Researchers at the German Heart Center (Deutsches Herzzentrum, Munich) conducted a double-blind study that randomly assigned 1,721 patients with acute non-STEMI to receive abciximab plus unfractionated heparin (861 patients) or bivalirudin (860 patients). The researcher’s goal was to test the hypothesis that abciximab and heparin would be superior to bivalirudin with respect to the primary composite end point of death, large recurrent myocardial infarction (MI), urgent target-vessel revascularization, or major bleeding within 30 days. Secondary end points included composite of death, any recurrent MI, urgent target-vessel revascularization, and major bleeding within 30 days.

The results showed that the primary end point occurred in 10.9% of the patients in the abciximab group (94 patients) and in 11% in the bivalirudin group (95 patients). Death, any recurrent MI, or urgent target-vessel revascularization occurred in 12.8% of the patients in the abciximab group (110 patients) and in 13.4% in the bivalirudin group (115 patients). Conversely, major bleeding occurred in 4.6% of the patients in the abciximab group as compared with 2.6% in the bivalirudin group. The results indicate that patients receiving the abciximab plus heparin combination faced about an 80% greater relative risk of bleeding. The study was published in the November 24, 2011, issue of the New England Journal of Medicine (NEJM).

“Understanding which treatment works better is important because non-STEMI heart attack patients are in danger of further cardiovascular problems,” said lead author Adnan Kastrati, MD. “The results of PCI in these patients are strongly dependent on the efficacy and safety of the anticlotting drugs used during the procedure.”

The researchers suggested that the lack of protection against ischemic events noted with abciximab is further suggested by the failure of the drug to reduce the frequency of even small recurrent MI, as well as other data suggesting that neither was the drug associated with a reduction in risk of stent thrombosis. In all, the results suggest that bivalirudin alone provides anti-ischemic protection similar to that offered by the combination abciximab and heparin, and with less risk of major bleeding.

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German Heart Center