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Outcome of drug-eluting versus bare-metal stenting used according to on- and off-label criteria
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. (UCR)
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2009 (English)In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 53, no 16, 1389-1398 p.Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use. BACKGROUND: DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations. METHODS: The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics. RESULTS: There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications. CONCLUSIONS: In contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS.

Place, publisher, year, edition, pages
2009. Vol. 53, no 16, 1389-1398 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-124673DOI: 10.1016/j.jacc.2008.09.067ISI: 000265160200001PubMedID: 19371822OAI: oai:DiVA.org:uu-124673DiVA: diva2:317850
Available from: 2010-05-05 Created: 2010-05-05 Last updated: 2010-05-19Bibliographically approved

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