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

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 redu...

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Main Authors: P.P. Olimpieri, A. Di Lenarda, F. Mammarella, L. Gozzo, A. Cirilli, M. Cuomo, M.M. Gulizia, F. Colivicchi, G. Murri, D. Gabrielli, F. Trotta
Format: Article
Language:English
Published: Elsevier 2020-02-01
Series:International Journal of Cardiology: Heart & Vasculature
Online Access:http://www.sciencedirect.com/science/article/pii/S2352906719302118
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spelling doaj-974bab5da1d24842a57d83fc0216350c2020-11-25T02:18:35ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672020-02-0126Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registriesP.P. Olimpieri0A. Di Lenarda1F. Mammarella2L. Gozzo3A. Cirilli4M. Cuomo5M.M. Gulizia6F. Colivicchi7G. Murri8D. Gabrielli9F. Trotta10Agenzia Italiana del Farmaco, Rome, ItalyCardiovascular Center, University Hospital and Health Services of Trieste, Italy; Corresponding authors.Agenzia Italiana del Farmaco, Rome, Italy; Corresponding authors.Agenzia Italiana del Farmaco, Rome, ItalyAgenzia Italiana del Farmaco, Rome, ItalyAgenzia Italiana del Farmaco, Rome, ItalyCardiology Division, High Specialization Hospital “Garibaldi” of Catania, ItalyCardiology Division San Filippo Neri Hospital, ASL ROMA 1, Rome, ItalyCardiology Division San Filippo Neri Hospital, ASL ROMA 1, Rome, ItalyCardiology Division, Hospital “Murri”, Fermo, ItalyAgenzia Italiana del Farmaco, Rome, ItalyBackground: 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: Monitoring registries, Real world data, NOACs, AF, Appropriatenesshttp://www.sciencedirect.com/science/article/pii/S2352906719302118
collection DOAJ
language English
format Article
sources DOAJ
author P.P. Olimpieri
A. Di Lenarda
F. Mammarella
L. Gozzo
A. Cirilli
M. Cuomo
M.M. Gulizia
F. Colivicchi
G. Murri
D. Gabrielli
F. Trotta
spellingShingle P.P. Olimpieri
A. Di Lenarda
F. Mammarella
L. Gozzo
A. Cirilli
M. Cuomo
M.M. Gulizia
F. Colivicchi
G. Murri
D. Gabrielli
F. Trotta
Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
International Journal of Cardiology: Heart & Vasculature
author_facet P.P. Olimpieri
A. Di Lenarda
F. Mammarella
L. Gozzo
A. Cirilli
M. Cuomo
M.M. Gulizia
F. Colivicchi
G. Murri
D. Gabrielli
F. Trotta
author_sort P.P. Olimpieri
title Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
title_short Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
title_full Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
title_fullStr Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
title_full_unstemmed Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries
title_sort non-vitamin k antagonist oral anticoagulation agents in patients with atrial fibrillation: insights from italian monitoring registries
publisher Elsevier
series International Journal of Cardiology: Heart & Vasculature
issn 2352-9067
publishDate 2020-02-01
description 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: Monitoring registries, Real world data, NOACs, AF, Appropriateness
url http://www.sciencedirect.com/science/article/pii/S2352906719302118
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