title: Comparison of Bivalirudin versus Bivalirudin plus glycoprotein IIb/IIIa inhibitor versus heparin plus glycoprotein IIb/IIIa inhibitor in patients with acute coronary syndromes having percutaneous intervention for narrowed saphenous vein aorto-coronary grafts (the ACUITY trial investigators).
abstract: Clinical outcomes in patients with acute coronary syndromes randomized in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial who underwent percutaneous coronary intervention (PCI) of saphenous vein grafts (SVGs) were examined. The ACUITY trial assessed the safety and efficacy of bivalirudin alone versus bivalirudin plus a glycoprotein (GP) IIb/IIIa inhibitor versus heparin plus a GP IIb/IIIa inhibitor in 13,819 patients with moderate- and high-risk acute coronary syndromes, 7,789 of whom underwent PCI. A total of 329 patients (4.2%) underwent PCI of SVGs in ACUITY. The primary end points at 30 days were composite ischemia or major adverse cardiac events (death, myocardial infarction, or unplanned target vessel revascularization), major bleeding (unrelated to coronary artery bypass grafting), and net adverse clinical events (composite ischemia or major bleeding). The rates of ischemic, bleeding, and net clinical end points were similar with bivalirudin monotherapy, bivalirudin plus a GP IIb/IIIa inhibitor, and heparin plus a GP IIb/IIIa inhibitor. Net adverse clinical outcome rates at 30 days were 22%, 26%, and 22% (p = 0.67), respectively, for the 3 groups. Major adverse cardiac event rates at 1 year were 37%, 37%, and 43% (p = 0.95), respectively. Minor bleeding unrelated to coronary artery bypass grafting at 30 days was significantly lower with bivalirudin alone compared with heparin plus a GP IIb/IIIa inhibitor (26% vs 38%, p = 0.05). In conclusion, bivalirudin is an effective anticoagulant in PCI of SVGs in acute coronary syndromes, with similar rates of major adverse cardiac events and net adverse cardiac events and lower minor bleeding complications in comparison with heparin plus a GP IIb/IIIa inhibitor or bivalirudin plus a GP IIb/IIIa inhibitor.
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Kumar
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Ajay
authors.initials: A
authors.lastname: Kirtane
authors.forename: Michel
authors.initials: M
authors.lastname: Bertrand
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Somjot
authors.initials: S
authors.lastname: Brar
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Eric
authors.initials: E
authors.lastname: Heller
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Moses
authors.forename: Gregg
authors.initials: G
authors.lastname: Stone
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy / Q000601:surgery*; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage*; D001026:Coronary Artery Bypass; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010446:Peptide Fragments / Q000008:administration & dosage*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011994:Recombinant Proteins / Q000008:administration & dosage; D012501:Saphenous Vein / Q000637:transplantation; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin