title: Novel approaches for preventing or limiting events (Naples) III trial: randomized comparison of bivalirudin versus unfractionated heparin in patients at increased risk of bleeding undergoing transfemoral elective coronary stenting.
abstract: OBJECTIVE
  This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI.
  
  
  METHODS
  This is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding.
  
  
  RESULTS
  The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10).
  
  
  CONCLUSIONS
  The results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503).
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy. Electronic address: carlobriguori@clinicamediterranea.it.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Visconti
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Amelia
authors.initials: A
authors.lastname: Focaccio
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Michael
authors.initials: M
authors.lastname: Donahue
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Golia
authors.affiliation: Vascular Surgery Unit, Clinica Mediterranea, Naples, Italy.
authors.forename: Lucio
authors.initials: L
authors.lastname: Selvetella
authors.affiliation: Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Ricciardelli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000139:chemically induced*; D006493:Heparin / Q000009:adverse effects*; D006629:Hirudins / Q000009:adverse effects*; D006801:Humans; D007558:Italy; D008297:Male; D010446:Peptide Fragments / Q000009:adverse effects*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D011446:Prospective Studies; D011677:Punctures; D011994:Recombinant Proteins / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: anticoagulant; bivalirudin; bleeding; heparin; percutaneous coronary intervention