Outcome of drug-eluting versus bare-metal stenting used according to on- and off-label criteria.
OBJECTIVE
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.
Carlsson
Jörg
J
Department of Internal Medicine, Division of Cardiology, Kalmar County Hospital, Kalmar, Sweden. jorgc@ltkalmar.se
James
Stefan K
SK
Lindbäck
Johan
J
Scherstén
Fredrik
F
Nilsson
Tage
T
Stenestrand
Ulf
U
Lagerqvist
Bo
B
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D011356:Product Labeling; D012307:Risk Factors; D016896:Treatment Outcome