Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes

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 24 h, 48 h or placebo. In the dalteparin substudy, 974 patients received 5 days of s.c. dalteparin, instead of a 48 h infusion of unfractionated heparin (UFH). Major and minor bleedings were more frequent for abciximab (24 and 48 It 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, less than or equal to 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. (C) 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.