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!
Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)
The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.
It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...
17.10.2017 | Event News
10.10.2017 | Event News
10.10.2017 | Event News
18.10.2017 | Materials Sciences
18.10.2017 | Physics and Astronomy
18.10.2017 | Physics and Astronomy