Navigation Links
First results of Angiomax (bivalirudin) vs. heparin in transcatheter aortic valve interventions

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:

  • Reduced rates of in-hospital major bleeding
  • Reduced rates of in-hospital net adverse clinical events (major bleeding, all-cause mortality, myocardial infarction or stroke)

Dr. Dangas noted, "Technologies to enable heart valve replacement or repair without cracking open a patient's chest are emerging rapidly. Last week's US approval of the SapienTM valve is the most recent example."

Anticoagulants are needed peri-procedurally to prevent clotting on the treated area and clotting in other organs such as the brain, which can result in a stroke; however, anticoagulants carry a risk of vascular and bleeding complications. Dr. Dangas said, "Advances in procedures such as PCI, valvuloplasty and TAVI may require improvements in anticoagulation to yield improved patient outcomes."

Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company said, "These results validate the commitment we made to study Angiomax once our patent rights were supported. I look forward to seeing the BRAVO program move ahead with a planned study in more patients next year. With continued certainty, we will be positioned to explore the potential of Angiomax to deliver clinical and economic advantages in other uses."


Contact: Rebecca Hollins
The Medicines Company

Related medicine news :

1. Medical Training School, Pima Medical Institute Offering First Bachelor's Degree Program
2. Retired Military Brass Support First Ladys Call to Reduce Child Obesity, Improve Nutrition
3. NASBE Supports First Lady Michelle Obama in Fight Against Childhood Obesity
4. PolicyLink CEO Angela Glover Blackwell Released the Following Statement on First Lady Michelle Obamas Childhood Obesity Initiative
5. MSU launches first anti-counterfeiting research program
6. AMA Joins First Lady in Fight Against Childhood Obesity
7. National Wildlife Federation Says Outdoor Time for Kids Can Help First Lady Achieve Her “Let's Move” Goal
8. First blinded study of venous insufficiency prevalence in MS shows promising results
9. Akron Institute of Herzing University Launches Its First Bachelors Degree Programs to Prepare Students for Even Greater Success in Business, Health Care and IT
10. First Gene Variants Linked to Stuttering Discovered
11. FAB-HOMES™ Presents First Passive House Collection
Post Your Comments:
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... 23, 2016  MedSource announced today that it ... software solution of choice.  This latest decision demonstrates ... to their clients by offering a state-of-the-art electronic ... establishes nowEDC as the EDC platform of choice ... clients.  "nowEDC has long been a preferred EDC ...
Breaking Medicine Technology: