Efficacy of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: one-year follow-up results of the Assessment of the Safety of a New Thrombolytic-3 (ASSENT-3) randomized trial in acute myocardial infarction

Am Heart J. 2004 Jun;147(6):993-8. doi: 10.1016/j.ahj.2003.12.028.

Abstract

Background: In the ASsessment of the Safety of a New Thrombolytic 3 (ASSENT-3) study, full-dose tenecteplase plus enoxaparin or half-dose tenecteplase plus abciximab reduced the frequency of ischemic complications of acute myocardial infarction, when compared to full-dose tenecteplase plus unfractionated heparin. The aim of the present study was to determine the effect of these fibrinolytic regimens on 1-year mortality.

Methods and results: Vital status at 1 year was available for 5942 patients (97.5%) of the 6095 initially enrolled in the study. At 1 year, 515 patients (8.7%) had died. Elderly or female patients and patients with low body weight, previous myocardial infarction, anterior wall myocardial infarction, and diabetes were at increased risk for death at 1 year. Mortality at 1 year was 7.9 % (n = 161) in the heparin group, 8.1% (n = 166) in the enoxaparin group, and 9.3% (n = 188) in the abciximab group (P =.226). Overall, pairwise comparisons did not show a significant difference among treatment regimens: relative risk 1.03 (95% CI 0.82-1.30) for enoxaparin versus heparin (P =.794) and relative risk 1.18 (95% CI 0.95-1.47) for abciximab versus heparin (P =.144). However, 1-year outcome tended to be worse with abciximab in diabetic patients.

Conclusion: Mortality at 1 year after acute myocardial infarction remains high. Despite a reduction in ischemic complications after acute myocardial infarction with the use of full-dose tenecteplase plus enoxaparin or half-dose tenecteplase plus abciximab, mortality at 1 year was similar in these treatment groups.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abciximab
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / administration & dosage*
  • Aspirin / administration & dosage
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Enoxaparin / administration & dosage*
  • Female
  • Fibrinolytic Agents / therapeutic use
  • Follow-Up Studies
  • Heparin / administration & dosage
  • Heparin / analogs & derivatives*
  • Humans
  • Immunoglobulin Fab Fragments / administration & dosage*
  • Infusions, Intravenous
  • Injections, Intravenous
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Myocardial Infarction / drug therapy*
  • Myocardial Infarction / mortality
  • Survival Rate
  • Tenecteplase
  • Tissue Plasminogen Activator / administration & dosage*

Substances

  • Antibodies, Monoclonal
  • Enoxaparin
  • Fibrinolytic Agents
  • Immunoglobulin Fab Fragments
  • Heparin
  • Tissue Plasminogen Activator
  • Aspirin
  • Tenecteplase
  • Abciximab