title: Bivalirudin versus heparin in women undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized clinical trials.
abstract: BACKGROUND
  The anticoagulant of choice during percutaneous coronary intervention (PCI) in women is not well established.
  
  
  METHODS
  An electronic search was conducted for trials that randomized patients undergoing PCI to bivalirudin versus heparin, and reported outcomes of interest in women. Random effects DerSimonian-Laird risk ratios (RR) were calculated. Main outcome was net adverse clinical events (NACE) at 30-days. Other outcomes included major adverse cardiac events (MACE), all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), and major bleeding at 30-days. 1-year all-cause mortality and MACE were also examined.
  
  
  RESULTS
  Nine trials that randomized women undergoing PCI to bivalirudin (n=3960) versus heparin (n=4050) were included. At 30-days, bivalirudin was associated with reduced risk of NACE (RR=0.85; 95% CI 0.73-0.98; p=0.03), mainly driven by reduction in major bleeding (RR=0.59; 95% CI 0.49-0.71; p<0.001) compared with heparin. No difference in MACE (p=0.92), all-cause mortality (p=0.23), MI (p=0.86); or TVR (p=0.53) was demonstrated between both groups. At 1-year, the risk of MACE and all-cause mortality was similar in both groups. On a subgroup analysis, the benefit associated with bivalirudin appeared to be less evident when Glycoprotein IIb/IIIa inhibitors (GPI) was used as bailout therapy with heparin, however without significant interaction. Furthermore, in STEMI population, no difference in NACE, MACE, or major bleeding was observed between both groups.
  
  
  CONCLUSIONS
  In women undergoing PCI, bivalirudin is associated with reduced risk of major bleeding and NACE compared with heparin especially when GPI is routinely used.
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
authors.forename: Marwan
authors.initials: M
authors.lastname: Saad
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
authors.forename: Ramez
authors.initials: R
authors.lastname: Nairooz
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, Wayne State University/Detroit Medical Center, Detroit, MI, USA.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Rashed
authors.affiliation: Department of Cardiovascular Medicine, Blackpool Teaching Hospital NHS Foundation Trust, Lancashire Cardiac Centre, Blackpool, UK.
authors.forename: Hesham K
authors.initials: HK
authors.lastname: Abdelaziz
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, University of Iowa Carver College of Medicine, Iowa City, IA, USA.
authors.forename: Amgad
authors.initials: A
authors.lastname: Mentias
authors.affiliation: Division of Cardiovascular Medicine, Rhode Island Hospital, Brown Medical School, Providence, RI, USA. Electronic address: jabbott@lifespan.org.
authors.forename: J Dawn
authors.initials: JD
authors.lastname: Abbott
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D003327:Coronary Disease / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: Bivalirudin; PCI; heparin; women