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New oral anticoagulants 'offer efficacy, safety and convenience' for stroke prevention in atrial fibrillation

2012 ESC Guidelines

Introduction of new therapies prompts update of ESC guidelines for the management of AF.

Atrial Fibrillation

An update of the ESC Guidelines on the management of atrial fibrillation is likely "to have a major impact in reducing the complications of this arrhythmia", according to the chairman of the development Task Force, Professor John Camm from St George's Hospital, London.(1)

Among the update's new additions to the guidelines of 2010 are the application of the CHA2DS2DS2-VASc score (in place of the CHADS2 score) for the identification of patients at risk of stroke and the use of novel oral anticoagulants as a preferred alternative to vitamin K antagonists. New data derived from recent clinical trials lay behind the need for an update, notably the AVERROES, ROCKET AF and ARISTOTLE studies - in addition to the earlier reported RE-LY trial.

As background to the recommendations, the authors note that atrial fibrillation (AF) is now prevalent in almost 2% of the general population, with the average age of patients steadily rising - presently between 75 and 85 years. AF is associated with a five-fold risk of stroke and three-fold risk of heart failure.

The new update clearly states that the evidence in favour of aspirin in stroke prevention is weak, with a high risk of bleeding in elderly AF patients, and suggests restricting its use to patients who refuse anticoagulation. The new anticoagulants are recommended as having " all shown non-inferiority compared with [vitamin K antagonists], with better safety" in clinical trials. They are thus "broadly preferable" in the vast majority of patients with non-valvular AF, but, because experience remains limited, they are recommended within the context of "strict adherence to approved indications".

As a key point summary, the guidelines state that the novel anticoagulants "offer efficacy, safety, and convenience compared with oral anticoagulation with [vitamin K antagonists]". Thus, where an oral anticoagulant is recommended, one of the novel anticoagulants — either a direct thrombin inhibitor (dabigatran) or an oral factor Xa inhibitor (eg, rivaroxaban or apixaban if and when approved by regulatory authorities) — should be considered for most patients with AF. There is, however, "insufficient evidence" to recommend one over another.

The update also takes note of the intravenous antiarrhythmic agent vernakalant, recently approved for the cardioversion of AF of short duration. Contraindications are prominently reported, but, as a key point, it is described as "effective in cardioversion of patients with AF ?7 days or AF ?3 days after cardiac surgery" and providing a rapid antiarrhythmic effect, with approximately 50% of patients converting within 90 minutes after the start of treatment and a median time to conversion of 8–14 minutes.

The ESC's 2010 AF guideline recommended a risk-factor based approach to risk stratification, defining "major" and "clinically relevant non-major" risk factors according to a CHA2DS2-VASc (congestive heart failure/left ventricular dysfunction, hypertension, age =75 [doubled], diabetes, stroke [doubled] – vascular disease, age 65–74 and sex category). This, state the new guidelines, should be applicable to the most common stroke risk factors found in everyday practice, but is better than others at identifying "truly low risk" patients in whom antithrombotic therapy is not indicated.

Commenting on the guidelines, Professor Camm said: "This 2012 focused update of the 2010 ESC Guidelines for the management of AF concentrates on the early detection of AF, more sensitive stroke risk stratification, and effective stroke prophylaxis with old and new anticoagulant drugs and left atrial appendage occlusion devices. The guidelines also introduce vernakalant as a new drug for the rapid cardioversion of recent onset AF applicable to a broad range of patients with some important exceptions.

"The guidelines also update rhythm control with antiarrhythmic drugs and left atrial ablation. The use of dronedarone is not recommended in patients with permanent AF or with moderate or severe heart failure and its use is relegated to a therapy of last resort for patients even with mild heart failure. On the other hand, catheter ablation is given a strong recommendation for patients with paroxysmal AF and little or no atrial remodeling provided it is conducted by experienced operators, and its use as a first-line therapy is also endorsed in similar circumstances.

"The 2012 Update is constructed with the objective of guiding physicians on the most appropriate way to use new therapies that have emerged since 2010 and how to modify their approach to older therapies for which new data has been generated.

"Taken together these changes should lead to a major improvement of the care of patients with atrial fibrillation, the most prevalent sustained cardiac rhythm disturbance.”

References

The content of the press release has been approved by the investigator.

2012 focused update of the ESC Guidelines for the Management of Patients with Atrial Fibrillation - doi:10.1093/eurheartj/ehs253 of the ESC Guidelines for the Management of Patients with Atrial Fibrillation (2010 version) (European Heart Journal 2010; 31:2369-2429; doi:10.1093/eurheartj/ehq278

Notes to editor

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 75,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2012
ESC Congress 2012 will take place from 25 to 29 August at the Messe München centre in Munich, Germany. Information on the scientific programme is available here. More information on ESC Congress 2012 is available from the ESC Press Office or contact us at press@escardio.org