Key result
DOACs match warfarin for thrombotic prevention but are linked to fewer bleeding and safety events.
Why the study?
The study aimed to analyze the clinical characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation treated with oral anticoagulants.
Do direct oral anticoagulants improve clinical outcomes, safety, and treatment persistence compared to warfarin in Colombian patients with non-valvular atrial fibrillation?
Cohort (n=2,076)
Yes
Do direct oral anticoagulants improve clinical outcomes, safety, and treatment persistence compared to warfarin in Colombian patients with non-valvular atrial fibrillation?
Hazard Ratio: 1.28 (95% CI 0.68–2.42)
p-value: p=0.447
Real-world evidence from Colombia demonstrates that DOACs offer a superior safety profile and better treatment persistence compared to warfarin, while maintaining comparable effectiveness for stroke prevention in non-valvular atrial fibrillation.
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 CHA 2 DS 2 -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.
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Machado‐Duque et al. (2023) conducted a cohort in Non-valvular atrial fibrillation (NVAF) (n=2,076). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Thrombotic events (ischemic stroke or systemic embolism) (HR 1.28 (warfarin vs DOACs), 95% CI 0.68-2.42, p=0.447). DOACs were as effective as warfarin in preventing thrombotic events (HR 1.28, p=0.447 for warfarin vs DOACs) but were associated with a significantly lower risk of bleeding and safety events.
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