title: Sex-related effectiveness of bivalirudin versus abciximab and heparin in non-ST-segment elevation myocardial infarction.
abstract: BACKGROUND
  Female sex independently predicts bleeding risk after percutaneous coronary intervention (PCI). Bivalirudin is safer than abciximab plus heparin in patients with non-ST-segment elevation myocardial infarction (NSTEMI). Thus, a greater benefit of bivalirudin in women would be expected.
  
  
  METHODS
  We performed a sex-based analysis of the patients with NSTEMI (n = 1,721, 399 women) enrolled in the ISAR-REACT 4 trial and randomized to receive bivalirudin or abciximab plus heparin. Main outcome was a 30-day composite of death, large recurrent myocardial infarction, urgent target vessel revascularization, or major bleeding. Secondary outcome was 1-year composite of death, myocardial infarction, or target vessel revascularization.
  
  
  RESULTS
  No difference in the main outcome was observed in groups with bivalirudin or abciximab plus heparin: 12.6% versus 15.5% (hazard ratio [HR] 0.81, 95% CI 0.48-1.37) among women and 10.6% versus 9.5% (HR 1.12, 95% CI 0.77-1.64) among men. Major bleeding occurred in 4.5% in the bivalirudin group versus 7.5% in the abciximab plus heparin group (HR 0.60, 95% CI 0.26-1.39) among women and 2.0% versus 3.8% (HR 0.52, 0.27-1.02) among men. At 1 year, the secondary outcome was observed in 24.1% in the bivalirudin group versus 28.7% in the abciximab plus heparin group among women, HR of 0.80 (95% CI 0.55-1.17), and in 20.6% and 19.0%, respectively, HR of 1.10 (95% CI 0.86-1.40) among men.
  
  
  CONCLUSIONS
  Despite a higher peri-PCI bleeding risk in women, bivalirudin is as effective as and safer than abciximab plus heparin in women and men with NSTEMI undergoing PCI.
authors.affiliation: Klinikum der Universitaet Munich, Munich, Germany. julinda.mehilli@med.uni-muenchen.de
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.forename: Lamin
authors.initials: L
authors.lastname: King
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Fatima
authors.initials: F
authors.lastname: Maimer Rodrigues da Cunha
authors.forename: David
authors.initials: D
authors.lastname: Jochheim
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
mesh_terms: D000077284:Abciximab; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D005260:Female; D006629:Hirudins; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012737:Sex Factors; D015912:Thrombolytic Therapy
chemical_list: D000911:Antibodies, Monoclonal; D000991:Antithrombins; D006629:Hirudins; D007140:Immunoglobulin Fab Fragments; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; C074619:bivalirudin; D000077284:Abciximab