On-X Life Technologies, Inc., an Austin-based biotech company known for the development of pyrolytic carbon heart valves, has announced the results of its On-X Anticoagulation Clinical Trial (PROACT). The results of the randomized clinical trial will be presented in the plenary session at the American Association for Thoracic Surgery Annual (AATS) meeting by John D. Puskas, who is Associate Chief of Cardiothoracic Surgery—and Chief of Cardiac Surgery at Emory University.
The essentials of On-X Anticoagulation Clinical Trial (PROACT):
The results of the randomized controlled trial of On-X Anticoagulation Clinical Trial (PROACT) suggest that the disease process can be effectively controlled by using less aggressive anti-coagulant regimens after aortic valve replacement with an On-X Prosthetic Heart Valve than the ones that are currently available and approved by the American College of Cardiology and American Heart Association.
The trial provided evidence that the patients who were managed with a lower dose of anti- coagulant agent reported less complications and bleeding tendencies than those who were treated with standard dose of anticoagulants. In this regard, 375 aortic valve replacement cases were analyzed and studied as part of the randomized trial.
Dr. Puskas commented:
“The major concern with the use of anticoagulants such as warfarin is bleeding. 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.”
Statistical analysis of On-X Anticoagulation Clinical Trial (PROACT):
International normalized ratio (INR) is used to measure the activity and effectiveness of an anticoagulant to ascertain clotting tendencies. The normal INR value ranges from 0.8 to 1.2 in the absence of any external anticoagulant agent. However, if an anticoagulant agent like warfarin is being employed, the INR value can vary. For practical purposes, an INR value of 2.0-3.0 is recommended in the setting of aortic valve replacement (without significant thromboembolic risk factors.
The On-X Anticoagulation Clinical Trial (PROACT) in patients with On-X aortic valve replacement indicated a lower targeted INR of 1.5-2.0 that resulted in 50% less bleeding incidents in the test subjects (a significant statistical benefit).
On-X Life Technologies CEO, Clyde Bake commented:
“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. 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.”
About the On-X Prosthetic Heart Valve and On-X LTI:
On-X® Life Technologies (On-X LTI) developed On-X pure pyrolytic carbon that is regarded as a significant breakthrough in medical grade carbon technology. The biggest advantage of these valves over other prosthetic heart devices includes a more natural design that mimics natural valves in physiology and thereby offers less resistance to the flow of blood. The smooth flow and low turbulence is responsible for lower risk of thrombo-embolic events and other vascular defects with On-X Prosthetic Heart Valve when compared to other mechanical valves. Founded in 1994 by Jack Bokros, Ph.D, On-X® Life Technologies (On-X LTI) is a privately held company that has FDA, CE and Japanese approval for sale of cardiac valves.