On-X lower your INR target mailer.

Brinntache · Aug 3, 2022

I got this in the mail, telling me to "take this postcard with you to discuss this information with your physician."
Anyone else get this? No link to the study behing the FDA approval, no discussion of the risks from dropping the target INR.
Why advertise On-X to a doctor who already uses On-X?
If it was approved in 2015, they should have 7 years of data of real-world results. Where is that data?
Can't say I am too keen on those "Potential Adverse Events".

Jennie · Aug 3, 2022

I haven't received this yet. I just got my On-X in November last year. Is this being sent to all On-X recipients, or just at the 3-month mark? This isn't a new idea from them. I've been looking at their website for a few years now, seeing the possible reduction of INR being listed as a positive feature. My cardiologist said that 1.8 is my target. But, I'm happy staying in the 2.0-3.0 range.

Brinntache · Aug 3, 2022

Jennie said:
I haven't received this yet. I just got my On-X in November last year. Is this being sent to all On-X recipients, or just at the 3-month mark?

I got mine last April so... I have no idea why it was sent now. Advertising I suspect. I want to see the post-FDA approval data before I ask for a lower INR target. (Currently 2.5.)

pellicle · Aug 3, 2022

Brinntache said:
the post-FDA approval data before I ask for a lower INR target. (Currently 2.5.)

LOL ... you're funny ;-)

we all know that these organisations only do what is financially beneficial. Here is the (quite shakey) pre-approval study data
https://pubmed.ncbi.nlm.nih.gov/20598989/
and here is the analysis of that document (interesting in itself)
https://www.sciencedirect.com/science/article/abs/pii/S000287031000356X?via=ihub
I know that you probably know this, but its a good opportunity to spread the word.

And to the casual reader I would also take the opportunity to remind you that "you should not believe or rely on anything you read here" ... except apparently the two or three who love to keep saying that.

Best Wishes

treichert0312 · Aug 3, 2022

Curious about how many studies are out there with FDA approval, or European pre-market testing. The Eliquis option to warfarin study is just starting.
INR lowering study PROACT is the one referenced in the On-x instruction manual, appendix A.
I think my surgeon told me the Eliquis study was looking for 1000 candidates, expected to fill up by November.

Chuck C · Aug 4, 2022

Thanks for post this. This is the first time which I have had the chance to read the entire letter which so many have mentioned before.

I note that they make no mention of the fact that in PROACT the patients were on 81mg aspirin daily, in addition to the warfarin. I have many issues with PROACT, as does my surgeon, but to leave out the fact that aspirin was also used seems incredibly irresponsible. One can only hope that their cardiologist read the entire study and remembers the small, but important, details like that. Not all cardiologists have their patients on aspirin. If a cardiologist goes with this postcard info and does not have their patient also on aspirin, they are going outside of the predicted results from the study into unchartered water with such a low INR.

On-x removes their own liability, as they instruct you to show this postcard to your physician. The responsibility is now with him to know this small detail. In my experience, many times physicians will not be aware of small details like this. It is hit and miss. This underscores the importance to always be your own medical advocate. I think it is a terrible idea to target INR o 1.5-2.0. But if you are convinced by the postcard and decide to bring it to your physician, I hope folks read the entire PROACT study, print it and bring not just the postcard but the entire study to their cardiologist and ask very specific questions- such as about the aspirin and also about the fact that the study group had higher numbers of thrombotic events than those in the control arm with the standard INR range.

In a previous post I discussed some concerns I have with the PROACT Trial, which is the trial which On-X used to get approval for the lower INR range.

https://www.valvereplacement.org/threads/new-to-this-group.888360/#post-913154