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Outcomes Similar for Off-Label and On-Label Stent Use

Last Updated: April 15, 2009.

On-label and off-label uses of bare-metal and drug-eluting stents are associated with similar rates of heart attack and death across the range of clinical indications, researchers report in the April 21 issue of the Journal of the American College of Cardiology.

WEDNESDAY, April 15 (HealthDay News) -- On-label and off-label uses of bare-metal and drug-eluting stents are associated with similar rates of heart attack and death across the range of clinical indications, researchers report in the April 21 issue of the Journal of the American College of Cardiology.

Jorg Carlsson, M.D., from Kalmar County Hospital in Kalmar, Sweden, and colleagues examined outcomes in 17,198 patients who underwent coronary stenting for an on-label indication (10,431 bare-metal stents, 6,767 drug-eluting stents) as defined by the U.S. Food and Drug Administration and 16,355 patients who underwent stenting for an off-label indication (9,907 bare-metal stents, 6,448 drug-eluting stents).

After a follow-up of one to four years, the researchers found that the incidence of myocardial infarction and death was similar for on-label use of drug-eluting and bare-metal stents (adjusted hazard ratio, 1.02) and for off-label use of both types of stents (adjusted hazard ratio, 0.95). Off-label use of drug-eluting stents was associated with a similar combined risk of death and myocardial infarction as bare-metal stents for a range of clinical conditions.

"In contemporary Swedish practice, neither on- nor off-label use of drug-eluting stents is associated with worse outcome than use of bare-metal stents," Carlsson and colleagues conclude.

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