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Risk of arterial and venous thrombotic events among patients with COVID-19: a multi-national collaboration of regulatory agencies from Canada, Europe, and United States

Abstract:
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability.
Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE.
Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09– 0.13%) in Canada to 1.01% (0.97– 1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21– 0.26%) in Canada to 0.84% (0.80– 0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06– 0.07%) in England to 1.04% (1.01– 1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24– 0.26%) in England to 1.02% (0.99– 1.04%) in the US.
Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.2147/clep.s448980

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Role:
Author
ORCID:
0000-0001-7955-0600
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Role:
Author
ORCID:
0000-0001-7090-2761
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Role:
Author
ORCID:
0000-0003-0879-0994
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Author
ORCID:
0000-0003-0574-2890


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Funder identifier:
https://ror.org/01gavpb45


Publisher:
Taylor & Francis
Journal:
Clinical Epidemiology More from this journal
Volume:
16
Pages:
71-89
Place of publication:
New Zealand
Publication date:
2024-02-10
Acceptance date:
2024-01-23
DOI:
EISSN:
1179-1349
Pmid:
38357585


Language:
English
Keywords:
Pubs id:
1624851
Local pid:
pubs:1624851
Deposit date:
2025-07-14
ARK identifier:

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