Document Detail

Profile of bleeding and ischaemic complications with bivalirudin and unfractionated heparin after percutaneous coronary intervention.
MedLine Citation:
PMID:  19147609     Owner:  NLM     Status:  MEDLINE    
AIMS: The aim of this study was to identify a subset of patients at high risk of bleeding or myocardial infarction from a percutaneous coronary intervention and to investigate whether such high-risk subsets derive preferential benefit from heparin or bivalirudin. METHODS AND RESULTS: This study included 4570 patients with coronary artery disease enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment trial and randomized to receive bivalirudin or heparin. Primary outcomes were in-hospital incidence of major bleeding and 30-day incidence of myocardial infarction. Major bleeding, myocardial infarction, and bleeding plus myocardial infarction occurred in 140, 204, and 34 patients, respectively. Older age, female sex, lower body weight, low cholesterol, multi-lesion intervention, complex lesions, and heparin therapy were independent correlates of increased risk of bleeding. Multi-lesion intervention, unstable angina, and lower body weight correlated independently with increased risks of myocardial infarction. Compared with heparin, bivalirudin was associated with a reduction in major bleeding (3.1 vs. 4.6%, P = 0.008), but mostly in low-risk patients. A reduction in the bleeding risk inversely correlated with an increase in the risk of myocardial infarction with bivalirudin (R = -0.61). CONCLUSION: Bivalirudin and unfractionated heparin have a differential effect on risk of bleeding and myocardial infarction across various subsets of patients.
Raisuke Iijima; Gjin Ndrepepa; Julinda Mehilli; Robert A Byrne; Stefanie Schulz; Franz-Josef Neumann; Gert Richardt; Peter B Berger; Albert Schömig; Adnan Kastrati
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-01-15
Journal Detail:
Title:  European heart journal     Volume:  30     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-02-02     Completed Date:  2009-03-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  290-6     Citation Subset:  IM    
Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636 Munich, Germany.
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MeSH Terms
Aged, 80 and over
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects*,  methods
Anticoagulants / adverse effects*,  therapeutic use
Coronary Disease / radiography,  therapy
Double-Blind Method
Hemorrhage / etiology*
Heparin / adverse effects*,  therapeutic use
Hirudins / adverse effects*
Middle Aged
Myocardial Infarction / etiology*,  prevention & control
Peptide Fragments / adverse effects*,  therapeutic use
Recombinant Proteins / adverse effects,  therapeutic use
Risk Factors
Reg. No./Substance:
0/Anticoagulants; 0/Hirudins; 0/Peptide Fragments; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin

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