Document Detail

Sex-related effectiveness of bivalirudin versus abciximab and heparin in non-ST-segment elevation myocardial infarction.
MedLine Citation:
PMID:  23537970     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: Female sex independently predicts bleeding risk after percutaneous coronary intervention (PCI). Bivalirudin is safer than abciximab plus heparin in patients with non-ST-segment elevation myocardial infarction (NSTEMI). Thus, a greater benefit of bivalirudin in women would be expected.
METHODS: We performed a sex-based analysis of the patients with NSTEMI (n = 1,721, 399 women) enrolled in the ISAR-REACT 4 trial and randomized to receive bivalirudin or abciximab plus heparin. Main outcome was a 30-day composite of death, large recurrent myocardial infarction, urgent target vessel revascularization, or major bleeding. Secondary outcome was 1-year composite of death, myocardial infarction, or target vessel revascularization.
RESULTS: No difference in the main outcome was observed in groups with bivalirudin or abciximab plus heparin: 12.6% versus 15.5% (hazard ratio [HR] 0.81, 95% CI 0.48-1.37) among women and 10.6% versus 9.5% (HR 1.12, 95% CI 0.77-1.64) among men. Major bleeding occurred in 4.5% in the bivalirudin group versus 7.5% in the abciximab plus heparin group (HR 0.60, 95% CI 0.26-1.39) among women and 2.0% versus 3.8% (HR 0.52, 0.27-1.02) among men. At 1 year, the secondary outcome was observed in 24.1% in the bivalirudin group versus 28.7% in the abciximab plus heparin group among women, HR of 0.80 (95% CI 0.55-1.17), and in 20.6% and 19.0%, respectively, HR of 1.10 (95% CI 0.86-1.40) among men.
CONCLUSION: Despite a higher peri-PCI bleeding risk in women, bivalirudin is as effective as and safer than abciximab plus heparin in women and men with NSTEMI undergoing PCI.
Julinda Mehilli; Franz-Josef Neumann; Gjin Ndrepepa; Lamin King; Stefanie Schulz; Fatima Maimer Rodrigues da Cunha; David Jochheim; Robert A Byrne; Jörg Hausleiter; Ilka Ott; Steffen Massberg; Adnan Kastrati; Jürgen Pache
Publication Detail:
Type:  Journal Article     Date:  2013-02-19
Journal Detail:
Title:  American heart journal     Volume:  165     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  537-43     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 Mosby, Inc. All rights reserved.
Klinikum der Universitaet Munich, Munich, Germany. Electronic address:
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