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Bivalirudin Not Inferior to Heparin-Glycoprotein IIb/IIIa Inhibitor Combination in Angioplasty: Presented at AHA

By Ed Susman

CHICAGO, IL -- November 20, 2002 -- Bivalirudin appears to be superior to heparin alone and at least as effective as a heparin/glycoprotein IIb/IIIa inhibitor combination in treating patients undergoing coronary angioplasty, researchers say.

This finding from the REPLACE-2 trial was presented in a late-breaking report at the 2002 Scientific Session of the American Heart Association here on November 17.

Dr. A. Michael Lincoff, associate professor at the Cleveland Clinic Foundation in Cleveland, Ohio, United States, said the study established the anti-coagulant bivalirudin as a treatment that can reduce the incidence of bleeding and transfusion, as well as costs in the catheter-based procedures.

Researchers enrolled 6,002 patients in this study, which was conducted in the United States, Canada, Western Europe and Israel. They tested how well bivalirudin fared, looking at the quadruple composite end point of death, heart attack, urgent revisualization and major bleeding.

Dr. Lincoff said the relative risk reduction in the quadruple end point between bivalirudin and heparin alone reached 38 percent, which achieved statistical significance at the p=0.001 level. When they looked at the same comparison with a triple end point -- not including bleeding -- there was a relative risk reduction of about 39 percent, also reaching statistical significance at the p=0.001 level.

Also, patients who received bivalirudin experienced significantly fewer bleeding complications than did those who received the heparin/glycoprotein IIb/IIIa inhibitor combination.

About 9.2 percent of patients in the bivalirudin arm of the study experienced a quadruple end point event compared with 10 percent of the patients receiving the combination of heparin and glycoprotein IIb/IIIa. Those results showed no treatment outcome differences, Dr. Lincoff said. In the triple end point analysis, 7.6 percent of bivalirudin patients, and 7.1 percent of the combination patients experienced an event.

In this study, all patients in the heparin arm received heparin plus a IIb/IIIa inhibitor. Patients receiving bivalirudin were given bivalirudin alone or in combination with a glycoprotein IIb/IIIa inhibitor on a provisional basis at the discretion of the investigator. This decision was based on protocol-suggested situations. Use of a provisional agent did not unblind the study drug, Dr. Lincoff pointed out.

He explained that in clinical practice, the ability to use one drug rather that a combination "would make treatment in the cath lab easier and less expensive."

Dr. James Ferguson, MD, co-director of cardiovascular research at the Texas Heart Institute, in Houston, said, "I don't think the results establish bivalirudin as a replacement treatment but it appears to be a good alternative."

The REPLACE-2 study was supported by the Medicines Company, Parsippany, New Jersey.

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