title: Comparison between on-label versus off-label use of drug-eluting coronary stents in clinical practice: results from the German DES.DE-Registry.
abstract: BACKGROUND
  Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited.
  
  
  METHODS
  We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter <2.5 or >3.5 mm.
  
  
  RESULTS
  Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p < 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p < 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62-1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78-1.42).
  
  
  CONCLUSIONS
  In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.
authors.affiliation: Department of Cardiology, Medizinische Klinik B, Herzzentrum Ludwigshafen, Bremserstrasse 79, 67063, Ludwigshafen, Germany. bauer-timm@gmx.de
authors.forename: Timm
authors.initials: T
authors.lastname: Bauer
authors.forename: Christoph A
authors.initials: CA
authors.lastname: Nienaber
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Akin
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Matthias
authors.initials: M
authors.lastname: Hochadel
authors.forename: Jochen
authors.initials: J
authors.lastname: Senges
authors.forename: Thomas
authors.initials: T
authors.lastname: Fetsch
authors.forename: Ulrich
authors.initials: U
authors.lastname: Tebbe
authors.forename: Stefan N
authors.initials: SN
authors.lastname: Willich
authors.forename: Jürgen
authors.initials: J
authors.lastname: Stumpf
authors.forename: Georg V
authors.initials: GV
authors.lastname: Sabin
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Ralf
authors.initials: R
authors.lastname: Zahn
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications / Q000401:mortality / Q000628:therapy*; D015331:Cohort Studies; D017023:Coronary Angiography; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D016896:Treatment Outcome