On-X in FDA trials

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pellicle

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very interesting, esp as i'll be getting an On-X valve in the next few months
If they pass, you can bet it will trickle to other bi-leaflet mech valves too. Myself with an ATS however I will be sticking with warfarin until the evidence is completely clear (even if I had an On-X). The devil you know is always the better option.

Besides all these things On-X has done are for only two reasons
  1. Find a drug that gives a performance almost as good as warfarin but with no monitoring
  2. Appeal to peoples irrational fear of warfarin (which has no real justification when INR monitoring is performed weekly)
 
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jlcsn2015

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Merry Christmas to all,
I like the idea in principle, but
1 pill of Warfa costs less than $1...,
this other thing is listed online for $62.00
Just my thinking, some people may not care about the cost.
 

almost_hectic

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yeah, yeah, negativity as per usual. If it passes, this WONT automatically trickle to all other bi-leaflet valves anytime soon. The On-X valves is not just another bi-leaflet design, it has a number of unique design advances. In this regard the most relevant of which is the unique carbon, different from traditional carbon valves https://www.cryolife.com/products/contract-manufacturing/on-x-pyrolytic-carbon/
And yes, Coumadin is of course cheap as far as pills go. However the testing equipment, test strips and monitoring service however for those of us on Coumadin is far from cheap.
I for one am interested to see what comes of this. Yes I already take a blood thinner everyday. that will likely never change. But if it’s possible to switch to one that’s just as effective without weekly monitoring, that leads me to believe it’s less prone to the yo-yo effect of Coumadin, and hopefully with less interactions with foods.
I for one look forward to these potential advances on the horizon, and applaud the people advancing the science and what that may influence in the future.
 

nobog

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yeah, yeah, negativity as per usual. If it passes, this WONT automatically trickle to all other bi-leaflet valves anytime soon. The On-X valves is not just another bi-leaflet design, it has a number of unique design advances. In this regard the most relevant of which is the unique carbon, different from traditional carbon valves https://www.cryolife.com/products/contract-manufacturing/on-x-pyrolytic-carbon/
The only reason the On-X valve is special is because they say so, mainly;

"provides needed wear resistance without the silicon"
Other mechanical valves can go decades with wear in the single digit micron range

"very precise dimensional control"
All mechanical valves are made on computer-controlled machines and have accuracies of one-tenth of a human hair

"The surface can be polished to a high gloss where articulation or thromboresistance"
Clearances between the leaflets and the orifice (in the closed position) cause blood damage (high velocity jets) in all mechanical valves. (articulation ?)

So yes, the On-X is just another heart valve. Super polish? Low profile? Laminar Flow? High EOA? The manufactures can spin it any way they want when in the end, the only thing that matters is 20 years of clinical data.
 

tom in MO

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I wonder who would participate in this clinical trial. Why bet one's life for the ability to use Eliquis over Warfarin? What does the participant get out of it? Do they get paid? Since the INR range for the trial is 2-3, this is higher than the INR range of 1.5-2 when on warfarin with an On-X. Higher INR & once a year testing vs. lower INR and biweekly testing appears to be the decision rule.
 

Protimenow

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I agree - it WILL trickle down. Even if the study validates Apixaban as acceptable for use in patients with On-X valves, people (and maybe their doctors) who have other valves will probably try apixaban -- FDA approval or not.

I didn't see anything in the release that indicated how the warfarin group would be managed -- would their INR be managed weekly, monthly, or not at all? If they create a study that is doomed to create negative outcomes in people on warfarin (and this is possible), would the conclusion that Apixaban is safer be valid?

Aside from the much higher cost of Apixaban, what are the costs of reversing the effects? If a person taking Apixaban should get into an accident or need emergency surgery, how will the anticoagulation be reversed? It's not as easy as packed platelets and Vitamin K.

It's certainly interesting to see that Bristol-Myers Squibb was finally able to get FDA approval of testing of Apixaban in On-X patients, but I'm not convinced about its value.

Also-- one more thing -- self testing isn't the burden that almost_hectic seemed to suggest. You can get cheap, reliable meters on eBay, the test strips are around $5 each, or less. If you amortize the cost of a meter ($850 or so retail) over two years, and add in the cost of lancet and strip, it's only around $13 or so each week for self-testing. And, after year two, the cost should be less than $6 a week.

almost_hectic also mentioned yo yo INR. This only happens when the person managing the INR doesn't know how to do it. There are great resources here that can help with the management of INR without the yo yo effect.

Unless I'm convinced otherwise, I'm happy to stay on warfarin and self testing. Management has been easy, I've not experiened the yo yo, testing is easy - and costs less than the cost of gas (to get to the lab), the cost for parking, and the lab charges.

To make a long argument short -- I don't see how apixaban can provide a worthwhile advantage over Warfarin and weekly self-testing. I have doubts about the design of the study. I doubt that I would see any benefit - except to Bristol-Myers Squibb - for qualifying a very expensive medicaton as a substitute to warfarin.

If some day, a drug manufacturer can come up with an anticoagulant that is reliable; that can be easily, safely, and reliably reversed without an extremely expensive protocal; costs as little as warfarin, and doesn't require weekly testing to confirm its effects, I would be extremely interested. Apixaban (Eliquis) isn't it.
 

almost_hectic

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If some day, a drug manufacturer can come up with an anticoagulant that is reliable; that can be easily, safely, and reliably reversed without an extremely expensive protocal; costs as little as warfarin, and doesn't require weekly testing to confirm its effects, I would be extremely interested. Apixaban (Eliquis) isn't it.
That some day will never come unless open minded people are willing to advance the science. This is a step in that direction. I don’t have any trouble managing INR, some day I might, no telling what the future may bring. It would be comforting to think the future may hold alternatives to Coumadin. I was merely optimistic of the search for those alternatives. If so many of you wish to reject the findings before they even do the research, that’s entirely your choice.
 

Protimenow

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Naah. I'm all FOR advancing research and advancing science and technology. I speculated about a drug that would make warfarin unnecessary.

I also am interested in true, well designed, scientific trials. What was described in that press release didn't sound lik a well designed trial -- it read as if it was a biased trial paid for by the drug's manufacturer. If there was more information about the design to show that it was properly designed, and not set up to bias results against the use of warfarin, I would certainly support it.

If it shows effectiveness for ON-X valves and, perhaps, follow-up studies could show similar safety and effectiveness for other mechanical valves, so be it. If, in 20 or 30 years, the drug goes off patent and generics become affordable; and an easy and inexpensive way to quickly reverse the effects becomes known and readily available, this would be good. I wouldn't mind moving warfarin to a status of a historically interesting but unnecessary drug. (I don't expect to be around long enough to see this).

Research is good. Biased research isn't necessarily as good.

No - I'm not arguing.
 

Superman

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I don’t think it’s a bad thing to do research for an alternative that doesn’t require monitoring. Anything else, though, would have some pretty tough shoes to fill.

Cheap,
Easy to monitor,
Easy to reverse if needed,
Cheap,
And really cheap as far as meds go

I can get a 90 day supply for $10 cash.
 

dick0236

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I don’t think it’s a bad thing to do research for an alternative that doesn’t require monitoring. Anything else, though, would have some pretty tough shoes to fill.

.......And really cheap as far as meds go

I can get a 90 day supply for $10 cash.
I agree that Warfarin is cheap.......easy to monitor.....pretty predictable and yes, cheap. I remember a time, in the 1960s and '70's, Coumadin was still patent protected for DuPont Chemicals and cost a whopping $100+/month for a THIRTY DAY supply..........and that was a helluva lot of money in those days. At my age, even if given the opportunity, I doubt I would switch away from Warfarin.........as they say "The devil you know is better than the devil you don't know":devilish:
 

pellicle

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If so many of you wish to reject the findings before they even do the research, that’s entirely your choice.
who is rejecting findings? I'm only saying that for me there is no problem to solve.

I mean but I'm still satisfied with my 30 year old 4WD and 14 year old motorcycle.
I'm satisfied that Warfarin cost me about $6 per month VS Plavix at about $100 a month and apixaban about $450.

I guess if you're not paying for it (due to the vaguaries of the US Medical Insurance system) then it doesn't matter.

(I can however see why big pharma would be disinterested in keeping warfarin going)
 
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pellicle

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yeah, yeah, negativity as per usual.
why is it that if one does not squeal excitedly and rush to support it but stands back and asks questions its negativity?

does life have to be so polar that one can't express genuine critical questions without being labelled as negative?

My view of the world isn't only jet black and searing white, there is room for some middle ground where I live.
 

almost_hectic

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Im not sure if you’re really asking me a question or just inviting some sort of debate. I don’t think you honestly care what I think..
 

jlcsn2015

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Yes, as usual , some people will say anything to prove they are right,
and that is fine, as long as they keep their fight to themselves,
Be happy ! and enjoy
 
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