Rao MP, et al. - This study was performed on anticoagulated patients with atrial fibrillation (AF), with an intent to determine the outcomes and history of falling and to verify if benefits of apixaban vs warfarin were consistent in this population. Findings demonstrated a higher risk of major bleeding, including intracranial, and death among AF patients receiving anticoagulation and having a history of falling. Notably, regardless of the history of falling, the efficacy and safety of apixaban compared with warfarin were found to be consistent.

Methods

• In the ARISTOTLE trial, 16,491 out of a total of 18,201 patients had information about history of falling – 753 with history of falling and 15,738 without history of falling.
• Stroke or systemic embolism was the primary efficacy outcome, and major bleeding was the primary safety outcome.

Results

• Findings demonstrated that patients with vs without a history of falling were older, more likely to be female and have dementia, cerebrovascular disease, depression, diabetes, heart failure, osteoporosis, fractures, and higher CHA₂DS₂-VASc and HAS-BLED scores.
• Researchers found that rates of major bleeding (adjusted HR 1.39; 95% CI 1.05–1.84; p=0.020), including intracranial bleeding (adjusted HR 1.87, 95% CI 1.02–3.43; p=0.044), and death (adjusted HR 1.70; 95% CI 1.36–2.14; p<0.0001) were higher in patients with a history of falling, but these patients had similar rates of stroke or systemic embolism and hemorrhagic stroke.
• Data showed that there was no evidence of a differential effect of apixaban compared with warfarin on any outcome, regardless of history of falling.
• In addition, results revealed that among those with a history of falling, occurrence of subdural bleeding was reported in 5 of 367 patients treated with warfarin and 0 of 386 treated with apixaban.