1. 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.
- Author
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Sinnaeve PR, Alexander JH, Bogaerts K, Belmans A, Wallentin L, Armstrong P, Adgey JA, Tendera M, Diaz R, Soares-Piegas L, Vahanian A, Granger CB, and Van De Werf FJ
- Subjects
- Abciximab, Aged, Aged, 80 and over, Aspirin administration & dosage, Drug Administration Schedule, Drug Therapy, Combination, Female, Fibrinolytic Agents therapeutic use, Follow-Up Studies, Heparin administration & dosage, Humans, Infusions, Intravenous, Injections, Intravenous, Injections, Subcutaneous, Male, Middle Aged, Myocardial Infarction mortality, Survival Rate, Tenecteplase, Antibodies, Monoclonal administration & dosage, Enoxaparin administration & dosage, Heparin analogs & derivatives, Immunoglobulin Fab Fragments administration & dosage, Myocardial Infarction drug therapy, Tissue Plasminogen Activator administration & dosage
- 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.
- Published
- 2004
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