Document Detail


Bivalirudin vs. unfractionated heparin during percutaneous coronary interventions in patients with stable and unstable angina pectoris: 1-year results of the ISAR-REACT 3 trial.
MedLine Citation:
PMID:  20150324     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: In ISAR-REACT 3, 30-day outcomes in 4570 biomarker negative patients undergoing percutaneous coronary intervention (PCI) > or =2 h after pre-treatment with 600 mg of clopidogrel revealed less bleeding with bivalirudin compared with unfractionated heparin, but no difference in 30-day net clinical benefit. The objective of the present analysis was to assess the impact of bivalirudin vs. heparin on 1-year outcomes in ISAR-REACT 3.
METHODS AND RESULTS: The primary outcome for this analysis was the composite of death, myocardial infarction, or target vessel revascularization 1 year after randomization. The composite of death or myocardial infarction was a secondary outcome. At 1 year, the primary outcome occurred in 17.1% of patients assigned to bivalirudin vs. 17.5% assigned to heparin [hazard ratio (HR), 0.98; 95% confidence interval (CI), 0.86-1.13; P = 0.816]. The combined incidence of death or myocardial infarction was 7.7% in the bivalirudin group vs. 6.7% in the heparin group (HR, 1.15; 95% CI, 0.93-1.43; P = 0.200). The mortality rate was 1.9% in the bivalirudin group and 1.7% in the heparin group (HR, 1.10; 95% CI, 0.71-1.70; P = 0.667). At 1 year, no significant differences in the primary outcome were observed with bivalirudin and heparin in any of the subgroups analysed.
CONCLUSION: Bivalirudin and unfractionated heparin during PCI provide comparable outcomes at 1 year in biomarker negative patients undergoing PCI after pre-treatment with 600 mg of clopidogrel.
CLINICAL TRIAL REGISTRATION INFORMATION: URL www.clinicaltrials.gov; Unique identifier NCT00262054.
Authors:
Stefanie Schulz; Julinda Mehilli; Gjin Ndrepepa; Franz-Josef Neumann; Katrin A Birkmeier; Sebastian Kufner; Gert Richardt; Peter B Berger; Albert Schömig; Adnan Kastrati;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-02-11
Journal Detail:
Title:  European heart journal     Volume:  31     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-04     Completed Date:  2011-03-15     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  582-7     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00262054
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MeSH Terms
Descriptor/Qualifier:
Angina Pectoris / therapy*
Angioplasty / methods*
Anticoagulants / administration & dosage*
Death, Sudden, Cardiac / etiology
Double-Blind Method
Female
Heparin / administration & dosage*
Hirudins / administration & dosage*
Humans
Infusions, Intravenous
Male
Middle Aged
Myocardial Infarction / etiology
Myocardial Revascularization / methods
Peptide Fragments / administration & dosage*
Recombinant Proteins / administration & dosage
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Hirudins; 0/Peptide Fragments; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin
Comments/Corrections
Comment In:
Eur Heart J. 2010 Mar;31(5):522-4   [PMID:  20150323 ]

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


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