Key result
Increased fall risk links to ~30% higher major bleeding, while edoxaban outperforms warfarin.
Why the study?
Anticoagulation is often avoided in patients with atrial fibrillation who are at an increased risk of falling, motivating an evaluation of the relative efficacy and safety of edoxaban versus warfarin in this population.
Does edoxaban improve efficacy and safety outcomes compared with warfarin in patients with atrial fibrillation judged to be at an increased risk of falling?
RCT (n=900)
Does edoxaban improve efficacy and safety outcomes compared with warfarin in patients with atrial fibrillation judged to be at an increased risk of falling?
In atrial fibrillation patients at increased risk of falling, edoxaban provides a greater absolute risk reduction in severe bleeding events and all-cause mortality compared with warfarin, supporting its use in this high-risk population.
Answers are grounded in this paper and cite their sources.
Edoxaban yields greater absolute reductions in severe bleeding and mortality versus warfarin in fall-risk AF patients; extends consistent benefit to this high-risk subgroup.
Background Anticoagulation is often avoided in patients with atrial fibrillation who are at an increased risk of falling. Objectives This study assessed the relative efficacy and safety of edoxaban versus warfarin in the ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial in patients with atrial fibrillation judged to be at increased risk of falling. Methods We performed a pre-specified analysis of the ENGAGE AF-TIMI 48, comparing patients with versus without increased risk of falling. Results Nine hundred patients (4.3%) were judged to be at increased risk of falling. These patients were older (median, 77 vs. 72 years; p < 0.001), and had a higher prevalence of comorbidities including prior stroke/transient ischemic attack, diabetes, and coronary artery disease. After multivariable adjustment, patients at increased risk of falling experienced more bone fractures caused by falling (adjusted hazard ratio [HRadj]: 1.88; 95% confidence interval [CI]: 1.49 to 2.38; p < 0.001), major bleeding (HRadj: 1.30; 95% CI: 1.04 to 1.64; p = 0.023), life-threatening bleeding (HRadj: 1.67; 95% CI: 1.11 to 2.50; p = 0.013), and all-cause death (HRadj: 1.45; 95% CI: 1.23 to 1.70; p < 0.001), but not ischemic events including stroke/systemic embolic event (HRadj: 1.16; 95% CI: 0.89 to 1.51; p = 0.27). No treatment interaction was observed between either dosing regimens of edoxaban and warfarin for the efficacy and safety outcomes. Treatment with edoxaban resulted in a greater absolute risk reduction in severe bleeding events and all-cause mortality compared with warfarin. Conclusions Edoxaban is an attractive alternative to warfarin in patients at increased risk of falling, because it is associated with an even greater absolute reduction in severe bleeding events and mortality. (Effective aNticaoGulation with factor xA next Generation in Atrial Fibrillation [ENGAGE AF-TIMI 48]; NCT00781391).
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Steffel et al. (2016) conducted an RCT in Atrial fibrillation with increased risk of falling (n=900). Edoxaban (and increased risk of falling subgroup) vs. Warfarin (and without increased risk of falling) was evaluated on Major bleeding (in patients with vs without increased risk of falling) (HR 1.30, 95% CI 1.04-1.64, p=0.023). Increased fall risk predicted higher major bleeding (HR 1.30; 95% CI 1.04-1.64) and death (HR 1.45; P<0.001), while edoxaban yielded greater absolute reductions in severe bleeding and death vs warfarin.
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