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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.
Lo Re Iii, Vincent; Cocoros, Noelle M; Hubbard, Rebecca A; Dutcher, Sarah K; Newcomb, Craig W; Connolly, John G; Perez-Vilar, Silvia; Carbonari, Dena M; Kempner, Maria E; Hernández-Muñoz, José J; Petrone, Andrew B; Pishko, Allyson M; Rogers Driscoll, Meighan E; Brash, James T; Burnett, Sean; Cohet, Catherine; Dahl, Matthew; DeFor, Terese A; Delmestri, Antonella; Djibo, Djeneba Audrey; Duarte-Salles, Talita; Harrington, Laura B; Kampman, Melissa; Kuntz, Jennifer L; Kurz, Xavier; Mercadé-Besora, Núria; Pawloski, Pamala A; Rijnbeek, Peter R; Seager, Sarah; Steiner, Claudia A; Verhamme, Katia; Wu, Fangyun; Zhou, Yunping; Burn, Edward; Paterson, J Michael; Prieto-Alhambra, Daniel.
Affiliation
  • Lo Re Iii V; Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Cocoros NM; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Hubbard RA; Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
  • Dutcher SK; Harvard Pilgrim Healthcare Institute, Boston, MA, USA.
  • Newcomb CW; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Connolly JG; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Perez-Vilar S; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Carbonari DM; Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
  • Kempner ME; Harvard Pilgrim Healthcare Institute, Boston, MA, USA.
  • Hernández-Muñoz JJ; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Petrone AB; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Pishko AM; Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
  • Rogers Driscoll ME; Harvard Pilgrim Healthcare Institute, Boston, MA, USA.
  • Brash JT; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Burnett S; Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
  • Cohet C; Harvard Pilgrim Healthcare Institute, Boston, MA, USA.
  • Dahl M; Division of Hematology and Oncology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • DeFor TA; Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
  • Delmestri A; Harvard Pilgrim Healthcare Institute, Boston, MA, USA.
  • Djibo DA; IQVIA, Real World Solutions, Brighton, UK.
  • Duarte-Salles T; Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada.
  • Harrington LB; Therapeutics Initiative, University of British Columbia, Vancouver, British Columbia, Canada.
  • Kampman M; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
  • Kuntz JL; Canadian Network for Observational Drug Effect Studies (CNODES), Toronto, Ontario, Canada.
  • Kurz X; Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.
  • Mercadé-Besora N; HealthPartners Institute, Bloomington, MN, USA.
  • Pawloski PA; Pharmaco- and Device Epidemiology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
  • Rijnbeek PR; CVS Health, Blue Bell, PA, USA.
  • Seager S; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
  • Steiner CA; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
  • Verhamme K; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
  • Wu F; Health Canada, Ottawa, Ontario, Canada.
  • Zhou Y; Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA.
  • Burn E; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
  • Paterson JM; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
  • Prieto-Alhambra D; HealthPartners Institute, Bloomington, MN, USA.
Clin Epidemiol ; 16: 71-89, 2024.
Article in En | MEDLINE | ID: mdl-38357585
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Etiology_studies / Observational_studies / Risk_factors_studies Language: En Journal: Clin Epidemiol Year: 2024 Document type: Article Affiliation country: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Etiology_studies / Observational_studies / Risk_factors_studies Language: En Journal: Clin Epidemiol Year: 2024 Document type: Article Affiliation country: United States