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

Sinnaeve, Peter R; Alexander, John H; Bogaerts, Kris; Belmans, Ann; Wallentin, Lars; Armstrong, Paul; Adgey, Jennifer A.A; Tendera, Michal; Diaz, Rafael; Soares-Piegas, Leopoldo; Vahanian, Alec; Granger, Christopher B; Van De Werf, Frans J

doi:10.1016/j.ahj.2003.12.028

« Previous Next »American Heart Journal
Volume 147, Issue 6 , Pages 993-998, June 2004

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☆

Peter R Sinnaeve, MD, PhD
- Department of Cardiology, University of Leuven, Leuven, Belgium
- Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA
- Reprint requests: Frans Van de Werf, MD, PhD, Department of Cardiology, Gasthuisberg University Hospital, Herestraat 49, B-3000 Leuven, Belgium.
John H Alexander, MD
- Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA
Kris Bogaerts
- Biostatistical Center, University of Leuven, Leuven, Belgium
Ann Belmans
- Biostatistical Center, University of Leuven, Leuven, Belgium
Lars Wallentin, MD, PhD
- Department of Cardiology, Uppsala University Hospital, Uppsala, Sweden
Paul Armstrong, MD
- Department of Cardiology, University of Alberta, Edmonton, Alberta, Canada
Jennifer A.A Adgey, MD
- Regional Medical Cardiology Centre, Royal Victoria Hospital, Belfast, United Kingdom
Michal Tendera, MD
- Division of Cardiology, Silesian School of Medicine, Katowice, Poland
Rafael Diaz, MD
- Estudios Cardiologicos Latinoamerica, Instituto Cardiovascular de Rosario, Rosario, Argentina
Leopoldo Soares-Piegas, MD, PhD
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Alec Vahanian, MD
- Department of Cardiology, Bichat Hospital, Paris, France
Christopher B Granger, MD
- Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA
Frans J Van De Werf, MD, PhD
- Department of Cardiology, University of Leuven, Leuven, Belgium

Received 23 June 2003; accepted 16 December 2003.

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.