title: Comparison of bivalirudin and unfractionated heparin plus protamine in patients with coronary heart disease undergoing percutaneous coronary intervention (from the Antithrombotic Regimens aNd Outcome [ARNO] trial).
abstract: Previous studies have compared bivalirudin and unfractionated heparin (UFH) plus the routine use of glycoprotein IIb/IIIa inhibitors. They have demonstrated that bivalirudin can decrease bleeding complications without a significant increase in ischemic complications, resulting in a better net clinical outcome, as defined by the efficacy (ischemic complications) or safety (bleeding complications) end point. The aim of the present study was to compare bivalirudin and UFH plus protamine in patients undergoing elective percutaneous coronary intervention and pretreated with clopidogrel and aspirin. We randomly assigned 850 patients with stable or unstable coronary artery disease to bivalirudin or UFH followed by protamine at the end of the percutaneous coronary intervention. The primary end point was in-hospital major bleeding. The main secondary end points were the 1-month composite of death, myocardial infarction, unplanned target vessel revascularization; and the 1-month net clinical outcome. The rate of major bleeding (primary end point) was 0.5% in patients randomized to bivalirudin and 2.1% in patients randomized to UFH (p = 0.033). At 30 days, the rate of major bleeding was 0.9% in the bivalirudin arm and 2.8% in the UFH arm (p = 0.043). The composite of death, myocardial infarction, and target vessel revascularization rate and the net clinical outcome rate was 2.8% and 6.4% (p = 0.014) and 3.3% and 7.8% (p = 0.004), respectively, in the bivalirudin and UFH arms. In conclusion, in percutaneous coronary intervention patients pretreated with clopidogrel and aspirin, bivalirudin was associated with less major bleeding and fewer ischemic complications and a better net clinical outcome than UFH.
authors.affiliation: Division of Cardiology, Careggi Hospital, Florence, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Parodi
authors.forename: Angela
authors.initials: A
authors.lastname: Migliorini
authors.forename: Renato
authors.initials: R
authors.lastname: Valenti
authors.forename: Benedetta
authors.initials: B
authors.lastname: Bellandi
authors.forename: Umberto
authors.initials: U
authors.lastname: Signorini
authors.forename: Guia
authors.initials: G
authors.lastname: Moschi
authors.forename: Piergiovanni
authors.initials: P
authors.lastname: Buonamici
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Cerisano
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000925:Anticoagulants / Q000008:administration & dosage*; D000991:Antithrombins; D003327:Coronary Disease / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology / Q000517:prevention & control; D006487:Hemostasis / Q000187:drug effects*; D006493:Heparin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006494:Heparin Antagonists / Q000008:administration & dosage; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D007558:Italy / Q000453:epidemiology; D008297:Male; D010446:Peptide Fragments / Q000008:administration & dosage*; D011479:Protamines / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006494:Heparin Antagonists; D006629:Hirudins; D010446:Peptide Fragments; D011479:Protamines; D011994:Recombinant Proteins; C078918:ITF 300; D006493:Heparin; C074619:bivalirudin