The first dose of COVID-19 vaccine was associated with an elevated risk of thrombosis with thrombocytopenia syndrome (IRR 5.2; 95% CI 1.9-13.4), particularly in females and those aged 39-59 years.
Observational (n=15,210,992)
Does COVID-19 vaccination increase the risk of acute cardiovascular events in the general population?
COVID-19 vaccination is associated with a transiently increased risk of TTS after the first dose (particularly in females and individuals aged 39-59) and MI after the second dose, but not with arrhythmia, CAD, or VTE.
Effect estimate: IRR 5.2 (95% CI 1.9-13.4)
Abstract Background COVID-19 itself and vaccinations have been associated with cardiovascular events, including amongst others arrhythmia, myocarditis, myocardial infarction (MI), stroke, thrombosis with thrombocytopenia syndrome (TTS), and venous thromboembolism (VTE). However, risk estimates vary significantly across studies due to differences in analysis across age and gender groups, which for some of them are effect modifiers. Purpose The primary objective of this study was to assess the association between COVID-19 vaccination and acute cardiovascular events . The secondary objective focused on whether the vaccine doses, platforms (adenovirus vs mRNA), or demographic factors (age and gender) modified the effect. This study used data from the Covid Vaccine Monitoring study. Methods We used a self-controlled risk interval (SCRI) design on data from the United Kingdom Clinical Practice Research Datalink (CPRD). Vaccinated individuals were included if they had experienced any of the events during the 60-day control or 28-day risk period after each COVID-19 vaccination dose, and had at least 12 months of data in the data source at start of the control window that was prior to risk window. The primary outcome was the first diagnosis of acute cardiovascular events, including arrhythmia, coronary artery disease (CAD), thrombosis with thrombocytopenia syndrome (TTS), myocardial infarction (MI), and venous thromboembolism (VTE). Exposures included the first, second, third, and fourth doses of COVID-19 vaccines. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated using conditional Poisson regression, comparing a 28-day post-vaccination risk window with a 90-day pre-vaccination control period. Subgroup analyses were conducted based on age, gender, dose and vaccine dose with adjustments for calendar time. COVID-19 infection was included as a time-varying covariate to adjust for its potential confounding effect. Results The study included 15,210,992 individuals (49.5% women, mean age: 40.3 ± 26.67 years), of whom 81.7% received at least one vaccine dose. TTS risk was significantly elevated after the first dose of COVID-19 vaccine (IRR = 5.2, 95% CI: 1.9–13.4), with the highest risk observed in females (IRR = 8.7, 95% CI: 1.2–61.8) compare to male (IRR= 5.4, 95% CI: 1.7–17.3) and those aged 39–59 years (IRR = 17.4, 95% CI: 1.5–192.2). MI risk increased after the second dose of the COVID-19 vaccine (IRR = 1.4, 95% CI: 1.0–2.1), particularly in individuals aged 29–39 years (IRR = 7.0, 95% CI: 1.1–46.1). No associations were observed for other events (arrhythmia, CAD, VTE). Conclusion The findings suggest that COVID-19 vaccine is associated with an increased risk of TTS in specific subgroups, particularly females and individuals aged 39–59 years. The SCRI design effectively minimized confounding, enhancing the reliability of these results.
Tarazjani et al. (Sat,) conducted a observational in Acute cardiovascular events (n=15,210,992). COVID-19 vaccines vs. 90-day pre-vaccination control period was evaluated on First diagnosis of acute cardiovascular events (arrhythmia, CAD, TTS, MI, VTE) (IRR 5.2, 95% CI 1.9-13.4). The first dose of COVID-19 vaccine was associated with an elevated risk of thrombosis with thrombocytopenia syndrome (IRR 5.2; 95% CI 1.9-13.4), particularly in females and those aged 39-59 years.