Vincent Lo Re Iii, Noelle M Cocoros, Rebecca A Hubbard, Sarah K Dutcher, Craig W Newcomb, John G Connolly, Silvia Perez-Vilar, Dena M Carbonari, Maria E Kempner, José J Hernández-Muñoz, Andrew B Petrone, Allyson M Pishko, Meighan E Rogers Driscoll, James T Brash, Sean Burnett, Catherine Cohet, Matthew Dahl, Terese A DeFor, Antonella Delmestri, Djeneba Audrey Djibo, Talita Duarte-Salles, Laura B Harrington, Melissa Kampman, Jennifer L Kuntz, Xavier Kurz, Núria Mercadé-Besora, Pamala A Pawloski, Peter R Rijnbeek, Sarah Seager, Claudia A Steiner, Katia Verhamme, Fangyun Wu, Yunping Zhou, Edward Burn, J Michael Paterson, Daniel Prieto-Alhambra
{"title":"COVID-19 患者发生动脉和静脉血栓事件的风险：加拿大、欧洲和美国监管机构的跨国合作。","authors":"Vincent Lo Re Iii, Noelle M Cocoros, Rebecca A Hubbard, Sarah K Dutcher, Craig W Newcomb, John G Connolly, Silvia Perez-Vilar, Dena M Carbonari, Maria E Kempner, José J Hernández-Muñoz, Andrew B Petrone, Allyson M Pishko, Meighan E Rogers Driscoll, James T Brash, Sean Burnett, Catherine Cohet, Matthew Dahl, Terese A DeFor, Antonella Delmestri, Djeneba Audrey Djibo, Talita Duarte-Salles, Laura B Harrington, Melissa Kampman, Jennifer L Kuntz, Xavier Kurz, Núria Mercadé-Besora, Pamala A Pawloski, Peter R Rijnbeek, Sarah Seager, Claudia A Steiner, Katia Verhamme, Fangyun Wu, Yunping Zhou, Edward Burn, J Michael Paterson, Daniel Prieto-Alhambra","doi":"10.2147/CLEP.S448980","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"16 ","pages":"71-89"},"PeriodicalIF":3.4000,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10865892/pdf/","citationCount":"0","resultStr":"{\"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.\",\"authors\":\"Vincent Lo Re Iii, Noelle M Cocoros, Rebecca A Hubbard, Sarah K Dutcher, Craig W Newcomb, John G Connolly, Silvia Perez-Vilar, Dena M Carbonari, Maria E Kempner, José J Hernández-Muñoz, Andrew B Petrone, Allyson M Pishko, Meighan E Rogers Driscoll, James T Brash, Sean Burnett, Catherine Cohet, Matthew Dahl, Terese A DeFor, Antonella Delmestri, Djeneba Audrey Djibo, Talita Duarte-Salles, Laura B Harrington, Melissa Kampman, Jennifer L Kuntz, Xavier Kurz, Núria Mercadé-Besora, Pamala A Pawloski, Peter R Rijnbeek, Sarah Seager, Claudia A Steiner, Katia Verhamme, Fangyun Wu, Yunping Zhou, Edward Burn, J Michael Paterson, Daniel Prieto-Alhambra\",\"doi\":\"10.2147/CLEP.S448980\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":10362,\"journal\":{\"name\":\"Clinical Epidemiology\",\"volume\":\"16 \",\"pages\":\"71-89\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-02-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10865892/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Epidemiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/CLEP.S448980\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Epidemiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/CLEP.S448980","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
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.
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.
期刊介绍：
Clinical Epidemiology is an international, peer reviewed, open access journal. Clinical Epidemiology focuses on the application of epidemiological principles and questions relating to patients and clinical care in terms of prevention, diagnosis, prognosis, and treatment.
Clinical Epidemiology welcomes papers covering these topics in form of original research and systematic reviews.
Clinical Epidemiology has a special interest in international electronic medical patient records and other routine health care data, especially as applied to safety of medical interventions, clinical utility of diagnostic procedures, understanding short- and long-term clinical course of diseases, clinical epidemiological and biostatistical methods, and systematic reviews.
When considering submission of a paper utilizing publicly-available data, authors should ensure that such studies add significantly to the body of knowledge and that they use appropriate validated methods for identifying health outcomes.
The journal has launched special series describing existing data sources for clinical epidemiology, international health care systems and validation studies of algorithms based on databases and registries.
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