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From the Department of Medical Technology Assessment (Ligthart, Vlemmix), University Medical Centre Nijmegen, Nijmegen, the Netherlands; the Technology Assessment Unit (Ligthart, Vlemmix, Dendukuri, Brophy), McGill University Health Centre, Montréal, Que.; and the Departments of Epidemiology and Biostatistics (Dendukuri, Brophy) and Medicine (Brophy), McGill University, Montréal, Que.
Correspondence to: Dr. James M. Brophy, Divisions of Cardiology and Clinical Epidemiology, Rm. R4.12, McGill University Health Centre, Royal Victoria Hospital, 687 Pine Ave. W, Montréal QC H3A 1A1; james.brophy{at}mcgill.ca
Abstract
Background: Drug-eluting stents have been seen as an attractive alternative to bare-metal stents for percutaneous coronary interventions (PCIs) because of the decreased need for revascularization. However, comparative clinical trials have shown no difference in patient outcomes, and drug-eluting stents are considerably more expensive than their bare-metal counterparts. We conducted a systematic review of all published comparative cost-effectiveness analyses to identify the factors contributing to the heterogeneity of their conclusions.
Methods: We retrieved all articles published between Jan. 1, 2000, and July 31, 2006, in which the cost-effectiveness, from a third-party payer perspective, of drug-eluting stents was compared with that of bare-metal stents for PCI in unrestricted patient populations. Electronic databases, Web sites from health technology assessment groups and references of identified articles were searched. Our outcome variable was whether the study's conclusions favoured widespread use of drug-eluting stents, as assessed by 4 independent reviewers. Study characteristics such as quality, funding source, country and year of publication were extracted. Two-by-2 tables and Fisher's exact test were used to study the association between covariates and the outcome variable. A classification and regression tree (CART) model was used for multivariate analysis.
Results: We identified 19 cost-effectiveness analyses. Ten were in favour of widespread use of drug-eluting stents, and 9 favoured more restrained use. Only 1 of 9 high-quality studies supported widespread use, as compared with 9 of 10 lower quality studies (p < 0.001). All of the 7 sponsored studies argued in favour of widespread use, as compared with 3 of the 12 studies without sponsorship (p = 0.003). Studies from the United States were more likely than those from other countries to endorse unlimited use (p = 0.032). A CART model with 2 covariates study quality and sponsorship provided the best fit (error rate 10.5%).
Interpretation: Conclusions drawn by cost-effectiveness analyses of drug-eluting stents for PCI are associated with the study's quality, funding source and country of origin. Vigilance regarding these study characteristics is required when interpreting findings from cost-effectiveness analyses.
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