Title: Efficacy and safety of unfractionated heparin versus enoxaparin: a pooled analysis of ASSENT-(3) and -(3) PLUS data
Authors: Armstrong, Paul W ×
Chang, Wei-Ching
Wallentin, Lars
Goldstein, Patrick
Granger, Christopher B
Bogaerts, Kris
Danays, Thierry
Van de Werf, Frans #
Issue Date: May-2006
Publisher: Canadian Medical Association
Series Title: Canadian Medical Association Journal vol:174 issue:10 pages:1421A-1426
Abstract: BACKGROUND: The optimal antithrombotic therapy to accompany tenecteplase in cases of acute ST-segment elevation myocardial infarction (STEMI) remains unclear. We undertook a prespecified pooled analysis of data from the ASSENT-3 and ASSENT-3 PLUS trials. METHODS: We created a combined database of the 2040 and 818 patients who received enoxaparin in ASSENT-3 and ASSENT-3 PLUS, respectively, and compared them with the 2038 and 821 patients who received unfractionated heparin. RESULTS: The efficacy end point (a composite of 30-day mortality, reinfarction or refractory ischemia) was 12.2% with enoxaparin versus 16.0% with unfractionated heparin (p < 0.001); the combined end point of efficacy plus safety (a composite of 30-day mortality, reinfarction, refractory ischemia, intracranial hemorrhage [ICH] or major systemic bleeding) was 15.0% versus 18.0%, respectively (p = 0.003) [corrected] The 1049 patients urgently revascularized had greater benefit from enoxaparin (15.4% v. 10.1%, p = 0.013), yet the excess in major systemic bleeding evident with enoxaparin (3.3% v. 2.4%, p = 0.01) was largely confined to the 3492 patients without or before revascularization. Although ICH rates in the groups were similar (1.3% v. 0.9%, p = 0.26), an excess of ICH occurred among those administered enoxaparin during the ASSENT-3 PLUS trial (6.7% v. 0.8%, p = 0.013), especially among women over 75 years of age. INTERPRETATION: These data demonstrated the benefit of enoxaparin used in conjunction with tenecteplase, but raised caution about its prehospital use to treat STEMI in elderly women.
ISSN: 0820-3946
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat)
× corresponding author
# (joint) last author

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