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e abciximab and enoxaparin groups reduced the rates of complications due to ischemia after heart attack and that both drugs had very similar death rates. In a sub-analysis of the data, the Duke researchers also sought to determine whether there was any difference in the outcomes of patients enrolled in the trial who had diabetes. In their sub-study, they closely examined the three individual measurements that make up the composite endpoint.

Both abciximab and enoxaparin with tenecteplase were effective in non-diabetics.

"When looking at diabetics, however, treatment with abciximab resulted in more deaths and a trend toward more recurrent heart attacks but less refractory chest pain," said Karen Pieper, statistician at the Duke Clinical Research Institute. "Treatment with enoxaparin, on the other hand, resulted in somewhat lower risk of death but a trend toward more recurrent heart attacks and similar refractory chest pain."

When studies have low rates of events -- such as death, another heart attack or refractory ischemia -- researchers will commonly group all events into what is known as a composite endpoint. When composite endpoints are used, fewer patients need to be enrolled to achieve statistical significance.

"If mortality rates in general for heart attacks are decreasing, as they have been, you need to enroll more patients to show a benefit of therapy," said Duke cardiologist John Alexander, M.D., senior member of the team. "Alternatively, you can come up with other additional endpoints and combine them in a composite."

However, interpretation of a drug's effect on composite endpoints like those used in ASSENT-3 must be made cautiously. For example, while enoxaparin showed better mortality rates than its competitor in patients with diabetes, abciximab appear to better decrease the incidence of refractory chest pain. While it is possible that reducing refractory chest pain will reduce mortality rates down the road, there
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Contact: Richard Merritt
merri006@mc.duke.edu
919-684-4148
Duke University Medical Center
20-Nov-2002

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