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Clinical Epidemiology Volume 16, 2024 - Issue
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ORIGINAL RESEARCH

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

Vincent Lo Re III1 Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;2 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-7955-0600View further author information
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Noelle M Cocoros3 Department of Population Medicine, Harvard Medical School, Boston, MA, USA;4 Harvard Pilgrim Healthcare Institute, Boston, MA, USAORCID Iconhttps://orcid.org/0000-0001-7090-2761View further author information
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Rebecca A Hubbard2 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USAORCID Iconhttps://orcid.org/0000-0003-0879-0994View further author information
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Sarah K Dutcher5 Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USAORCID Iconhttps://orcid.org/0000-0003-0574-2890View further author information
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Craig W Newcomb2 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USAView further author information
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John G Connolly3 Department of Population Medicine, Harvard Medical School, Boston, MA, USA;4 Harvard Pilgrim Healthcare Institute, Boston, MA, USAORCID Iconhttps://orcid.org/0000-0003-1916-557XView further author information
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Silvia Perez-Vilar5 Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USAORCID Iconhttps://orcid.org/0000-0003-1272-1502View further author information
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Dena M Carbonari2 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USAORCID Iconhttps://orcid.org/0000-0003-0310-270XView further author information
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Maria E Kempner3 Department of Population Medicine, Harvard Medical School, Boston, MA, USA;4 Harvard Pilgrim Healthcare Institute, Boston, MA, USAView further author information
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José J Hernández-Muñoz5 Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USAORCID Iconhttps://orcid.org/0000-0002-2553-3159View further author information
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Andrew B Petrone3 Department of Population Medicine, Harvard Medical School, Boston, MA, USA;4 Harvard Pilgrim Healthcare Institute, Boston, MA, USAORCID Iconhttps://orcid.org/0000-0001-8413-6236View further author information
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Allyson M Pishko6 Division of Hematology and Oncology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USAORCID Iconhttps://orcid.org/0000-0001-9997-454XView further author information
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Meighan E Rogers Driscoll3 Department of Population Medicine, Harvard Medical School, Boston, MA, USA;4 Harvard Pilgrim Healthcare Institute, Boston, MA, USAORCID Iconhttps://orcid.org/0000-0003-1371-9658View further author information
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James T Brash7 IQVIA, Real World Solutions, Brighton, UKView further author information
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Sean Burnett8 Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada;9 Therapeutics Initiative, University of British Columbia, Vancouver, British Columbia, CanadaView further author information
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Catherine Cohet10 Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0002-0022-7251View further author information
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Matthew Dahl8 Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada;11 Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, CanadaView further author information
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Terese A DeFor12 HealthPartners Institute, Bloomington, MN, USAView further author information
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Antonella Delmestri13 Pharmaco- and Device Epidemiology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UKORCID Iconhttps://orcid.org/0000-0003-0388-3403View further author information
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Djeneba Audrey Djibo14 CVS Health, Blue Bell, PA, USAORCID Iconhttps://orcid.org/0000-0003-3378-0691View further author information
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Talita Duarte-Salles15 Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;16 Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0002-8274-0357View further author information
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Laura B Harrington17 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USAORCID Iconhttps://orcid.org/0000-0001-5951-8291View further author information
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Melissa Kampman18 Health Canada, Ottawa, Ontario, CanadaView further author information
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Jennifer L Kuntz19 Kaiser Permanente Northwest Center for Health Research, Portland, OR, USAORCID Iconhttps://orcid.org/0000-0002-0017-6853View further author information
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Xavier Kurz10 Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0002-9838-7754View further author information
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Núria Mercadé-Besora15 Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, SpainORCID Iconhttps://orcid.org/0009-0006-7948-3747View further author information
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Pamala A Pawloski12 HealthPartners Institute, Bloomington, MN, USAORCID Iconhttps://orcid.org/0000-0002-1005-5764View further author information
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Peter R Rijnbeek16 Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0003-0621-1979View further author information
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Sarah Seager7 IQVIA, Real World Solutions, Brighton, UKView further author information
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Claudia A Steiner20 Kaiser Permanente Colorado Institute for Health Research, Aurora, CO, USA;21 Colorado Permanente Medical Group, Denver, CO, USAView further author information
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Katia Verhamme16 Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0001-8162-4904View further author information
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Fangyun Wu8 Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada;22 ICES, Toronto, Ontario, CanadaView further author information
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Yunping Zhou23 Humana Healthcare Research, Inc., Louisville, KY, USAView further author information
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Edward Burn13 Pharmaco- and Device Epidemiology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UKORCID Iconhttps://orcid.org/0000-0002-9286-1128View further author information
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J Michael Paterson8 Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada;22 ICES, Toronto, Ontario, CanadaORCID Iconhttps://orcid.org/0000-0001-5995-1714View further author information
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Daniel Prieto-Alhambra13 Pharmaco- and Device Epidemiology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK;16 Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, NetherlandsORCID Iconhttps://orcid.org/0000-0002-3950-6346View further author information
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Pages 71-89 | Received 09 Nov 2023, Accepted 23 Jan 2024, Published online: 10 Feb 2024

Figures & data

Table 1 Overview of Data Sources Used for This Study

Table 2 Characteristics of Patients Initially Diagnosed with COVID-19 in the Ambulatory (ie, Outpatient, Emergency Department, or Institutional) Setting Prior to and During COVID-19 Vaccine Availability, by Country

Table 3 90-Day Absolute Risk of Arterial and Venous Thromboembolism Events Among Ambulatory-Diagnosed Patients with COVID-19 Prior to and During COVID-19 Vaccine Availability, by Country

Figure 1 Country-level estimates (95% confidence intervals) of 90-day absolute risk of arterial (red) and venous (blue) thromboembolism events among patients initially diagnosed with COVID-19 in the ambulatory (ie, outpatient, emergency department, or institutional) setting, by month of diagnosis across the pre- and post-vaccine availability periods.

Figure 1 Country-level estimates (95% confidence intervals) of 90-day absolute risk of arterial (red) and venous (blue) thromboembolism events among patients initially diagnosed with COVID-19 in the ambulatory (ie, outpatient, emergency department, or institutional) setting, by month of diagnosis across the pre- and post-vaccine availability periods.

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