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Published on: February 26, 2013
Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or
Roy Taoutel1, Michael D Ezekowitz1,2,3, Usman A Chaudhry2,3
1Lankenau Medical Center Main Line Health, Wynnewood, PA, USA.
Insights
Direct-acting oral anticoagulants (DOACs) effectively prevent stroke in elderly atrial fibrillation (AF) patients aged 80+. While reduced DOAC doses showed higher non-CNS bleeds and mortality, stroke prevention remained consistent across doses.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Direct-acting oral anticoagulants (DOACs) are standard for stroke prevention in atrial fibrillation (AF).
- Limited data exists on DOAC efficacy and safety in patients aged 80 years and older.
- Elderly patients often have comorbidities influencing treatment decisions.
Purpose of the Study:
- To evaluate the safety and efficacy of reduced-dose versus full-dose DOACs in patients with AF aged 80 years and older.
- To compare rates of stroke and systemic embolization (SSE), bleeding events, and mortality between DOAC dose groups.
- To identify baseline characteristics associated with DOAC dose selection in this elderly population.
Main Methods:
- Retrospective analysis of AF patients aged ≥80 years prescribed reduced or full-dose DOACs (Dabigatran, Rivaroxaban, Apixaban).
- Data collected from January 1, 2011, to May 31, 2017.
- Multivariable analysis to identify differences in baseline characteristics and outcomes.
Main Results:
- Patients on reduced-dose DOACs were older, had poorer renal function, and more comorbidities.
- Rates of SSE and central nervous system (CNS) bleeds were low and similar between groups.
- Non-CNS bleed rates were significantly higher in the reduced-dose group (10.89%/yr vs 4.15%/yr).
- Mortality rates were significantly higher in the reduced-dose group (6.24%/yr vs 1.75%/yr), even after adjustment.
Conclusions:
- DOACs effectively reduce SSE with low CNS bleeding risk in elderly AF patients (≥80 years), irrespective of dose.
- Higher non-CNS bleed and mortality rates in the reduced-dose group are attributed to higher-risk baseline characteristics.
- Further research is needed to understand the causes of non-CNS bleeds and mortality in this population.
Abstract:
Direct-acting oral anticoagulants (DOACs) represent the standard for preventing stroke and systemic embolization (SSE) in patients with atrial fibrillation (AF). There is limited information for patients ≥ 80 years. We report a retrospective analysis of AF patients ≥ 80 years prescribed either a US Food and Drug Administration (FDA)-approved reduced (n = 514) or full dose (n = 199) DOAC (Dabigatran, Rivaroxaban, or Apixaban) between January 1st, 2011 (first DOAC commercially available) and May 31st, 2017. The following multivariable differences in baseline characteristics were identified: patients prescribed a reduced dose DOAC were older (p < 0.001), had worse renal function (p = 0.001), were more often prescribed aspirin (p = 0.004) or aspirin and clopidogrel (p < 0.001), and more often had new-onset AF (p = 0.001). SSE and central nervous system (CNS) bleed rates were low and not different (1.02 vs 0 %/yr and 1.45 vs 0.44 %/yr) for the reduced and full dose groups, respectively. For non-CNS bleeds, rates were 10.89 vs 4.15 %/yr (p < 0.001, univariable) for the reduced and full doses, respectively. The mortality rate was 6.24 vs 1.75 %/yr (p = 0.001, univariable) for the reduced and full doses. Unlike the non-CNS bleed rate, mortality rate differences remained significant when adjusted for baseline characteristics. Thus, DOACs in patients ≥ 80 with AF effectively reduce SSE with a low risk of CNS bleeding, independent of DOAC dose. The higher non-CNS bleed rate and not the mortality rate is explained by the higher risk baseline characteristics in the reduced DOAC dose group. Further investigation of the etiology of non-CNS bleeds and mortality is warranted.
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