title: Five-year clinical outcomes of drug-eluting stents according to on-label and off-label use.
abstract: OBJECTIVE
  To compare the clinical outcomes of 'on-label' and 'off-label' drug-eluting stents (DESs) over a 5-year follow-up period.
  
  
  METHODS
  A total of 929 patients that underwent percutaneous coronary intervention with DESs were enrolled. Patients were divided into two groups according to on-label (n = 449) and off-label (n = 480) indications. Off-label use was defined as implantation of DESs for acute myocardial infarction (MI), very small vessel, a long stenotic lesion, chronic total occlusion, a bifurcation lesion, an ostial lesion, left main coronary artery disease, multivessel disease, a saphenous vein graft lesion, and a lesion with thrombus. Endpoints were composite of major adverse cardiac events (MACEs), which included all-cause death, ischemic-driven target vessel revascularization (Id-TVR), MI, and stent thrombosis (ST). Clinical outcomes in the two groups were compared for up to 5 years postimplantation.
  
  
  RESULTS
  At 1 year postimplantation, the off-label group had higher incidences of total MACEs (8.2% vs. 3.7%, p = 0.005), Id-TVR (5.0% vs. 1.6%, p = 0.004), and ST (1.7% vs. 0.3%, p = 0.042), and at 5 years postimplantation, the off-label group continued to have higher incidences of total MACEs (17.5% vs. 9.4%, p < 0.001), Id-TVR (13.1% vs. 5.8%, p = 0.024), and ST (2.1% vs. 0.3%, p = 0.021). Multivessel disease and diabetes were found to be independent risk factors of MACE in patients with an off-label indication.
  
  
  CONCLUSIONS
  Patients treated with an on-label DES had better long-term clinical outcomes than those treated with an off-label DES.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Kyu-Hwan
authors.initials: KH
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Ung
authors.initials: U
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Chan-Hee
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Jang-Won
authors.initials: JW
authors.lastname: Son
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Jong-Seon
authors.initials: JS
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Dong-Gu
authors.initials: DG
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
authors.forename: Young-Jo
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Daegu Veterans Hospital, Daegu, Korea.
authors.forename: Jeong-Hwan
authors.initials: JH
authors.lastname: Cho
mesh_terms: D000368:Aged; D002423:Cause of Death; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017410:Practice Guidelines as Topic; D011356:Product Labeling; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Drug-eluting stent; Off-label use; Outcome assessment (health care)