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. 2020 Jan 23:26:100465.
doi: 10.1016/j.ijcha.2019.100465. eCollection 2020 Feb.

Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries

Affiliations

Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries

P P Olimpieri et al. Int J Cardiol Heart Vasc. .

Abstract

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with an increased risk of stroke and thromboembolism. Anticoagulation with Vitamin K antagonists (VKAs) or with novel oral anti-coagulants (NOACs) represents the cornerstone of the pharmacological treatment to reduce the risk of thromboembolism. This study aims to provide real-world data from a whole large European country about NOAC use in "non-valvular atrial fibrillation" (NVAF).

Methods: We analysed the Italian Medicines Agency (AIFA) monitoring registries collecting data of a nationwide cohort of patients with "NVAF" treated with NOACs. Using logistic regression analysis, baseline characteristics and treatment discontinuation information were compared among initiators of the 4 NOACs.

Results: In the reference period, the NOAC database collected data for 683,172 patients. The median age was 78 years with 19.5% aged 85 or older. Overall, the treatments were in accordance with guidelines. About 1/3 of patients switched from a prior VKA treatment; in the 72.3% of cases, these patients had a labile International Normalized Ratio (INR) at first prescription. The most prescribed NOAC was rivaroxaban, followed by apixaban, dabigatran and edoxaban.

Conclusions: This study is the largest European real-world study ever published on NOACs. It includes all Italian patients treated with NOACs since 2013 accounting for about 1/3 of subjects with AF. The enrolled population consisted of very elderly patients, at high risk of ischemic adverse events. The AIFA registries are consolidated tools that guarantee the appropriateness of prescription and provide important information for the governance of National Health System by collecting real-world data.

Keywords: AF; Appropriateness; Monitoring registries; NOACs; Real world data.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Odds ratios (ORs) and theirs 95% confidence intervals for NOAC choice according to the baseline characteristics resulting from the multivariate logistic regression models. The specific population of each drug has been compared with the remaining patients treated with the other NOACs. ORs and their 95% confidence intervals are colored in red, yellow, purple and turquoise respectively for apixaban, edoxaban, dabigatran and rivaroxaban.
Fig. 2
Fig. 2
Circle plot of the up to 24 months switch flow for a subset of the entire population. All patients treated with apixaban (red), dabigatran (purple) or rivaroxaban (turquoise) and with at least one switch in the reference period were included in the analysis.

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