Fast track — ArticlesOutcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis
Introduction
The long-term safety of the two polymer-based drug-eluting stents approved by the US Food and Drug Administration (FDA)—a sirolimus-eluting stent and a paclitaxel-eluting stent—was questioned by recent studies, which reported increased rates of death, myocardial infarction, or late stent thrombosis compared with bare-metal stents.1, 2, 3, 4, 5 These studies were hampered by few patients, limited durations of follow-up, or an observational study design.
Network meta-analyses6, 7 or mixed treatment comparisons8, 9, 10 would allow us to do a unified, coherent analysis of all randomised controlled trials that compared either of the two drug-eluting stents with bare-metal stents or the two drug-eluting stents head-to-head, while fully respecting randomisation. We established a collaborative group of investigators who provided trial data based on standardised definitions of outcomes,11, 12 and did a network meta-analysis.
Section snippets
Search strategy and selection criteria
We searched Medline, EmBase, the Cochrane Central Register of Controlled Trials (CENTRAL), and relevant websites (www.acc.org, www.tctmd.com, www.theheart.org, www.clinicaltrialresults.org) for studies in any language (from the inception of each database to March, 2007), searched reference lists and conference abstracts by hand, checked relevant reviews, book chapters, and the proceedings of the relevant FDA advisory panels, and contacted manufacturers and trialists. Two investigators (CSt, SA)
Results
We screened the titles and abstracts of 870 potentially eligible reports, examined the full text of 84 articles reporting on 41 different trials, and identified 38 trials13, 14, 15, 20, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58 that met our inclusion criteria (figure 1). Investigators or manufacturers provided data for 29 trials.13, 14, 20, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38, 39, 40, 43,
Discussion
Our collaborative network meta-analysis indicates that drug-eluting stents and bare-metal stents are associated with similar rates of overall and cardiac mortality, and that use of sirolimus-eluting stents is associated with a reduction in the risk of myocardial infarction compared with use of bare-metal and paclitaxel-eluting stents. About 100 patients will have to receive sirolimus-eluting stents, rather than bare-metal or paclitaxel-eluting stents, to prevent one myocardial infarction over 4
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Contributed equally to this report