Non-vitamin K antagonist oral anticoagulation agents in patients with atrial fibrillation: Insights from Italian monitoring registries.
AF
Appropriateness
Monitoring registries
NOACs
Real world data
Journal
International journal of cardiology. Heart & vasculature
ISSN: 2352-9067
Titre abrégé: Int J Cardiol Heart Vasc
Pays: Ireland
ID NLM: 101649525
Informations de publication
Date de publication:
Feb 2020
Feb 2020
Historique:
received:
17
09
2019
revised:
12
12
2019
accepted:
25
12
2019
entrez:
6
2
2020
pubmed:
6
2
2020
medline:
6
2
2020
Statut:
epublish
Résumé
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). 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 32021902
doi: 10.1016/j.ijcha.2019.100465
pii: S2352-9067(19)30211-8
pii: 100465
pmc: PMC6994529
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100465Informations de copyright
© 2019 Published by Elsevier B.V.
Déclaration de conflit d'intérêts
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.
Références
Europace. 2016 Aug;18(8):1150-7
pubmed: 26830891
Eur Heart J Cardiovasc Pharmacother. 2017 Jul 1;3(3):151-156
pubmed: 28158553
J Am Coll Cardiol. 2017 Sep 26;70(13):1573-1583
pubmed: 28935034
Europace. 2015 Feb;17(2):187-93
pubmed: 25236181
Am J Cardiovasc Drugs. 2016 Oct;16(5):349-63
pubmed: 27262433
Europace. 2013 Apr;15(4):486-93
pubmed: 23220354
Europace. 2018 Jun 1;20(6):e78-e86
pubmed: 28666358
Europace. 2016 May;18(5):788
pubmed: 26843573
Europace. 2015 Apr;17(4):530-8
pubmed: 25694537
Europace. 2018 May 1;20(5):747-757
pubmed: 29016832
N Engl J Med. 2015 Aug 6;373(6):511-20
pubmed: 26095746
Europace. 2019 Feb 1;21(2):230-238
pubmed: 30060174
Pharmacotherapy. 2017 Oct;37(10):1221-1230
pubmed: 28730619
Europace. 2017 Jul 1;19(7):1091-1095
pubmed: 28641379
Curr Med Res Opin. 2017 Jul;33(7):1337-1341
pubmed: 28425296
Int J Cardiol. 2017 Jun 1;236:363-369
pubmed: 28131705
Eur Heart J. 2013 Sep;34(35):2746-51
pubmed: 23900699
Adv Ther. 2019 Jan;36(1):162-174
pubmed: 30499067
Eur Heart J. 2016 Oct 7;37(38):2893-2962
pubmed: 27567408
Am J Cardiol. 2013 Mar 1;111(5):705-11
pubmed: 23273528
J Am Heart Assoc. 2018 Mar 10;7(6):
pubmed: 29525778
Bioinformatics. 2014 Oct;30(19):2811-2
pubmed: 24930139
Lancet. 2015 Jul 11;386(9989):154-62
pubmed: 25960110
Eur Heart J. 2017 Mar 21;38(12):907-915
pubmed: 27742807
Circ J. 2013;77(6):1380-8
pubmed: 23657131
Circulation. 2014 Feb 25;129(8):837-47
pubmed: 24345399
Br J Clin Pharmacol. 2019 Nov;85(11):2524-2539
pubmed: 31318059
Europace. 2018 Aug 1;20(8):1382-1387
pubmed: 29893840
J Am Heart Assoc. 2017 Feb 14;6(2):
pubmed: 28196815
Thromb Haemost. 2016 Jan;115(1):31-9
pubmed: 26246112
Eur Heart J. 2015 Dec 7;36(46):3238-49
pubmed: 26163482
Sci Rep. 2016 Aug 11;6:31477
pubmed: 27510920
BMJ. 2016 Jun 16;353:i3189
pubmed: 27312796
PLoS One. 2018 Nov 1;13(11):e0205989
pubmed: 30383768