Abstract
Objective
The safety of direct oral anticoagulants (DOACs) in oldest old patients with nonvalvular
atrial fibrillation (NVAF) in daily clinical practice has not been systematically
assessed. This study examined the safety of DOACs and dicumarol (a vitamin K antagonist)
in NVAF geriatric patients.
Design
Prospective study from January 2010 through June 2015, with follow-up through January 2016.
Setting
Geriatric medicine department at a tertiary hospital.
Participants
A total of 554 outpatients, 75 years or older, diagnosed of NVAF and starting oral
anticoagulation.
Measurements
The main outcome was bleeding, which was classified into major (including those life-threatening)
and nonmajor episodes. Statistical analyses were performed with Cox regression.
Results
A total of 351 patients received DOACs and 193 dicumarol. Patients on DOACs were older,
with more frequent comorbidities, mobility limitation and disability in activities
of daily living, as well as higher mortality, than those treated with dicumarol. The
incidence of any bleeding was 19.2/100 person-years among patients on DOACs and 13.7/100
person-years on dicumarol; corresponding figures for major bleeding were 5.2 for those
on DOACs, and 3.3 for those on dicumarol. In crude analyses, hazard ratios (95% confidence
intervals) for any bleeding, and for mayor bleeding in patients on DOACs vs dicumarol
were 1.60 (1.04-2.44) and 2.22 (0.88-5.59), respectively. Excess risk of bleeding
associated with DOACs vs dicumarol disappeared after adjustment for clinical characteristics,
so that corresponding figures were 1.19 (0.68-2.08) and 1.01 (0.35-2.93). Results
did not vary across subgroups of high-risk patients.
Conclusion
In very old patients with NVAF, the higher risk of bleeding associated with DOACs
vs dicumarol could be mostly explained by the worse clinical profile of patients receiving
DOACs. Risk of bleeding was rather high, and warrants close clinical monitoring.
Keywords
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Article info
Publication history
Published online: June 08, 2018
Footnotes
The authors declare no conflicts of interest.
Identification
Copyright
© 2018 AMDA - The Society for Post-Acute and Long-Term Care Medicine.
