ArticlesA hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents
Introduction
During the past decade, the use of stents has become common practice during percutaneous coronary intervention both to treat acute complications of balloon angioplasty and to decrease rates of angiographic restenosis.1, 2 However, rates of angiographic restenosis even in patients who receive stents are 15–40% at 6 months.3 Restenosis after percutaneous coronary intervention with stenting occurs primarily within the stent (in-stent restenosis) and is almost entirely due to neointimal hyperplasia.4, 5 Studies evaluating stents coated with antimitotic drugs have shown promise at reducing restenosis rates.6 These drugs are commonly released in a controlled way from biocompatible polymer coatings that act as drug reservoirs.7 Medium-term results from several randomised clinical trials suggest that drug-eluting stents (DES) substantially lower rates of angiographic restenosis and the subsequent need for repeat revascularisation procedures compared with bare-metal stents (BMS). However, there have been concerns about the safety of DES, because rare but clinically important complications may become apparent only in larger or combined studies.8, 9 We therefore undertook a meta-analysis of all randomised clinical trials examining DES to quantify more accurately their effect on clinical events and restenosis rates.
Section snippets
Search strategy
We carried out this meta-analysis in accordance with the standard protocol recommended by the Quality of Reporting of Meta-analyses group.10 We searched the PubMed database (Dec 16, 1998, to April 18, 2004) with the keywords “drug*” and “restenosis”. 1137 papers were discovered. The titles were screened so that antimitotic drugs currently under investigation for the treatment of restenosis could be identified. We defined antimitotic drugs as agents that directly inhibit the cell cycle. We then
Results
Our literature search identified 15 randomised clinical trials (figure 1), involving 5835 patients, that investigated DES, including four with sirolimus, seven with paclitaxel, and four with other drugs (table 1).15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 Two trials examining stents eluting QP2 and dactinomycin were terminated prematurely owing to adverse events and had incomplete follow-up reporting.27, 28 In view of the heterogeneity of the antimitotic drugs and polymer
Discussion
The objective of our meta-analysis was to quantify the treatment effect and safety of DES. We found no evidence that DES have any effect on medium-term mortality or rates of myocardial infarction, although further data are needed before definitive conclusions can be drawn. However, the restenosis rate on routine follow-up angiography was substantially lower with DES than with BMS, with consequent reductions in rates of target-lesion revascularisation and major adverse cardiac events. These
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