RESUMO
UNLABELLED: AIM. To assess safety and efficacy of enoxaparin in patients with UA/NSTEMI in an open-label, multi-centre, non-comparative study and to compare the results with data from large-scale randomized trials ESSENCE and TIMI-11B. METHODS: Patients hospitalized with a diagnosis of recent UA/NSTEMI were treated with 1 mg/kg enoxaparin every 12 hours for 2-8 days. The composite endpoint of the study was death, myocardial infarction (MI) or recurrent angina at day 15 (or hospital discharge). Minor and major bleedings were recorded. RESULTS: A total of 1902 patients were enrolled in 109 centers across 24 countries, of which 1901 received at least one injection of enoxaparin and 1785 (93.8%) completed the study (follow-up). Throughout the study (day 180) 21.4% of patients underwent at least one revascularization, of which 4.4% were urgent. The incidence of the composite efficacy endpoint was 16.3% after 15 days and 27.9% on day 180, which was comparable with the enoxaparin arm of the ESSENCE/TIMI 11B studies, and lower than the incidence found in the UFH arm of those studies. At day 15 or hospital discharge the occurrence of major and minor haemorrhages was 1.1 and 6.6%, respectively, which was lower than in ESSENCE/TIMI 11B. More bleeding complications (major and minor) were noted in patients aged
