.93) and CD (RR=0.73 [0.22 to 2.45], P=0.61) were not different between patients treated with DEB and with DES. However, all-cause mortality was lower in patients treated with DEB (RR=0.45 [0.23 to 0.87, P=0.019) and in particular when compared to only first generation DES (RR 0.33 [0.15-0.74], P=0.007). There was no statistical evidence for publication bias.
  
  
  CONCLUSIONS
  The results of this meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of DES-ISR.
authors.affiliation: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden; Clinic of Cardiology, University Clinical Centre of Kosova, Prishtina, Republic of Kosovo. Electronic address: gani.bajraktari@umu.se.
authors.forename: Gani
authors.initials: G
authors.lastname: Bajraktari
authors.affiliation: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
authors.forename: Haki
authors.initials: H
authors.lastname: Jashari
authors.affiliation: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden; Clinic of Cardiology, University Clinical Centre of Kosova, Prishtina, Republic of Kosovo.
authors.forename: Pranvera
authors.initials: P
authors.lastname: Ibrahimi
authors.affiliation: Department of Cardiology, La Princesa University Hospital, Institute of Health Research, IIS-IP, University Autonoma of Madrid, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.affiliation: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
authors.forename: Fisnik
authors.initials: F
authors.lastname: Jashari
authors.affiliation: Department of Adult Cardiology, Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.affiliation: Clinic of Cardiology, University Clinical Centre of Kosova, Prishtina, Republic of Kosovo.
authors.forename: Shpend
authors.initials: S
authors.lastname: Elezi
authors.affiliation: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Henein
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000401:mortality; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006801:Humans; D064887:Observational Studies as Topic; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D016896:Treatment Outcome
keywords: Coronary artery disease; Drug-eluting balloon; Drug-eluting stent; In-stent restenosis