Atrial Fibrillation Clinical Trial
Official title:
APAF Apixaban in Atrial Fibrillation Registry
Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.
Atrial fibrillation (AF) confers a substantial risk of mortality and morbidity from stroke
and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden
in Europe. Stroke prevention is central to the management of AF patients, with oral
anticoagulation (OAC) using well-controlled adjusted dose vitamin K antagonists or novel OACs
being recommended for patients with AF with ≥1 stroke risk factors. Also, the 2012 focused
update of the ESC guidelines strongly advocates a clinical practice shift so that the initial
decision step now is the identification of 'truly low risk' patients, essentially those
age<65 without any stroke risk factors (both male and female), who do not need any
antithrombotic therapy. The ESC guidelines only recommend use of the CHA2DS2-VASc score for
stroke risk assessment, and the 'low risk' patients are defined as those with a CHA2DS2-VASc
score=0 (males) or score=1 (females). Subsequent to this initial step of identifying the low
risk patients, effective stroke prevention (which is essentially OAC) can then be offered to
AF patients with ≥1 stroke risk factors, with treatment decisions made in consultation with
patients and incorporating their preferences. Despite these recommendations, a substantial
number of patients with AF is not treated with OAC. On the other hand, patients with AF and
low risk are being "overtreated", receiving OAC despite a CHADS-VASc score of 0. Therefore,
this registry will determine, if patients with non-valvular AF are treated ac-cording to
current guidelines.
Apixaban is an oral factor Xa inhibitor, which has been tested in a number of indications. In
the AVERROES study in patients with non-valvular atrial fibrillation deemed not suitable for
treatment with a vitamin-K antagonist apixaban compared to aspirin reduced the incidence of
stroke and systemic embolism without increasing bleeding complications. In the large
ARISTOTELE study apixaban was superior to warfarin, it re-duced the primary endpoint of
stroke and systemic embolism caused less bleeding and reduced all-cause mortality.
Subsequently apixaban has been approved by the European health authorities for the use in
patients with atrial fibrillation. It is therefore of interest to determine use of apixaban
in real life with respect to patient selection, adherence to therapy and midterm efficacy and
safety.
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