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; https://doi.org/10.3390/jcm10132879

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

Conclusion

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.

References

Show references

Find this article online at J Clin Med

Share this page with your colleagues and friends: