한빛사논문
You-Jung Choi1,2†, Jaehyun Lim2†, Sungho Bea3,4, Jieun Lee1, Jah Yeon Choi1, Seung Young Rho1, Dae-In Lee1, Jin Oh Na1*‡, and Hyung-Kwan Kim2*‡
1Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital and Korea University College of Medicine, Seoul, Republic of Korea;
2Division of Cariology, Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea;
3School of Pharmacy, Sungkyunkwan University, Suwon, Republic of Korea; and
4Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA
*Corresponding authors: Jin Oh Na, Hyung-Kwan Kim
†These authors contributed equally to this work as co-first authors.
‡These authors contributed equally to this work as co-corresponding authors.
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.
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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