title: Outcomes of stent thrombosis and restenosis during extended follow-up of patients treated with bare-metal coronary stents.
abstract: BACKGROUND
  Concern regarding risk of late thrombosis after "off-label" treatment with drug-eluting stents has prompted increased use of bare-metal stents (BMS) in current practice. The sequelae of late BMS failures, however, have been poorly characterized.
  
  
  RESULTS
  We performed a retrospective study of 4503 consecutive patients treated with at least 1 BMS and dual antiplatelet therapy between 1994 and 2000. The cumulative incidence of stent thrombosis was 0.5% at 30 days (95% CI, 0.3% to 0.7%), 0.8% at 1 year (95% CI, 0.6% to 1.1%), and 2.0% at 10 years (95% CI, 1.5% to 2.5%). Risk of late (30 days to 1 year) and very late (>1 year) BMS thrombosis was increased among patients considered off label for drug-eluting stent use (P=0.024). When saphenous vein graft interventions were excluded, however, risk after off-label use was not significantly increased (P=0.23). Other correlates included vein graft intervention, prior myocardial infarction (MI), peripheral vascular disease, and ulcerated lesion (P<0.001). Mortality was markedly increased after late and very late BMS thrombosis, particularly during the first 30 days (hazard ratios, 22 [95% CI, 3.1 to 159] and 40 [95% CI, 15 to 107], respectively). The 10-year incidence of clinical restenosis was 18.1% (95% CI, 16.5% to 19.7%), presenting with MI in 2.1% (95% CI, 1.6% to 2.6%). Restenosis presenting with MI was associated with increased mortality compared with no restenosis (hazard ratio, 2.37; P<0.001) and with restenosis with a non-MI presentation (hazard ratio, 2.42; P<0.001).
  
  
  CONCLUSIONS
  The incidence of BMS thrombosis and of MI caused by restenosis during extended follow-up is significant. Both complications are associated with mortality.
authors.affiliation: Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minn 55905, USA.
authors.forename: Brendan
authors.initials: B
authors.lastname: Doyle
authors.forename: Charanjit S
authors.initials: CS
authors.lastname: Rihal
authors.forename: Crochan J
authors.initials: CJ
authors.lastname: O'Sullivan
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Lennon
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Wiste
authors.forename: Malcolm
authors.initials: M
authors.lastname: Bell
authors.forename: John
authors.initials: J
authors.lastname: Bresnahan
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000639:trends; D015331:Cohort Studies; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000209:etiology / Q000401:mortality; D003328:Coronary Thrombosis / Q000453:epidemiology* / Q000209:etiology / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals / Q000009:adverse effects*; D008875:Middle Aged; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects* / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals