Incidence of venous thrombotic events and events of special interest in a retrospective cohort of commercially insured US patients

Author:

Weller Susan CORCID,Porterfield LauraORCID,Davis JohnORCID,Wilkinson Gregg SORCID,Chen LuORCID,Baillargeon JacquesORCID

Abstract

ObjectiveTo estimate the US incidence of thrombotic events and related rare diagnoses.DesignClaims-based retrospective cohort study of incidence.SettingUS commercial health insurance administrative claims database.ParticipantsAdults 25–64 years of age between 2015 and 2019 with a minimum of 12 consecutive thrombosis-free months of continuous enrolment beginning 2014 were selected.Main outcomesAge (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 other major venous thrombotic events, and events of special interest, including immune thrombocytopenic purpura (ITP), haemolytic-uremic syndrome (HUS) and heparin-induced thrombocytopenia (HIT).ResultsOf 13 249 229 enrollees (half female/male), incidence of venous thromboembolic events (deep vein thrombosis (DVT), pulmonary embolism (PE), CVT or other major venous thrombotic conditions) was 247.89 per 100 000 person-years (95% CI: 245.96 to 249.84). Incidence of VTE was 213.79 with ICD codes alone (95% CI: 211.99 to 215.59) and 129.34 (95% CI: 127.95 to 130.75) when also requiring a filled anticoagulation prescription or an inferior vena cava (IVC) filter. Incidence was 6.37 for CVT (95% CI: 6.07 to 6.69), 26.06 for ITP (95% CI: 25.44 to 26.78), 0.94 for HUS (95% CI: 0.82 to 1.06) and 4.82 for HIT (95% CI: 4.56 to 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 to 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. Incidence of PE and CVT increased significantly over the 5-year period, while DVT rates decreased.ConclusionsThese results are the first US estimates for the incidence of thrombotic and rare events of interest 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.

Funder

Sealy Center For Vaccine Sciences

Texas Academy of Family Physicians

Publisher

BMJ

Subject

General Medicine

Reference27 articles.

1. EMA Press Office . AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low platelets, 2021. Eur. Med. Agency. Available: https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood [Accessed 12 Apr 2021].

2. Steenhuysen J, Pushkala A . J&J COVID-19 vaccine under EU review over blood clots., 2021. Reuters. Available: https://www.reuters.com/article/us-health-coronavirus-europe-vaccines-idUSKBN2BW2FI [Accessed 12 Apr 2021].

3. US case reports of cerebral venous sinus thrombosis with thrombocytopenia after Ad26.COV2.S vaccination, March 2 to April 21, 2021;See;JAMA,2021

4. Current incidence of venous thromboembolism and comparison with 1998: a community-based study in Western France

5. Thromboembolism and the Oxford-AstraZeneca COVID-19 vaccine: side-effect or coincidence?;Østergaard;Lancet,2021

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