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Bivalirudin Monotherapy Benefits Cardiac Patients

Study supports use of bivalirudin as a substitute for heparin plus glycoprotein IIb/IIIa inhibitors

WEDNESDAY, Nov. 22 (HealthDay News) -- In patients with moderate- or high-risk acute coronary syndromes, treatment with bivalirudin alone is associated with similar rates of ischemia, significantly lower rates of bleeding and an improved net outcome compared to heparin plus glycoprotein IIb/IIIa inhibitors, according to a study in the Nov. 23 issue of the New England Journal of Medicine.

Gregg W. Stone, M.D., of the Columbia University Medical Center in New York City, and colleagues assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone.

A nominal 7 percent decrease in bleeding events was seen with bivalirudin, plus a glycoprotein IIb/IIIa inhibitor offset the nominal 7 percent increase in ischemic events. A significant 47 percent reduction in bleeding with bivalirudin monotherapy offset the non-inferior 8 percent increase in ischemic events and produced a small but significant 14 percent reduction in net clinical outcomes at 30 days.

"The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial provides strong support for the use of bivalirudin as a substitute for heparin plus glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes who undergo early invasive management, in particular if they are pretreated with clopidogrel," states an accompanying editorial.

The study was supported by the Medicines Company and Nycomed.

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