Drug-coated balloons in treatment of in-stent restenosis: A meta-analysis of randomised controlled trials

Eliano Pio Navarese, David Austin, Paul A. Gurbel, Felicita Andreotti, Udaya Tantry, Stefan James, Antonino Buffon, Marek Kozinski, Karolina Obonska, Kevin Bliden, Young Hoon Jeong, Jacek Kubica, Vijay Kunadian

Research output: Contribution to journalArticlepeer-review

22 Scopus citations


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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)279-287
Number of pages9
JournalClinical Research in Cardiology
Issue number4
StatePublished - Apr 2013
Externally publishedYes


  • Angioplasty
  • Coronary artery disease
  • Drug-coated balloons
  • Drug-eluting stents
  • Meta-analysis
  • Randomized controlled trials

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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