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Am J Med. 2018 Mar;131(3):269-275.e2. doi: 10.1016/j.amjmed.2017.10.036. Epub 2017 Nov 6.

Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial.

Author information

1
Cape Fear Heart Associates, New Hanover Regional Medical Center, Wilmington, NC.
2
University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania. Electronic address: vinereanu@gmail.com.
3
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
4
University of Oslo, Norway.
5
Boston University School of Medicine, Mass.
6
Bristol-Myers Squibb, Princeton, NJ.
7
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
8
Mayo Clinic College of Medicine, Rochester, Minn.

Abstract

PURPOSE:

We assessed outcomes among anticoagulated patients with atrial fibrillation and a history of falling, and whether the benefits of apixaban vs warfarin are consistent in this population.

METHODS:

Of the 18,201 patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study, 16,491 had information about history of falling-753 with history of falling and 15,738 without history of falling. The primary efficacy outcome was stroke or systemic embolism; the primary safety outcome was major bleeding.

RESULTS:

When compared with patients without a history of falling, patients with a history of falling were older, more likely to be female and to have dementia, cerebrovascular disease, depression, diabetes, heart failure, osteoporosis, fractures, and higher CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or TIA or thromboembolism, Vascular disease, Age 65-74 years, Sex category female) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratio, Elderly, Drugs or alcohol) scores. Patients with a history of falling had higher rates of major bleeding (adjusted hazard ratio [HR] 1.39; 95% confidence interval [CI], 1.05-1.84; P = .020), including intracranial bleeding (adjusted HR 1.87; 95% CI, 1.02-3.43; P = .044) and death (adjusted HR 1.70; 95% CI, 1.36-2.14; P < .0001), but similar rates of stroke or systemic embolism and hemorrhagic stroke. There was no evidence of a differential effect of apixaban compared with warfarin on any outcome, regardless of history of falling. Among those with a history of falling, subdural bleeding occurred in 5 of 367 patients treated with warfarin and 0 of 386 treated with apixaban.

CONCLUSIONS:

Patients with atrial fibrillation and a history of falling receiving anticoagulation have a higher risk of major bleeding, including intracranial, and death. The efficacy and safety of apixaban compared with warfarin were consistent, irrespective of history of falling.

KEYWORDS:

Anticoagulation; Apixaban; Atrial fibrillation; Bleeding; History of falls; Stroke; Warfarin

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