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Effects of dabigatran according to age in atrial fibrillation
  1. Mandy N Lauw1,2,
  2. John W Eikelboom1,
  3. Michiel Coppens1,2,
  4. Lars Wallentin3,
  5. Salim Yusuf1,
  6. Michael Ezekowitz4,5,
  7. Jonas Oldgren3,
  8. Juliet Nakamya1,
  9. Jia Wang1,
  10. Stuart J Connolly1
  1. 1 McMaster University and Hamilton Health Sciences, Population Health Research Institute, Hamilton, Ontario, Canada
  2. 2 Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
  3. 3 Department of Medical Sciences, Clinical Research Center, University of Uppsala, Uppsala, Sweden
  4. 4 Jefferson Medical College and Lankenau Medical Center, Philadelphia, Pennsylvania, USA
  5. 5 N/A, Cardiovascular Research Foundation, New York , New York, USA
  1. Correspondence to Mandy N Lauw, Population Health Research Institute, Hamilton Health Sciences, General Hospital 237 Barton Street East, Hamilton, ON L8L 2X2, Canada ; mandy.lauw{at}phri.ca

Abstract

Objective The prevalence of atrial fibrillation (AF) and the risk of stroke and bleeding vary according to age. To estimate effects of dabigatran, compared with warfarin, on stroke, bleeding and mortality in patients with AF in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial according to age, we analysed treatment effects using age as a continuous variable and using age categories.

Methods RE-LY included 10 855 (59.9%) patients aged <75 years, 4231 patients (23.4%) aged 75–79 years, 2305 (12.7%) aged 80–84 years and 722 (4.0%) aged ≥85 years at baseline.

Results Benefits of dabigatran versus warfarin regarding stroke (HR range 0.63 (95% CI 0.46 to 0.86) to 0.70 (0.31 to 1.57) for dabigatran 150 mg twice daily), HR range 0.52 (0.21 to 1.29) to 1.08 (0.73 to 1.60) for dabigatran 110 mg twice daily) and intracranial bleeding were maintained across all age groups (interaction p values all not significant). There was a highly significant interaction (p value interaction <0.001) between age and treatment for extracranial major bleeding, with lower rates with both doses of dabigatran compared with warfarin in younger patients (HR 0.78 (0.62 to 0.97) for 150 mg twice daily, HR 0.72 (0.57 to 0.90) for 110 mg twice daily) but similar (HR 1.50 (1.03 to 2.18) for 110 mg twice daily) or higher rates (HR 1.68 (1.18 to 2.41) for 150 mg twice daily) in older patients (≥80 years).

Conclusion Effects of dabigatran compared with warfarin on stroke prevention and intracranial bleeding are consistent across all age groups. Effects of dabigatran on extracranial major bleeding are age dependent, supporting selection of dabigatran 110 mg twice daily for elderly patients (age ≥80 years).

Trial registration number Clinical trial registration number: https://clinicaltrials.gov NCT00262600.

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