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. Lo Re Iii, V., Cocoros, N. M., Hubbard, R. A., Dutcher, S. K., Newcomb, C. W., Connolly, J. G., Perez-Vilar, S., Carbonari, D. M., Kempner, M. E., Hernández-Muñoz, J. J., Petrone, A. B., Pishko, A. M., Rogers Driscoll, M. E., Brash, J. T., Burnett, S., Cohet, C., Dahl, M., DeFor, T. A., Delmestri, A., Djibo, D. A., Duarte-Salles, T., Harrington, L. B., Kampman, M., Kuntz, J. L., Kurz, X., Mercadé-Besora, N., Pawloski, P. A., Rijnbeek, P. R., Seager, S., Steiner, C. A., Verhamme, K., Wu, F., Zhou, Y., Burn, E., Paterson, J. M., & Prieto-Alhambra, D. Clin Epidemiol, 16:71-89, 2024. 1179-1349 Lo Re Iii, Vincent Orcid: 0000-0001-7955-0600 Cocoros, Noelle M Orcid: 0000-0001-7090-2761 Hubbard, Rebecca A Orcid: 0000-0003-0879-0994 Dutcher, Sarah K Orcid: 0000-0003-0574-2890 Newcomb, Craig W Connolly, John G Orcid: 0000-0003-1916-557x Perez-Vilar, Silvia Orcid: 0000-0003-1272-1502 Carbonari, Dena M Orcid: 0000-0003-0310-270x Kempner, Maria E Hernández-Muñoz, José J Orcid: 0000-0002-2553-3159 Petrone, Andrew B Orcid: 0000-0001-8413-6236 Pishko, Allyson M Orcid: 0000-0001-9997-454x Rogers Driscoll, Meighan E Orcid: 0000-0003-1371-9658 Brash, James T Burnett, Sean Cohet, Catherine Orcid: 0000-0002-0022-7251 Dahl, Matthew DeFor, Terese A Delmestri, Antonella Orcid: 0000-0003-0388-3403 Djibo, Djeneba Audrey Orcid: 0000-0003-3378-0691 Duarte-Salles, Talita Orcid: 0000-0002-8274-0357 Harrington, Laura B Orcid: 0000-0001-5951-8291 Kampman, Melissa Kuntz, Jennifer L Orcid: 0000-0002-0017-6853 Kurz, Xavier Orcid: 0000-0002-9838-7754 Mercadé-Besora, Núria Orcid: 0009-0006-7948-3747 Pawloski, Pamala A Orcid: 0000-0002-1005-5764 Rijnbeek, Peter R Orcid: 0000-0003-0621-1979 Seager, Sarah Steiner, Claudia A Verhamme, Katia Orcid: 0000-0001-8162-4904 Wu, Fangyun Zhou, Yunping Burn, Edward Orcid: 0000-0002-9286-1128 Paterson, J Michael Orcid: 0000-0001-5995-1714 Prieto-Alhambra, Daniel Orcid: 0000-0002-3950-6346 Journal Article New Zealand 2024/02/15 Clin Epidemiol. 2024 Feb 10;16:71-89. doi: 10.2147/CLEP.S448980. eCollection 2024.
doi  abstract   bibtex   
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.
@article{RN356,
   author = {Lo Re Iii, V. and Cocoros, N. M. and Hubbard, R. A. and Dutcher, S. K. and Newcomb, C. W. and Connolly, J. G. and Perez-Vilar, S. and Carbonari, D. M. and Kempner, M. E. and Hernández-Muñoz, J. J. and Petrone, A. B. and Pishko, A. M. and Rogers Driscoll, M. E. and Brash, J. T. and Burnett, S. and Cohet, C. and Dahl, M. and DeFor, T. A. and Delmestri, A. and Djibo, D. A. and Duarte-Salles, T. and Harrington, L. B. and Kampman, M. and Kuntz, J. L. and Kurz, X. and Mercadé-Besora, N. and Pawloski, P. A. and Rijnbeek, P. R. and Seager, S. and Steiner, C. A. and Verhamme, K. and Wu, F. and Zhou, Y. and Burn, E. and Paterson, J. M. and Prieto-Alhambra, D.},
   title = {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},
   journal = {Clin Epidemiol},
   volume = {16},
   pages = {71-89},
   note = {1179-1349 Lo Re Iii, Vincent Orcid: 0000-0001-7955-0600 Cocoros, Noelle M Orcid: 0000-0001-7090-2761 Hubbard, Rebecca A Orcid: 0000-0003-0879-0994 Dutcher, Sarah K Orcid: 0000-0003-0574-2890 Newcomb, Craig W Connolly, John G Orcid: 0000-0003-1916-557x Perez-Vilar, Silvia Orcid: 0000-0003-1272-1502 Carbonari, Dena M Orcid: 0000-0003-0310-270x Kempner, Maria E Hernández-Muñoz, José J Orcid: 0000-0002-2553-3159 Petrone, Andrew B Orcid: 0000-0001-8413-6236 Pishko, Allyson M Orcid: 0000-0001-9997-454x Rogers Driscoll, Meighan E Orcid: 0000-0003-1371-9658 Brash, James T Burnett, Sean Cohet, Catherine Orcid: 0000-0002-0022-7251 Dahl, Matthew DeFor, Terese A Delmestri, Antonella Orcid: 0000-0003-0388-3403 Djibo, Djeneba Audrey Orcid: 0000-0003-3378-0691 Duarte-Salles, Talita Orcid: 0000-0002-8274-0357 Harrington, Laura B Orcid: 0000-0001-5951-8291 Kampman, Melissa Kuntz, Jennifer L Orcid: 0000-0002-0017-6853 Kurz, Xavier Orcid: 0000-0002-9838-7754 Mercadé-Besora, Núria Orcid: 0009-0006-7948-3747 Pawloski, Pamala A Orcid: 0000-0002-1005-5764 Rijnbeek, Peter R Orcid: 0000-0003-0621-1979 Seager, Sarah Steiner, Claudia A Verhamme, Katia Orcid: 0000-0001-8162-4904 Wu, Fangyun Zhou, Yunping Burn, Edward Orcid: 0000-0002-9286-1128 Paterson, J Michael Orcid: 0000-0001-5995-1714 Prieto-Alhambra, Daniel Orcid: 0000-0002-3950-6346 Journal Article New Zealand 2024/02/15 Clin Epidemiol. 2024 Feb 10;16:71-89. doi: 10.2147/CLEP.S448980. eCollection 2024.},
   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.},
   keywords = {Covid-19
ischemic stroke
myocardial infarction
thromboembolism
venous thromboembolism},
   ISSN = {1179-1349 (Print) 1179-1349},
   DOI = {10.2147/clep.S448980},
   year = {2024},
   type = {Journal Article}
}

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