Division of Vascular Medicine, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, USA.
Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
J Thromb Haemost. 2022 Jul;20(7):1638-1644. doi: 10.1111/jth.15725. Epub 2022 Apr 20.
COVID-19 vaccinations in the United States are effective in preventing illness and hospitalization yet concern over post-vaccination venous thromboembolism (VTE) risk has led to vaccine hesitancy.
The aim of this study was to compare VTE rates before and after COVID-19 vaccination. COVID-19 vaccinated patients ≥18 years between November 1, 2020 through November 1, 2021 were analyzed using electronic medical records across the Mayo Clinic enterprise. The primary outcome was imaging confirmed acute VTE (upper or lower deep vein thrombosis or pulmonary embolism) occurring 90 days before and after the date of first vaccine dose.
A total of 792 010 patients with at least one COVID-19 vaccination were identified (Pfizer, n = 452 950, Moderna, n = 290 607, and Janssen [Johnson & Johnson], n = 48 453). A total of 1565 VTE events occurred in the 90 days before (n = 772) and after (n = 793) COVID-19 vaccination. VTE post-vaccination occurred in 326 patients receiving Moderna (0.11%, incidence rate [IR] 4.58 per 1000p-years), 425 patients receiving Pfizer (0.09%, IR 3.84 per 1000p-years), and 42 receiving Janssen (0.09%, IR 3.56 per 1000p-years). Compared to the pre-vaccination timeframe, the adjusted hazard ratio (aHR) for VTE after the Janssen vaccination was 0.97 (95% confidence interval [CI] 0.63-1.50), aHR 1.02 (95% CI 0.87-1.19) for Moderna, and aHR 1.00 (95% CI 0.87-1.15) for Pfizer.
In this large cohort of COVID-19 vaccinated patients, no increased risk for acute VTE post-vaccination was identified for the authorized vaccines in the United States.
美国的 COVID-19 疫苗接种在预防疾病和住院方面非常有效，但对疫苗接种后静脉血栓栓塞（VTE）风险的担忧导致了疫苗犹豫。
本研究旨在比较 COVID-19 疫苗接种前后的 VTE 发生率。使用 Mayo 诊所企业的电子病历分析了 2020 年 11 月 1 日至 2021 年 11 月 1 日期间≥18 岁的 COVID-19 接种患者。主要结局是在第一剂疫苗接种日期前后 90 天内发生影像学证实的急性 VTE（上或下深静脉血栓形成或肺栓塞）。
共确定了 792010 例至少接种过一次 COVID-19 疫苗的患者（辉瑞，n=452950 例；莫德纳，n=290607 例；强生[约翰逊&约翰逊]，n=48453 例）。在 COVID-19 疫苗接种前 90 天（n=772）和后 90 天（n=793）共发生 1565 例 VTE 事件。接种 Moderna 疫苗后有 326 例（0.11%，发病率[IR]为每 1000 人年 4.58 例），接种辉瑞疫苗后有 425 例（0.09%，IR 为每 1000 人年 3.84 例），接种强生疫苗后有 42 例（0.09%，IR 为每 1000 人年 3.56 例）发生 VTE。与接种前时间段相比，接种 Janssen 疫苗后的 VTE 调整后的危险比（aHR）为 0.97（95%置信区间[CI]为 0.63-1.50），接种 Moderna 的 aHR 为 1.02（95% CI 为 0.87-1.19），接种辉瑞的 aHR 为 1.00（95% CI 为 0.87-1.15）。
在这项大规模的 COVID-19 疫苗接种患者队列中，未发现美国授权疫苗接种后急性 VTE 的风险增加。
