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

Roy Taoutel; Michael D Ezekowitz; Usman A Chaudhry; Carly Weber; Dana Hassan; Ed J Gracely; Mohammed H Kamareddine; Benjamin I Horn; Glenn R Harper

doi:10.1016/j.ijcha.2022.101130

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

Int J Cardiol Heart Vasc. 2022 Oct 10:43:101130. doi: 10.1016/j.ijcha.2022.101130. eCollection 2022 Dec.

Authors

Roy Taoutel¹, Michael D Ezekowitz^{1

2

3}, Usman A Chaudhry^{2

3}, Carly Weber¹, Dana Hassan¹, Ed J Gracely⁴, Mohammed H Kamareddine¹, Benjamin I Horn¹, Glenn R Harper²

Affiliations

¹ Lankenau Medical Center Main Line Health, Wynnewood, PA, USA.
² Bryn Mawr Hospital Main Line Health, Bryn Mawr, PA, USA.
³ Sidney Kimmel Medical College at Jefferson University, Philadelphia, PA, USA.
⁴ Department of Epidemiology and Biostatistics, Drexel University, Philadelphia, PA, USA.

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.