European Society of Cardiology Publishes New Guidelines for Management of Atrial Fibrillation and Stroke Risk
By Christine Welniak and Mellanie True Hills
November 1, 2010 — New medical guidelines from the European Society of Cardiology (ESC) incorporating the latest research put Europe ahead of the US when it comes to standardized treatment of atrial fibrillation. The previous guidelines, which were a cooperative endeavor between multiple European and American medical societies and organizations, were published in 2006. Since then, research has led to a better understanding of the mechanisms of atrial fibrillation as well as the risk factors for stroke.
Differing American and European regulatory pathways is one reason that the European Society of Cardiology sought to establish its own set of guidelines separate from those developed by the American College of Cardiology and the American Heart Association. Drugs and devices often have a faster approval process in Europe than in the US, so Europeans may have access to more treatment options. However, the majority of doctors will wait for a new drug or device to be included in medical guidelines before using it.
The Heart of the Guidelines
Stroke prevention and symptom relief are at the heart of the new ESC Guidelines for the Management of Atrial Fibrillation, which incorporate new ways to assess a patient’s risk for stroke and bleeding as well as new drugs and devices aimed at stroke prevention.
These new guidelines make it completely clear that those with paroxysmal atrial fibrillation face similar stroke risk to those with persistent or longstanding persistent afib. The updated European guidelines recommend that doctors consider patients with paroxysmal AF similarly to individuals who have more severe forms of afib if the patient has risk factors for stroke, such as hypertension or diabetes. Although a patient’s CHADS2 score remains the starting point for identifying stroke risk, the European guidelines go farther in terms of helping doctors ascertain which patients need to be on anticoagulant medication (Coumadin or warfarin). The guidelines—reiterating what was in the 2006 joint document with the American Heart Association and American College of Cardiology—recommend that patients who have a CHADS2 score of 2 or more be placed on an anticoagulant. However, doctors may not be sure of what to do with patients with a CHADS2 score of 1, which means that some patients who need protection against stroke aren’t prescribed an anticoagulant.
New Approaches to Stroke Risk
That’s why the European guidelines recommend that doctors use a new risk scoring system—one that we’ve written about previously—called the CHA2DS2-VASc score for patients who have a CHADS2 risk score of 0–1. CHA2DS2-VASc takes into account other stroke risk factors, such as gender, vascular disease, and age 65–75. By applying the CHA2DS2-VASc schema to seemingly “low risk” patients, more strokes could be avoided.
The guidelines also formalize the use of the HAS-BLED tool, which we’ve also written about, to determine a patient’s bleeding risk. Bleeding is a common side effect of anticoagulation medications, such as Coumadin and the newer, as yet unapproved, antithrombotic (clot-preventing) medications.
Even though dabigatran has not yet received approval in Europe for stroke prevention in atrial fibrillation, it was included in the European guidelines. That’s a departure from standard practice in the development of guidelines. However, it is widely believed that dabigatran will receive approval in Europe soon because results from the Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) trial for stroke prevention in atrial fibrillation were compelling in terms of dabigatran’s safety and efficacy compared to warfarin. (Breaking with historical pattern, the US FDA approved dabigatran for stroke prevention in atrial fibrillation on October 19, 2010—ahead of the Europeans.) Other similar new anticoagulants, such as rivaroxaban and apixaban, are either finishing up clinical trials or their trial results are being reported on soon.
The guidelines also state that left atrial appendage occlusion devices may be considered for patients who cannot take anticoagulation medications. Presently, the WATCHMAN and the Amplatzer Cardiac Plug, which are left atrial appendage occlusion devices implanted via a catheter, are approved in Europe and both devices are in clinical studies in the US.
How the Patient Feels Matters a Great Deal
Symptom relief is a major goal of treatment, according to the European guidelines, which incorporate a symptom score for the first time ever. Patients with a score of 1 have little or no symptoms, whereas patients who have a score of 4 are so impacted by afib that they have had to discontinue certain daily activities. The European Heart Rhythm Association (EHRA) symptom scoring system, shown in Table 1 below, can be used as a shortcut to quickly determine a treatment strategy for a patient with new onset AF or to evaluate how a patient is responding to a particular treatment.
Mild symptoms; normal daily activity not affected
Severe symptoms; normal daily activity affected
|Disabling symptoms; normal daily activity discontinued|
Table 1: Source: European Heart Rhythm Association (EHRA) Symptom Scoring System, European Society of Cardiology Guidelines for the Management of Atrial Fibrillation, 2010, page 10.
In general, most patients are initially treated with rate control medications such as beta blockers to alleviate symptoms. Patients who continue to have symptoms after taking rate control medication may be placed on a short-term strategy to restore normal sinus rhythm through IV dosing of antiarrhythmic medication, like amiodarone or the recently approved vernakalant, or have electrical cardioversion. Some patients are placed on long-term oral antiarrhythmic drugs, like dronedarone, which was addressed for the first time by these guidelines. Dronedarone has been shown to be less toxic and better tolerated by patients than amiodarone, but has a lower efficacy rate.
Catheter Ablation As a First Option
Another “first timer” in the ESC guidelines was catheter ablation, which was elevated to be a first-line treatment for certain patients with afib. In the US guidelines, patients are generally only considered for catheter ablation if they have failed at least one antiarrhythmic drug. In Europe, medical practice could start to change since the ESC now formally recommends that certain patients don’t have to try an antiarrhythmic medication as a prerequisite to catheter ablation. Patients with paroxysmal atrial fibrillation who have no or minimal heart disease, and who continue to be highly symptomatic despite rate control medications, can have a catheter ablation if they don’t want to take antiarrhythmic drugs. The guidelines reiterate that experienced operators tend to have higher catheter ablation success rates than those who have performed a relatively small number of ablations. In addition, the European guidelines characterize the benefit-risk of catheter ablation for persistent and longstanding persistent atrial fibrillation as being “less well established.”
Implications of the New ESC Guidelines
As of now, the European guidelines are the most advanced and complete atrial fibrillation guidelines in the world. But as we’re writing this comes word of new Canadian guidelines that were discussed at the Canadian Cardiovascular Society meeting and will be published soon. We’re anxious to get hold of them and see how they compare.
It’s unclear at this time when the American College of Cardiology and the American Heart Association will update the US guidelines for the management of atrial fibrillation. Although certain treatment options available to Europeans may not receive US approval for some time, other key components of the new European Society of Cardiology guidelines don’t rely on FDA approval. For instance, incorporating the CHA2DS2-VASc stroke risk score and the HAS-BLED bleeding risk score into the ACC/AHA guidelines could mean fewer Americans with atrial fibrillation suffering from clot and bleeding strokes.
So what do these new guidelines mean to you as an afib patient? There is a wealth of information for those with atrial fibrillation in these new guidelines as they are based on the latest research and taking into consideration the degree of evidence for certain recommendations. There are also many valuable details for those with unique circumstances. Regardless of where you’re located, this is valuable research information that you can use to discuss your treatment with your doctor.
The problem for us patients is that the guidelines are a bit long and challenging to read and assimilate due to extensive medical terminology. And much of it may not even be relevant to you. Since each patient is different, and has different medical needs, we have summarized for you in a separate article, New ESC Guidelines Provide Leading-Edge Atrial Fibrillation Treatment Guidance, what you’ll find in the guidelines, and where to find it, so that you can just dip into the portions that are most relevant for you. In that article we’ve also pulled out detailed quotes and facts that we believe are important to many in the afib community, and referenced the pages where that information was pulled from so that you can locate the rest of the related details.
Read related information:
- European Society of Cardiology Guidelines for the Management of Atrial Fibrillation
- 2006 ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
- CHA2DS2-VASc score
- HAS-BLED tool
- Stroke and Atrial Fibrillation
For the sake of transparency we’d like to note that two of the authors/task force members, Prof. John Camm (chairperson) and Prof. Gregory Y.H. Lip, are members of our StopAfib.org Medical Advisory Board and also serve on the European Action for Stroke Prevention coalition that we participate in. Other authors, reviewers, and members of the guidelines committee, including Profs. Paulus Kirchhof, Richard Hobbs, and Panos Vardas, serve with us on the European coalition as well.
Christine Welniak writes about atrial fibrillation, heart failure, and stroke for patients, medical professionals, and investors.