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Acuity One-Year Findings Meet All Primary Endpoints in Favor of,Angiomax (Bivalirudin) Alone Treatment Group

3,819 ACS patients in 17 countries, ACUITY is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital. The trial design employed an early invasive strategy, starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group. In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10% of patients in the ACUITY trial. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management, bypass surgery, or angioplasty, also known as percutaneous coronary intervention or PCI.

About ACS

ACS includes a range of conditions, such as chest pain and heart attack, which are caused by insufficient blood supply to the heart due to blockages in coronary arteries, usually caused by blood clots. Patients with ACS symptoms are at significant risk for heart attack or death. Each year in the United States, 5 million people go to the emergency department with chest pain, of which about 1.4 million are identified with ACS.

The American Heart Association and the of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management (e.g., various anti-clotting drugs), bypass surgery, or PCI. Heparin plus a GPI is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GPI can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed increases the risk of death.

About Angiomax(R) (bivalirudin)

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