Safety and efficacy of abciximab combined with dalteparin in treatment of acute coronary syndromes
January 2002
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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.
- Male
- Comparative Study
- Aged
- Cohort Studies
- Female
- Humans
- Middle aged
- Follow-Up Studies
- Risk Factors
- Acute Disease
- Syndrome
- Treatment Outcome
- Europe/epidemiology
- United States/epidemiology
- Antibodies, Monoclonal/*therapeutic use
- Immunoglobulin Fab Fragments/*therapeutic use
- Drug Therapy, Combination
- Double-Blind Method
- Cross-Over Studies
- Drug Evaluation
- Safety
- Anticoagulants/*therapeutic use
- Hemorrhage/epidemiology/etiology
- Cerebrovascular Accident/epidemiology/etiology
- Coronary Disease/complications/*drug therapy/epidemiology
- Dalteparin/*therapeutic use
- Heparin, Low-Molecular-Weight/*therapeutic use
- Platelet Glycoprotein GPIIb-IIIa Complex/*therapeutic use
- Thrombocytopenia/epidemiology/etiology
- abciximab
- dalteparin
- patient
- cohort
- treatment
- dalteparin cohort
- bleeding
- placebo
- group
- trial
- heparin
- study
- ufh cohort
- syndrome
- 30 days
- intervention
- infarction
- <0001
- heart
- /iiia