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Schering-Plough Announces Results of the Early ACS Trial
Date:3/30/2009

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No statistical difference was observed between the groups in either the primary or secondary endpoints. The primary endpoint occurred in 9.3 percent of the study group (receiving double-bolus plus infusion early administration of eptifibatide 12 or more hours prior to angiography), compared with 10.0 percent of the delayed provisional group (p=0.23). At 30 days, the death or (re)MI rate for the study group was 11.2 percent compared to 12.3 percent for the delayed provisional group (p=0.079).

Significantly higher rates of bleeding were observed in the study group, with 118 patients experiencing a TIMI major bleeding event, compared to 83 in the delayed provisional group (p=0.015). Investigators reported a 7.6 percent vs. 5.1 percent rate of moderate or severe bleeding (p<0.001) in the study group as compared to the delayed provisional group, as measured by the GUSTO scale. Red blood cell transfusions occurred in 8.6 percent of patients in the study group vs. 6.7 percent of patients in the delayed provisional group (p=0.001). There were no significant differences in mortality or any serious adverse events between the two groups.

"This was a very well-treated population that demonstrates the influence of aggressive and sophisticated therapies," said Dr. Newby. "Further evaluation of the safety and efficacy data at one year should provide additional insights into the early use of eptifibatide in this patient population."

Within the trial, the single largest group was PCI patients (n=5,559). An analysis of those randomized to receive early eptifibatide showed that these patients experienced fewer primary and secondary composite events after PCI than those randomized to the delayed provisional eptifibatide strategy.

"Consistent with findings from prior trials, in this double-bolus study, NSTE ACS patients undergoing PCI experienced fewer post-PCI ischemic complications with early eptifibat
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SOURCE Schering-Plough
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