title: Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents.
abstract: OBJECTIVE
  This study sought to evaluate the long-term safety of the zotarolimus-eluting stent (ZES) using a pooled analysis of pivotal trials.
  
  
  BACKGROUND
  Drug-eluting stents, compared with bare-metal stents (BMS), have reduced restenosis; however, individual trials of these stents have not had sufficient power to ascertain long-term safety.
  
  
  METHODS
  We combined patient level data from 6 prospective randomized single-arm multicenter trials involving 2,132 patients treated with ZES and 596 patients treated with a BMS control. The median follow-up was 4.1 years, with 5-year follow-up completed in 1,256 patients (97% of those eligible). The recommended minimum duration of dual antiplatelet therapy in these studies was 3 to 6 months regardless of stent type. An independent events committee adjudicated all events. The 2 treatment groups were compared after adjustment for between trial variation and for individual patient clinical and angiographic characteristics by propensity score.
  
  
  RESULTS
  The cumulative incidence of adverse events at 5 years for ZES and BMS were: death: 5.9% versus 7.6% (adjusted hazard ratio: 0.81, p = 0.34), cardiac death: 2.4 versus 3.7% (0.83, p = 0.57), myocardial infarction: 3.4 versus 4.8% (0.77, p = 0.37), target lesion revascularization: 7.0% vs. 16.5% (0.42, p < 0.001), stent thrombosis (definite or probable): 0.8 versus 1.7% (0.50, p = 0.21). After adjustment for variation in study and patient characteristics, there were no significant differences in stent thrombosis or the clinical safety event rates at 5 years between ZES and BMS.
  
  
  CONCLUSIONS
  Over 5 years, there was no increased risk of death, myocardial infarction, or stent thrombosis, and there was a benefit of prevention of repeat revascularization procedures in ZES compared with BMS.
authors.affiliation: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA. lmauri1@partners.org
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Songtao
authors.initials: S
authors.lastname: Jiang
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Kweli P
authors.initials: KP
authors.lastname: Thompson
mesh_terms: D016001:Confidence Intervals; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D023903:Coronary Restenosis / Q000517:prevention & control; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; C489443:zotarolimus; D020123:Sirolimus