STUDY SHOWS BIVALIRUDIN LOWERS RISK OF BLOOD TRANSFUSION IN CORONARY PROCEDURES

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STUDY SHOWS BIVALIRUDIN LOWERS RISK OF BLOOD TRANSFUSION IN CORONARY PROCEDURES
17 February 2007 - Emory University

Research presented this week at the Cardiovascular Revascularization Therapies 2005 conference in Washington, DC concludes that for patients receiving a coronary stent or angioplasty procedure, the risk of needing a blood transfusion is 32 percent lower with the use of the antithrombotic drug bivalirudin, when compared to the combination of heparin and a glycoprotetin inhibitor.

"One of the most important reasons to minimize the risk of blood transfusion is that patients who receive a blood transfusion have a 5-fold increase risk of death at one year," says Emory Heart Center cardiologist, Steven V. Manoukian MD, senior author of the abstract. "Previous studies indicate that blood transfusion is an independent predictor of mortality in patients undergoing percutaneous coronary intervention. However, we hypothesized that although transfusions increase mortality associated with PCI, the type of antithrombotic therapy employed might impact these risks."

The research team (including Michele D. Voeltz, MD, of the Emory University School of Medicine; Michael J. Attubato, MD, and Frederick Feit, MD, of New York University School of Medicine and A. Michael Lincoff, MD, of the Cleveland Clinic, and John A. Bittl of the Munroe Regional Medical Center in Ocala, Florida) reviewed the available blood product transfusion and mortality data for patients enrolled in the previously published Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 Trial. The REPLACE-2 trial compared 2 glycoprotein inhibitors (brand names Reopro and Integrilin) to the direct thrombin inhibitor bivalirudin (brand name Angiomax). Similar to the blood thinner heparin, antithrombotic drugs reduce complications associated with angioplasty and stents.

Of the 6,001 patients in REPLACE-2, 126 patients (2 percent), received a transfusion of any blood product. At 30 days, 1.7 percent of BIV patients received transfusions compared to 2.5 percent of (GPI+H) patients. Of the BIV patients who required transfusion, 22% received one of the two glycoprotein inhibitors. Also, patients undergoing coronary stent procedures were 32% less likely to require blood transfusions if they were treated with the direct thrombin inhibitor bivalirudin, than with the combination of a glycoprotein inhibitor plus heparin. Patients who received transfusion were 7.5 times more likely to die by 6 months after the procedure, and 5.4 times more likely to die by one year.

"These results define the enormous risk for patients who are transfusion in relation to a coronary stent procedure," says Dr. Manoukian. "In addition, they prove that using bivalirudin instead of glycoprotein unhibitors plus heparin can reduce the risk of transfusion and therefore reduce the risk of death following the procedure."

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