Eptifibatide: Result of EVA-AMI Trial Released
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November 4, 2007 By Scott P. Williams [1]
Orlando, FL: The results of the EVA-AMI trial suggest that a double bolus of eptifibatide is as efficacious as abciximab when used in the treatment of ST segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). The results were released today at the American Heart Association’s 2007 Scientific Sessions.
Abciximab has been shown to reduce ischemic complications in patients undergoing primary PCI. Eptifibatide reduced events in patients with elective PCI comparable to abciximab, but no head to head trial of the two agents is available in primary PCI.
The EVA-AMI trial was an international multicenter randomized open-parallel group comparison of eptifibatide and abciximab. The study enrolled 400 STEMI patients who had ischemic symptoms for less than 12 hours, and who were treated with aspirin, clopidogrel and unfractionated heparin or enoxaparin scheduled for primary PCI. Prior to PCI patients were randomized to receive either a double bolus of eptifibatide followed by a 24 hour eptifibatide infusion, or a single bolus of abciximab with a subsequent 12 hour infusion.
The study was performed to demonstrate non-inferiority of eptifibatide compared to abciximab as adjunctive treatment in patients undergoing primary PCI. ST segment resolution 1 hour post-PCI was the study’s primary endpoint. The secondary endpoint was death, myocardial infarction, target vessel revascularization, and bleeding until day 7, 30 days and 6 months. The assumption was that both parameters will achieve a 60% rate of complete ST resolution at 60 minutes after PCI. The non-inferiority margin was set to 15%.
There were no significant differences in the baseline characteristics between the 2 groups. 84.3% of patients had TIMI 3 patency in the abciximab group and 82.4% had TIMI 3 patency in the eptifibatide group. Complete ST resolution 60 minutes post PCI was demonstrated in 59.6% (n=109) in the abciximab group and 62.1% (n=111) in the eptifibatide group, p=ns. In the intention to treat analysis, complete resolution was found in 47.5% (n=200) in the abciximab vs. 50.2% (n=225) in the eptifibatide groups. Death occurred in 3.5% in the abciximab group and eptifibatide group. Heart failure occurred in 8.5% in the abciximab and 6.4% in the eptifibatide groups. TVR occurred in 4% and 2.7% in the abciximab and eptifibatide groups. CABG was performed in 0.5% and 0.9% in the abciximab and eptifibatide groups. Major bleeding occurred in 0% and 1.8% in the abciximab and eptifibatide groups. Minor bleeding occurred in 4.5% and 4.1% in the abciximab and eptifibatide groups.
The authors concluded that eptifibatide given as a double bolus is equally effective as abciximab as adjunct to PPCI with respect to myocardial reperfusion. The preliminary clinical events did not show any differences between the two components. Therefore eptifibatide seems an alternative to abciximab in patients with STEMI undergoing PPCI.
Dr Robert Wilcox congratulated the authors on the study and commented that this was a well conducted study. He also commented that from previous studies, ECG criteria can be used as a primary endpoint to demonstrate outcomes in this patient population.
References
1. U Zeymer, et al. Institute fur Herzinfarktforschung Ludwigshafen, Germany.
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