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First results of Angiomax (bivalirudin) vs. heparin in transcatheter aortic valve interventions
Date:11/8/2011

San Francisco, CA November 8, 2011: Clinical researchers here reported the first results of a pilot study with the anticoagulant Angiomax (bivalirudin) as an adjunct to catheter-based procedures in patients with severely defective aortic heart valves in whom surgery was not possible. The results showed a 60% reduction in major bleeding events (from 13% to 5%, p = 0.003) in patients treated with Angiomax compared to patients treated with heparin. This investigational use of Angiomax is not approved in these procedures, collectively known as transcatheter aortic valve interventions. Angiomax is approved for patients undergoing percutaneous coronary interventions (PCI) with provisional glycoprotein IIb/IIIa inhibitor (GPI).

George D. Dangas, MD, PhD, of Mount Sinai Medical Center New York, NY led this study, which was also conducted at the University of Miami Health System (Drs. Annapoorna S. Kini and Mauricio Cohen were the respective team leaders) in a program called BRAVO (BivaliRudin to improve Aortic Valve intervention Outcomes), which is sponsored by The Medicines Company (NASDAQ: MDCO). The data were reported here at the Cardiovascular Research Foundation (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

The data reported by Dr. Dangas were the results from a two-center retrospective registry of 428 patients with severe aortic stenosis undergoing balloon valvuloplasty (BAV) via transfemoral access and the use of bivalirudin. BAV involves the insertion of a compressed balloon into a catheter, a long, thin, tube-like device. The catheter and balloon are inserted into the femoral artery through a small cut in the leg and threaded to the site of the diseased valve. The balloon is then inflated in an effort to increase the opening size of the valve and improve blood flow.

The study met its two objectives, demonstrating patients treated with bivalirudin versus unfractionated heparin experienced:

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Contact: Rebecca Hollins
rebecca.hollins@themedco.com
973-290-6081
The Medicines Company
Source:Eurekalert

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