Document Detail


One-year outcomes with abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary interventions in patients with non-ST-segment elevation myocardial infarction: updated results from the ISAR-REACT 4 trial.
MedLine Citation:
PMID:  23455033     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy.
METHODS AND RESULTS: The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed.
CONCLUSIONS: In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days.
CLINICAL TRIAL REGISTRATION INFORMATION: URL www.clinicaltrials.gov; Unique identifier NCT00373451.
Authors:
Stefanie Schulz; Adnan Kastrati; Miroslaw Ferenc; Steffen Massberg; Kathrin A Birkmeier; Karl-Ludwig Laugwitz; Sebastian Kufner; Michael Gick; Michael Dommasch; Helmut Schühlen; Albert Schömig; Peter B Berger; Julinda Mehilli; Franz-Josef Neumann;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  9     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2013 Aug 
Date Detail:
Created Date:  2013-08-22     Completed Date:  2014-05-14     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  430-6     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00373451
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MeSH Terms
Descriptor/Qualifier:
Aged
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Anticoagulants / adverse effects,  therapeutic use*
Antithrombins / adverse effects,  therapeutic use*
Double-Blind Method
Drug Combinations
Female
Heparin / adverse effects,  therapeutic use*
Hirudins / adverse effects
Humans
Immunoglobulin Fab Fragments / adverse effects,  therapeutic use*
Male
Myocardial Infarction / therapy*
Peptide Fragments / adverse effects,  therapeutic use*
Percutaneous Coronary Intervention / adverse effects
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Recombinant Proteins / adverse effects,  therapeutic use
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Anticoagulants; 0/Antithrombins; 0/Drug Combinations; 0/Hirudins; 0/Immunoglobulin Fab Fragments; 0/Peptide Fragments; 0/Platelet Aggregation Inhibitors; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 9005-49-6/Heparin; X85G7936GV/abciximab
Comments/Corrections
Comment In:
EuroIntervention. 2013 Aug 22;9(4):423-6   [PMID:  23965346 ]

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


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