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Breakthrough
New Clot Prevention Drug May Beat Standard

Replacing heparin and a powerful antiplatelet agent with a single drug called bivalirudin is the best way to treat people with acute coronary syndromes who are close to having a major heart attack, according to a new study led by Gregg W. Stone, M.D., the director of research and education for the Center for Interventional Vascular Therapy at CUMC and NewYork-Presbyterian Hospital, and chairman of the Cardiovascular Research Foundation. The study appeared in the New England Journal of Medicine.
   Most of the 1.5 million Americans who go to the hospital with chest pain and other symptoms that presage a major heart attack receive heparin and a powerful antiplatelet drug called a GPIIb/IIIa inhibitor, along with several other drugs to reduce dangerous clotting. But heparin and GPIIb/IIIa inhibitors carry a risk of bleeding associated with a five to 25-fold increase in death. Bivalirudin is a novel anticoagulant drug that potently inhibits blood clotting while having a low rate of bleeding complications. Bivalirudin is widely used in patients undergoing angioplasty and stenting, but had not been widely studied in patients with acute coronary syndromes.
   Dr. Stone and colleagues performed a randomized trial in 13,819 patients with acute coronary syndromes at 450 hospitals worldwide and found that bivalirudin cut the rate of major bleeding complications in half while working just as well as heparin and GPIIb/IIIa inhibitors in clot prevention. The best strategy for these patients, Dr. Stone says, is to start them on bivalirudin, aspirin, and clopidogrel, and add a GPIIb/IIIa inhibitor only if the initial drugs are insufficient.
   “Bivalirudin should have a major impact on treatment of patients with acute coronary syndromes, making therapy much safer for patients,” Dr. Stone says.
   In a second paper to be published in JAMA, Dr. Stone and colleagues examined the best strategy to administer GPIIb/IIIa inhibitors. Giving GPIIb/IIIa inhibitors only to patients undergoing catheterization, instead of to all patients in the emergency room, reduced bleeding but was associated with a possible slight increase in ischemia. “Overall, both strategies are acceptable, though using the drugs only in patients undergoing angioplasty might be somewhat preferable,” Dr. Stone says. “However, both strategies of using GPIIb/IIIa inhibitors combined with heparin result in less favorable outcomes for these high risk patients than simply using bivalirudin alone,” Dr. Stone concluded.
The research was funded by the Medicines Company, the maker of bivalirudin, and Nycomed, which markets the drug in Europe.

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