On-X Life Technologies, Inc. announced that Mervyn Williams, M.D. of Provincial Hospital in Port Elizabeth, South Africa will be presenting results of a ten-year clinical study of the On-X Prosthetic Heart Valve. The data, in particular, will be on the use of the valve in poorly anticoagulated patients in South Africa. Currently, patients with prosthetic mechanical heart valves require life long anticoagulation therapy with warfarin, and antiplatelet therapy with aspirin is strongly recommended if no contraindications exist. One of the major limitations of mechanical heart valves has been the increased thrombotic risk partially as a result from the prosthesis creating turbulent flow, damaging red blood cells and platelets – all of which increase the risk of thrombus formation, valve malfunction, and thromboembolic events such as a stroke. One of the drawbacks of lifelong anticoagulation with warfarin is the increased bleed risk and a need to maintain a very narrow therapeutic window requiring frequent dose adjustments and blood draws.
The On-X valve uses a pure pyrolytic carbon material that allows for a more thromboresistant surface, reduced blood turbulence and blood damage, which can potentially reduce the likelihood of thrombus formation and complications.
Data from the ten-year study in South Africa will be important to understand On-X Valve’s performance and patient stroke estimates in poorly controlled anticoagulated patients.
Currently, there is an ongoing prospective randomized clinical trial, PROACT, in the United States and Canada assessing the safety of lower doses of anticoagulation (warfarin) or antiplatelet therapy alone (aspirin/clopidogrel) compared to standard therapy in patients with On-X Heart valves. This will be a pivotal study to look out for with estimated study completion date of March 2015.
Link: On-X Life Technologies…