FDA Approval: On-X aortic valves with less warfarin

[RobThatsMe]

I thought this information was worth sharing, and wanted to pass this on, as I found it on another site.
The new FDA approval indicates a 1.5 - 2.0 INR range for the On-X mechanical aortic valves, but as always, read the info, and check with your doctor.

FDA Approval: On-X aortic valves with less warfarin

 

[T in YVR]

Very cool. Thanks for sharing. If nothing else, for those times when my INR dips to 1.9 - 2.1 (which happens), it does provide a bit of peace of mind I suppose (my range is 2-3)....I'm glad I chose On-X. I'm sure they are all good, but it just feels like a very progressive valve from the research I did.
Tony

http://www.onxlti.com/fda-approval-onx-aortic-less-warfarin/

 

[Heart Of The Sunrise]

Thanks, Rob..I agree with T...when I go low,,,,there is some peace of mind.
I may elect to stay 2.0 -2.5. I see my cardio this month...certainly going to discuss this.

 

[ottagal]

Thanks for posting the 'official' news! I presume this came as a result of the PRO ACT trial.

 

[T in YVR]

@ ottagal - Yes, it was a result of that trial - they have the official PR on the On-X web site.
Tony

 

[pellicle]

I sort of think its interesting that a big deal is made out of the 'lower AC requirements" when there would seem to be nothing really wrong with having INR at around 2 (for aortic, naturally mitral is different) and as I cited from one of the papers referenced in ottagal's post:

http://www.ncbi.nlm.nih.gov/pubmed/15653962/

The intention-to-treat analysis of the results of the German Experience With Low Intensity Anticoagulation study leads to the unexpected result that despite a sophisticated reporting system, the incidence of moderate and severe TE and bleeding complications was comparably low in all INR strata and more or less within the so-called background incidence reported for an age-related "normal" population.

would seem to indicate that having an INR lower didn't really make a big difference ... so perhaps this targeting lower AC therapy is more about marketing than addressing any observable problem.

(unless of course I'm not reading that all right)

 

[RobThatsMe]

For me personally, knowing that the approved range is 1.5 - 2.0, provides peace of mind, as I will try to be between 2.0 and 2.5. If I happen to fall below the 2.0, I still have a safety margin. Currently, my set range is 2.5-3.5. So yes it does make a difference for me, especially knowing that with age, it may be a little safer to have the lower INR range. Just my thoughts on this, that I will review with my doctor.

 

[T in YVR]

I agree with Rob. I think it makes a big difference. Peace of mind for certain....I try and keep my INR between 2.2-2.7 (not too low and not too high in my range of 2-3). 1.5-2.0 provides a bit of comfort. Also, I'm not sure if/how this would come into play, but for any health issues that resulted in, or involved internal bleeding, maybe this give you a bit more ability to keep your INR lower during any recovery or healing - not sure.

 

[pellicle]

Hi

...1.5-2.0 provides a bit of comfor

that part I agree with entirely, and indeed posted exactly that point just the other day, the point I was talking about however is ths:

1) there seems to be a *urgency* in many to focus on keeping their INR to the lowest level, so much so that its almost a common thread here of "how can I keep my INR at 2

2) the evidence is emerging that being at the low end of coagulation INR does not confer any benefits (hence the reference to that study above)

so while its nice that it can dip low (and to be honest there is already a significant amount of evidence that it can dip low for some days with no harm) the marketing of "low INR" is also a bit dangerous and seems to have no benefits.

 

[MrsBray]

I can't find anything on the FDA website? I'd like to take a copy to my coumidin nurse, but am wary of taking something from the product manufacturer.

 

[T in YVR]

@Mrs Bray - I think you are quite safe to take the initial news of this (the press release) to your doctor (or coumadin nurse) as is with out any official FDA doc....I assume all you are looking for is an initial opinion, and to have a conversation about it. Deciding right off the bat to cut your dosage and lower your target range would be another matter....I'd be extremely uneasy about doing that! The liability associated with a falsified or misleading press release would be pretty major. I realize there are many people on here that do not like the marketing that On-X does, but I would highly doubt it represents any inaccuracies of something of this nature. I emailed it to my cardio and he thanked me and said he'd research it and let me know if he hears any more on it with respect to any guidance that doctors are given re: INR ranges on On-X. I doubt you will see many people dropping their INR ranges on this right away (I certainly wouldn't).
Tony

 

[pellicle]

Mrs Bray
I am on the side of T in YVR here, to me there is no obvious benefit in lowering ones INR beyond a particular level. I refer again to my fav chart:

so to me, keep around 2.5, know that the valve won't cause you problems if you dip below 2, so don't sweat it if you fall a smidge below 2.0 and just enjoy life

 

[tom in MO]

I can't find anything on the FDA website? I'd like to take a copy to my coumidin nurse, but am wary of taking something from the product manufacturer.

Just tell your nurse what you learned. I learned from my surgeon that my INR should be between 2-2.5 not the 2-3 my coumadin clinic had me on. The surgeon told me my St. Jude had been re-evaluated and the lower range found OK. It was new info. I told my nurse, she first was surprised that I was questioning the range but said she'd talk to the doctor in charge of the coumadin clinic. I got a call back with doctor's orders for a new INR range of 2-2.5.

I have had no problems maintaining the 2-2.5 range. My functional dose level has not changed for 2 years. I do eat vitamin K containing food daily throughout the year and home test about every 2-3 weeks.

 

[camgough]

I personally think this is great news, and the reason why so many people have chosen the On-X valve, myself included.

I'm not sure what your chart is supposed to show or represent, but in fairness pellicle, it's only applicable to this conversation if it were related to incidents with the On-X aortic valve.

It will take time for surgeons, doctors and nurses to shift to a lower INR for certain patients, but there is no doubt that it will. This is a simple evolution of medical technology that will continue to change and improve.

 

[pellicle]

Hi

I'm not sure what your chart is supposed to show or represent, but in fairness pellicle, it's only applicable to this conversation if it were related to incidents with the On-X aortic valve.

I understood that there were On-X valves in the data this was collected from. The chart shows the numbers of "events" (both thromobembolytic and bleeds IIRC) based on INR .. as you can see its very low from 2 to 4. Its really quite simple. The data was collected over a very large cross clinic system. If you don't think its applicable to On-X valves then you must think there is some special magic in the On-X that confers immunity to events with higher INR. That On-X has gained FDA approval is merely a bureaucratic step in the process which may eventually be followed by the other makers. Every study ever on the current generation pyrolytic valves (StJudes OnX and ATS) has shown them to be very very similar. So if the On-X has something special I suspect its largely marketing.

My point was that if you can read those numbers that if you drift over 2 you won't burst into blood and bleed, and I put the graph there for those who can read graphs to understand how the risks go at either end of the INR range.

 

[camgough]

Reading graphs is not the issue, the issue is the lack of source and labeling on the graph. Although the newer generation mechanical valves are similar, only On-X has the improved approval for reduced INR in some areas. I am in Canada, and as far as I know, the labeling has not changed here. My surgeon says 2-2.5 for me, but he's not concerned in I'm 1.7-2.7.

Whether you like the marketing or not, medical authorities are not going to approve something that may not be beneficial or safe for patients. Perhaps other valves will follow, but like it or not, On-X has the study, data and results to set them apart.

 

[pellicle]

Hi

Reading graphs is not the issue, the issue is the lack of source and labeling on the graph.

the axes of the graph are labelled on the one I see in my browser, if you wanted the source you could have asked for it...

 

[Boomanchu]

I see no benefit at all from dropping your target down from 2.5. I fell and split my head open the other night and didn't bleed all too much.......more than before warfarin but at 2.5 at the time and nothing scary. If any one of us can occasionally dip below our target it can happen at 2.0 also so why flirt with trouble. I'm thinking that to spike high enough to truly be at risk of a bleed something out of the ordinary must happen and that .5 lower target isn't gonna be a factor. Myself, I will just rest a bit easier knowing that a dip of .5 or a tad more isn't too scary and leave it at that. Now that new tripple leaflet valve being developed in Sweden that may require no ACT is an interesting topic

 

[jhusker2]

I wonder if the same will apply to the ONX Mitral? Nothing is really stated on their website that would make me believe lower warfarin for the mitral is around the corner as well...

 

[sood]

Is this just a step towards not needing warfarin anymore and perhaps just using plavix and aspirin to keep INR between 1.5-2.0? I wonder if that is the end game they are shooting for. I am pretty happy with my on-x valve choice.