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.
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.
Authors: Timm Bauer; Christoph A Nienaber; Ibrahim Akin; Karl-Heinz Kuck; Matthias Hochadel; Jochen Senges; Thomas Fetsch; Ulrich Tebbe; Stefan N Willich; Jürgen Stumpf; Georg V Sabin; Sigmund Silber; Gert Richardt; Ralf Zahn Journal: Clin Res Cardiol Date: 2011-03-18 Impact factor: 5.460
Authors: Ulf Ekelund; Lisa Kurland; Fredrik Eklund; Paulus Torkki; Anna Letterstål; Per Lindmarker; Maaret Castrén Journal: Scand J Trauma Resusc Emerg Med Date: 2011-06-13 Impact factor: 2.953