Key result
Direct oral anticoagulants showed no significant differences in mortality, ischemic stroke, or major bleeding rates between morbidly obese and non-obese patients with atrial fibrillation.
Why the study?
Morbidly obese patients were underrepresented in trials supporting DOAC approval for stroke prevention, and guideline recommendations advised against their use in this population.
Do direct oral anticoagulants have similar rates of mortality, thrombotic, and haemorrhagic events in patients with nonvalvular atrial fibrillation and morbid obesity compared to those without morbid obesity?
Cohort (n=2,492)
Yes
Do direct oral anticoagulants have similar rates of mortality, thrombotic, and haemorrhagic events in patients with nonvalvular atrial fibrillation and morbid obesity compared to those without morbid obesity?
Absolute Event Rate: 5.2% vs 6%
p-value: p=0.662
Direct oral anticoagulants appear safe and effective in patients with nonvalvular atrial fibrillation and morbid obesity, with no significant differences in mortality, stroke, or major bleeding compared to non-obese patients.
Supports DOAC safety in morbid obesity; extends low-certainty observational data but leaves open need for RCTs.
Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide and the main cause of anticoagulation, being direct oral anticoagulants (DOAC) increasingly used in this context. On the other hand, obesity is a known risk thromboembolic factor. In the clinical trials that led to the approval of DOAC for ischemic stroke prevention, patients with morbid obesity were underrepresented. The International Society of Thrombosis and Haemostasis suggests not using these drugs in morbid obese patients. Thus, the primary objectives of this study were to analyse the rates of mortality, thrombotic and haemorrhagic events in patients with morbid obesity. As secondary objectives, factors statistically associated with these events were analysed. Methods: multicentre retrospective study that included patients diagnosed with AF on treatment with DOAC from January 2013 to December 2016. The subgroup of patients with morbid obesity (BMI > 40 and / or weight > 120 kg) was analysed. Mean follow-up was 1.7 years. Results: Amongst 2,492 patients included in the study, 135 patients had morbid obesity (mean age was 71 ± 11 years). The mean scores of the CHA2DS2-VASc and HAS-BLED risk scales were 3.7 ± 1.6 and 2.2 ± 0.9, respectively. Neither differences were found regarding mortality (5.2 vs 6/100 patient-years, p = 0.662), ischemic stroke (0.8 vs 1.9/100 patient-years, p = 0.261) and major bleeding rates (3 vs 3.1/100 patient-years, p = 0.983) between morbidly obese population and general population. Nor was there an association found between the degree of obesity and any of the events studied. Conclusion: DOAC are safe and effective in morbidly obese patients.
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Navarro-Almenzar et al. (2021) conducted a cohort in Nonvalvular atrial fibrillation and morbid obesity (n=2,492). Direct oral anticoagulants (DOAC) vs. Non-morbidly obese patients was evaluated on Mortality (p=0.662). Direct oral anticoagulants showed no significant differences in mortality, ischemic stroke, or major bleeding rates between morbidly obese and non-obese patients with atrial fibrillation.
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