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Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study.
J Intern Med. 2020 Jun 30 [Online ahead of print]JI

Abstract

BACKGROUND

Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population.

OBJECTIVES

This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin.

METHODS

This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013-30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score-matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB.

RESULTS

Amongst NVAF patients, 34% (N = 150 487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55-0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72-0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57-0.66) and dabigatran (HR: 0.79, 95% CI: 0.70-0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08-1.21) was associated with a higher risk vs warfarin.

CONCLUSION

Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real-world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population.

Authors+Show Affiliations

From the, Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK. Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.STATinMED Research, Ann Arbor, MI, USA. New York City College of Technology (CUNY), New York, NY, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Pfizer, Inc., Groton, CT, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Pfizer, Inc., New York, NY, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.Pfizer, Inc., New York, NY, USA.Bristol-Myers Squibb Company, Lawrenceville, NJ, USA. University of North Carolina, Chapel Hill, NC, USA.New York City College of Technology (CUNY), New York, NY, USA.Department of Hospital Medicine, Ochsner Clinic Foundation, New Orleans, LA, USA. Ochsner Clinical School, The University of Queensland School of Medicine, New Orleans, LA, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32602228

Citation

Lip, G Y H., et al. "Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Frail Elderly Patients: Insights From the ARISTOPHANES Study." Journal of Internal Medicine, 2020.
Lip GYH, Keshishian AV, Kang AL, et al. Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study. J Intern Med. 2020.
Lip, G. Y. H., Keshishian, A. V., Kang, A. L., Dhamane, A. D., Luo, X., Li, X., Balachander, N., Rosenblatt, L., Mardekian, J., Pan, X., Di Fusco, M., Garcia Reeves, A. B., Yuce, H., & Deitelzweig, S. (2020). Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study. Journal of Internal Medicine. https://doi.org/10.1111/joim.13140
Lip GYH, et al. Oral Anticoagulants for Nonvalvular Atrial Fibrillation in Frail Elderly Patients: Insights From the ARISTOPHANES Study. J Intern Med. 2020 Jun 30; PubMed PMID: 32602228.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study. AU - Lip,G Y H, AU - Keshishian,A V, AU - Kang,A L, AU - Dhamane,A D, AU - Luo,X, AU - Li,X, AU - Balachander,N, AU - Rosenblatt,L, AU - Mardekian,J, AU - Pan,X, AU - Di Fusco,M, AU - Garcia Reeves,A B, AU - Yuce,H, AU - Deitelzweig,S, Y1 - 2020/06/30/ PY - 2020/03/31/received PY - 2020/05/29/revised PY - 2020/06/08/accepted PY - 2020/7/1/pubmed PY - 2020/7/1/medline PY - 2020/7/1/entrez KW - anticoagulation treatment KW - atrial fibrillation KW - cardiology KW - stroke KW - warfarin JF - Journal of internal medicine JO - J. Intern. Med. N2 - BACKGROUND: Patient frailty amongst patients with nonvalvular atrial fibrillation (NVAF) is associated with adverse health outcomes and increased risk of mortality. Additional evidence is needed to evaluate effective and safe NVAF treatment in this patient population. OBJECTIVES: This subgroup analysis of the ARISTOPHANES study compared the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) amongst frail NVAF patients prescribed nonvitamin K antagonist oral anticoagulants (NOACs) or warfarin. METHODS: This comparative retrospective observational study of frail, older NVAF patients who initiated apixaban, dabigatran, rivaroxaban or warfarin from 01JAN2013-30SEP2015 was conducted using Medicare and 3 US commercial claims databases. To compare each drug, 6 propensity score-matched (PSM) cohorts were created. Patient cohorts were pooled from 4 databases after PSM. Cox models were used to estimate hazard ratios (HR) of S/SE and MB. RESULTS: Amongst NVAF patients, 34% (N = 150 487) met frailty criteria. Apixaban and rivaroxaban were associated with a lower risk of S/SE vs warfarin (apixaban: HR: 0.61, 95% CI: 0.55-0.69; rivaroxaban: HR: 0.79, 95% CI: 0.72-0.87). For MB, apixaban (HR: 0.62, 95% CI: 0.57-0.66) and dabigatran (HR: 0.79, 95% CI: 0.70-0.89) were associated with a lower risk and rivaroxaban (HR: 1.14, 95% CI: 1.08-1.21) was associated with a higher risk vs warfarin. CONCLUSION: Amongst this cohort of frail NVAF patients, NOACs were associated with varying rates of stroke/SE and MB compared with warfarin. Due to the lack of real-world data regarding OAC treatment in frail patients, these results may inform clinical practice in the treatment of this patient population. SN - 1365-2796 UR - https://www.unboundmedicine.com/medline/citation/32602228/Oral_Anticoagulants_for_Non-Valvular_Atrial_Fibrillation_In_Frail_Elderly_Patients:_Insights_from_the_ARISTOPHANES_Study L2 - https://doi.org/10.1111/joim.13140 DB - PRIME DP - Unbound Medicine ER -
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