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. 2022 Oct 10:43:101130.
doi: 10.1016/j.ijcha.2022.101130. eCollection 2022 Dec.

Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or Full Dose Direct-Acting Oral Anticoagulant

Roy Taoutel  1 , Michael D Ezekowitz  1   2   3 , Usman A Chaudhry  2   3 , Carly Weber  1 , Dana Hassan  1 , Ed J Gracely  4 , Mohammed H Kamareddine  1 , Benjamin I Horn  1 , Glenn R Harper  2
Affiliations

Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or Full Dose Direct-Acting Oral Anticoagulant

Roy Taoutel et al. Int J Cardiol Heart Vasc. .

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.

Keywords: A2.5, Apixaban 2.5 mg twice daily; A5, Apixaban 5 mg twice daily; AF, atrial fibrillation; Atrial fibrillation; BMMSA, Bryn Mawr Medical Specialists Association; CKD, chronic kidney disease; CNS, central nervous system; CrCl, creatinine clearance; D110, Dabigatran 110 mg twice daily; D150, Dabigatran 150 mg twice daily; D75, Dabigatran 75 mg twice daily; DOAC; DOACs, direct-acting oral anticoagulants; Direct-acting oral anticoagulants; ESRD, end-stage renal disease; Elderly; FDA, Food and Drug Administration; R15, Rivaroxaban 15 mg daily; R20, Rivaroxaban 20 mg daily; SSE, stroke and systemic embolization.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Michael D. Ezekowitz reports financial support was provided by Boston Scientific. Michael D. Ezekowitz reports financial support was provided by Sanofi-Aventis US LLC. Glenn Harper reports a relationship with Pfizer, Bristol Myers Squibb that includes: funding grants. Michael D. Ezekowitz reports a relationship with Pfizer, Bristol Myers Squibb that includes: funding grants. Michael D. Ezekowitz reports a relationship with Boehringer Ingelheim that includes: funding grants. Michael D. Ezekowitz reports a relationship with Johnson and Johnson that includes: funding grants.].

Figures

Fig. 1
Fig. 1
Outcomes in all patients prescribed a reduced or full dose DOAC (mean ± 1 SD).
Fig. 2
Fig. 2
Kaplan-Meier curves for time to SSE (A), death (B), non-CNS bleed (C), and CNS bleed (D) for all reduced dose and full dose DOAC groups.
See this image and copyright information in PMC

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