Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials.
OBJECTIVE
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.
Dibra
Alban
A
Deutsches Herzzentrum and 1. Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany.
Kastrati
Adnan
A
Alfonso
Fernando
F
Seyfarth
Melchior
M
Pérez-Vizcayno
Maria-José
MJ
Mehilli
Julinda
J
Schömig
Albert
A
D000368:Aged; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus