Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.
BACKGROUND
The US Food and Drug Administration recently concluded that data on off-label drug-eluting stent (DES) safety are limited. However, in actual clinical practice, DES are often used for off-label indications, and observational studies demonstrate that complications are higher when compared with on-label use. We aimed to determine whether clinical outcomes differ after DES and bare-metal stent implantation in a patient cohort defined by DES off-label indications.


RESULTS
We used the national revascularization registry in Scotland to identify patients who underwent coronary stenting for an off-label indication between January 2003 and September 2005. Individual-level linkage to comprehensive national admission and death databases was used to ascertain the end points of death, myocardial infarction, and target-vessel revascularization. We calculated propensity scores on the basis of clinical, demographic, and angiographic variables and matched DES to bare-metal stents on a 1:1 basis. The final study population consisted of 1642 patients, well matched for important covariables at baseline. Event-free survival was calculated over 24 months with the Kaplan-Meier method. All-cause death was more common after bare-metal stent implantation during follow-up (7.7% versus 6.6%; hazard ratio 0.63; 95% confidence interval, 0.40 to 0.99; P=0.04). No difference in the rates of myocardial infarction were noted (7.3% versus 7.5%; hazard ratio 1.02; 95% confidence interval, 0.69 to 1.54; P=0.92). Target-vessel revascularization was reduced in patients treated with DES (13.9% versus 10.7%; hazard ratio 0.67; 95% confidence interval, 0.49 to 0.93; P=0.02).


CONCLUSIONS
At 24 months, patients treated with DES for off-label indications had lower rates of death and target-vessel revascularization and similar rates of myocardial infarction, as compared with patients treated with bare-metal stents.
Austin
David
D
University of Glasgow, UK.
Oldroyd
Keith G
KG
McConnachie
Alex
A
Slack
Rachel
R
Eteiba
Hany
H
Flapan
Andrew D
AD
Jennings
Kevin P
KP
Northcote
Robin J
RJ
Pell
Alastair C H
AC
Starkey
Ian R
IR
Pell
Jill P
JP
D000368:Aged; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000401:mortality; D015331:Cohort Studies; D054059:Coronary Occlusion / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology* / Q000401:mortality; D056687:Off-Label Use / Q000706:statistics & numerical data; D057216:Propensity Score; D012042:Registries; D012606:Scotland; D016019:Survival Analysis; D016896:Treatment Outcome
D008670:Metals