Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Abstract

Purpose

The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs).

Patients and Methods

Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out.

Results

A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3±10.4 years. Patients were followed for a mean of 2.3±1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA₂DS₂-VASc Score was 3.6±1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68–2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82–6.52) and persistence events (HR: 4.51; 95% CI: 3.81 −5.33).

Conclusion

The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.

Keywords:

• anticoagulation
• direct oral anticoagulant
• non-valvular atrial fibrillation
• warfarin
• real-world study
• pharmacoepidemiology

Data Sharing Statement

protocols.io. Access availability from DOI: dx.doi.org/10.17504/protocols.io.rm7vzb852vx1/v1.

Acknowledgments

This manuscript was submitted for participation in ISPOR Europe and accepted. Only the abstract was published in Value in Health. 2022.25(7):S590.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Reyes JM, Castaño-Gamboa N, and Mesa A are employees of Pfizer. Pfizer did not participate in the management or data analysis of the study information. Gaviria-Mendoza A, Machado-Duque ME, Valladales-Restrepo L, and Machado-Alba JE have developed studies funded by GSK, Pfizer, Biotoscana, Sanofi, Sanofi-Pasteur, Abbot, Tecnoquímicas, Bayer, and Novartis. Machado-Duque ME and Machado-Alba JE also report grants from Pfizer, during the conduct of the study. Gaviria-Mendoza A also reports grants from Audifarma, during the conduct of the study. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study (B1801420) received funding from Pfizer Colombia.