Document Detail

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).
MedLine Citation:
PMID:  20381652     Owner:  NLM     Status:  MEDLINE    
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.
Guido Parodi; Angela Migliorini; Renato Valenti; Benedetta Bellandi; Umberto Signorini; Guia Moschi; Piergiovanni Buonamici; Giampaolo Cerisano; David Antoniucci
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2010-02-20
Journal Detail:
Title:  The American journal of cardiology     Volume:  105     ISSN:  1879-1913     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-12     Completed Date:  2010-06-15     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1053-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Elsevier Inc. All rights reserved.
Division of Cardiology, Careggi Hospital, Florence, Italy.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary / methods*
Anticoagulants / administration & dosage*
Coronary Disease / blood,  diagnosis,  therapy*
Dose-Response Relationship, Drug
Drug Therapy, Combination
Follow-Up Studies
Hemorrhage / epidemiology,  prevention & control
Hemostasis / drug effects*
Heparin / administration & dosage,  analogs & derivatives*
Heparin Antagonists / administration & dosage
Hirudins / administration & dosage*
Infusions, Intravenous
Italy / epidemiology
Peptide Fragments / administration & dosage*
Protamines / administration & dosage*
Recombinant Proteins / administration & dosage
Retrospective Studies
Treatment Outcome
Reg. No./Substance:
0/Anticoagulants; 0/Antithrombins; 0/Heparin Antagonists; 0/Hirudins; 0/Peptide Fragments; 0/Protamines; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 129480-74-6/ITF 300; 9005-49-6/Heparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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