A comparison of bare-metal and drug-eluting stents for off-label indications.
BACKGROUND
Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown.


METHODS
We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm.


RESULTS
Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents.


CONCLUSIONS
Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.
Marroquin
Oscar C
OC
Cardiovascular Institute, University of Pittsburgh, Pittsburgh, USA. marroquinoc@upmc.edu
Selzer
Faith
F
Mulukutla
Suresh R
SR
Williams
David O
DO
Vlachos
Helen A
HA
Wilensky
Robert L
RL
Tanguay
Jean-François
JF
Holper
Elizabeth M
EM
Abbott
J Dawn
JD
Lee
Joon S
JS
Smith
Conrad
C
Anderson
William D
WD
Kelsey
Sheryl F
SF
Kip
Kevin E
KE
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D019370:Observation; D011356:Product Labeling; D016016:Proportional Hazards Models; D012307:Risk Factors; D015607:Stents; D016019:Survival Analysis