On-X® Life Technologies, Inc. (On-X LTI) announced today that four clinical trial reports, documenting the On-X® Prosthetic Heart Valve's extraordinary performance, will be presented at the upcoming meeting of the Society for Heart Valve Disease in Barcelona, Spain being held June 25-28, 2011. The reports will include interim clinical results from the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), which is being conducted in 36 major institutions in the United States, a comparison of the On-X heart valve with three competitive mechanical valves in Australia, a Ten-year Multiple Center European Study and a Ten-year Study in Poorly Controlled Anticoagulated Patients in South Africa. All four studies provide evidence of the continuing superior performance of the On-X Prosthetic Heart Valve.
"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 preliminary report of PROACT trial data for the high risk aortic patient test and control groups shows 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. High-risk aortic patients are those who have a higher potential for thrombotic or bleeding events. All patients received an On-X valve as a replacement for their aortic valve. 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 the test and control groups. The test group was maintained with a daily dose of either 81 or 325 milligrams 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.
PROACT was initiated in 2006 and is currently ongoing in 36 centers throughout the United States and Canada because of the exceptional clinical outcomes seen in clinical trials since the On-X valve was introduced in 1996. The purpose of the PROACT trial is to determine if patients implanted with the On-X valve can be safely maintained with reduced levels of warfarin (brand name Coumadin®) anticoagulation or eliminated use of warfarin altogether.
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.
Until the completion and analysis of study data, On-X Life Technologies, Inc. continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.
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