Apr 07, 2023
CLINICAL CHARACTERISTICS, PATTERNS OF USE, AND INCIDENCE OF ADVERSE EVENTS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION TREATED WITH ORAL ANTICOAGULANTS
- 1Universidad Tecnológica de Pereira
External link: https://doi.org/10.2147/VHRM.S391549
Protocol Citation: Jorge Machado Alba 2023. CLINICAL CHARACTERISTICS, PATTERNS OF USE, AND INCIDENCE OF ADVERSE EVENTS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION TREATED WITH ORAL ANTICOAGULANTS. protocols.io https://dx.doi.org/10.17504/protocols.io.rm7vzb852vx1/v1
Manuscript citation:
Machado-Duque ME, Gaviria-Mendoza A, Reyes JM, Mesa A, Castaño-Gamboa N, Valladales-Restrepo LF, Machado-Alba JE, Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia. Vascular Health and Risk Management doi: 10.2147/VHRM.S391549
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: September 26, 2022
Last Modified: April 07, 2023
Protocol Integer ID: 70526
Keywords: Anticoagulation; Direct Oral Anticoagulant; Non-valvular Atrial Fibrillation; Warfarin; Real-world study; Pharmacoepidemiology
Funders Acknowledgement:
Pfizer
Grant ID: B1801420
Abstract
Purpose: The aim was to analyze the characteristics, treatment patterns, persistence, 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, aged ≥18 years and of any sex, the first prescription of an OA (index) between January/2013 and June/2018, with a follow-up until June/2019. Data from the clinical history, patient characteristics, pharmacological variables, treatment switch, cerebrovascular events and safety were searched. Descriptive analyzes 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%, diabetes mellitus in 22.6% and severe renal failure in 5.2%. The mean CHA₂DS₂-VASc Score was 3.6±1.5. The main efficacy and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. From these, most events were in patients using warfarin at index (3.5% for stroke and 4.1% for gastrointestinal bleeding). The 18.0% of patients switched index OA during follow-up, while 11.7% discontinued the treatment.
Conclusion: The patients with NVAF in this study were mainly older adults with multiple comorbidities and high CHA₂DS₂-VASc score. The frequency of clinical events was similar to other observational studies, with low percentage of discontinuation.
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