Acute Ischemic Heart Disease 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, a,b John H. Alexander, MD, b Kris Bogaerts, c Ann Belmans, c Lars Wallentin, MD, PhD, d Paul Armstrong, MD, e Jennifer A. A. Adgey, MD, f Michal Tendera, MD, g Rafael Diaz, MD, h Leopoldo Soares-Piegas, MD, PhD, i Alec Vahanian, MD, j Christopher B. Granger, MD, b and Frans J. Van De Werf, MD, PhD a Leuven, Belgium, Durham, NC, Uppsala, Sweden, Edmonton, Alberta, Canada, Belfast, United Kingdom, Katowice, Poland, Rosario, Argentina, Sa ˜o Paulo, Brazil, and Paris, France 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 myo- cardial 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 ab- ciximab 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 com- plications 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. (Am Heart J 2004;147:993– 8.) Pharmacologic reperfusion strategies for acute myo- cardial infarction still suffer from several shortcomings, including suboptimal patency rates, inadequate tissue- level reperfusion, recurrent ischemia, and reinfarc- tion. 1,2 Newer antithrombotic agents may offer advan- tages over the current standard of unfractionated heparin (UFH) and aspirin. Glycoprotein IIb/IIIa inhibi- tors in combination with reduced doses of fibrinolytics improve early patency and tissue-level perfusion. 3–5 Low-molecular–weight heparins have been shown to reduce reocclusion and reinfarction rates when com- pared to UFH. 6,7 The ASsessment of the Safety of a New Thrombolytic 3 (ASSENT-3) study evaluated the efficacy and safety of full-dose tenecteplase plus enoxaparin or half-dose te- From the a Department of Cardiology, University of Leuven, Leuven, Belgium, b Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, c Biostatistical Center, University of Leuven, Leuven, Belgium, d Department of Cardiology, Uppsala University Hospital, Uppsala, Sweden, e Department of Cardiology, University of Al- berta, Edmonton, Alberta, Canada, f Regional Medical Cardiology Centre, Royal Victo- ria Hospital, Belfast, United Kingdom, g Division of Cardiology, Silesian School of Med- icine, Katowice, Poland, h Estudios Cardiologicos Latinoamerica, Instituto Cardiovascular de Rosario, Rosario, Argentina, i Instituto Dante Pazzanese de Cardio- logia, Sa ˜o Paulo, Brazil, and j Department of Cardiology, Bichat Hospital, Paris, France. Guest Editor for this manuscript was Carl J. Pepine, MD, University of Florida College of Medicine, Gainesville, Fla. Submitted June 23, 2003; accepted December 16, 2003. Reprint requests: Frans Van de Werf, MD, PhD, Department of Cardiology, Gasthuis- berg University Hospital, Herestraat 49, B-3000 Leuven, Belgium. E-mail: frans.vandewerf@uz.kuleuven.ac.be 0002-8703/$ - see front matter © 2004, Elsevier Inc. All rights reserved. doi:10.1016/j.ahj.2003.12.028 Clinical Investigations