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COVID-19 & Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE)

    Basic Details
    Status
    Complete
    Last Updated
    Thursday, June 20, 2024
    Original Posting Date
    Health Outcome(s)
    arterial thromboembolism (ATE)
    venous thromboembolism (VTE)
    Purpose
    Methods, Characterization, or Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Study Summary

    Evidence suggested that COVID-19 infection may induce a hypercoagulable state resulting in arterial thromboembolism (ATE) or venous thromboembolism (VTE). However, studies examining thrombotic complications from COVID-19 to date had included small samples, rarely included a comparator group, and had not evaluated characteristics associated with these outcomes. FDA initiated this study in the Sentinel System to determine the 90-day incidence of hospitalized ATE and VTE in patients with COVID-19 and subsequent 30-day mortality, identify risk factors for ATE and VTE events, and compare the incidence of ATE and VTE among patients with COVID-19 vs. patients with influenza. Patients were evaluated separately based on the setting (outpatient vs. inpatient) and timing (before vs. during COVID-19 vaccination availability) of their COVID-19 diagnosis. 

    Among patients hospitalized with COVID-19, the 90-day absolute risks of ATE and VTE were 15.8%-16.3% and 9.5%-10.9%, respectively (range represents periods before and during vaccine availability). Compared with patients with influenza, the risk of ATE was not significantly higher among patients with COVID-19 either before or during vaccine availability; however, risk of VTE was significantly higher among patients with COVID-19 before (HR 1.60; 95% CI: 1.43-1.79) and during vaccine availability (HR 1.89; 95% CI: 1.68-2.12). Among those with an ATE or VTE event, 30-day mortality was significantly higher in patients with inpatient-diagnosed COVID-19 versus influenza both before vaccine availability [(ATE: HR 3.45; 95% CI: 2.68-4.45) (VTE: HR 2.96; 95% CI: 1.84-4.76)] and during vaccine availability [(ATE: HR 3.45; 95% CI: 2.69-4.44) (VTE: HR 3.80; 95% CI: 2.41-6.00)].

    Among patients with ambulatory-diagnosed COVID-19, the 90-day absolute risks of hospitalized ATE and VTE were 1.01%-1.06% and 0.73%-0.88%, respectively. Compared with patients with influenza, the risk of ATE was higher among patients with COVID-19 both before (HR 1.53; 95% CI: 1.38-1.69) and during vaccine availability (HR 1.69; 95% CI: 1.53-1.86). Risk of VTE also was higher among patients with COVID-19 before (HR 2.86; 95% CI: 2.46-3.32) and during vaccine availability (HR 3.56; 95% CI: 3.08-4.12). Among those with an ATE or VTE event, 30-day mortality was significantly higher in patients with ambulatory-diagnosed COVID-19 versus influenza both before vaccine availability [(ATE: HR 2.65; 95% CI: 1.88-3.73) (VTE: HR 2.36; 95% CI: 1.34-4.18)] and during vaccine availability [(ATE: HR 2.53; 95% CI: 1.82-3.51) (VTE: HR 2.58; 95% CI: 1.48-4.50)]. The results from this study informed FDA’s public health response during the COVID-19 pandemic.