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Retrospective, multicenter analysis of the safety and effectiveness of direct oral anticoagulants for the treatment of venous thromboembolism in obesity

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Abstract

Background

Direct oral anticoagulants (DOACs) are the preferred treatment for venous thromboembolism (VTE). However, DOAC use in patients with a BMI greater than 40 kg/m2 has not been well studied despite the growing prevalence of obesity, and current literature is often underpowered.

Methods

This multicenter, retrospective, observational study evaluated patients 18 years and older who received DOACs for acute VTE treatment. Patients receiving DOACs for recurrent VTE or for failure of another agent were excluded. The primary efficacy outcome was recurrent VTE and the primary safety outcome was major bleeding within 12 months (or one month after stopping anticoagulation therapy). A propensity score analysis was performed to balance patient characteristics and evaluate the primary endpoints by BMI group. Time-to-event outcomes were analyzed using weighted Kaplan-Meier curves.

Results

There were 165 patients with a BMI of at least 40 kg/m2 and 320 patients with a BMI less than 40 kg/m2. The majority received apixaban (373, 77%). Recurrent VTE occurred in 5 (3.0%) and 13 (4.1%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 0.66; 95% CI: 0.16–2.69). Major bleeding occurred in 5 (3.0%) and 15 (4.7%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 1.19; 95% CI: 0.36–3.92).

Conclusion

There was no significant difference in VTE recurrence or major bleeding related to BMI among patients treated with DOACs. This study showed that DOACs may be a safe and effective VTE treatment option in patients with obesity.

Key points

Data supporting the use of direct oral anticoagulants (DOACs) for the treatment of venous thromboembolism (VTE) in patients with obesity are limited.

This multicenter analysis aimed to evaluate the effectiveness and safety of DOACs in patients with and without obesity.

The majority of patients received apixaban.

VTE recurrence and rates of major bleeding were not different between patients with a BMI of at least 40 kg/m2 compared to a BMI less than 40 kg/m2.

This study adds to the growing body of evidence supporting the use of DOACs, particularly apixaban, in patients with obesity, although future prospective trials and additional data in patients at extremes of body weight will be useful.

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Acknowledgements

Kathleen Sargent, PharmD, data collection & manuscript design; Yogini Patel, PharmD, BCPS, data collection; Anne E. Rose, PharmD, study design; Sahar Torabi, PharmD, data collection.

Funding

No funds, grants, or other support were received for this work.

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Authors and Affiliations

  1. UC Health Memorial Hospital, Department of Pharmacy, Colorado Springs, CO, USA

    Jeffrey D. Sperry

  2. Department of Pharmacy, University of California, Davis, Sacramento, CA, USA

    Aletha Loeb

  3. Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA

    Melissa J. Smith

  4. Department of Pharmacy, University of Massachusetts Chan Medical School, Worcester, MA, USA

    Tessa B. Brighton

  5. Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA

    Julie A. Ehret, Joli D. Fermo & Jennifer N. Mazur

  6. Department of Pharmacy Services, Beth Israel Lahey Health, Burlington, MA, USA

    Morgan E. Gentili

  7. School of Pharmacy and Pharmaceutical Sciences, Northeastern University, Boston, MA, USA

    Jason W. Lancaster

  8. Department of Pharmacy, University of Kentucky HealthCare, Lexington, KY, USA

    Katherine Spezzano

  9. Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, USA

    Jennifer A. Szwak

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  1. Jeffrey D. Sperry
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Correspondence to Jennifer A. Szwak.

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This study was approved by the Investigational Review Board (IRB) of each participating institution.

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Jennifer A. Szwak is a member of an advisory board for Baxter Pharmaceuticals. All other authors declare no conflict of interest.

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Sperry, J.D., Loeb, A., Smith, M.J. et al. Retrospective, multicenter analysis of the safety and effectiveness of direct oral anticoagulants for the treatment of venous thromboembolism in obesity. J Thromb Thrombolysis 57, 603–612 (2024). https://doi.org/10.1007/s11239-024-02955-6

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