Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials

J Am Coll Cardiol. 2007 Feb 6;49(5):616-23. doi: 10.1016/j.jacc.2006.10.049. Epub 2006 Dec 4.


Objectives: We sought to synthesize the available evidence on the effectiveness of drug-eluting stents for bare-metal in-stent restenosis.

Background: Although there is clinical evidence that drug-eluting stents are associated with better results than other treatments for in-stent restenosis, they are not yet approved for this indication. Meta-analysis of randomized trials may yield more precise estimates of treatment effects and enable a rapid adoption of effective treatments in clinical practice.

Methods: Data sources included PubMed and conference proceedings. Prespecified criteria were met by 4 randomized studies comparing sirolimus- or paclitaxel-eluting stents versus balloon angioplasty or vascular brachytherapy in 1,230 patients with bare-metal in-stent restenosis. Studies reported the clinical outcomes of efficacy and safety during a minimum of 9 months. The primary outcome was target lesion revascularization.

Results: No significant heterogeneity was found across trials, thus showing a similar effect size regardless of the use of balloon angioplasty or vascular brachytherapy as comparators. The risk of target lesion revascularization (odds ratio 0.35, 95% confidence interval [CI] 0.25 to 0.49; p < 0.001) and that of angiographic restenosis (odds ratio 0.36, 95% CI 0.27 to 0.49; p = 0.001) were markedly lower in patients treated with drug-eluting stents. There were no differences between patients treated with drug-eluting stents and those treated with other techniques with respect to the composite of death or myocardial infarction (odds ratio 1.04, 95% CI 0.54 to 2.03; p = 0.55).

Conclusions: Drug-eluting stents are markedly superior to conventional techniques (balloon angioplasty and vascular brachytherapy) and should be considered as first-line treatment for patients with bare-metal in-stent restenosis.

Publication types

  • Meta-Analysis

MeSH terms

  • Aged
  • Female
  • Graft Occlusion, Vascular / prevention & control*
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Randomized Controlled Trials as Topic
  • Sirolimus / administration & dosage*
  • Stents*
  • Treatment Outcome
  • Tubulin Modulators / administration & dosage*


  • Immunosuppressive Agents
  • Tubulin Modulators
  • Paclitaxel
  • Sirolimus