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Presented at ACC 2003 Late Breaking Clinical Trials

A ggrastat- Phase of the AGGRASTAT to ZOCOR (A to Z) Trial Comparison of the safety and efficacy of unfractionated heparin versus enoxaparin in combination with tirofiban and aspirin in individuals who present with non-ST elevation acute coronary syndromes. Presented at ACC 2003

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Presented at ACC 2003 Late Breaking Clinical Trials

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  1. Aggrastat-Phaseof the AGGRASTAT to ZOCOR (A to Z) TrialComparison of the safety and efficacy of unfractionated heparin versus enoxaparin in combination with tirofiban and aspirin in individuals who present with non-ST elevation acute coronary syndromes Presented at ACC 2003 Late Breaking Clinical Trials

  2. Background • Enoxaparin (ENOX) has demonstrated superiority to unfractionated heparin (UFH) in ACS populations managed conservatively in the absence of GP IIb/IIIa inhibitors (TIMI 11, ESSENCE) • GP IIb/IIIa inhibitors are now recommended for high risk ACS patients in whom an invasive strategy is planned • Trials suggest additional benefit of a low molecular weight heparin (LMWH) over UFH when used in combination with GP IIb/IIIa inhibitors (INTERACT) • The goal of the A Phase of A to Z was to compare the safety and efficacy of enoxaparin (ENOX) vs unfractionated heparin (UFH) in combination with tirofiban and aspirin in the management of NSTEMI-ACS

  3. 7 Day Primary EndpointComposite of Death, MI and Refractory Ischemia Non-inferiority = upper bound of one-sided 95% CI < 1.144 Upper BoundOne-Sided 95%CI in A to Z: 1.05, Hazard ratio of 0.88, p=NS Non-inferiority criteria met Incidence (%) Presented at ACC 2003 Late Breaking Clinical Trials

  4. Conclusions: • A to Z met its primary hypothesis: Among pts with NSTEMI ACS treated with tirofiban and ASA, Enoxaparin is non-inferior to UFH for the composite of Death, MI and Refractory Ischemia • Based on the data from TIMI 11, ESSENCE, INTERACT and A to Z, enoxaparin is an attractive alternative to heparin when used in combination with tirofiban and ASA • SYNERGY will further address the efficacy of enoxaparin among patients treated with an early invasive strategy

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