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
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."
About Angiomax® (bivalirudin) for Injection
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life.
In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA 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. Angiomax is not approved for use in ACS patients not undergoing PCI. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "plans" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether results of clinical studies such as the results described above will be indicative of results in later clinical studies, whether clinical trial results will warrant submission of applications for regulatory approval, including for additional patient populations, whether the Company will be able to obtain regulatory approvals in additional patient populations, whether physicians, patients and other key decision-makers will accept clinical trial results, whether the Company is able to maintain market exclusivity for Angiomax in the United States in light of the risk of an adverse court decision or adverse legislation relating to the term of the principal patent covering Angiomax or through the enforcement of our other U.S. patents covering Angiomax and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Rebecca Hollins | EurekAlert!
ECG procedure indicates whether an implantable defibrillator will extend a patient's life
02.09.2019 | Technische Universität München
Fracking prompts global spike in atmospheric methane
14.08.2019 | European Geosciences Union
How long the battery of your phone or computer lasts depends on how many lithium ions can be stored in the battery's negative electrode material. If the battery runs out of these ions, it can't generate an electrical current to run a device and ultimately fails.
Materials with a higher lithium ion storage capacity are either too heavy or the wrong shape to replace graphite, the electrode material currently used in...
To process information, photons must interact. However, these tiny packets of light want nothing to do with each other, each passing by without altering the...
Researchers from the Department of Atomically Resolved Dynamics of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg, the University of Hamburg and the European Molecular Biology Laboratory (EMBL) outstation in the city have developed a new method to watch biomolecules at work. This method dramatically simplifies starting enzymatic reactions by mixing a cocktail of small amounts of liquids with protein crystals. Determination of the protein structures at different times after mixing can be assembled into a time-lapse sequence that shows the molecular foundations of biology.
The functions of biomolecules are determined by their motions and structural changes. Yet it is a formidable challenge to understand these dynamic motions.
At the International Symposium on Automotive Lighting 2019 (ISAL) in Darmstadt from September 23 to 25, 2019, the Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP, a provider of research and development services in the field of organic electronics, will present OLED light strips of any length with additional functionalities for the first time at booth no. 37.
Almost everyone is familiar with light strips for interior design. LED strips are available by the metre in DIY stores around the corner and are just as often...
Later during this century, around 2060, a paradigm shift in global energy consumption is expected: we will spend more energy for cooling than for heating....
19.09.2019 | Event News
10.09.2019 | Event News
04.09.2019 | Event News
20.09.2019 | Life Sciences
20.09.2019 | Life Sciences
20.09.2019 | Life Sciences