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

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

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy*
  • Brain Ischemia / epidemiology
  • Brain Ischemia / etiology
  • Brain Ischemia / prevention & control*
  • Cause of Death / trends
  • Diabetes Mellitus, Type 2 / complications*
  • Factor Xa Inhibitors / administration & dosage
  • Female
  • Global Health
  • Humans
  • Incidence
  • Intracranial Hemorrhages / epidemiology*
  • Male
  • Middle Aged
  • Pyrazoles / administration & dosage*
  • Pyridones / administration & dosage*
  • Survival Rate / trends
  • Thromboembolism / epidemiology
  • Thromboembolism / etiology
  • Thromboembolism / prevention & control*
  • Treatment Outcome

Substances

  • Factor Xa Inhibitors
  • Pyrazoles
  • Pyridones
  • apixaban