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Lower One-Year Mortality Reported Among Angiomax-Treated Patients at High Risk of Death

PARSIPPANY, N.J.--(BUSINESS WIRE)--Aug. 10, 2004-- Long-term findings of the REPLACE-2 angioplasty clinical trial were released today for publication in the August 11, 2004 issue of The Journal of the American Medical Association (JAMA). The JAMA article includes new analyses that report significantly lower mortality at one year among high risk patients treated with Angiomax® (bivalirudin), an anti-clotting agent used during angioplasty.

REPLACE-2 studied the effects of anticoagulation therapy in more than 6,000 patients undergoing percutaneous coronary intervention, a procedure commonly known as angioplasty, which is conducted on more than one million Americans annually to clear restricted blood flow in coronary arteries. The trial compared Angiomax versus a combination of heparin and platelet blockers known as GP IIb/IIIa inhibitors (GP IIb/IIIa inhibitors were used provisionally in 7% of patients in the Angiomax group).

The JAMA article notes that REPLACE-2 was the largest study of acute anticoagulation therapies (known as antithrombotics) ever conducted in patients undergoing percutaneous intervention. The study was sponsored by The Medicines Company (Nasdaq: MDCO - News).

Lead author, A. Michael Lincoff, MD of The Cleveland Clinic Foundation reported in the article, "Rates of mortality by 1 year trended lower in the bivalirudin group in all pre-specified patient subgroups."

The article adds, "Among patients at high risk, however, death occurred significantly less frequently with bivalirudin than with heparin plus GP IIb/IIIa blockade (6.0% vs 3.9% respectively, p=0.047)."

The new analysis identified high risk patients by defining characteristics (known as baseline variables) that categorized patients as low-, medium- or high-risk. The authors found that eight baseline variables, such as age and prior heart diseases, were predictive of one-year mortality.

The latest mortality results add to previously reported REPLACE-2 findings demonstrating Angiomax benefits of significantly less bleeding (p less than 0.001), less thrombocytopenia (p less than 0.001), reduced infusion times (p less than 0.001) and lower cost (p less than 0.001). These findings were published and/or presented previously in JAMA and in scientific symposia such as the American Heart Association's Annual Scientific Sessions and the American College of Cardiology Annual Scientific Sessions.

Clive Meanwell, Chairman and CEO of The Medicines Company noted, "Peer review, as conducted by JAMA, provides a high standard of scientific scrutiny for the trial conduct and this report demonstrates once again the importance and robustness of the REPLACE-2 results. We again thank Principal Investigator Dr. Michael Lincoff, Study Chairman Dr. Eric Topol, and their colleagues for conducting this excellent study."

Brent Furse, Vice President and General Manager, Emergency Department and Endovascular Therapeutics Business, of The Medicines Company commented, "This latest analysis demonstrates long-term efficacy of Angiomax. Together with the ease of use, safety and cost-reducing benefits previously reported, this analysis provides a compelling story to interventional cardiologists."

About Angiomax
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated reductions in both ischemic and bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in ischemic and bleeding complications remain evident even in high-risk patients.

In the U.S., Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at

Source: The Medicines Company

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