AATS Report: Prospective Randomized On-X Life Technologies, Inc. Heart Valve Clinical Trial (PROACT) Provides Evidence of Reduced Complications
MINNEAPOLIS — May 6, 2013 — On-X® Life Technologies, Inc. (On-X LTI) announced today that interim results for the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) are being presented at the American Association for Thoracic Surgery Annual (AATS) meeting by John D. Puskas, M.D., M.Sc., Chief of Cardiac Surgery—Emory University Hospital Midtown, Associate Chief of Cardiothoracic Surgery—Emory University, and International Principle Investigator for the PROACT trial. The presentation by Dr. Puskas will be the first of the meeting’s plenary session.
The interim results of the PROACT trial provide evidence that patients may be safely managed with less aggressive anticoagulant therapy than is currently recommended by the American Heart Association and American College of Cardiology after replacement of the aortic valve with an On-X® Prosthetic Heart Valve. Indeed, in this series of 375 aortic valve replacement patients, those managed with lower anticoagulation had reduced bleeding complications compared to those patients treated with standard doses of anticoagulation as are used for other mechanical heart valves.
“The major concern with the use of anticoagulants such as warfarin is bleeding,” said Dr Puskas. “The PROACT trial results show that On-X aortic heart valve recipients can be safely maintained at much lower INR levels than have been used for other mechanical heart valves, thereby significantly reducing the risk of bleeding complications.”
The level of anticoagulation activity is measured as international normalized ratio (INR). INR is used to determine the clotting tendency of blood. INR in the absence of anticoagulation therapy is normally 0.8-1.2. The target range for INR in anticoagulant use (e.g., warfarin) varies depending upon indication for therapy. Professional societies have recommended that patients with mechanical aortic heart valves in the absence of thromboembolic risk factors be maintained at 2.0-3.0 INR.
The trial for the On-X aortic valve studied an INR range of 1.5-2.0 INR for aortic valve patients at higher than normal risk of thromboembolism. The lower target INR in the PROACT trial has resulted in a statistically significant reduction of over 50 percent in bleeding events for the test patients.
“The PROACT trial results showing reduced bleeding events for patients receiving the On-X aortic valve are extremely meaningful for patients choosing a prosthetic valve,” said Clyde Baker, On-X Life Technologies CEO. “Pending review and approval by the FDA, younger aortic heart valve replacement patients—those 65 years and under—may have a much safer and permanent solution to aortic valve disease. They can make a choice for low complications and not be faced with the trauma of a likely future cardiac reoperation.”
More about the On-X Prosthetic Heart Valve The On-X heart valve is the result of a breakthrough in medical grade carbon technology—On-X pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X carbon enabled On-X LTI to make significant valve design changes that result in a prosthesis that acts more like a natural valve in its treatment of blood. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and therefore significantly reduces the potential for life-threatening blood clots.
About On-X LTI
On-X® Life Technologies (On-X LTI) develops heart valve replacements that significantly improve the quality of life of patients. Jack Bokros, Ph.D., and his associates founded On-X LTI in 1994 to further advance prosthetic heart valve technology by capitalizing on their new form of pyrolytic carbon. The company has FDA, CE and Japanese approval for sale of the On-X valve. On-X LTI also provides contract-manufacturing services utilizing its patented pyrolytic carbon to manufacturers of other medical products, including orthopedic joint and spine prostheses. Headquartered in Austin, Texas, On-X LTI is a privately held company. More information is located at www.onxlti.com.
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