title: Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents.
abstract: BACKGROUND
  Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear.
  
  
  OBJECTIVE
  To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features.
  
  
  METHODS
  From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents.
  
  
  METHODS
  The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated.
  
  
  RESULTS
  Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05).
  
  
  CONCLUSIONS
  Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.
authors.affiliation: Baylor College of Medicine, Houston, Tex. USA.
authors.forename: Htut K
authors.initials: HK
authors.lastname: Win
authors.forename: Angel E
authors.initials: AE
authors.lastname: Caldera
authors.forename: Kelly
authors.initials: K
authors.lastname: Maresh
authors.forename: John
authors.initials: J
authors.lastname: Lopez
authors.forename: Charanjit S
authors.initials: CS
authors.lastname: Rihal
authors.forename: Manish A
authors.initials: MA
authors.lastname: Parikh
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
authors.forename: Sachin
authors.initials: S
authors.lastname: Marulkar
authors.forename: Deborah
authors.initials: D
authors.lastname: Nassif
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003257:Consumer Product Safety; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D012042:Registries; D012306:Risk; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents / Q000009:adverse effects / Q000706:statistics & numerical data; D016019:Survival Analysis; D013927:Thrombosis / Q000453:epidemiology; D016896:Treatment Outcome; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel; D020123:Sirolimus