Objective: To estimate the US incidence of thrombotic events and related rare diagnoses.
Design: Claims-based retrospective cohort study of incidence.
Setting: US commercial health insurance administrative claims database.
Participants: Adults 25-65 years of age between 2015 and 2019 with a minimum of 12 consecutive thrombosis-free months of continuous enrollment beginning 2014 were selected.
Main Outcomes: Age (10 year intervals) and sex stratum specific incidence rates per 100,000 person-years were determined for: venous thromboembolism (VTE), cerebral venous thrombosis (CVT), and any major thrombosis. Incidence also was estimated for immune thrombocytopenic purpura (ITP), hemolytic-uremic syndrome (HUS), and heparin-induced thrombocytopenia (HIT).
Results: Among approximately 15 million enrollees per year (half female/male), incidence of any thrombotic event (DVT, PE, CVT, or other thrombosis) was 247.89 per 100,000 person-years (95% CI: 245.96, 249.84). Incidence of VTE was 213.79 with ICD codes alone (95% CI: 211.99, 215.59) and 127.18 (95% CI: 125.80, 128.58) when also requiring a filled anticoagulation prescription. Incidence rates were 6.37 for CVT (95% CI: 6.07, 6.69), 26.06 for ITP (95% CI: 25.44, 26.78), 0.94 for HUS (95% CI: 0.82, 1.06), and 4.82 for HIT (95% CI: 4.56, 5.10). The co-occurrence of CVT with either ITP or HIT (diagnoses within 14 days of one another) was 0.090 (95% CI: 0.06, 0.13). Incidence tended to increase with age and was higher for women under 55. Incidence for CVT, HUS, and CVT with ITP or HIT was higher for women in all age groups.
Conclusions: These results are the first US estimates for incidence of thrombotic and rare events in a large, commercially-insured US population. Findings provide a critically important reference for determining excess morbidity associated with COVID-19 and more generally for vaccine pharmacovigilance.