Effectiveness of Drug-Eluting Stents in Patients With Bare-Metal In-Stent Restenosis. Meta-Analysis of Randomized Trials

Alban Dibra, Adnan Kastrati, Fernando Alfonso, Melchior Seyfarth, Maria José Pérez-Vizcayno, Julinda Mehilli, Albert Schömig

Research output: Contribution to journalArticlepeer-review

147 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)616-623
Number of pages8
JournalJournal of the American College of Cardiology
Volume49
Issue number5
DOIs
StatePublished - 6 Feb 2007
Externally publishedYes

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