2019冠状病毒病患者发生动脉和静脉血栓形成事件的风险：加拿大、欧洲和美国监管机构的多国合作
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.
作者信息
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
机构信息
Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
出版信息
Clin Epidemiol. 2024 Feb 10;16:71-89. doi: 10.2147/CLEP.S448980. eCollection 2024.
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.
目的
很少有研究考察不同国家中新冠病毒病（COVID-19）相关血栓栓塞的绝对风险随时间如何变化。欧洲药品管理局、加拿大卫生部和美国食品药品监督管理局的研究人员开展合作，以评估北美（加拿大、美国）和欧洲（英格兰、德国、意大利、荷兰和西班牙）七个国家在COVID-19疫苗可用之前及期间，门诊（如门诊、急诊科、护理机构）环境中COVID-19确诊后90天内动脉血栓栓塞（ATE）和静脉血栓栓塞（VTE）的绝对风险。
患者与方法
我们对来自七个指定国家门诊环境中最初被诊断为COVID-19的患者进行了队列研究。COVID-19确诊后对患者随访90天。主要结局为自诊断日期起90天内的ATE和VTE。我们测量了ATE和VTE的90天绝对风险的国家层面估计值（及其95%置信区间）。
结果
这七个队列包括在COVID-19疫苗可用之前（截至2020年11月）门诊环境中最初被诊断为COVID-19的1,061,565例患者。在此期间，ATE的90天绝对风险在加拿大为0.11%（0.09 - 0.13%），在美国为1.01%（0.97 - 1.05%）；VTE的90天绝对风险在加拿大为0.23%（0.21 - 0.26%），在英格兰为0.84%（(0.80 - 0.89%）。这七个队列包括在疫苗可用期间（2020年12月起）的3,544,062例COVID-19患者。在此期间，ATE的90天绝对风险在英格兰为0.06%（0.06 - 0.07%），在美国为1.04%（1.01 - 1.06%）；VTE的90天绝对风险在英格兰为0.25%（0.24 - 0.26%），在美国为1.02%（0.99 - 1.04%）。
结论
在COVID-19疫苗可用之前及期间，门诊COVID-19诊断后90天内ATE和VTE的绝对风险在不同国家存在异质性。
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