title: Clinical outcomes of patients with diabetes and atrial fibrillation treated with apixaban: results from the ARISTOTLE trial.
abstract: 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.
  
  
  
  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.
  
  
  
  Apixaban has similar benefits on reducing stroke, decreasing mortality, and causing less intra-cranial bleeding than warfarin in patients with and without diabetes.
authors.affiliation: University of Alberta, Edmonton, Canada jae2@ualberta.ca justin.ezekowitz@ualberta.ca justin.ezekowitz@capitalhealth.ca justinezekowitz@med.ualberta.ca.
authors.forename: Justin A
authors.initials: JA
authors.lastname: Ezekowitz
authors.affiliation: Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-IIT, Haifa, Israel.
authors.forename: Basil S
authors.initials: BS
authors.lastname: Lewis
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.
authors.forename: Renato D
authors.initials: RD
authors.lastname: Lopes
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Wojdyla
authors.affiliation: Western Infirmary, Glasgow, UK.
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Hanna
authors.affiliation: Oslo University Hospital, Oslo, Norway.
authors.forename: Dan
authors.initials: D
authors.lastname: Atar
authors.affiliation: INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina.
authors.forename: M
authors.initials: M
authors.lastname: Cecilia Bahit
authors.affiliation: Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.
authors.forename: Matyas
authors.initials: M
authors.lastname: Keltai
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Jose L
authors.initials: JL
authors.lastname: Lopez-Sendon
authors.affiliation: St. John's Medical College, Bangalore, India.
authors.forename: Prem
authors.initials: P
authors.lastname: Pais
authors.affiliation: National Institute of Cardiology, Warsaw, Poland.
authors.forename: Witold
authors.initials: W
authors.lastname: Ruzyllo
authors.affiliation: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.affiliation: Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D002545:Brain Ischemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D002423:Cause of Death / Q000639:trends; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D065427:Factor Xa Inhibitors / Q000008:administration & dosage; D005260:Female; D014943:Global Health; D006801:Humans; D015994:Incidence; D020300:Intracranial Hemorrhages / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles / Q000008:administration & dosage*; D011728:Pyridones / Q000008:administration & dosage*; D015996:Survival Rate / Q000639:trends; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban
keywords: Atrial fibrillation; Clinical outcomes; Diabetes; Oral anti-coagulant