PB0557 - Effectiveness and safety of Direct Oral Anticoagulants (DOACs) in extremely obese compared to non-extremely obese patients in an observational prospective single-centre unselected patient registry

Background: Extreme obesity (BMI≥40kg/m2 or weight≥120kg) can affect DOACs’ pharmacokinetics, increasing the volume of distribution and the drug clearance. A systematic review and meta-analysis of the impact of weight on DOAC in clinical trials showed no significant difference. To date, guidelines advise being cautious with prescribing DOACs to obese, especially with BMI≥40kg/m2.

Aims: To compare effectiveness and safety between extremely obese and non-extremely obese patients in a real-world registry with Edoxaban prescription predominance (68.3%).

Methods: The patients, who have provided written informed consent, were assessed for demographic and clinical characteristics, validated laboratory tests, rigorous education and follow-up inside the MACACOD registry (Clinical Application Model of Direct Oral Anticoagulants, NCT04042155) from July 2019 to January 2022. Ethical approval was obtained.
Major thrombotic complications (MTC) comprised ischemic stroke and systemic embolism. Major hemorrhagic complications (MHC), events with a Bleeding Academic Research Consortium (BARC) scale above 2 points. Secondary outcomes are Clinically Relevant Non-Major Thrombosis (CRNMT) or Bleedings (CRNMB), including peripheral thrombosis, myocardial infarction, transient ischemic attack and bleeding with a BARC scale of 2 points or less.

Results: Our registry includes 1030 patients with at least one follow-up, 1000 anticoagulated for Atrial Fibrillation and 30 for venous thromboembolism. A total of 25 present extreme obesity (2.43%) and 1005 present non-extreme obesity.
The extremely obese cohort was significantly younger, with a higher Charlson Comorbidity Index (CCI) and better Creatinine Clearance (ClCr) (Table1). However, there was a higher incidence of MHC and mortality in extremely obese than in non-extremely obese. There’s no difference in MTC or CRNMT+B (Table2).

Conclusion(s): In our registry, despite extremely obese patients being younger and with better ClCr, they are more comorbid and have more hemorrhagic complications and more mortality than non-extremely obese patients, with no difference in the incidence of thrombotic complications.
Acknowledgments to DAIICHI-SANKYO Spain for the support.