On-X Life Technologies Releases Expected Timelines for Reduced Anticoagulation Study

[TheGymGuy]

Day 2? Shoot, I am going to walk out from ICU after 4-8 hours, and be the only person to be discharged on the same day after a procedure like this Ha!

I cannot wait for peer-reviews of this data, it would be great to really understand occurrence of some events vs others. Also, I do not mind 2-2.5 INR range at all. If we knew that sometimes dipping under 2.0 is also ok, would just be a great safety mechanism.

 

[sensei Ade]

Mine too, dude

 

[chaconne]

Chaconne, TheGymGuy and I are already on the way to the hospital to get our On-X valves removed. We can stop by and pick you up if you like. Let me know.

This is tempting, but then I would have to give up my cool ring!!!

 

[ElectLive]

An observation about the interim data as it relates to INR:

In related threads of the past, several members have argued that the reduced INR protocol would only make things harder. The logic is sound: you are still on Warfarin, you are still testing, but the protocol range is half as "wide" (1.5 to 2.0) so that much harder to stay in range. So, do the data prove this out? Yes. But not nearly as much as might have been suspected.

70% in range for the control group vs. 68.4% in range for the test group, very similar. Mean INR of 2.49 for control and 1.89 for test (so closer to the high end of the target zone). Standard deviation of .63 for control and .5 for test. But the percentage of high readings is interesting, and probably not surprising: 14.5% for control and 25.7% for the test group. So, it seems to me at least that this is indicating that it's not drastically harder to stay in the tighter range, but it is obviously more of a challenge, and the patients and/or doctors appear to have erred more on the high side of the 1.5 to 2.0 range, as would be expected.

By the way, On-X has advertised that as a "bonus" of sorts with the PROACT trial, lots of data illustrating the benefits of home testing (for instance at least 50% and sometimes up to 70% of the various adverse events within the study were when INR was out of range).

 

[Bryan B]

I think that where On-X is really hoping to "hit a home run" is in the low-risk study where patients are being maintained with aspirin and clopidogrel only. If they can show only a minor increase in thrombotic events with a major reduction in bleeding events they might have something. In the high risk study I don't see enough of a difference to really make the On-X superior to other valves as far as anticoagulation management is concerned.

I originally decided to go with the On-X prior to my Bentall procedure in 2011. My surgeon had never used an On-X in a Bentall procedure but said he would do it if that's what I wanted. At the time On-X didn't have a valve with root on the market so in the end so I chose a Medtronic porcine valve with root. Once he got in there he said the diameter of my aortic root was too large for the Medtronic valve/root so I ended up with an Edwards Perimount valve with dacron root sewn in. Personally I hope that the trials give positive results as that would benefit all heart valve patients in the long run. IMO it's competition that drives improvements in technology, which in turn will ultimately improve all valve patient's lives.

 

[Lynlw]

I think that where On-X is really hoping to "hit a home run" is in the low-risk study where patients are being maintained with aspirin and clopidogrel only. If they can show only a minor increase in thrombotic events with a major reduction in bleeding events they might have something. In the high risk study I don't see enough of a difference to really make the On-X superior to other valves as far as anticoagulation management is concerned.

I originally decided to go with the On-X prior to my Bentall procedure in 2011. My surgeon had never used an On-X in a Bentall procedure but said he would do it if that's what I wanted. At the time On-X didn't have a valve with root on the market so in the end so I chose a Medtronic porcine valve with root. Once he got in there he said the diameter of my aortic root was too large for the Medtronic valve/root so I ended up with an Edwards Perimount valve with dacron root sewn in. Personally I hope that the trials give positive results as that would benefit all heart valve patients in the long run. IMO it's competition that drives improvements in technology, which in turn will ultimately improve all valve patient's lives.

True, Altho there are a couple studies Ive read that show that might not be the case. like this '
"Clopidogrel is an effective antiplatelet drug for preventing cardiovascular events and death but also increases the risk of bleeding. There is emerging evidence that bleeding is associated with an increased risk of recurrent ischaemic events and death, even when the bleeding is not severe enough to be considered life-threatening" http://eurheartjsupp.oxfordjournals.org/content/8/suppl_G/G38.full

Also there is a certain percentage of people (2-14%) who can not take Plavix, since it doesnt work for them they're non responsive, (there is a black box warning about it) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204253.htm
I would imagine you could be tested BEFORE choosing the valve to see IF you ever could take plavix/aspirin IF/when it is approved, but /i don't recall hearing of people doing that. The other thing i some people have more problems with Plavix than Coumadin and so far i'm pretty sue there is No antidote for plavix

 

[Bryan B]

Lyn,

Notice I only said that On-X is "hoping" to hit a home run with the the low-risk study more than with the high-risk study. That doesn't mean they won't strike out instead. Also I should have prefaced my statement with "IMO" as that is all it is. I do agree that Plavix has it's own set of issues and is not to be taken lightly. What I was trying to convey is that IMO I think On-X has more of their eggs in the low-risk basket than the high-risk basket from a purely business point of view. IMO I also believe that any successful advances in valve design will only help to accelerate more advances in the future spurred on by competition.

 

[vprnet]

This is great news. Keep in mind this is a phase 4 study that requires successful passage through the first 3. On-x life designed this valve to make it to this point and if their initial phase 1 studies of those non-compliant warfarin users were not so promising this news release would be a pipe dream. That phase one study and that Dr Bokros designed many of the advances in mech valves at the other major companies sold me on it. For someone like me that would just like to not think about an under dose or missed dose or re surgery this is another step in that direction.

Long before my AVR a friend lost his elderly dad to a brain hemorrhage attributed in part go his warfarin medication. I never forgot this and believe that as we age we become more susceptible to the risks of internal bleeds. Any reduction in antiquag therapy is a welcome.