In this medical health video learn about the On-X Valve PROACT Trial and what results it is getting.
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The On-X Valve PROACT Trial Dr. John Puskas: There have been several interesting studies with this particular valve, this new valve that would suggest that patients who don't take their Coumadin reliably for social reasons or financial reasons, are better off with this new mechanical valve than the old ones, are less likely to have a clot. We don't encourage people don't take the Coumadin, that's not what I'm saying, but we have seen in several hundred patients in South Africa, for instance, young patients who have Rheumatic heart disease and mechanical valve replacements and who may not take their Coumadin reliably or sometimes not at all, that the incidence of sudden death or terrible clots forming is surprisingly low with this new valve, much lower than we would expect or than we saw in the similar populations with the older design valves. So that was kind of encouraging and made one think well this is the worst-case scenario, they are not taking their Coumadin at all and in fact very few are dying, very, very few. And then perhaps this valve is so new, so much better than the old valves that we could do a trial to test this valve with lower doses of Coumadin or potentiating no Coumadin and select populations and that's what this new PROACT trial is about. Gary Pederson: The doctor came through the hospital and I had the initial examination and explained to me that there is a new kind of valve that he would like to have me to take a look at and the advantage of the mechanical valve as opposed to a tissue valve. So I took his advice and went with the carbon-based valve. Dr. John Puskas: The PROACT trial for which I am privileged to serve as principal investigator is an FDA sponsored trial, to test a simple theory that is, in this valve which is bionic valve that's approved for use in United States, will this valve be safely used with lower than traditional doses of Coumadin. And so this trial is testing function of this On-X valve in the mitral and aortic positions with normal doses of Coumadin or much lower doses of Coumadin. For patients who have the aortic valve and are considered low risk patients, one group of patients will actually be randomized to have no Coumadin after three months, and they'll have Aspirin and Plavix, instead; those are two different sorts of blood thinners that are frequently given to patients who have stents, we know that Aspirin and Plavix can be given safely because we've given it to many, many hundreds of thousands of patients who have had stents. But we have never used Aspirin and Plavix alone to treat mechanical heart valves and prevent clots in those patients. So this is a very important trial because it would change the paradigm or the thinking about mechanical valves. If, in fact, this valve has shown to be safe without Coumadin, then all the risks of bleeding or clotting, stroke problems, bleeding problems with mechanical valves and Coumadin could be avoided in those patients for whom it has shown to be safe. Dr. Allen Graeve: If we can prove that you can take Aspirin and Plavix and have no higher or maybe even less risk of Thromboembolism that if you are Coumadin, will revolutionize heart valve surgery in the aortic position. Gary Pederson: For me, I am not having to do blood checks all the time to find out what my Coumadin level is, well I am not uncoumadin and therefore I don't have a fear of being cut and having blood thinned out so much that it can't stop. So I am not afraid of that at all. Dr. John Puskas: This is an FDA trial. It is dictated that every patient will be followed for five years. So the trial is intended to enroll 1200 patients approximately 300 have been enrolled now. So about a quarter of the way through enrollment and enrollment is progressing well in 40 different centers in North America. To really get the final results will take at least five years from now before we have the results for those first patients enrolled. We'll have some pretty good ideas along t