Características clínicas, patrones de uso e incidencia de eventos adversos en pacientes con fibrilación auricular no valvular tratados con anticoagulantes orales en Colombia

Objective: The objective was to analyze the characteristics, treatment patterns, and clinical results of Colombian patients with nonvalvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OA). Patients and Methods: Retrospective cohort of patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first OC prescription (index) between January/2013 and June/2018, and follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were sought. The International Classification of Diseases-10 codes were used to identify the sample of patients and the results. Patients were followed up to an overall composite outcome of effectiveness events (thrombotic events), bleeding/safety, or persistence (anticoagulant change/discontinuation). Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOAC) were performed. Results: A total of 2076 patients with NVAF were included. 57.0% of the patients were women and the mean age was 73.3 ± 10.4 years. The patients were followed for a mean of 2.3 ± 1.6 years. 8.7% received warfarin before the index date. The most common OC was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Arterial hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA2DS2-VASc score was 3.6 ± 1.5. 71.0% (n=326/459) of the patients with warfarin presented the overall composite outcome, and 24.6% of the DOACs (n=397/1617). The main efficacy and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%), respectively. There were no significant differences between warfarin and DOAC patients with respect to thrombotic events (HR: 1.28; 95% CI: 0.68–2.42), but warfarin was associated with greater 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: NVAF patients in this study were mainly older adults with multiple comorbidities. Compared with warfarin, DOACs were found to be equally effective, but safer and less likely to be discontinued or switch