Impact of frailty on the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation: a nationwide cohort study

Author:

Grymonprez Maxim1ORCID,Petrovic Mirko2,De Backer Tine L3,Steurbaut Stephane45,Lahousse Lies16ORCID

Affiliation:

1. Department of Bioanalysis, Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University , Ottergemsesteenweg 460, 9000 Ghent , Belgium

2. Department of Geriatrics, Ghent University Hospital , C. Heymanslaan 10, 9000 Ghent , Belgium

3. Department of Cardiology, Ghent University Hospital , C. Heymanslaan 10, 9000 Ghent , Belgium

4. Centre for Pharmaceutical Research, Research group of Clinical Pharmacology and Clinical Pharmacy , Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Jette, Belgium

5. Department of Hospital Pharmacy , UZ Brussel, Laarbeeklaan 101, 1090 Jette, Belgium

6. Department of Epidemiology , Erasmus Medical Center, PO Box 2040, Rotterdam 3000 CA , The Netherlands

Abstract

Abstract Aims Data on non-vitamin K antagonist oral anticoagulants (NOACs) use in patients with atrial fibrillation (AF) and frailty are scarce. Therefore, the impact of frailty on AF-related outcomes and benefit–risk profiles of NOACs in patients with frailty were investigated. Methods and results AF patients initiating anticoagulation between 2013 and 2019 were included using Belgian nationwide data. Frailty was assessed with the Claims-based Frailty Indicator. Among 254 478 anticoagulated AF patients, 71 638 (28.2%) had frailty. Frailty was associated with higher all-cause mortality risks [adjusted hazard ratio (aHR) 1.48, 95% confidence interval (CI) (1.43–1.54)], but not with thromboembolism or bleeding. Among subjects with frailty (78 080 person-years of follow-up), NOACs were associated with lower risks of stroke or systemic embolism (stroke/SE) [aHR 0.77, 95%CI (0.70–0.86)], all-cause mortality [aHR 0.88, 95%CI (0.84–0.92)], and intracranial bleeding [aHR 0.78, 95%CI (0.66–0.91)], a similar major bleeding risk [aHR 1.01, 95%CI (0.93–1.09)], and higher gastrointestinal bleeding risk [aHR 1.19, 95%CI (1.06–1.33)] compared with VKAs. Major bleeding risks were lower with apixaban [aHR 0.84, 95%CI (0.76–0.93)], similar with edoxaban [aHR 0.91, 95%CI (0.73–1.14)], and higher with dabigatran [aHR 1.16, 95%CI (1.03–1.30)] and rivaroxaban [aHR 1.11, 95%CI (1.02–1.21)] compared with VKAs. Apixaban was associated with lower major bleeding risks compared with dabigatran [aHR 0.72, 95%CI (0.65–0.80)], rivaroxaban [aHR 0.78, 95%CI (0.72–0.84)] and edoxaban [aHR 0.74, 95%CI (0.65–0.84)], but mortality risk was higher compared with dabigatran and edoxaban. Conclusion Frailty was an independent risk factor of death. Non-vitamin K antagonist oral anticoagulants had better benefit–risk profiles than VKAs in patients with frailty, especially apixaban, followed by edoxaban.

Funder

Research Foundation Flanders

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Health Policy

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