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Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms

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Abstract

Background

Direct oral anticoagulants (DOACs) have become favorable choices for anticoagulation due to their fixed-dose schedule, limited need for monitoring, and non-inferiority or superiority to warfarin. DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m2 due to limited data regarding safety and efficacy.

Objective

The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing < 120 kg.

Methods

A single-center, retrospective study was conducted in patients weighing ≥ 120 kg who received either apixaban, dabigatran, or rivaroxaban for stroke risk reduction in NVAF, and matched to patients who weighed < 120 kg. The primary outcome was the incidence of stroke, deep vein thrombosis, pulmonary embolism, or myocardial infarction, while the safety outcome was the incidence of major or clinically relevant non-major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) definitions.

Results

A total of 318 patients weighing ≥ 120 kg with NVAF and meeting the inclusion criteria were evaluated and matched with 318 patients weighing < 120 kg. The primary outcome occurred in 2.5% of patients in the ≥ 120 kg group and in 3.1% of patients in the < 120 kg group (p = 0.632). The safety outcome occurred in 5.3% and 6.6% of patients in these respective groups (p = 0.503).

Conclusion

Apixaban, dabigatran, or rivaroxaban may be well-tolerated and effective anticoagulant options in patients with NVAF weighing ≥ 120 kg.

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Acknowledgements

The authors are grateful for the assistance of Erin Weeda in study design and statistical analysis ideas and would like to recognize Jessica Crane, Casey Cummings, and Anna Kroninger for assistance with data collection.

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Authors and Affiliations

  1. Department of Pharmacy Services, Medical University of South Carolina, 150 Ashley Avenue, MSC 584, Charleston, SC, 29425, USA

    Eryne E. Wiethorn, Carolyn Magee Bell & Barbara S. Wiggins

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  1. Eryne E. Wiethorn
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  2. Carolyn Magee Bell
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  3. Barbara S. Wiggins
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Corresponding author

Correspondence to Eryne E. Wiethorn.

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Funding

This research was not supported by any funding.

Conflicts of interest

Eryne Wiethorn, Carolyn Magee Bell, and Barbara Wiggins have no conflicts of interest to disclose.

Ethics approval

Approval was obtained from the Ethics Committee of the Medical University of South Carolina. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

Consent to participate

This study was retrospective, therefore consent to participate was not required.

Consent for publication

This study was retrospective, therefore consent to publish was not required.

Availability of data and material

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code availability

All code for data cleaning and analysis associated with the current study is available from the corresponding author upon reasonable request.

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Wiethorn, E.E., Bell, C.M. & Wiggins, B.S. Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms. Am J Cardiovasc Drugs 21, 545–551 (2021). https://doi.org/10.1007/s40256-021-00470-0

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  • DOI: https://doi.org/10.1007/s40256-021-00470-0

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