title: Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention: a subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial.
abstract: BACKGROUND
  Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points.
  
  
  OBJECTIVE
  The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial.
  
  
  METHODS
  A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted.
  
  
  RESULTS
  Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality.
  
  
  CONCLUSIONS
  Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
authors.forename: Matthews
authors.initials: M
authors.lastname: Chacko
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Wolski
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: John A
authors.initials: JA
authors.lastname: Bittl
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tsuchiya
authors.forename: Amadeo
authors.initials: A
authors.lastname: Betriu
authors.forename: Michael H
authors.initials: MH
authors.lastname: Yen
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.forename: Leslie
authors.initials: L
authors.lastname: Cho
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000401:mortality; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000209:etiology*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D010446:Peptide Fragments / Q000009:adverse effects* / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D012737:Sex Factors
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin