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Atrial fibrillation

Alternatives to warfarin for atrial fibrillation: the new anticoagulants

New anticoagulants (blood thinning medication) - dabigatran, rivaroxaban and apixaban - have come onto the market since we first interviewed people about their experiences of atrial fibrillation (AF). Designed to reduce the risk of stroke, the medications offer an alternative to warfarin for people with AF. Like all medications, they have both advantages and disadvantages.
 

Dr Tim Holt discusses the pros and cons of the new anticoagulants.

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There are three new drugs that are used now. Dabigatran, rivaroxaban and apixaban and these are called the new anticoagulants and they have certain advantages over warfarin, most obviously that they don’t require you to have regular blood tests to monitor how thin your blood is because, by and large, the dose that you’re prescribed, provided it’s the right one for your age range, is likely to be the correct dose for all people in that group. So you don’t have to adjust the dose but the other advantage is that the limitations on diet, which, you know, the advice over restricting certain foods in the diet, which applies to warfarin, doesn’t apply to these other drugs. And so the person is more likely to be able to relax about that. However, they are new drugs. We still haven’t enough experience of using them to know for sure how safe they are in the long run. They’re not without side effects and they’re not without interactions with other drugs, so they need to be used carefully in selected people for whom there are problems with warfarin or people who are unable or unprepared to take warfarin.
Attitudes to new medications
At the time of our first interviews, some people were aware that new medications were becoming available and welcomed the possibility of taking a drug which would free them from the constraints of regular blood tests. James had already spoken to his GP about the possibility of taking a new medication, and said ‘I’d love to be on them because it’d save me going for the [blood] tests.’ Mary said she would consider paying privately to take suitable alternatives, if they were not available on the NHS but were appropriate for her.
 

Martin was interested in an alternative anticoagulant which did not need monitoring and had no side effects.

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Age at interview: 73
Sex: Male
Age at diagnosis: 71
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Well, if they were available I would certainly consider them, because if they are better than aspirin but there’s one, I can’t remember the name, it doesn’t matter, but it does you don’t need to monitor it. You just take and I think you take one tablet a day and it’s it is as effective as warfarin, without any of the side effects. I don’t know anything about how it works physiologically, but I know it’s extremely expensive. So if it was available, yes, I think most people would take that up because they wouldn’t have to go to hospital every fortnight and have a blood test and then be told, “Oh, alter your dose.
 

Brendan had discussed the newer anticoagulants with his doctor but was happy to stay on warfarin.

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Age at interview: 59
Sex: Male
Age at diagnosis: 57
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I can’t remember the name of the drug but I mean I think there’s been a fairly recent breakthrough. Which I have, I mean I discussed with the consultant, not sure whether it was last time or the time before that the consultant, I discussed it with him. At that stage, we thought since the warfarin since I have no problem with warfarin, since it’s relatively stable, that it might be better just to stay with warfarin. And I haven’t really thought about it since then, you know. I haven’t really worried about it since then but it’s something I’d keep under review.
Yet some people we talked to were ambivalent or remained wary. Dot had heard of the new medications but felt that taking warfarin and having blood tests now was ‘a small price to pay’ to prevent a stroke. Others expressed concerns, including the cost of the new drugs to the NHS (and whether this would impact upon prescription rates), and problems with the lack of an antidote to reverse the effects of the drug in people with life-threatening bleeding. For Eileen, the new anticoagulants were just ‘too new for my liking.’ She wondered whether the effects of the newer drugs could be reversed in the case of internal bleeding: ‘they can reverse warfarin; there’s no antidote for the other ones yet’. For the moment, she continued to take warfarin, adding that it was ‘better the devil you know’. Anne was cautious: ‘there’s always a miracle drug coming onto the market, which a little way down the road, you find has got real problems.’ Similarly, Freda did not expect the new drugs to be ‘miracle cures’.
 

David X pondered whether new alternatives had been sufficiently trialled, and recognised the role of the National Institute for Health and Care Excellence (NICE) in decision-making.

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Age at interview: 73
Sex: Male
Age at diagnosis: 61
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The latest developments on replacements for warfarin are very interesting but, of course, we’ve still got to say, fine, they’ve had clinical exposure. They’ve had trials. You can’t put anything on the market until the trials are completed. I know in the past, there have been some pharmaceutical companies who have suppressed some of the trial data. That has been very dangerous and very wrong, and the ethics around them should be improved and I think the oversight should be improved. I know there’s a lot of criticism of NICE that they haven’t allowed certain drugs to be put into clinical practice, whereas I think they are a bulwark against bad ethics. And they’re also there to make sure that you get a good bang for your buck because there’s only a limited pot of money. 
 

David Y supported the introduction of new drugs, but believed cost prevented them being more widely available.

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Age at interview: 67
Sex: Male
Age at diagnosis: 64
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I’ve already I’ve already made the consultant cardiologist aware, at the last meeting, when he said to me about going back on warfarin, that I, he I said to him, “I understand there’s another tablet that they’ve been testing throughout Europe.” And he said, “What do you feel about it?” And I said, “I’m very supportive. Absolutely supportive of the tablet and, hopefully, it can be introduced in the UK.” Yeah, so I’m very much pro, I, you know, I’ve read what AFA have said about it and I personally don’t, can’t see anything against it. It seems to me, at the moment, NICE are very sceptical because of their cost analysis they’ve done, and I can’t necessarily, as a patient, agree with that because I think they’re primarily putting cost against patient care and patient risk. 
Experiences of taking new anticoagulants
We spoke to four people who had started taking the new anticoagulants since we first interviewed them. For them, the opportunity to take medication which offered similar protection against stroke as warfarin but without the need for constant monitoring and blood tests was one of the main advantages of the new anticoagulants. David X’s doctor advised him to start taking rivaroxaban instead of clopidogrel (a drug which reduces the risk of blood clots forming) when he turned 75 because ‘they believed I need a proper anticoagulation therapy and not just clopidogrel’. James found it ‘a pain in the neck’ having to go ‘a couple of times a week’ for blood tests in an unsuccessful attempt to get his levels of warfarin right. He said he was ‘all set towards having another stroke’, when his doctor prescribed rivaroxaban.
 

After resisting pressure to go on warfarin for years, Elisabeth X finally decided to go on dabigatran to reduce her risk of stroke.

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Age at interview: 74
Sex: Female
Age at diagnosis: 30
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I have, because I’ve been in AF, I’ve had AF for such a long time, since I was thirty, for a very long time, there’s been a pressure on me to go onto warfarin, which I did not want to do, mainly for quality of life, the fact that you have to, you know, are constantly having blood tests to make sure that all is well. And so I kept on saying, “All right, I’ll do it when I’m sixty.” Or, “I’ll do it when I’m sixty five, I’ll.” And I went on and on like this, putting off the decision being persuaded by not just the consultants at the cardiology unit but also by my daughters, who are doctors, that my risk of stroke, etcetera, etcetera, that I ought to be on a more effective blood thinner than aspirin. And I, finally, because, eventually, they have produced a blood thinner, which is not warfarin, that’s dabigatran, I finally agreed last, I think it was some time last autumn that I would go onto dabigatran. 

And the advantage of taking a blood thinner, as opposed to not taking one at all, I suppose are that the older you get, the more likely, in AF, of your risk of stroke and that is that is quite a, you know, that is quite a serious risk anyway because, obviously, your risk goes up as you get older. So yeah, I mean I can see that it was sensible to go onto it.
 
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Anne’s doctor recommended rivaroxaban after she experienced problems with warfarin. She has not had an episode of AF since.

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Age at interview: 71
Sex: Female
Age at diagnosis: 70
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I was one of those people who wasn’t very well controlled on warfarin and I was having to I bought my own equipment and tested myself and I was having to change the medication pretty well weekly, although I had a very similar diet week on week. And I think they just thought that, you know, this is a drug with fewer side effects and is less influenced by lifestyle changes or, you know, it’s much more consistent.

As far as I know, it’s just been a positive thing. It’s been much less troublesome and, whether the fact that I haven’t had further attacks is to do with it or to do with something quite different or whether I’m going to have an attack today, I just, you know, don’t know but I, the fact is I haven’t had another attack.
One of the key concerns expressed by people taking the new anticoagulants was the increased risk of bleeding and lack of an antidote. As Elisabeth X said: ‘If I were in say a car crash or had a really serious fall, the risk of bleeding can’t be controlled’. 

Dr Tim Holt explains that while bleeding can usually be managed in hospital, unlike warfarin, the new anticoagulants do not have a simple antidote.
 

Elisabeth X hopes that an antidote will be developed for the new anticoagulants.

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Age at interview: 74
Sex: Female
Age at diagnosis: 30
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I gather is that they’re working on an antidote but that would be I think that would probably make acceptable to a lot of people to feel that, should there be a situation where, for instance, they need immediate surgery, which is another problem. I had to have an endoscopy a couple of weeks ago for a totally unrelated problem and, because I had to stop the dabigatran for seventy two hours before I could undergo the surgery. And had had that been an emergency operation, it would have been a problem right.
David X and James have both had problems with bleeding since taking the new anticoagulants. They are unsure whether this is related to their blood thinning medication. About six months after starting rivaroxaban, David X noticed ‘there was bleeding subcutaneously (beneath the skin)’ on either side of his left ankle which in a short time became ‘a really big haematoma’ on his left thigh.
 

David X pondered whether new alternatives had been sufficiently trialled, and recognised the role of the National Institute for Health and Care Excellence (NICE) in decision-making.

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Age at interview: 73
Sex: Male
Age at diagnosis: 61
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The latest developments on replacements for warfarin are very interesting but, of course, we’ve still got to say, fine, they’ve had clinical exposure. They’ve had trials. You can’t put anything on the market until the trials are completed. I know in the past, there have been some pharmaceutical companies who have suppressed some of the trial data. That has been very dangerous and very wrong, and the ethics around them should be improved and I think the oversight should be improved. I know there’s a lot of criticism of NICE that they haven’t allowed certain drugs to be put into clinical practice, whereas I think they are a bulwark against bad ethics. And they’re also there to make sure that you get a good bang for your buck because there’s only a limited pot of money. 
 

James wonders whether rivaroxaban caused bleeding when he had the stitches out following a hip operation.

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Age at interview: 63
Sex: Male
Age at diagnosis: 59
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I had the stitches out and I started blood, started oozing through the stitches. In fact, it absolutely poured out of me, which caused me concern and that, and when I, if I go to the dentist I think to have a tooth out, I have to go to the hospital to have it out.

Do they take you off the rivaroxaban before surgery then?

They take me, they took me off the rivaroxaban, definitely took me off the rivaroxaban but it just, when they took the stitches out after my hip operation, it started pouring out of my, pouring out of the stitch holes.

And what did they do? What did they do about that?

They took, I was taken to, eventually, taken to [name of hospital], where they dressed it and it stopped bleeding eventually. It was old blood that poured out of my stitches. It wasn’t new blood.

Did they connect that at all to the rivaroxaban?

No, nobody connected to the rivaroxaban but I just, it’s just something that, something that’s crossed my mind might not, it might not be anything to do with my rivaroxaban.
(For more see ‘Atrial fibrillation, stroke risk and blood thinning medication’ and ‘What is it like being on warfarin’).
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