title: Drug-eluting Balloon Versus Second Generation Drug Eluting Stents in the Treatment of In-stent Restenosis: A Systematic Review and Meta-analysis.
abstract: BACKGROUND
  In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.
  
  
  METHODS
  A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).
  
  
  RESULTS
  Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57mm), higher late loss in MLD (0.11, 0.02-0.19mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB.
  
  
  CONCLUSIONS
  While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.
authors.affiliation: Eastern Heart Clinic, Prince of Wales Hospital, Sydney, NSW, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia. Electronic address: kevin.liou@sesiahs.health.nsw.gov.au.
authors.forename: Kevin
authors.initials: K
authors.lastname: Liou
authors.affiliation: Eastern Heart Clinic, Prince of Wales Hospital, Sydney, NSW, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Nigel
authors.initials: N
authors.lastname: Jepson
authors.affiliation: The Systematic Review Unit, The Collaborative Research (CORE) Group, Macquarie University, Sydney, NSW, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Cao
authors.affiliation: Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Roger
authors.initials: R
authors.lastname: Luo
authors.affiliation: Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Sarvpreet
authors.initials: S
authors.lastname: Pala
authors.affiliation: Eastern Heart Clinic, Prince of Wales Hospital, Sydney, NSW, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Sze-Yuan
authors.initials: SY
authors.lastname: Ooi
mesh_terms: D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular / Q000628:therapy*; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic
keywords: Coronary artery disease; Drug eluting balloon; Drug eluting stent; In-stent restenosis; Outcome assessment; Percutaneous coronary intervention