title: Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials.
abstract: BACKGROUND
  Drug-coated balloons (DCBs) have been developed for the percutaneous treatment of coronary artery disease. An initial focus has been the management of in-stent restenosis (ISR) but randomised controlled trials (RCTs) have been small and powered only for angiographic endpoints.
  
  
  OBJECTIVE
  The aim of the work was to assess the clinical and angiographic outcomes of patients treated for ISR with DCB versus control (balloon angioplasty or drug-eluting stents) by a meta-analysis of RCTs.
  
  
  METHODS
  A comprehensive search was performed of RCTs where patients with ISR were randomly assigned to either DCB or alternative coronary intervention. Outcome measurements were death, myocardial infarction (MI), target lesion revascularisation (TLR), binary definition of restenosis and in-lesion late luminal loss (LLL).
  
  
  RESULTS
  Four studies were identified that fulfilled the inclusion criteria. Pooled odds ratios (ORs) were calculated for patients treated for ISR (n = 399). Mean follow-up duration was 14.5 months. DCBs were associated with lower rates of TLR [8.8 vs. 29.7 % OR (95 % confidence interval, CI) 0.20 (0.11-0.36), p < 0.0001], binary restenosis [10.3 vs. 41.3 % OR (95 % CI) 0.13 (0.07-0.24), p < 0.00001] and MI [0.5 vs. 3.8 %, OR (95 % CI) 0.21 (0.04-1.00), p = 0.05]. No significant heterogeneity was identified.
  
  
  CONCLUSIONS
  Drug-coated balloons appear to be effective versus control in reducing TLR and possibly MI versus balloon angioplasty or drug-eluting stents in the management of ISR.
authors.affiliation: Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Skłodowskiej-Curie Street No 9, 85-094, Bydgoszcz, Poland. eliano.navarese@alice.it
authors.forename: Eliano Pio
authors.initials: EP
authors.lastname: Navarese
authors.forename: David
authors.initials: D
authors.lastname: Austin
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gurbel
authors.forename: Felicita
authors.initials: F
authors.lastname: Andreotti
authors.forename: Udaya
authors.initials: U
authors.lastname: Tantry
authors.forename: Stefan
authors.initials: S
authors.lastname: James
authors.forename: Antonino
authors.initials: A
authors.lastname: Buffon
authors.forename: Marek
authors.initials: M
authors.lastname: Kozinski
authors.forename: Karolina
authors.initials: K
authors.lastname: Obonska
authors.forename: Kevin
authors.initials: K
authors.lastname: Bliden
authors.forename: Young-Hoon
authors.initials: YH
authors.lastname: Jeong
authors.forename: Jacek
authors.initials: J
authors.lastname: Kubica
authors.forename: Vijay
authors.initials: V
authors.lastname: Kunadian
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003324:Coronary Artery Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D006801:Humans; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic