Design

• Multicenter, parallel, double-blind study, randomized 525 patients at high risk for ischemic events who had unstable angina or non–Q-wave/non–ST-elevation (NSTE) myocardial infarction (MI) in the previous 24 hours.
• All patients received AGGRASTAT (0.4 µg/kg/min for 30 minutes followed by 0.1 µg/kg/min infusion) and acetylsalicylic acid (ASA) plus either enoxaparin or unfractionated heparin (UFH).
• The primary endpoint was safety, evaluated by Thrombolysis In Myocardial Infarction (TIMI) bleeding incidence. Death, MI, refractory ischemia, or rehospitalization for unstable angina at 30 days was also assessed.

Results

• There was no statistically significant difference between AGGRASTAT plus enoxaparin and AGGRASTAT plus UFH on TIMI major bleeds, minor bleeds, “loss no site” bleeds, transfusions, or thrombocytopenia, although cutaneous and oral bleeds were significantly greater with AGGRASTAT plus enoxaparin versus AGGRASTAT plus UFH (p≤0.02).
• The risk of death or MI did not differ significantly between groups, but reductions in the risk of refractory ischemia requiring urgent intervention (0.6% vs. 4.3%, p=0.01) and rehospitalization for unstable angina (1.6% vs. 7.1%, p=0.002) at 30 days were significantly greater with AGGRASTAT plus enoxaparin.

Conclusion

• AGGRASTAT in combination with enoxaparin and ASA was well tolerated with a safety profile comparable to AGGRASTAT plus UFH and ASA.