Author + information
- Received June 5, 2008
- Revision received August 8, 2008
- Accepted September 18, 2008
- Published online April 21, 2009.
- Jörg Carlsson, MD, PhD*,* (, )
- Stefan K. James, MD, PhD†,
- Johan Lindbäck, PhD†,
- Fredrik Scherstén, MD, PhD‡,
- Tage Nilsson, MD, PhD†,
- Ulf Stenestrand, MD, PhD§,
- Bo Lagerqvist, MD, PhD†,
- SCAAR (Swedish Coronary Angiography and Angioplasty Registry) Study Group
- ↵*Reprint requests and correspondence:
Dr. Jörg Carlsson, Länssjukhuset i Kalmar, Lasarettsvägen, S-39185 Kalmar, Sweden
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.
The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and the Uppsala Clinical Research Centre (UCR) are funded by the Swedish Association of Local Authorities and Regions and the Swedish Heart Foundation. This study was also sponsored by a grant from the Swedish Board of Health and Welfare and the Swedish Medical Products Agency.
- Received June 5, 2008.
- Revision received August 8, 2008.
- Accepted September 18, 2008.
- American College of Cardiology Foundation