Article Impact Level: HIGH Data Quality: STRONG Summary of European Heart Journal, ehae335. https://doi.org/10.1093/eurheartj/ehae335 Dr. You-Jung Choi et al.
Points
- The study evaluated the risk of thrombo-embolic events after COVID-19 vaccination in patients with atrial fibrillation/flutter (AF/AFL), analyzing data from South Korea’s National Health Insurance Service.
- There was no overall increased risk of thrombo-embolic events within 21 days post-vaccination, with an incidence rate ratio (IRR) of 0.93 (95% CI, 0.77–1.12).
- Patients with AF/AFL not on anticoagulant therapy showed a significantly higher IRR of 1.88 (95% CI, 1.39–2.54) for thrombo-embolic events following vaccination.
- There were no significant variations in thrombo-embolic risk by sex, age, or vaccine type.
- While COVID-19 vaccination is generally safe for patients with AF/AFL, those not on oral anticoagulants may require careful risk assessment and management when considering vaccination.
Summary
This study evaluated the risk of thrombo-embolic events following COVID-19 vaccination in patients with atrial fibrillation/flutter (AF/AFL). Using a modified self-controlled case-series approach, the researchers analyzed a nationwide-linked database from the National Health Insurance Service in South Korea, which included individuals aged 12 years and older who were vaccinated or unvaccinated between February and December 2021. The primary outcome was a composite of thrombo-embolic events, including ischemic stroke, transient ischemic attack, and systemic thromboembolism. The risk period was defined as 0–21 days following vaccination.
The study included 124,127 individuals with AF/AFL. The incidence rate ratio (IRR) of thrombo-embolic events within 21 days after COVID-19 vaccination, compared to the unexposed control period, was 0.93 (95% confidence interval [CI], 0.77–1.12), indicating no overall increased risk. No significant risk variations were observed by sex, age, or vaccine type. However, a subgroup analysis revealed that patients not on anticoagulant therapy had a significantly higher IRR of 1.88 (95% CI, 1.39–2.54) for thromboembolic events following vaccination.
In conclusion, COVID-19 vaccination was generally not associated with an increased risk of thrombo-embolic events in patients with AF/AFL. However, the study highlights that individuals with AF/AFL who are not on oral anticoagulants may face an increased risk post-vaccination, suggesting the need for careful individual risk assessment and management in this group when advising on vaccination.
Link to the article: https://academic.oup.com/eurheartj/article/45/32/2983/7712558
References Choi, Y.-J., Lim, J., Bea, S., Lee, J., Choi, J. Y., Rho, S. Y., Lee, D.-I., Na, J. O., & Kim, H.-K. (2024). Thromboembolism after coronavirus disease 2019 vaccination in atrial fibrillation/flutter: A self-controlled case series study. European Heart Journal, ehae335. https://doi.org/10.1093/eurheartj/ehae335