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Media Contact: Sherry Baker 07 March 2005    
  (404) 377-1398   Print  | Email ]

Study Shows Bivalirudin Lowers Risk for Anemic Patients Undergoing Angioplasty
When a person with heart disease who is also anemic undergoes percutaneous coronary intervention (PCI), in which angioplasty and stenting is employed to widen narrowed blood vessels, does anemia increase the risk of complications?

Research presented today at the American College of Cardiology's 54th Annual Scientific Sessions in Orlando concludes having anemia before a PCI procedure increases major bleeding and the risk of early death -- but the use of the drug bivalirudin prior to PCI can significantly reduce these risks.

"The relationship between anemia, bleeding complications, and mortality associated with PCI has been unclear. We wanted to see if anemia increases the risk of bleeding complications and early mortality in patients undergoing PCI, and if the antithrombotic regimen used in anemic patients influences the magnitude of these risks," explains Emory Heart Center cardiologist, Steven V. Manoukian MD, senior author of the abstract.

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) reviewed the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 Trial, which compared 2 glycoprotein inhibitors (brand names Reopro and Integrilin) to the direct thrombin inhibitor bivalirudin (brand name Angiomax). "These are all antithrombotic drugs which (similar to the blood thinner heparin) reduce complications associated with angioplasty and stents," explains Dr. Manoukian.

Of the 6,010 patients in REPLACE-2, 23 percent were found to be anemic, based upon hemoglobin values, prior to PCI. Major bleeding was found to be a more common PCI complication in anemic patients -- 4.9 percent compared to 2.8 percent of the non-anemic patients in the study. However, anemic patients treated with bivalirudin had a 44 percent lower relative risk of major bleeding and the relative risk of minor bleeding was 52 percent lower in anemic patients treated with bivalirudin when compared to the other therapies.

"Our major finding is that anemia in our patients is more common than we realized, and that it should be taken very seriously, because it significantly increases the risks related to PCI including bleeding and death. In addition, the anemia doesn't need to be very severe for it to cause an increase in these risks," says Dr. Manoukian. "Bivalirudin reduces complications in all patients (as shown in REPLACE-2) and especially in anemic patients, a high-risk group that might particularly benefit from it. In addition, bivalirudin offers a superior safety profile and we believe its use will continue to grow."

Drs. Attubato, Feit, Lincoff, and Manoukian disclosed commercial relationships with The Medicines Company, which sponsored REPLACE-2.

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