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Efficacy and safety of unfractionated heparin versus enoxaparin: a pooled analysis of ASSENT-3 and -3 PLUS data

From the University of Alberta (Armstong, Chang), Edmonton, Alta.; University Hospital (Wallentin), Uppsala, Sweden; CHRU, Lille (Goldstein), and Boehringer Ingelheim France, Reims (Danays), France; Duke Clinical Research Institute (Granger), Durham, NC; and Biostatistical Centre (Bogaerts) and University Hospital, Gasthuisberg (Werf), Leuven, Belgium.

Correspondence to: Dr. Paul W. Armstrong, University of Alberta, 51 Medical Sciences Building, Rm. 2, Edmonton AB T6G 2H7; fax 780 492-9486; paul.armstrong{at}ualberta.ca

Background: The optimal antithrombotic therapy to accompany tenecteplase in cases of acute ST-segment elevation myocardial infarction (STEMI) remains unclear. We undertook a prespecified pooled analysis of data from the ASSENT-3 and ASSENT-3 PLUS trials.

Methods: We created a combined database of the 2040 and 818 patients who received enoxaparin in ASSENT-3 and ASSENT-3 PLUS, respectively, and compared them with the 2038 and 821 patients who received unfractionated heparin.

Results: The primary efficacy end point, a composite of 30-day mortality, reinfarction or refractory ischemia, was 16.0% with enoxaparin versus 12.2% with unfractionated heparin (p < 0.001); the efficacy plus safety (intracranial hemorrhage [ICH] or major systemic bleeding) end point, 18.0% versus 15.0% (p = 0.003). The 1049 patients urgently revascularized had greater benefit from enoxaparin (15.4% v. 10.1%, p = 0.013), yet the excess in major systemic bleeding evident with enoxaparin (3.3% v. 2.4%, p = 0.01) was largely confined to the 3492 patients without or before revascularization. Although ICH rates in the groups were similar (1.3% v. 0.9%, p = 0.26), an excess of ICH occurred among those administered enoxaparin during the ASSENT-3 PLUS trial (6.7% v. 0.8%, p = 0.013), especially among women over 75 years of age.

Interpretation: These data demonstrated the benefit of enoxaparin used in conjunction with tenecteplase, but raised caution about its prehospital use to treat STEMI in elderly women.

This article has been cited by other articles:

				S. Schulman, R. J. Beyth, C. Kearon, and M. N. Levine Hemorrhagic Complications of Anticoagulant and Thrombolytic Treatment: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest, June 1, 2008; 133(6_suppl): 257S - 298S. [Abstract] [Full Text] [PDF]

				R. De Caterina, S. Husted, L. Wallentin, G. Agnelli, F. Bachmann, C. Baigent, J. Jespersen, S. D. Kristensen, G. Montalescot, A. Siegbahn, et al. Anticoagulants in heart disease: current status and perspectives Eur. Heart J., April 10, 2007; (2007) ehl492v1. [Full Text] [PDF]

				A. L. Bailey and S. R. Steinhubl Low-molecular-weight heparins as adjunctive therapy to thrombolytics: extracting the best data. Can. Med. Assoc. J., May 9, 2006; 174(10): 1431 - 1432. [Full Text] [PDF]

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