Copyright © 2004 by the European Society of Cardiology.
Clinical research
Enoxaparin versus unfractionated heparin in patients treated with tirofiban, aspirin and an early conservative initial management strategy: results from the A phase of the A-to-Z trial
a Donald W. Reynolds Cardiovascular Clinical Research Center, 5323 Harry Hines Blvd, Rm HA 9.133, UT Southwestern Medical Center, Dallas, TX 75390-9047, USA
b Duke Clinical Research Institute, Durham, NC, USA
c Brigham and Women's Hospital and TIMI Study Group, Boston, MA, USA
d Merck and Company, Whitehouse Station, NJ, USA
e Green Lane Hospital, Auckland, New Zealand
f University of Edinburgh, Edinburgh, UK
Received March 2, 2004; revised June 11, 2004; accepted June 17, 2004 * Corresponding author. Tel.: +1-214-645-7500; fax: +1-214-645-7501 (E-mail: james.delemos{at}utsouthwestern.edu).
AIMS: In high risk patients with non-ST elevation acute coronary syndromes (ACS), enoxaparin is generally preferred to unfractionated heparin (UFH). However, less is known about the relative merits of these two forms of heparin in patients receiving concomitant glycoprotein IIb/IIIa inhibitors.
METHODS AND RESULTS: The A phase of the A-to-Z trial was an open label non-inferiority trial in which 3987 patients with non-ST elevation ACS were randomised to receive either enoxaparin or UFH in combination with aspirin and tirofiban. Inclusion required either ST depression or cardiac biomarker elevation. While the selection of an early management strategy (invasive or conservative) was at the discretion of the local investigator, investigators were asked to designate their plans for an invasive or conservative strategy on the case record form. An early conservative strategy was specified for 1778 patients (45%); this subgroup forms the population for the present analyses. Among patients with a planned conservative strategy, baseline characteristics were similar between those randomised to UFH (n=872) and those randomised to enoxaparin (n=906). The primary endpoint of death, new MI, or documented refractory ischaemia within 7 days of randomisation occurred in 10.6% of patients randomised to UFH and 7.7% of patients randomised to enoxaparin (HR 0.72; 95% CI 0.53–0.99; p=0.04). The combined rate of TIMI major, minor, or loss no-site bleeding was 1.3% in patients treated with UFH and 1.8% in those treated with enoxaparin (p=ns).
CONCLUSIONS: When a conservative approach to catheterisation and PCI was planned for ACS patients receiving tirofiban and aspirin, enoxaparin was associated with superior efficacy and similar bleeding vs UFH.
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