On-X Life Technologies, Inc. to Highlight Reduced Anticoagulation Study Results, Long-Term and Patient Survival Data with the On-X Valve at STS Meeting
Published: Jan 24, 2012
The preliminary report of PROACT (Prospective Randomized On-X Clinical Trial) trial data presented at the American College of Cardiology meeting in 2011 for the high risk aortic patient test and control groups showed that as hypothesized, patients in the test group with INRs between 1.5 and 2.0 are currently equal in composite thromboembolism and hemorrhage rates compared to the control group of patients. All patients received an On-X valve as a replacement for their aortic valve. High-risk aortic patients are those who have a higher potential for thrombotic or bleeding events. These were randomized into Test and Control groups for the trial. Both patient groups were maintained with standard anticoagulation therapy for the first three months after surgery and then randomized into their groups. The Test group was maintained with a daily dose of 81milligrams of baby aspirin plus warfarin to achieve an INR target of 1.5 to 2.0. The Control group continued with standard anticoagulation therapy throughout the trial.
The recently presented South African study provides a stunning example of the On-X valve's ability to reduce complications despite adverse anticoagulation compliance. For example, with an approximately 50 percent noncompliant patient group in this study, the thrombosis rate remains 0.2 percent per patient-year comparing favorably to competitive valves with 2.0 percent per patient-year to 6.0 percent per patient-year thrombosis rates in this same patient population.1
Several recent studies, which provide evidence of durability, reoperation and mortality benefits received by mechanical valve recipients in comparison with matched patient groups receiving biologic valves, will available to participants of the meeting. These data provide new and compelling evidence that mechanical valve patients with equal disease severity and age to those with tissue valves can expect a survival advantage and an equivalent combined morbid event rate compared to their matched biological valve recipients.
"We are very pleased with the continuing record of clinical evidence demonstrating the benefit of the On-X valve's unique design with many categories of patients in diverse geographic and clinical settings," said Clyde Baker, On-X LTI's president. "The results emphasize the ability of the On-X valve to tolerate an inconsistent INR level, to provide the lowest possible levels of clinical complications and to help heart valve replacement patients maintain an active life, without severe risk of reoperation at an advanced age."
The On-X 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 resulted 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, Inc. (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.
On-X is a registered trademark of On-X Life Technologies, Inc. All other trademarks mentioned herein belong to their respective companies.
The On-X Life Technologies Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10418
1. Williams MA, Crause L, Van Riet S. A comparison of mechanical valve performance in a poorly anticoagulated community. J Card Surg 2004;19:410-14
CONTACT: Clyde Baker
On-X Life Technologies, Inc.
512-339-8000 ext. 269