Need some advice please - thoughts on the Plavix/ Aspirin clinical trial?

[Justin1981]

Hi everyone,

My ascending aorta and BAVD have finally caught up to me and I am scheduled for surgery on the 29th of this month. I am otherwise very health and my surgeon does not foresee any complications around the surgery. I have also chosen the very highly recommended On-x Valve. I've had a year to prepare for this and with support of friends, family, and the amazing people on this forum I find myself surprisingly ready and at ease with this life saving procedure.

I was invited to join a clinical trial for my valve and Plavix/Aspirin vs: Coumadin. I know that this trial is still new but very exciting to all On-X users and that I can transfer over to Coumadin at any time. I also have learned after reading through countless posts that Coumadin isn't really all that bad so can any of those more seasoned than me speak to pros and cons around participating in this clinical trial?

As always thank you all, this forum has by far been more beneficial and reassuring to me than any other source.

Justin

 

[ElectLive]

Has any testing been done to determine if you are even eligible to take the Plavix/Aspirin protocol? At least 1/3 and potentially as many as 3/4 of patients will not have adequate response to one or both of these drugs: http://www.valvereplacement.org/forums/showthread.php?41786-On-X-Proact-Plavix-and-Aspirin-Response. So, just wanted to point that out first, if testing hasn't been done, that may end up answering the question for you. Also, I read that the Plavix/Aspirin trial enrollment target has now been met, do you know if that means that you would be part of a second wave of enrollment and/or not subject to the randomization of the study...ie you really get to choose rather than the "coin flip"?

First things first, let me just say, I'm a selfish patient at this stage in life, so I admittedly put personal health first. As an example, I'm type 1 diabetic, and if someone told me there was a trial for a pill to replace my insulin pump, I most certainly would never enroll, nor likely change even after proven results. It's just hard not to trust more what you know first hand, what has kept you safe and generally problem free through years and years of experience.

So, with that disclaimer, if you volunteer, you are accepting to take on a known but unquantifiable risk. The risk of bleeding may be lower. The risk of stroke may be higher. The overall risk (all types combined) may be about the same, or higher, or perhaps possibly lower. No one of course knows, and certainly no one can guarantee. Some would probably argue that it's not a known risk, perhaps the trial will prove all risks are actually reduced. For me, though, that's a big IF to accept, when stroke (or worse) are the unknown possible outcomes and history has always proven that Coumadin is the safest option for those with mechanical valves.

It's been about a decade now, but an Aspirin only protocol was trialed with the On-X in Germany and was pretty quickly halted. Pradaxa (approved for A-Fib) very recently went through an early dosing study trial in patients with mechanical valves and that was halted. The reduced anticoagulation arm of PROACT is also ongoing and up for FDA approval now, but despite the generally favorable results in terms of overall risk, the data, particularly early on (first year or two post-op), showed more evidence of what most would likely view the worst case type of risk...stroke.

Now, none of those studies/trials I just mentioned will tell you what's going to happen with Plavix/Aspirin and On-X, particularly in your specific case. But they help to illustrate that risk is worst case for those with prosthetic valves, and not all medicines apply universally when given to different patient groups.

On the other hand, there are the fringe benefits to the trial, such as the included home testing and I assume more proactive care. So it's certainly not without some benefit...let me not leave that out. I wish I could remember their names, but there is a member or two here that has been enrolled. I think one ended up randomized to Coumadin anyway, but another might have ended up on the Plavix/Aspirin protocol (maybe?). Hopefully someone will chime in to give you the first-hand perspective.

Best wishes to you no matter what route you take. I have nothing but the highest respect for the many patients that have volunteered in one way or another, and clearly everyone here has benefited directly and indirectly.

 

[AZ Don]

I certainly don't know as much about blood thinners as many on this site, but one thing I picked up from the discussions is that if for any reason there is a need to quickly reverse Coumadin (for example due to excessive bleeding, emergency surgery, etc.), it can be done quickly with vitamin K. I don't believe that the effects of Plavix can be reversed so quickly.

 

[pellicle]

Hi

... I find myself surprisingly ready and at ease with this life saving procedure.

good to hear

I was invited to join a clinical trial for my valve and Plavix/Aspirin vs: Coumadin. I know that this trial is still new but very exciting to all On-X users and that I can transfer over to Coumadin at any time. I also have learned after reading through countless posts that Coumadin isn't really all that bad so can any of those more seasoned than me speak to pros and cons around participating in this clinical trial?

I'm glad that there are people out there willing to go on such trials. I probably would have been too.

However I'm quite content with things as they are (although may be on pradaxa for a short burst.

This is not a comment directly about the trial, but about the alternative anti-coagulation and their reversability ramifications if you find yourself in the ER (for say, falling down some stairs and getting a broken nose as my pharmacist mate told me of)

This video is well worth watching:

http://vimeo.com/24204720

Just listen and note the words like: "untested" "unknown" "guesswork" "speculation" in relation to dabigatran (or pradaxa). As the point is made about renal (kidneys) clearing the drug from the system, and the clearance rate being 24 hours in a healthy person it is worthy to note that if you were in a car accident it would be quite likely that you would have kidney damage. Making the clearance rate longer.

 

[Justin1981]

Thank you everyone, you all pretty much were able to give me solid foundation to what my gut was telling me, but i wanted to be sure. I usually take the "i'd rather be safe that sorry" Route so Coumadin it is!

 

[Freddie]

Justin your a smart person.
FWIW, even on warfarin/coumadin you still might be put on aspirin, which is nothing to fret about.

 

[tom in MO]

Justin1981, I'd have done the same. I always wonder who has the kind of courage it takes to try a new heart valve or a new anticoagulent when there are existing ones that work...since it's courage I don't have. There are many unknown patients who have died before use to bring about the current "best practices."

 

[pellicle]

Hi

I always wonder who has the kind of courage it takes to try a new heart valve or a new anticoagulent when there are existing ones that work...since it's courage I don't have. There are many unknown patients who have died before use to bring about the current "best practices."

Probably in the early instances people like me. The next stage in the treatment of my sternal infection will likely be going on rificampin + penecillin . It seems that rifampicin antagonises warfarin and so I will need to switch for a few months.

The alternative to this is a sternal removal. That sounds unappealing to me, so I would like to try something less scorched earth first.

So in this instance I will likely be contributing to the data set.

 

[razewsda]

The search for alternates to Comoudin is ongoing - what I would like to know is there must be a subset of patients where coumadin doesn't work - continuous erratic results week to week - some body chemistry issue etc. What is the day to day answer for these folks?? Do they self administer Lovonex shots twice a day ?? Take two aspirin and three glasses of red wine a day?? I've never seen or read anything on this and would like to get some feedback.

 

[Protimenow]

The search for alternatives to warfarin IS ongoing. What's probably driving this quest is the glowing dollar signs that the drug companies see if a safer alternative can be found.

Unlike rats, with quick reproductive cycles and in some cases, less sensitivity to warfarin (and there are supposedly some recent strains of rodents that aren't harmed by warfarin), homo sapiens doesn't seem to have many members who are completely insensitive to the anticoagulation effects of warfarin. Although there are some DNA tests that can be useful for predicting response to warfarin BY RACIAL MARKERS, it seems as if everyone taking warfarin CAN be anticoagulated, although some people may require doses that would be far too high for others.

I haven't heard of ANYONE whose INR could not be raised using warfarin - although, as I said, the dosages that are required to do this can be quite high.

You probably haven't read about how people who don't respond to warfarin are handling their anticoagulation issues - because those people don't exist.

 

[razewsda]

Thanks - I doubt the number is "0" but it may be insignificantly small to your point so no feedback - on a broader perspective, I would welcome a "safer" alternative.

 

[kimcdougc]

I am 2 months post op and they are having a time trying to regulate my Coumadin level. One week 1.9 the next 4.2 etc. I haven't had any diet changes. They seem to think I am really sensitive to the Coumadin. We will see what it is tomorrow. Hope it is in range. I get to go every week for a test...it would be nice to go every two weeks. lol.

 

[Heart Of The Sunrise]

Justin: Good choice on the ON-X valve. I just passed the 4 month post-op point. As part of my anticoagulation therapy I take an 325mg asprin every morning.
This came at my surgeon's instruction. My cardio loves the ON-X valve so much he feels safe establishing my INR at 2.0 to 2.5. Initially it was 2.5 to 3.0.
Coumadin as been no problem. I am glad I choose the ON-X valve!!!! I rarely hear it.I feel great my EF went from 45 pre-op to 60 post-op. Good luck on the 29th!:thumbup:

 

[pellicle]

Hi

The search for alternates to Comoudin is ongoing - what I would like to know is there must be a subset of patients where coumadin doesn't work -

from what little I know there are drugs like Xarelto which can perhaps do the job for them, but may not be yet approved for valve use while being already approved for atrial fib. Just the other day I was reading of a person (I thought it was on this forum) who needed a massive dose of warfarin every day.

It does seem to me that while it works for the majority there are a significant statistical group who need an alternative.

 

[Protimenow]

A few comments:

Yes, there are probably a few people who require pretty high doses (up to 100 mg/week) of warfarin to reach the desired INR. (Conversely, I'm sure that there are others who probably do okay with less than 20 mg/week). Either way, the necessity is that the target INR is reached and that the INR remains within that range.

kimcdougc: It's a bit of an art to find the correct dosage when you first start on warfarin -- the person prescribing the doses has to kind of narrow the dosing target until the one that keeps you in range can be determined. Probably the most important part of this search is keeping your INR ABOVE 2.0 during that period.

You comment about going to testing every two weeks is one that concerns me. I test weekly. I choose to test weekly. I believe that it is the only way to know how your INR is without causing you to go for an extended period with your INR at a dangerous level. Even if my INR was EXACTLY THE SAME each time I test (it isn't, but is usually in range), I would STILL test weekly. To me, testing every two weeks, or every month, or (as some clinics seem to prefer) every TWO months makes no therapeutic sense. (Years ago, I went for a LONG TIME without testing and was lucky not to have had a stroke or other major problem. I 'did' form what looked like a wart on my face -- when I started testing and increased my coumadin dose, the 'wart' went away. It was apparently a blood clot -- instead of going to my brain and killing me, it just collected on my face.) Personally, I sometimes may go as many as ten days between tests, but prefer testing every week.

If you don't already have a meter, consider getting one. Self-testing is a very empowering thing -- you don't have to drive to a clinic or lab for testing, you can test whenever (and usually wherever) you want, and you get an immediate value. (I don't know if any of the meters are completely accurate, but they'll at least give you some idea that you're in range, if you ARE in range. Plus, if you compare the meter readings to lab values, you can get a pretty good sense of how your meter compares to the lab).

 

[kimcdougc]

A few comments:

Yes, there are probably a few people who require pretty high doses (up to 100 mg/week) of warfarin to reach the desired INR. (Conversely, I'm sure that there are others who probably do okay with less than 20 mg/week). Either way, the necessity is that the target INR is reached and that the INR remains within that range.

kimcdougc: It's a bit of an art to find the correct dosage when you first start on warfarin -- the person prescribing the doses has to kind of narrow the dosing target until the one that keeps you in range can be determined. Probably the most important part of this search is keeping your INR ABOVE 2.0 during that period.

You comment about going to testing every two weeks is one that concerns me. I test weekly. I choose to test weekly. I believe that it is the only way to know how your INR is without causing you to go for an extended period with your INR at a dangerous level. Even if my INR was EXACTLY THE SAME each time I test (it isn't, but is usually in range), I would STILL test weekly. To me, testing every two weeks, or every month, or (as some clinics seem to prefer) every TWO months makes no therapeutic sense. (Years ago, I went for a LONG TIME without testing and was lucky not to have had a stroke or other major problem. I 'did' form what looked like a wart on my face -- when I started testing and increased my coumadin dose, the 'wart' went away. It was apparently a blood clot -- instead of going to my brain and killing me, it just collected on my face.) Personally, I sometimes may go as many as ten days between tests, but prefer testing every week.

If you don't already have a meter, consider getting one. Self-testing is a very empowering thing -- you don't have to drive to a clinic or lab for testing, you can test whenever (and usually wherever) you want, and you get an immediate value. (I don't know if any of the meters are completely accurate, but they'll at least give you some idea that you're in range, if you ARE in range. Plus, if you compare the meter readings to lab values, you can get a pretty good sense of how your meter compares to the lab).

Once I get more regulated, I do intend to get a home monitoring device. Who writes the prescription for that? Your cardio dr? Thanks for your input. I do look forward to not having to go to a clinic every week. - Kim

 

[Protimenow]

Usually, the person who writes the prescription is your primary doctor (usually a GP or whatever they call them now), although your cardiologist can also write the prescriptions, if (s)he feels that it's not a bother to manage your anticoagulation.

Depending on your doctor and health plan (if you have one), you may be monitored and managed by a clinic, by your primary care physician, or by your cardiologist.

(Personally, although I am now going to a 'coagulation clinic', I am pretty critical of what they prescribe. I've been managing my INR for four years, using a great deal of care, and the charts and advice on this forum. I can't recommend that you self-manage - it works for me - but what I do suggest, when you get your meter (and even when you're tested at a lab or doctor office) is to record your results for future reference. I've kept a spreadsheet since 2009, with the date, the Prothrombin time and INR, current dose of Warfarin, and notes that include any issues that may be important. Keeping your own INR Diary has been a useful exercise for me -- it'll probably be of value to you, too).

 

[tom in MO]

kimcdougc, when I was getting blood draws, I told the hospital Coumadin Clinic (the people that called me up on the phone to tell me my warfarin dosage) I wanted to do home testing. They said fine, but I had to wait about 10 weeks. They told me they would put the wheels in motion. That's all I did. I asked my insurance company and did not get a straight answer other than its covered and talk to your doctor.

Allere, the firm that handles the home testing sent me a letter soon after I told my Coumadin Clinic. They called and knew more about my coverage than my insurance company...Allere was right. Then when the time came, a trainer called, set up an appointment and came with a new meter. She trained me. After training, a week later I did it by myself and had to talk to her afterwards. Since then, it's all been smooth going. I call in my results, they ask if I need any supplies, when I do, they come within the week.

Per frequency of testing, once you stabilize, many say that once a month is all that you need. My clinic will go to once a month if you are stable and getting blood draws, but they told me my plan allows me to test at most once a week. I personally believe once every two weeks is best for me. So that's what we do. My clinic goes to once a week if I am out of range. When I had an infected hand from a bad dog bite, they wanted testing in 3 days after taking the large doses of both oral and injectible antibiotics to see what the antibiotics did to my INR. We adjusted and tested weekly until I was off them. I needed a shot of pregnisone and they wanted testing a few days after that too.

 

[Protimenow]

Personally, I think that it's safer to test once a week. This way, if my INR SHOULD happen to be low for some unknown reason, it won't STAY low for more than a week. (Similarly, if it should spike above range, I won't be at risk of hemorrhage for more than a week). A fingerstick a week isn't that bad a tradeoff when compared to having a stroke.

My Anticoagulation clinic finally said that I can do self-testing. They said that I would have to bring my meter in to the clinic. They will have it tested by their lab. Then they'll enroll me in a service. (This sounds like Philips or Alere). Apparently, they are willing to pay (or to have me pay) the high fees that these services charge for what, in reality, should be about $5 a week. And, also apparently, they think that I'm too damned stupid to run the tests by myself or to report my INR. (They'd freak if they knew that I not only self-test, I also manage my dosage).

I recommended the weekly testing, mentioning one finger stick a week. In my case, I'm still testing with two, three or four meters, logging the readings and searching for what may be the most accurate meter. THREE finger sticks a week are also not that hard to deal with - even though I do a lot of typing when I'm not sticking my fingers.

I urge you to consider that WEEKLY testing is 'about right' for you, rather than testing every two weeks. This way, you'll have some time to make adjustments just in case your INR takes an unexpected swing.