title: Influence of sex on long-term outcomes after percutaneous coronary intervention with the paclitaxel-eluting coronary stent: results of the "TAXUS Woman" analysis.
abstract: OBJECTIVE
  We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients.
  
  
  BACKGROUND
  Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice.
  
  
  METHODS
  We analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 "real-world" registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent-treated women (n = 395) in the randomized trials.
  
  
  RESULTS
  In the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent-treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis.
  
  
  CONCLUSIONS
  This study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.
authors.affiliation: Department of Cardiovascular Medicine, Imperial College Healthcare National Health Service Trust, St. Mary’s Hospital, Praed Street, London, United Kingdom. g.mikhail@imperial.ac.uk
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.forename: Robert T
authors.initials: RT
authors.lastname: Gerber
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: John M
authors.initials: JM
authors.lastname: Lasala
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turco
authors.forename: Anita A
authors.initials: AA
authors.lastname: Joshi
authors.forename: Donald S
authors.initials: DS
authors.lastname: Baim
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D016001:Confidence Intervals; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality / Q000628:therapy; D023903:Coronary Restenosis / Q000188:drug therapy / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000188:drug therapy / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D016012:Poisson Distribution; D012042:Registries; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel