PMID- 12242074 OWN - NLM STAT- MEDLINE DCOM- 20030115 LR - 20190513 IS - 0195-668X (Print) IS - 0195-668X (Linking) VI - 23 IP - 19 DP - 2002 Oct TI - Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes. PG - 1538-45 AB - 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 h 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, < or = 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. CI - Copyright 2002 The European Society of Cardiology FAU - James, S AU - James S AD - Department of Cardiology, Thoraxcenter, Academic Hospital, Uppsala, Sweden. FAU - Armstrong, P AU - Armstrong P FAU - Califf, R AU - Califf R FAU - Husted, S AU - Husted S FAU - Kontny, F AU - Kontny F FAU - Niemminen, M AU - Niemminen M FAU - Pfisterer, M AU - Pfisterer M FAU - Simoons, M L AU - Simoons ML FAU - Wallentin, L AU - Wallentin L LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 RN - 0 (Antibodies, Monoclonal) RN - 0 (Anticoagulants) RN - 0 (Heparin, Low-Molecular-Weight) RN - 0 (Immunoglobulin Fab Fragments) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - S79O08V79F (Dalteparin) RN - X85G7936GV (Abciximab) SB - IM MH - Abciximab MH - Acute Disease MH - Aged MH - Antibodies, Monoclonal/*therapeutic use MH - Anticoagulants/*therapeutic use MH - Cohort Studies MH - Coronary Disease/complications/*drug therapy/epidemiology MH - Cross-Over Studies MH - Dalteparin/*therapeutic use MH - Double-Blind Method MH - Drug Evaluation MH - Drug Therapy, Combination MH - Europe/epidemiology MH - Female MH - Follow-Up Studies MH - Hemorrhage/epidemiology/etiology MH - Heparin, Low-Molecular-Weight/*therapeutic use MH - Humans MH - Immunoglobulin Fab Fragments/*therapeutic use MH - Male MH - Middle Aged MH - Platelet Glycoprotein GPIIb-IIIa Complex/*therapeutic use MH - Risk Factors MH - Safety MH - Stroke/epidemiology/etiology MH - Syndrome MH - Thrombocytopenia/epidemiology/etiology MH - Treatment Outcome MH - United States/epidemiology EDAT- 2002/09/21 10:00 MHDA- 2003/01/16 04:00 CRDT- 2002/09/21 10:00 PHST- 2002/09/21 10:00 [pubmed] PHST- 2003/01/16 04:00 [medline] PHST- 2002/09/21 10:00 [entrez] AID - S0195668X02932574 [pii] AID - 10.1053/euhj.2002.3257 [doi] PST - ppublish SO - Eur Heart J. 2002 Oct;23(19):1538-45. doi: 10.1053/euhj.2002.3257.