ELIQUIS trial for On-X valve patients

[Chuck C]

This is my prediction for the results and conclusion of the warfarin vs Eliquis trial.

Results:
Top line: Warfarin arm
Middle line: Eliquis arm
Bottom line: Placebo with no anti-coagulant (poor bastards)

Conclusion: No "significant" difference in outcomes. (Don't trust your lying eyes looking at the graph, just listen to us.)

PR department distribution to media partners- Headline: Survival between warfarin and Eliquis exactly the same.

 

[dwhist]

Have not seen it mentioned, maybe I missed, but I believe one of the issues with blood thinners other than warfarin is they do not have a reverser in case of need to stop major bleeding. I had emergency surgery 10 years ago and they were able to counter the warfarin effects to do the surgery quickly.

 

[Keithl]

Re: how many people are currently in the PROACT (On-X eliquis dosage) study, per the Cryolife earnings call from last month, they noted: We continue to make significant progress on the enrollment of our PROACT 10A trial. This is our prospective randomized clinical trial to determine if patients with the On-X aortic valve could be maintained safely and effectively on ELIQUIS versus warfarin. We currently have 471 patients enrolled in this study. Feedback from surgeons and patients participating in the trial remain very positive.

I don't care what mathematician or scientists say, 471 is a horrible sampling size and just as bad as the 1000 they used for the 1.5-2.0 INR recommendation. There are thousands and thousands of AVRs out there, and to me 471 or 1000 is not a decent representation.

Considering that it sounds like the purpose of the study is to FIND OUT if E is safe OR NOT for On-X patients, I don't know why anyone would even remotely consider enrolling since it being found to be NOT SAFE sounds like a possibility and if so, well, too bad for you.

I saw the horrible effects first hand a debilitating stroke can have on a person (my Mom), basically a fate worse than death being imprisoned in your own body unable to communicate yet being sentient. Agony does not begin to cover it. Death becomes a welcome relief. Keep your E study and shove it up your, er, nose.

To all that enroll I hope it works for them of course though.

I think the purpose is that it will be more predictable since depending on dietary intake INR can be fluctuating all over the place. I would prefer they look at E as a alternate bridging method over Lovenox injections.

I don’t understand how there is any advantage since a patient has to take apixaban twice a day versus warfarin qday. Compliance of meds will naturally go down. If you go to 3 times a day ,compliance isn’t going to happen in the long haul with consistency. YMMV.

Only Med that is taken consistently are pain meds. No problem there. That is a topic that stands on its own.

The 2x a day is definitely an issue. Heck I rebuffed their take warfarin at night recommendation becasue I am much more reliable taking meds at breakfast than I am at dinner.

The PROACT Xa clinical trial is being funded by CryoLife, Inc. with the expectation that if Eliquis gets approved based on this trial, that it will increase its market share in its On-X aortic valve business. They are hopeful that this then will attract younger patients to choose their On-X AV over other mechanical valves that would have required warfarin or biological valves that would have a higher likelihood of redo/additional procedures.

Note that there are already generic versions (expected to be much cheaper) of Eliquis but wont be available until the patent on Eliquis runs out in 2026 (assuming the manufacture doesn't fight to have it extended again). CryoLife, Inc., is expecting that if all goes well with this trial the FDA may approve Eliquis for On-X AV's by late 2024 or early 2025.

Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve

Generic versions of Eliquis

CryoLife, Q3 2021 Results - Earnings Call

When CryoLife and Eliquis can show me the chart similar to what is posted in some of the other threads with INR value vs. statistical number of event normalized over a few years for thousands and thousands of patients, maybe, but until then warfarin has a well proven track record that very few medicines enjoy.

 

[BillDaThrill]

Have not seen it mentioned, maybe I missed, but I believe one of the issues with blood thinners other than warfarin is they do not have a reverser in case of need to stop major bleeding. I had emergency surgery 10 years ago and they were able to counter the warfarin effects to do the surgery quickly.

Such a reversal agent for Eliquis was approved by the FDA 3 years ago. FDA Clears First Reversal Agent for Rivaroxaban, Apixaban Anticoagulants

 

[kentuckyed]

I've been taking Eliquis since my aortic valve (Edwards Magna Ease bovine pericardial tissue) and aorta aneurysm repair in 2015. Had a few episodes of a-fib and the cardiologist instituted the regimen. Tried to have him take me off it a few times but he said absolutely not. I really felt the a-fib was transitory and wouldn't return. No episodes of a-fib since on the drug, so who knows maybe they're right. But... the prescription list price is $1,796.49 for 3 months of 5 mg. tabs. US insurance coverage rules are crazy but I still pay an appreciable portion of that price.

 

[Chuck C]

Hi kentuckyed,

Had a few episodes of a-fib and the cardiologist instituted the regimen. Tried to have him take me off it a few times but he said absolutely not.

I really felt the a-fib was transitory and wouldn't return. No episodes of a-fib since on the drug, so who knows maybe they're right.

I would seek a second opinion from another cardiologist.

I don't believe that anti-coagulants do anything to prevent afib. They are prescribed to reduce the risk of clotting which can occur from afib. So, the fact that you have not had any afib in a long time should not be taken as any indication that the anti-coagulant is working.

Afib is common right after valve surgery and most of the time it is transitory. It was for me. I went into afib a few times in the week following surgery and was put on a couple of medications to control the afib and reduce the chance of an episode. After a month or so, I wanted very much to get off one of these meds, in particular amiodarone as it has terrible side effects. My cardiologist had me go off the med and had me wear a Zio patch for 2 weeks to monitor for any irregular beats or rhythm, including afib. It arrives in the mail and easy to apply. It showed my rhythm as normal, so he determined it was safe for me to go off of the amiodarone going forward.

It would seem that your cardiologist could do this for you to determine if you are still at risk for afib. You indicate that you have not had any episodes in a long time, but it is possible that you are going into afib and not feeling symptoms and a monitor will be able to determine this. If you are no longer at risk for afib and it was transitory following surgery, as you suspect, I can't see any reason why you are on anti-coagulant. That is one of the reasons that folks choose a tissue valve to avoid anti-coagulant. Some do develop chronic afib after valve surgery, but for most it is temporary.

Anyway, you might want to keep asking as to why your cardiologist still believes you are at risk for afib if there have been no known episodes and if he can use a Zio or other device to determine if you truly are at risk. You don't want to go off of the anti-coagulant without his blessing, but given the information you have presented, I think that a second opinion is a good idea if he is not able to give you good answers and take further steps to see if your rhythm has normalized. Anti-coagulants have side effects, and you don't want to be forced to be on one unless there is a valid medical reason.

 

[pellicle]

@kentuckyed
this is also my understanding.

I don't believe that anti-coagulants do anything to prevent afib. They are prescribed to reduce the risk of clotting which can occur from afib.

the clotting risk is driven from uneven pressures triggering internal clotting events which should not (normally) occur. Anti-coagulation therapy is used as a last line protection.

I second the call to get another opinion.

 

[pellicle]

I really felt the a-fib was transitory and wouldn't return.

I'm glad it has proven to be so, as it is for many.

. Had a few episodes of a-fib and the cardiologist instituted the regimen. Tried to have him take me off it a few times but he said absolutely not.

not least because courts prefer to follow the precautionary principle. Of course you yourself would not consider litigation if you'd had a stroke had you gone off the drugs and did have any recurrence of afib leading to a stroke, leading to permanent brain damage, leading to loss of income and quality of life. However he needs to take precautions, against those who would.

 

[dwhist]

"Such a reversal agent for Eliquis was approved by the FDA 3 years ago. FDA Clears First Reversal Agent for Rivaroxaban, Apixaban Anticoagulants"

Thanks, I was not aware of this occurring. Good news.

 

[Keithl]

I've been taking Eliquis since my aortic valve (Edwards Magna Ease bovine pericardial tissue) and aorta aneurysm repair in 2015. Had a few episodes of a-fib and the cardiologist instituted the regimen. Tried to have him take me off it a few times but he said absolutely not. I really felt the a-fib was transitory and wouldn't return. No episodes of a-fib since on the drug, so who knows maybe they're right. But... the prescription list price is $1,796.49 for 3 months of 5 mg. tabs. US insurance coverage rules are crazy but I still pay an appreciable portion of that price.

As others have said, get a second opinion. I would think warfarin and maybe metropol for a-fib. All the Eliquis does is prevent the a-fib from clotting it is not controlling the a-fib.

 

[Mister_James]

I've been taking Eliquis since my aortic valve (Edwards Magna Ease bovine pericardial tissue) and aorta aneurysm repair in 2015. Had a few episodes of a-fib and the cardiologist instituted the regimen. Tried to have him take me off it a few times but he said absolutely not. I really felt the a-fib was transitory and wouldn't return. No episodes of a-fib since on the drug, so who knows maybe they're right. But... the prescription list price is $1,796.49 for 3 months of 5 mg. tabs. US insurance coverage rules are crazy but I still pay an appreciable portion of that price.

And you think warfarin would be a hassle? Infact you would probably test once a month and may be even longer stretches because you are not at that high a risk as you would be if you had a mechanical valve.
You should definitely ask for for the rat poison.

 

[pellicle]

You should definitely ask for for the rat poison.

a postcard I got from my Finnish friends after I got out of hospital with my new mechanical valve.

I love Finland

 

[slipkid]

I would prefer they look at E as a alternate bridging method over Lovenox injections.

Interesting point. I would prefer ANYTHING over Lovenox injections. Don't know if I can face that again should I need that to be done. I had problems getting those done in addition to my enitre belly being blood red and black all over in response to the shots. Got little or no support from the cardiologist team as to how to do the injections correctly, complicated by my dosage not being equal to what was in the syringe, and totally wrong technique showed & done on me by my PCP.

 

[pellicle]

I had problems getting those done in addition to my enitre belly being blood red and black all over in response to the shots. Got little or no support from the cardiologist team as to how to do the injections correctly...

sounds like a red hot 5hitfight ... sorry to read that

 

[Brinntache]

Drug name	Average retail price	Lowest GoodRx price
warfarin	$18.59	$3.00
Eliquis	$556.15	$458.07
Xarelto	$553.65	$461.93

https://www.goodrx.com/classes/anti...atives-are-eliquis-and-xarelto-worth-the-cost

 

[Mister_James]

Drug name	Average retail price	Lowest GoodRx price
warfarin	$18.59	$3.00
Eliquis	$556.15	$458.07
Xarelto	$553.65	$461.93

https://www.goodrx.com/classes/anti...atives-are-eliquis-and-xarelto-worth-the-cost

This right here is enough for any reasonable person to ask is it 150x better than Warfarin

 

[pellicle]

This right here is enough for any reasonable person to ask is it 150x better than Warfarin

... I picked a Seiko watch for <US$200 because I can't see the value in a Rolex or a Seamaster. However others apparently do and thus we see the resurgence of the Swiss Watch Market(ing).

If I have to pull a microscope out to see the quality difference then its all about "something else".

Its worse than that when you look at the studies comparing to warfarin (and look at the monitoring levels of warfarin which they are comparing to).

Still I suspect this is exactly the reasons why none of these drugs is yet approved for valves.

 

[Superman]

Wouldn’t mechanical valves be a new use and potentially extend the patent keeping costs up for years? That would be the drug manufacturers goal here.

 

[pellicle]

Wouldn’t mechanical valves be a new use and potentially extend the patent keeping costs up for years? That would be the drug manufacturers goal here.

I'm sure Roche has a foot in each shoe for exactly that reason ;-)