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DOACs in Patients With AF and Low Body Weight
Study Questions:
How effective and safe are direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (AF) and extremely low body weight?
Methods:
The authors identified patients in the Korean National Health Insurance Service database between January 2014 and December 2016, who had a diagnosis of AF and body weight ≤60 kg (≤132 lbs), who were treated with DOAC therapy (n = 14,013) or warfarin (n = 7,576). The primary outcomes were ischemic stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), major bleeding, and all-cause death. Net clinical benefit was defined as the composite of ischemic stroke, ICH, hospitalization for GIB, and all-cause death. Subgroup analysis was performed in patients with body weight <50 kg. Propensity scoring was used to balance between the two treatment groups.
Results:
Patients included in the study were older (mean age 73 years) and high risk for stroke (mean CHA2DS2-VASc score = 4) and 28% with weight <50 kg. DOAC use was associated with lower risks of ischemic stroke (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.51-0.69) and major bleeding (HR, 0.71; 95% CI, 0.60-0.83) as compared to warfarin. DOAC use was also associated with a lower risk of ICH (HR, 0.55; 95% CI, 0.43-0.71). The net clinical benefit favored DOAC therapy (HR, 0.66; 95% CI, 0.61-0.72) in the overall population as well as the subpopulation of patients with weight <50 kg (HR, 0.67; 95% CI, 0.58-0.76). Of note, approximately 60% of patients used a reduced dose of DOAC.
Conclusions:
The authors concluded that in this Asian population of patients with AF and low body weight, use of DOACs was safer and more effective than warfarin.
Perspective:
To date, there have been little safety or efficacy data on the use of DOAC therapy in patients with very low body weight, leading to recommendations of dose reduction (Europace 2015;17:1467-507) or avoidance (J Thromb Thrombolysis 2016;41:206-32) in patients weighing <50-60 kg. This study provides some reassurance that use of DOACs in these very low weight patients can be safe and effective. However, it must be noted that this study was observational (not randomized) and included a majority of patients receiving reduced doses of DOACs. A reduced dose approach simply for low body weight has not been thoroughly tested in large, randomized, prospective studies. Additionally, there is no description of the quality of warfarin management in the control arm. Nonetheless, this analysis should give clinicians some reassurance that DOACs can be considered for patients with AF and very low body weight.
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Brain Ischemia, Geriatrics, Hemorrhage, Intracranial Hemorrhages, Secondary Prevention, Stroke, Thinness, Vascular Diseases, Warfarin
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