title: Drug-eluting stents versus bare-metal stents for off-label indications: a propensity score-matched outcome study.
abstract: 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.
authors.affiliation: University of Glasgow, UK.
authors.forename: David
authors.initials: D
authors.lastname: Austin
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.forename: Rachel
authors.initials: R
authors.lastname: Slack
authors.forename: Hany
authors.initials: H
authors.lastname: Eteiba
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Flapan
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Jennings
authors.forename: Robin J
authors.initials: RJ
authors.lastname: Northcote
authors.forename: Alastair C H
authors.initials: AC
authors.lastname: Pell
authors.forename: Ian R
authors.initials: IR
authors.lastname: Starkey
authors.forename: Jill P
authors.initials: JP
authors.lastname: Pell
mesh_terms: 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
chemical_list: D008670:Metals