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Published on: February 28, 2012
Thromboembolism after coronavirus disease 2019 vaccination in atrial fibrillation/flutter: a self-controlled case
You-Jung Choi1,2, Jaehyun Lim2, Sungho Bea3,4
1Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital and Korea University College of Medicine, Seoul, Republic of Korea.
Insights
COVID-19 vaccination is generally safe for patients with atrial fibrillation/flutter (AF/AFL), showing no increased risk of thrombo-embolic events. However, unvaccinated patients require careful assessment due to a higher risk post-vaccination.
Area of Science:
- Cardiology
- Vaccinology
- Public Health
Background:
- Concerns exist regarding COVID-19 vaccine safety in atrial fibrillation/flutter (AF/AFL) patients due to thrombo-embolic event reports.
- Evaluating vaccine-associated thrombo-embolic risk in AF/AFL populations is crucial.
Purpose of the Study:
- To assess the risk of thrombo-embolic events following COVID-19 vaccination in individuals with AF/AFL.
- To identify specific patient subgroups within the AF/AFL population who may face altered risks.
Main Methods:
- A modified self-controlled case-series study design was employed.
- Utilized a comprehensive South Korean nationwide-linked health database.
- Included individuals aged ≥12 years, analyzing thrombo-embolic events within 21 days post-vaccination.
Main Results:
- The overall incidence rate ratio (IRR) for thrombo-embolic events post-vaccination in AF/AFL patients was 0.93 (95% CI 0.77-1.12).
- No significant risk differences were observed based on sex, age, or vaccine type.
- Patients not on anticoagulant therapy showed a significantly higher IRR of 1.88 (95% CI 1.39-2.54).
Conclusions:
- COVID-19 vaccination does not appear to elevate the overall risk of thrombo-embolic events in patients with AF/AFL.
- Individual risk assessment is vital for AF/AFL patients not receiving oral anticoagulants.
- These patients require careful consideration due to a demonstrated increased risk of thrombo-embolic events post-vaccination.
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.
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.
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.
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.
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