title: Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.
abstract: OBJECTIVE
  This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications.
  
  
  BACKGROUND
  Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied.
  
  
  METHODS
  The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses.
  
  
  RESULTS
  Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months.
  
  
  CONCLUSIONS
  Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.
authors.affiliation: LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina, USA. bbrodie@triad.rr.com
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Brodie
authors.forename: Thomas
authors.initials: T
authors.lastname: Stuckey
authors.forename: William
authors.initials: W
authors.lastname: Downey
authors.forename: Angela
authors.initials: A
authors.lastname: Humphrey
authors.forename: Barbara
authors.initials: B
authors.lastname: Bradshaw
authors.forename: Chris
authors.initials: C
authors.lastname: Metzger
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.forename: Fred
authors.initials: F
authors.lastname: Krainin
authors.forename: Stanley
authors.initials: S
authors.lastname: Juk
authors.forename: Barry
authors.initials: B
authors.lastname: Cheek
authors.forename: Peter
authors.initials: P
authors.lastname: Duffy
authors.forename: Henry
authors.initials: H
authors.lastname: Smith
authors.forename: John
authors.initials: J
authors.lastname: Edmunds
authors.forename: Jay
authors.initials: J
authors.lastname: Varanasi
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000401:mortality; D003257:Consumer Product Safety; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D018579:Patient Selection; D011356:Product Labeling; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D008670:Metals