Efficacy and safety of unfractionated heparin versus enoxaparin: a pooled analysis of ASSENT-3 and -3 PLUS data
2006 (English)In: CMJA. Canadian Medical Association Journal. Onlineutg. Med tittel: ECMAJ. ISSN 1488-2329, ISSN 0820-3946, E-ISSN 0008-4409, Vol. 174, no 10, 1421-1426 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2006. Vol. 174, no 10, 1421-1426 p.
Area Under Curve, Drug Therapy; Combination, Emergency Treatment, Enoxaparin/*therapeutic use, Fibrinolytic Agents/*therapeutic use, Heparin/*therapeutic use, Humans, Intracranial Hemorrhages/epidemiology, Logistic Models, Myocardial Infarction/*drug therapy, Randomized Controlled Trials, Recurrence, Thrombolytic Therapy, Tissue Plasminogen Activator/therapeutic use
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-23981DOI: 10.1503/cmaj.051410PubMedID: 16682709OAI: oai:DiVA.org:uu-23981DiVA: diva2:51755