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Thromboembolism after coronavirus disease 2019 vaccination in atrial fibrillation/flutter: a self-controlled case series study.
- Source :
-
European heart journal [Eur Heart J] 2024 Aug 21; Vol. 45 (32), pp. 2983-2991. - Publication Year :
- 2024
-
Abstract
- Background and Aims: Concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines in patients with atrial fibrillation/flutter (AF/AFL) have arisen due to reports of thrombo-embolic events following COVID-19 vaccination in the general population. This study aimed to evaluate the risk of thrombo-embolic events after COVID-19 vaccination in patients with AF/AFL.<br />Methods: This was a modified self-controlled case-series study using a comprehensive nationwide-linked database provided by the National Health Insurance Service in South Korea to calculate incidence rate ratios (IRRs) of thrombo-embolic events. The study population included individuals aged ≥12 years who were either vaccinated (e.g. one or two doses) or unvaccinated during the period from February to December 2021. The primary outcome was a composite of thrombo-embolic events, including ischaemic stroke, transient ischaemic attack, and systemic thromboembolism. The risk period was defined as 0-21 days following COVID-19 vaccination.<br />Results: The final analysis included 124 127 individuals with AF/AFL. The IRR of thrombo-embolic events within 21 days after COVID-19 vaccination, compared with that during the unexposed control period, was 0.93 [95% confidence interval (CI) 0.77-1.12]. No significant risk variations were noted by sex, age, or vaccine type. However, patients without anticoagulant therapy had an IRR of 1.88 (95% CI 1.39-2.54) following vaccination.<br />Conclusions: In patients with AF/AFL, COVID-19 vaccination was generally not associated with an increased risk of thrombo-embolic events. However, careful individual risk assessment is required when advising vaccination for those not on oral anticoagulant, as these patients exhibited an increased risk of thrombo-embolic events post-vaccination.<br /> (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Young Adult
Atrial Flutter epidemiology
Incidence
Republic of Korea epidemiology
Vaccination adverse effects
Atrial Fibrillation epidemiology
COVID-19 prevention & control
COVID-19 epidemiology
COVID-19 complications
COVID-19 Vaccines adverse effects
Thromboembolism prevention & control
Thromboembolism epidemiology
Thromboembolism etiology
Subjects
Details
- Language :
- English
- ISSN :
- 1522-9645
- Volume :
- 45
- Issue :
- 32
- Database :
- MEDLINE
- Journal :
- European heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 38993069
- Full Text :
- https://doi.org/10.1093/eurheartj/ehae335