Someone please educate me.... I do not understand if a valve needs ACT now how is it that it may not in the future? ... Or is it that they are just not sure if it is needed?... I'm not sure that is a test case I would sign up for
I need to make a choice soon
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Someone please educate me.... I do not understand if a valve needs ACT now how is it that it may not in the future? ... Or is it that they are just not sure if it is needed?... I'm not sure that is a test case I would sign up for
Tanya,
Many members, I cannot recall, mentioned the second surgery to their surprise was easier than the first one. I am glad that you are already looking ahead positively and to a healthier life, which will help a lot with the surgery and the recovery. Good luck.
With my prayers to you now, for the coming 14 days, and onward
NOTE: I like your signature.
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M
Mary
ALCapshaw2
Well-known member
Someone please educate me.... I do not understand if a valve needs ACT now how is it that it may not in the future? ... Or is it that they are just not sure if it is needed?... I'm not sure that is a test case I would sign up for
This would be a good subject for a NEW THREAD.
Let's not add that Lengthy Discussion to this (alreadly long) thread.
A (hopefully short answer) is that On-X has been granted approval by the FDA for a Study of LOW and NO Anti-Coagulation for Low Risk Patients using Aspirin and Plavix. They have a Website which explains the Extensive Details which I will have to look up.
It is my understanding that an older manufacturer made a similar claim long ago with a poor outcome for patients who only took aspirin. I requested a copy of a paper written by a French Physician - a Dr. Baudet? - who was involved in that trial. I'll know more after I receive that paper.
As I said, if there is interest in continuing this topic, let's make it a New Thread.
Randomized On-X Anticoagulation Trial
Randomized On-X Anticoagulation Trial
The FDA approved Clinical Trial called "Randomized On-X Anticoagulation Trial", Clinical Trials Identifier NCT00291525, found at: http://www.clinicaltrials.gov/ct2/show/NCT00291525?term=nct00291525&rank=1
Purpose: Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.
Detailed Description: This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient.
This is also described on On-X website, and there is an Adobe (PDF) file that you can link to with a brochure on the study at: http://www.onxlti.com/onxlti-hv-proact.html
Also more info at this website:
http://www.onxlti.com/onxlti-hvm-clinical-trial.html
They were granted approval for 40 centers, not 20 as stated on the FDA website (typo?). There are currently 29 centers showing on the Clinical Trial info on FDA website; it gets updated as more centers are added.
The Clinical Trial has come up several times before. Previously there were VR.com members that chimed in that they would not be interested in participating, but there were also members that indicated that they would be interested in participating. Also discussion about the pros and cons of Plavix, etc.
When it is said that you would not have to use Warfarin that is true, but you would still have to use Plavix/aspirin; i.e., you would not be completely free of any medication like with a biological. However, note that the amount of Warfarin that you have to take could also possibly be reduced, if you chose to stay with Warfarin.
For those persons desiring to get into the Clinical Trial it is a requirement that you get your On-X implanted at one of the study centers. Personally, I could not work that out so I could not get into the Clinical Trial (but I would have been willing to do so if I could have).
Randomized On-X Anticoagulation Trial
The FDA approved Clinical Trial called "Randomized On-X Anticoagulation Trial", Clinical Trials Identifier NCT00291525, found at: http://www.clinicaltrials.gov/ct2/show/NCT00291525?term=nct00291525&rank=1
Purpose: Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.
Detailed Description: This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of 20 centers in the United States enrolling no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for 5 years in each patient.
This is also described on On-X website, and there is an Adobe (PDF) file that you can link to with a brochure on the study at: http://www.onxlti.com/onxlti-hv-proact.html
Also more info at this website:
http://www.onxlti.com/onxlti-hvm-clinical-trial.html
They were granted approval for 40 centers, not 20 as stated on the FDA website (typo?). There are currently 29 centers showing on the Clinical Trial info on FDA website; it gets updated as more centers are added.
The Clinical Trial has come up several times before. Previously there were VR.com members that chimed in that they would not be interested in participating, but there were also members that indicated that they would be interested in participating. Also discussion about the pros and cons of Plavix, etc.
When it is said that you would not have to use Warfarin that is true, but you would still have to use Plavix/aspirin; i.e., you would not be completely free of any medication like with a biological. However, note that the amount of Warfarin that you have to take could also possibly be reduced, if you chose to stay with Warfarin.
For those persons desiring to get into the Clinical Trial it is a requirement that you get your On-X implanted at one of the study centers. Personally, I could not work that out so I could not get into the Clinical Trial (but I would have been willing to do so if I could have).
jerseysue
Member
Valve choice reply
Valve choice reply
All my best with your surgery, and the St. Jude valve is excellent. I know one has been keeping me alive now for 15 yrs. and counting, and that's good enough for me! We wish you a speedy recovery afterwards!
Sue in AZ
Valve choice reply
All my best with your surgery, and the St. Jude valve is excellent. I know one has been keeping me alive now for 15 yrs. and counting, and that's good enough for me! We wish you a speedy recovery afterwards!
Sue in AZ
