title: Comparison of safety and efficacy of bivalirudin versus unfractionated heparin in high-risk patients undergoing percutaneous coronary intervention (from the Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin study).
abstract: Bivalirudin, a direct thrombin inhibitor, is as effective as unfractionated heparin (UFH), with decreased bleeding in patients with acute coronary syndromes who undergo percutaneous coronary intervention (PCI). The aim of this study was to evaluate the effectiveness of bivalirudin versus UFH in selected PCI patients at high bleeding risk. Four hundred one consecutive patients who underwent PCI fulfilling ≥ 1 enrollment criterion (age >75 years, chronic renal failure, and diabetes mellitus) were randomized to bivalirudin (bolus 0.75 mg/kg followed by infusion during the procedure; n = 198) or UFH (75 IU/kg; n = 203). In the overall population, 39% were aged >75 years, 22% had renal failure, 63% had diabetes, and 29% had acute coronary syndromes. The primary efficacy end point was the 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization). The primary safety end point was the occurrence of any bleeding or entry-site complications after PCI. All patients were preloaded with clopidogrel 600 mg. Glycoprotein IIb/IIIa inhibitors were used at the operators' discretion. Thirty-day major adverse cardiac event rates were 11.1% in the bivalirudin group and 8.9% in the UFH group (p = 0.56); the primary efficacy end point was reached mainly because of periprocedural myocardial infarction; 1 patient in the bivalirudin group had stent thrombosis. Occurrence of the primary safety end point was 1.5% in the bivalirudin group and 9.9% in the UFH group (p = 0.0001); this benefit was essentially driven by the prevention of entry-site hematomas >10 cm (0.5% vs 6.9%, p = 0.002). In conclusion, Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin (ARMYDA-7 BIVALVE) indicates that bivalirudin, compared with UFH, causes significantly lower bleeding and has a similar incidence of major adverse cardiac events in patients with older age, diabetes mellitus, or chronic renal failure who undergo PCI.
authors.affiliation: Campus Bio-Medico University of Rome, Rome, Italy. g.patti@unicampus.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Patti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pasceri
authors.forename: Luca
authors.initials: L
authors.lastname: D'Antonio
authors.forename: Andrea
authors.initials: A
authors.lastname: D'Ambrosio
authors.forename: Michele
authors.initials: M
authors.lastname: Macrì
authors.forename: Giordano
authors.initials: G
authors.lastname: Dicuonzo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colonna
authors.forename: Antonio
authors.initials: A
authors.lastname: Montinaro
authors.forename: Germano
authors.initials: G
authors.lastname: Di Sciascio
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000150:complications / Q000628:therapy*; D048909:Diabetes Complications / Q000628:therapy; D004359:Drug Therapy, Combination; D005260:Female; D006331:Heart Diseases / Q000453:epidemiology / Q000209:etiology; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects*; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000008:administration & dosage / Q000037:antagonists & inhibitors; D011183:Postoperative Complications; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D051437:Renal Insufficiency / Q000150:complications / Q000628:therapy; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin