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Rivaroxaban Plasma Concentration and Clinical Outcomes on Older Patients with Non-valvular Atrial Fibrillation and Pulmonary Infection

  • Original Research Article
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Abstract

Introduction

Infection may induce thrombotic and hemorrhagic events; however, it is currently unclear whether the inflammatory response affects the coagulation function and the clinical efficacy and safety of rivaroxaban in older patients with non-valvular atrial fibrillation (NVAF).

Objective

This project aimed to assess the effectiveness and safety of the non-vitamin K antagonist oral anticoagulant rivaroxaban in older patients with NVAF complicated by infection, and to provide a basis for possible drug dose adjustment.

Methods

A total of 152 NVAF patients aged ≥ 65 years admitted to the Fifth People’s Hospital of Shanghai from June 2020 to May 2022 were included in this prospective, observational study. The changes in steady-state plasma concentration of rivaroxaban and FXa inhibition rate were compared between patients with and without infection, and the impact on the occurrence of infection, thrombotic events, and bleeding events was compared through 1-year follow-up.

Results

Our results showed that patients in the infection group had abnormal inflammation markers, as well as an increased occurrence of bleeding and thrombotic events during hospitalization and follow-up. The high incidence of bleeding events in patients was closely related to the occurrence of infection, lymphocyte reduction, and increased neutrophil-lymphocyte ratio. The increase in thrombotic events was related to a decrease in rivaroxaban plasma concentration. Bleeding events in patients taking anticoagulant drugs are not necessarily due to drug accumulation.

Conclusions

Timely control of infection, assessment of bleeding and thrombotic risks, and selection of appropriate anticoagulation treatment strategies should be made in older NVAF patients who develop pulmonary infection.

Clinical Trials Registration

Chinese Clinical Trial Registry Number ChiCTR2000033144.

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Author information

Author notes

  1. Yan Yu and Haobin Li contributed equally to this work.

Authors and Affiliations

  1. Department of Pharmacy, Fifth People’s Hospital of Shanghai, Shanghai, China

    Yan Yu, Haobin Li, Jing Liu, Qing Liang & Guangchun Sun

  2. Department of General Practice, Fifth People’s Hospital of Shanghai, Shanghai, China

    Juan Xie

Authors
  1. Yan Yu
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Corresponding authors

Correspondence to Juan Xie or Guangchun Sun.

Ethics declarations

Funding

This study was sponsored by the Shanghai Municipal Health and Family Planning Commission (202040387, 20194Y0258), the Fifth People’s Hospital of Shanghai (2018WYZT04, 2020WYZD01), and the Health and Family Commission of Shanghai Minhang District (mwyjyx05).

Conflicts of Interest

Yan Yu, Haobin Li, Jing Liu, Qing Liang, Juan Xie, and Guangchun Sun declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.

Data Availability

Data will be made available upon reasonable request.

Code Availability

Not applicable.

Authors’ Contributions

GS And YY contributed to the conception of this study and proposed the amendments. JX enrolled the patients, diagnosed whether they have a pulmonary infection and collected the blood samples. HL, YY and JL collected the data, followed-up the patients, and completed data analysis. YY drafted this manuscript. QL revised the manuscript and edited the English.

Ethics Approval

The protocol of this study was approved by the Ethics Committee of Fifth People’s Hospital of Shanghai (Ethics Committee approval number: 2019 Lun Shen No. 107) and was registered on the Chinese Clinical Trial Registry (ChiCTR2000033144). All methods were carried out in accordance with atrial fibrillation guidelines and regulations.

Consent to Participate

All patients provided written informed consent before enrollment.

Consent for Publication

Not applicable.

Supplementary Information

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Supplementary file1 (PDF 321 KB)

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Yu, Y., Li, H., Liu, J. et al. Rivaroxaban Plasma Concentration and Clinical Outcomes on Older Patients with Non-valvular Atrial Fibrillation and Pulmonary Infection. Am J Cardiovasc Drugs 24, 129–139 (2024). https://doi.org/10.1007/s40256-023-00622-4

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