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Eur Heart J Cardiovasc Pharmacother. 2015 Apr;1(2):86-94. doi: 10.1093/ehjcvp/pvu024.

Clinical outcomes of patients with diabetes and atrial fibrillation treated with apixaban: results from the ARISTOTLE trial.

Author information

1
University of Alberta, Edmonton, Canada jae2@ualberta.ca justin.ezekowitz@ualberta.ca justin.ezekowitz@capitalhealth.ca justinezekowitz@med.ualberta.ca.
2
Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-IIT, Haifa, Israel.
3
Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.
4
Western Infirmary, Glasgow, UK.
5
Bristol-Myers Squibb, Princeton, NJ, USA.
6
Oslo University Hospital, Oslo, Norway.
7
INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina.
8
Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.
9
Hospital Universitario La Paz, Madrid, Spain.
10
St. John's Medical College, Bangalore, India.
11
National Institute of Cardiology, Warsaw, Poland.
12
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Abstract

AIMS:

We compared clinical outcomes in patients with AF with and without diabetes in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.

METHODS AND RESULTS:

The main efficacy endpoints were SSE and mortality; safety endpoints were major and major/clinically relevant non-major bleeding. A total of 4547/18 201 (24.9%) patients had diabetes who were younger (69 vs. 70 years), more had coronary artery disease (39 vs. 31%), and higher mean CHADS2 (2.9 vs. 1.9) and HAS-BLED scores (1.9 vs. 1.7) (all P < 0.0001) than patients without diabetes. Patients with diabetes receiving apixaban had lower rates of SSE [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.53-1.05), all-cause mortality (HR 0.83, 95% CI 0.67-1.02), cardiovascular mortality (HR 0.89, 95% CI 0.66-1.20), intra-cranial haemorrhage (HR 0.49, 95% CI 0.25-0.95), and a similar rate of myocardial infarction (HR 1.02, 95% CI 0.62-1.67) compared with warfarin. For major bleeding, a quantitative interaction was seen (P-interaction = 0.003) with a greater reduction in major bleeding in patients without diabetes even after multivariable adjustment. Other measures of bleeding showed a consistent reduction with apixaban compared with warfarin without a significant interaction based on diabetes status.

CONCLUSION:

Apixaban has similar benefits on reducing stroke, decreasing mortality, and causing less intra-cranial bleeding than warfarin in patients with and without diabetes.

KEYWORDS:

Atrial fibrillation; Clinical outcomes; Diabetes; Oral anti-coagulant

PMID:
27533976
DOI:
10.1093/ehjcvp/pvu024
[Indexed for MEDLINE]

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