Physicians' Academy for Cardiovascular Education

Low rates of stroke and bleeding with NOAC in AF patients at extremes of body weight

Literature - Boriani G, De Caterina R, Manu MC et al., - J Clin Med 2021, 10(13), 2879;

Introduction and methods

Underweight and overweight may be associated with increased thrombotic and hemorrhagic risks. Also, pharmacokinetics of anticoagulants may be altered in individuals at the extremes of body weight [1] and the effects of altered pharmacokinetics/pharmacodynamics of NOACs in these individuals are unknown [2,3]. The ISTH SSC (International Society of Thrombosis and Hemostasis Scientific and Standardisation Committee) suggested to avoid use of NOACs in obese patient (>120 kg or BMI >40 kg/m2), but clear guidance on use of NOACS in patients with underweight was not provided [4].

This subgroup analysis of ETNA-AF-Europe registry examined the clinical outcomes in patients treated with edoxaban across a range of body weight (≤60 kg [n=1310], >80-≤100 kg [n=4335], >100 kg [n=1446]) compared to the reference weight group (>60-≤80 kg, [n=5565]). Also, clinical outcomes were assessed across a range of BMI (<18.5 kg/m2, ≥25-<30 kg/m2, ≥30-<35 kg/m2, >35 kg/m2) compared to the normal BMI group (≥18-<25 kg/m2).

ETNA-AF-Europe is a multinational, multicenter, post-authorization, observational study in 10 European countries. This analysis reported on one-year outcomes of 13,092 AF patients treated with edoxaban. Annualized event rates (% per patient-year) were reported for safety and effectiveness outcomes. 62.7% Of patients in the lower weight group received recommended edoxaban 30 mg, suggesting that the remaining patients received a higher dose than recommended. A limited number of patients with higher weight received lower than recommended doses.

Main results


This subanalysis of the ETNA-AF-Europe registry showed that risk of stroke and bleeding was low in patients with AF treated with edoxaban, with no significant differences in rates across weight categories. A higher risk of death due to any cause was observed in lower and higher weight categories compared to the reference group (U-curve association), which is in contrast with previous findings that described an “obesity paradox” for mortality.


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