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European Heart Journal 2002 23(19):1538-1545; doi:10.1053/euhj.2002.3257
Copyright © 2002 by the European Society of Cardiology.
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Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes

S. Jamesa,f1, P. Armstrongb, R. Califfc, S. Hustedd, F. Kontnye, M. Niemminenf, M. Pfistererg, M.L. Simoonsh and L. Wallentina

a Department of Cardiology, Academic Hospital, Uppsala, Sweden
b Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
c Duke CRI, Durham, NC, USA
d Department of Cardiology, Aarhus, Amtssygehus Aarhus, Denmark
e Heart-lung center, Ullevál Hospital, Oslo, Norway
f University Hospital Internal Medicin, Helsinki, Finland
g University Hospital, Basel, Switzerland
h Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands

revised March 25, 2002; accepted March 27, 2002

Abstract

Aims The safety and efficacy of abciximab in addition to low-molecular-weight-heparin as the primary medical treatment of acute coronary syndromes has not previously been investigated.

Methods and Results The GUSTO IV–ACS trial included 7800 patients with chest pain and either ST-segment depression or a positive troponin test. They were randomized to abciximab for 24h, 48h or placebo. In the dalteparin substudy, 974 patients received 5 days of s.c. dalteparin, instead of a 48h infusion of unfractionated heparin (UFH). Major and minor bleedings were more frequent for abciximab (24 and 48h combined) than placebo both in the dalteparin (abciximab 5·0% vs placebo 1·8% P<0·05) and in the UFH cohort (3·8% vs 1·8% P<0·001). However, stroke rates were low, ≤0·6%. At 30 days there were no significant differences in the rate of death or MI, either in the dalteparin (abciximab 9·6% vs placebo 11·3%: O.R. 0·85; 95% C.I. 0·58–1·25) or in the UFH cohort (8·5% vs 7·6%: O.R.; 1·12: 0·95–1·34).

Conclusion Treatment with abciximab, aspirin and s.c. dalteparin is associated with a low risk of major side effects and is as safe as the combination of abciximab and UFH. Without early coronary intervention there is no indication for abciximab treatment. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.

Key Words: Angina, myocardial infarction, coagulation, heparin

f1 Correspondence: Stefan James MD, Department of Cardiology, Thoraxcenter, Academic Hospital, 751 85 Uppsala, Sweden


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