Background: Even after a decade of direct oral anticoagulants` (DOACs) use in clinical routine, uncertainty about safety and efficacy in the obese still remains.
Aims: The aim of the BIARIVA prospective pilot study was to investigate the association of body composition parameters with specific blood coagulation parameters in patients on anticoagulant treatment with oral factor Xa inhibitors rivaroxaban or edoxaban.
Methods: Specific blood coagulation parameters including anti-factor Xa activity levels and direct plasma concentration levels at peak and trough were explored for their association with body composition parameters by correlation analysis. Plasma concentrations levels were directly measured for rivaroxaban and calculated by formula for edoxaban. Body composition measurement comprised determination of fat-mass and fat-free mass by use of two different scaling systems, the bipolar BIACorpus RX 4000 scale and the tetrapolar Seca mBCA 500 scale. All patients provided written informed consent. The study protocol was approved by the local ethics committee.
Results: A total of 39 patients in the edoxaban group and 41 patients in the rivaroxaban group were considered for the final analysis. Median body mass index (BMI) was 33.60 [23.30-36.20] in edoxaban patients and 31.90 [24.50-37.75] kg/m² in rivaroxaban patients. Among edoxaban patients, a significant but only modest positive correlation was found for absolute fat-free mass with the absolute increase and also with peak levels of both anti-Xa activity and plasma concentration for both scale measures. No significant correlation was found for absolute fat mass with coagulation parameters. Results for percentage fat-mass did not present a conclusive trend. In the rivaroxaban group, correlations of blood coagulation parameters with body composition parameters did not reach a level of significance anyway.
Conclusions: The BIARIVA prospective pilot study did not unveil a definite trend towards blood coagulation parameters dependency on body composition indicating safety and efficacy of edoxaban and rivaroxaban even in the obese.
To cite this abstract in AMA style:Guetl K, Leitner DR, Beck A, Rabensteiner J, Gary T, Raggam RB, Toplak H. Direct Oral Factor-Xa-inhibitors for the Treatment of VTE in the Obese: Do Body Weight and Body Composition Matter? A Prospective Pilot Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/direct-oral-factor-xa-inhibitors-for-the-treatment-of-vte-in-the-obese-do-body-weight-and-body-composition-matter-a-prospective-pilot-study/. Accessed September 23, 2021.
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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/direct-oral-factor-xa-inhibitors-for-the-treatment-of-vte-in-the-obese-do-body-weight-and-body-composition-matter-a-prospective-pilot-study/