Physicians' Academy for Cardiovascular Education

Effectiveness and safety of anticoagulant therapy in patients with AF at low stroke risk

Oral anticoagulants in patients with atrial fibrillation at low stroke risk: a multicentre observational study

Literature - Komen JJ, Pottegård A, Mantel-Teeuwisse AK et al. - Eur Heart J. 2022 Mar 10;ehac111. doi: 10.1093/eurheartj/ehac111.

Introduction and methods

Background and aim of the study

Treatment with an oral anticoagulant is recommend in patients with AF and a CHA2Ds2-VASc score of ≥2 for males or ≥3 for females. In patients with a low risk of stroke (one non-sex-related CHA2DS2-VASc point), current guidelines recommend to individualize treatment with OAC based on net clinical benefit and patient preferences [1,2]. This observational study assessed the safety and effectiveness of DOAC, VKA or no treatment with an anticoagulant in patients with AF and a low stroke risk.


Patients were selected and pooled from four European databases from Denmark, Norway, Scotland, and the Stockholm region in Sweden. A total of 59076 patients with newly diagnosed AF and low stroke risk were included in the study. Low stroke risk was defined as a CHA2DS2-VASc score of 1 in male patients and a CHA2Ds2-VASc score of 2 in female patients. There were three possible levels of anticoagulant treatment status in the study: no treatment, DOAC treatment, and VKA treatment. Patients were followed until the first occurrence of either an outcome of interest, death, emigration, antiplatelet prescription, increase in CHA2DS2-VASc score or end of the 2.5 year follow-up.


The effectiveness outcome was a composite of ischemic or unspecified stroke. The primary safety outcome was any major bleed. Secondary safety outcomes included gastrointestinal (GI) bleeds or intracranial hemorrhage (ICH) as separate outcomes.

There was a composite outcome of stroke, major bleed, or death. In addition, a net clinical benefit was calculated (ischemic rate off treatment − ischemic rate on treatment) − weight × (ICH rate on treatment − ICH rate off treatment), with weight 1.0, 1.5 or 2.0.

Main results

DOAC vs. no treatment

NNT-y: 475).

VKA vs. no treatment



The results of this observational study suggest that treatment with DOAC may be associated with a positive net clinical benefit compared with VKA and no anticoagulation treatment in patients with AF and a low stroke risk. A randomized controlled trial is needed to confirm this association.


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Find this article online at Eur Heart J.

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