The skeptical cardiologist has been a strong advocate of the maintenance of sinus rhythm in patients with atrial fibrillation (AF) using enlightened medical management. I was pleased, therefore, to see the results of the EAST-AFNET trial which were presented at the European Society of Cardiology Meeting this week and published in NEJM simultaneously.
This multicenter European study randomized patients with relatively new onset, median 26 days earlier and
“(diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation–related symptoms.
2789 patients were randomized and followed for an average 5.1 years for multiple cardiac related outcomes:
The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy.
The majority of patients in the treatment arm (the columns on the left at baseline and after 2 years treatment) were initially treated with one of the two drugs I use almost exclusively and have written about in detail (flecainide here and amiodarone here.)
I was also pleased to see that only 8% of patients underwent early AF ablation but was surprised to see so much dronedarone usage (a drug I avoid) but do note that only 5.9% were taking it at 2 years.
Here are the results showing the lower events including death from CV cause and stroke with the rhythm control strategy (maintenance of sinus rhythm.)
I have to dig into this study in more detail to put it in perspective but for now it provides for me more evidence that an enlightened approach to medical management of AF for maintenance of normal rhythm is the best approach for most patients.
Antifibrillatorily Yours,
-ACP
19 thoughts on “More Support For Rhythm Control and Enlightened Medical Management of Atrial Fibrillation”
Hello Dr Pearson
I am a German national but a UK resident spending a total of 5 months a year in France until covid. I am now stuck in the UK. This presents a problem since my usual dose of 150mg Flecainide slow release is not available in the UK. My UK GP (after consultation with the cardiologist) has issued a prescription for 200mg of slow release Flecainide. I’m not happy taking a higher dosage since I don’t need it but the alternative is not ideal either. It would mean the immediate release form of the 150 mg dose and I am nervous if that would give me the same cover over a 24 H period. It just depends on how quickly the medication is metabolised.
My cardiologist has suggested in the past that I might consider a left atrial closure procedure which would mean not having to worry about anticoagulation. I could then also stop Flecainide and just use it as a pill in the pocket if I get an episode. Simply to alleviate the unpleasant symptoms. He did, however mention that the LACP may not be 100% effective. Then back to square one. Ablations do not have a wonderful success rate either and some patients need 2 or 3 and even then the result may not be a complete success. Afib seems to still have many question marks hanging over it. The conservative approach remains anticoagulation regardless. Rhythm and rate control if possible but not essential. Quite discouraging really. Unfortunately.
From a patient’s perspective:
In total I have had paroxysmal afib for 12 years. (77 year old female) Very brief once monthly episodes of no longer than 2 hours each time to start with. Then I was put on Flecainide 150mg slow release once a day which stopped any further episodes. For the last 11 years I have had no further afib. I know that because I am (or rather was) totally symptomatic. It’s a terrifying feeling of anxiety and fatigue and of course the anti arrhythmic beating of the heart. I have a structurally sound heart as shown by an echocardiogram. My cardiologist has wanted me to take an anticoagulant because this is what guide lines suggest. I have always resisted this course of action because my afib is controlled and because anticoagulants have their own problems. Of the NOAC only two have an antidote and even these can only be administered in a hospital setting. An accident or a fall can be fatal if on anticoagulants. I am not aware of any stroke vs bleeding risk from anticoagulation incidents studies. Also, what are the chances of continued stroke risk in completely controlled afib? It is claimed that patients are mostly unaware they have afib and therefore anticoagulation is necessary. I would dispute that. Obviously from my own experience. Why is there not some more nuanced approach to afib.
Renate,
Thanks for your input. You have good questions.
I can attest that many patients are totally unaware when they go into atrial fibrillation. It is for this reason that major guidelines recommmend an approach to anticoagulation that does not take into consideration how well controlled the afib is. Thus, higher risk (based on the CHADS2 scoring system which , for example, gives a patient like you 2 points for age greater than 75 and 1 for being a woman) patients are advised to take NOACs even if they have never had an episode of afib for 10 years.
The large studies that established benefit of NOACs lumped patients with paroxysmal atrial fibrillation irrespective of control of rhythm so although it makes sense that well-controlled patients like you are lower risk we don’t know that with certainty.
Your final questions is nicely worded. A “more nuanced approach to afib” would take into account factors like maintenance of SR, ability or inability to feel afib, home monitoring with ECG or monitoring with loop recorders or pacemaker telemetry and I like to think that is what my series on “enlightened” management is promoting. As time permits I’ll write a post on “a more nuanced approach to afib” which addresses your concerns in more detail
ps. I’m assuming you are a woman because I have a patient named Renate in my practice who is female.
pps. I’ve never written an rx for flecainide XL and was not aware of its existence. I don’t think it is available in the US. Are you receiving in US?
How refreshing to get such a prompt reply. Thank you for that.
I wonder how many afib patients are as symptomatic as I am. Personally I have never met any although I do know at least half a dozen people who have asymptomatic afib. I think this conclusion that all afib patients regardless of their type of afib fall under one umbrella is either hyper cautious or lazy. Moreover, nobody seems to be quite sure when a blood clot is formed due to arrhythmia. The general belief is 24 hours although I have also read 6 minutes. So now we accept 6 minutes because it covers doctors when prescribing anticoagulation. Why does female gender attract an extra point on the CHADS score? Is it because generally women are older when they have a stroke? Do – for ex – more 70 year old women than men have a stroke and is this due to afib?
I’m looking forward to reading your own ‘enlightened approach’ to afib.
PS Do you mean slow release by XL? If so, it is available in France for any dosage, i.e. 50, 100, 150 and 200mg. It is so much better than the immediate release version. In the UK only the 200mg version is available as slow release.
Renate,
Your welcome! it is equally refreshing to get such discerning questions.
I agree there are many doctors who are “hypercautious”.
And you are correct on the confusion about duration of AF needed to form a clot. Personally, I think 24 hours has the best evidence.
The female risk factor cause is unclear.
Yes, slow release by XL. Are you in France or UK?
A semantics question…I had been trained decades ago to use AF for atrial flutter and Af for atrial fibrillation. What are the official abbreviations? I notice you are using AF for afib.
Laura,
I have never seen AF and Af used the way you were trained. My experience has been in Missouri, Ohio, and Kentucky. Perhaps you were trained elsewhere?
I haven’t seen any standardized way of abbreviating atrial fibrillation although when speaking most doctors will call it afib.
When writing about afib these days I have for the most part shifted toward utilizing AF (less letters to type) and when I want to specifically address atrial flutter just spelling it out completely.
This works because fib is so much more common that flutter and I have yet to devote an entire post to flutter (notice how I introduced a new term for AF there.:))
Dear Doc Pearson,
While I agree with you that “at the beginning” (depending upon the amount of time that has gone by in FIB if it can be assessed), usage of an ADD to restore NSR and a “band-aid “may” be effective. However, unlikely though, in the long run. Many journals seem to indicate that if one goes into FIB after ADD, the ADD has failed and move on to ablation. When you say ablation “is risky”, if one looks at the percentages it is one of the most safest procedures that exist. It is actually becoming the first line of treatment. Of course, one should be choosing an EP that does more than 10 right sided flutter ablations per year.. Haha. I definitely believe Rhythm control over rate. If fails, there is simply one choice left unless co-morbitities prevent same. That would leave ablation 1,2,3 might not eliminate AFIB, because, as I am sure you are aware, it is unlikely to be a simple PVI. But if one is persistent and will take the time to find the right EP that possesses the “skill set” required, it will be terminated. Forever. Probably not at this juncture in this time period however, in due time it will. Have a good weekend. STOPAFIB.ORG is a great site to find all theinformation one needs.
Best,
Rob Grundfast
Rob,
I disagree that AF ablation is “one of the most safest procedures that exist.” Very serious complications can occur including ones which result in death of the patient.
AF ablation is only becoming “first line of treatment” because it is being inappropriately pushed on patients.
You seem to be suggesting that for “success” with ablation patients will need 3 or more ablation procedures. Subsequent ablations carry more risk than first time ablations and each one costs more than 70 thousand dollars.
I’m not a fan of STOPAFib.org. The site implies ablation is a cure for afib. It is not.
Dr. Pearson,
A patient’s perspective…
I am 77 and have had normal rate paroxysmal idiopathic Afib for 50 years. In that time it progressed from cardioversion every couple years to almost monthly. My cardiologist recently offered the choice of ablation or pharmacologic treatment with a pacemaker. I took the pacemaker.
My reading led me to the conclusion that ablation meant several hours of deep anesthesia and the concomitant increase in risk of cognitive decline. There was a 4% chance of a redo with a doubling of the anesthesia time. And there was a 4% of 4% chance of total failure meaning all the anesthesia to no benefit.
Pacemaker surgery was a half hour under local anesthesia. To me, that was a minor inconvenience compared to ablation’s considerable risk of cognitive decline and various other possible problems.
To me this is clinically correct old news: the best clinical insights exceed so-called knowledge by at least 1 step. HRS, MD, FACC
Some clinical insights are correct without RCT support but many turn out to be wrong when critically examined. This is how science advances the art and practice of medicine.
Can you say what they defined as “usual care”? Specifically, did it include rate control?
Early rhythm control required antiarrhythmic drugs or atrial fibrillation ablation, as well as cardioversion of persistent atrial fibrillation, to be initiated early after randomization. Local study teams chose the type of rhythm-control therapy independently to deliver this treatment, using protocol guidance based on current guidelines.20-22 Patients who were randomly assigned to early rhythm-control therapy were asked to transmit a patient-operated single-lead electrocardiogram (ECG) (Vitaphone) twice per week and when symp- tomatic. All abnormal ECG recordings were forwarded to the study site. Documentation of re- current atrial fibrillation triggered an in-person visit from the site team to escalate rhythm-con- trol therapy as clinically indicated.
Patients who were randomly assigned to usual care were initially treated with rate-control ther- apy without rhythm-control therapy. Rhythm-con- trol therapy was used only to mitigate uncon- trolledatrialfibrillation–relatedsymptomsduring adequate rate-control therapy (i.e., therapy that maintained the heart rate within guideline-rec- ommended targets).
3 things about this study.
The absolute risk reduction 1.1% doesn’t seem that great. I am not medical but what is threshold for ARR being significant enough that cost, quality of life and side effects from proposed therapies dictates treatment? Does NNT figure into that?
There was no mention of cardioversion, I thought that was a treatment for AFIB that was used frequently? Is that a wrong assumption?
The rhythm control therapies were broken down into percentages initially but there was no information about how the individual therapies performed in relation to the primary outcome target or the components. I am curious which treatment was the most efficacious in the primary target as well as components.It seems like there are a lot of confounding variables that would make this almost impossible to tease out. To me the study should have been more powered to provide that data, it would likely give HCPs better information to treat patients.
All good points. That’s why it needs more analysis
Cardioversions were likely used extensively in the rhythm control group although not in the graphic.
PS – I don’t see others’ comments on the new website. They were especially helpful, I thought.
Can you see them now?
I can make no sense of the difference between the left and right graphics as displayed. The original article is behind a paywall so no help there.
Thanks.