RESEARCH ARTICLE


Comparative Effectiveness and Safety of Rivaroxaban and Warfarin for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation in an Omani Tertiary Care Hospital



Maya Said Al-Maawali1, *, Hamed Hilal Al-Naamani2, Leila Neshat Mokadem3, Ghalib Al-Maawali2, Bushra Salman4, Ibrahim Al-Zakwani5, 6
1 Department of Pharmacy, National Heart Center, The Royal Hospital, Muscat, Oman
2 Department of Pharmacy, The Royal Hospital, Muscat, Oman
3 School of Pharmacy & Life Sciences, Robert Gordon University, Aberdeen, Scotland, UK.
4 Sultan Qaboos Comprehensive Cancer Care and Research Center, Muscat, Oman
5 Department of Pharmacy, Sultan Qaboos University Hospital, Muscat, Oman
6 Department of Pharmacology & Clinical Pharmacy, College of Medicine & Health Sciences, Sultan Qaboos University, Muscat, Oman


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Creative Commons License
© 2022 Al-Maawali et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at, Department of Pharmacy, National Heart Center, The Royal Hospital, Muscat, Oman; E-mail: m.sm22@hotmail.com


Abstract

Objective:

The aim of the study was to compare the effectiveness and safety of rivaroxaban and warfarin as well as to determine the appropriateness of dosing and prescribing of rivaroxaban in Omani patients with non-valvular atrial fibrillation (NVAF).

Methods:

This retrospective cohort study was conducted using the Royal Hospital data registry. The study included all adults newly diagnosed with NVAF and treated with rivaroxaban or warfarin. The outcomes measured include ischaemic stroke, gastrointestinal bleeding (GIB), non-gastrointestinal bleeding (NGIB), as well as appropriateness of dosing and prescribing of rivaroxaban.

Results:

The analysis included 96 rivaroxaban users and 183 warfarin users; 51% of the cohort included males. There were no significant differences observed in the risk of ischaemic stroke between the two groups (hazard ratio (HR), 1.1; 95% confidence interval (CI): 0.4-3.4; p=0.8). However, those on rivaroxaban exhibited a significantly higher rate of GIB compared to those on warfarin (HR, 5.9; 95% CI: 2.9-11.7; p=0.001). There were no differences observed with regards to NGIB between the two groups (HR, 0.9; 95% CI: 0.4-1.9; p=0.8). Dosing and prescribing of rivaroxaban were found to be appropriate in 89% of the patients, with only 6% being prescribed an inappropriately lower dose.

Conclusion:

The study demonstrated no significant differences in the risk of ischaemic stroke or NGIB between rivaroxaban and warfarin groups in newly diagnosed NVAF patients. However, rivaroxaban users were found to have a significantly higher risk of GIB. Rivaroxaban was appropriately prescribed to the majority of the patients, and only a small proportion of the group received an inappropriately lower dose of rivaroxaban.

Keywords: Non-valvular atrial fibrillation, Rivaroxaban, Warfarin, Ischaemic stroke, Gastrointestinal bleeding, Non-gastrointestinal bleeding.