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.
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.


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.


CONCLUSIONS
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.
Sinnaeve
Peter R
PR
Department of Cardiology, University of Leuven, Leuven, Belgium.
Alexander
John H
JH
Bogaerts
Kris
K
Belmans
Ann
A
Wallentin
Lars
L
Armstrong
Paul
P
Adgey
Jennifer A A
JA
Tendera
Michal
M
Diaz
Rafael
R
Soares-Piegas
Leopoldo
L
Vahanian
Alec
A
Granger
Christopher B
CB
Van De Werf
Frans J
FJ
D000077284:Abciximab; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*
D000911:Antibodies, Monoclonal; D017984:Enoxaparin; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D006493:Heparin; D010959:Tissue Plasminogen Activator; D001241:Aspirin; D000077785:Tenecteplase; D000077284:Abciximab