title: Impact of gender and antithrombin strategy on early and late clinical outcomes in patients with non-ST-elevation acute coronary syndromes (from the ACUITY trial).
abstract: Women with non-ST-elevation acute coronary syndrome are at increased risk for ischemic and bleeding complications compared with men. We examined the impact of gender and antithrombotic therapy for non-ST-elevation acute coronary syndrome on outcomes in patients in the ACUITY trial. Patients were randomized to heparin (unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin alone. We compared major bleeding unconnected to coronary artery bypass grafting, composite ischemia (death, myocardial infarction, or revascularization), and net clinical outcome (composite ischemia or bleeding) in (1) men versus women overall and undergoing percutaneous coronary intervention (PCI) and (2) women overall and undergoing PCI by antithrombotic strategy. Of 13,819 patients enrolled, 4,157 were women (30.1%). Women had similar 30-day composite ischemia (7% vs 8%, p = 0.07) but greater 30-day rates of major bleeding (8% vs 3% p <0.0001) and net clinical outcomes (13% vs 10% p <0.0001) than men. One-year composite ischemia and mortality was similar. In women, bivalirudin compared with heparin + GPI resulted in less 30-day major bleeding (5% vs 10%, p <0.0001) but similar composite ischemia (7% vs 6%, p = 0.15). No differences were observed in rates of 1-year composite ischemia or mortality in women who received bivalirudin versus heparin + GPI. Results were similar in women undergoing PCI. In conclusion, women had similar 30-day mortality and composite ischemia but higher net clinical adverse events due to more bleeding complications than men; 1-year mortality was similar for men and women. In women, bivalirudin monotherapy compared with a GPI-based strategy resulted in significantly decreased bleeding but similar rates of 1-year composite ischemia and mortality.
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA. ALansky@crf.org
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Ecatarina
authors.initials: E
authors.lastname: Cristea
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Karen P
authors.initials: KP
authors.lastname: Alexander
authors.forename: Michel E
authors.initials: ME
authors.lastname: Bertrand
authors.forename: Walter
authors.initials: W
authors.lastname: Desmet
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods / Q000401:mortality; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D002423:Cause of Death; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000627:therapeutic use; D011336:Probability; D016016:Proportional Hazards Models; D011994:Recombinant Proteins / Q000627:therapeutic use; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D012737:Sex Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D017984:Enoxaparin; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin