This was a multicentre, prospective, randomized, double-blind study in three parallel groups, involving 3468 patients. Patients received one of three treatment regimens: the
unfractionated heparin group received an intravenous bolus of
unfractionated heparin 5000 IU, followed by an activated partial thromboplastin time adjusted infusion of
unfractionated heparin for 6+/-2 days; the
nadroparin 6 group received an intravenous bolus of
nadroparin 86 anti-Xa IU. kg(-1), followed by twice daily
subcutaneous injections of
nadroparin 86 anti-Xa IU. kg(-1)for 6+/-2 days, and the
nadroparin 14 group received an intravenous bolus of
nadroparin 86 anti-Xa IU. kg(-1), followed by twice daily
subcutaneous injections of
nadroparin 86 anti-Xa IU. kg(-1)for 14 days. No statistically significant differences were observed between the three treatment regimens with respect to the primary outcome (
cardiac death,
myocardial infarction, refractory angina, or recurrence of
unstable angina at day 14). The absolute differences between the groups in the incidence of the primary outcome were: -0.3% (P=0.85) for the
nadroparin 6 group vs the
unfractionated heparin group and +1.9% (P=0.24) for the
nadroparin 14 group vs the
unfractionated heparin group. Furthermore, there were no significant intergroup differences regarding any of the secondary efficacy outcomes. However, there was an increased risk of major haemorrhages in the
nadroparin 14 group compared with
unfractionated heparin (3.5% vs 1.6%;P=0.0035).
CONCLUSIONS: