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


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).


CONCLUSIONS
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.
James
S
S
Department of Cardiology, Thoraxcenter, Academic Hospital, Uppsala, Sweden.
Armstrong
P
P
Califf
R
R
Husted
S
S
Kontny
F
F
Niemminen
M
M
Pfisterer
M
M
Simoons
M L
ML
Wallentin
L
L
D000077284:Abciximab; D000208:Acute Disease; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D015331:Cohort Studies; D003327:Coronary Disease / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D018592:Cross-Over Studies; D017985:Dalteparin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000627:therapeutic use*; D012307:Risk Factors; D012449:Safety; D020521:Stroke / Q000453:epidemiology / Q000209:etiology; D013577:Syndrome; D013921:Thrombocytopenia / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D007140:Immunoglobulin Fab Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D017985:Dalteparin; D000077284:Abciximab