Thrombotic outcomes in patients in a large clinical enterprise following COVID-19 vaccination

• Published in: Journal of thrombosis and thrombolysis 2023-04, Vol.55 (3), p.426-431
• Main Authors: Patterson, William M., Greene, Brady D., Tefera, Leben, Bena, James, Milinovich, Alex, Mehta, Neil, Chung, Mina K., Kapadia, Samir, Svensson, Lars G, Cameron, Scott J.
• Format: Article
• Language: English
• Subjects: Ad26COVS1; BNT162 Vaccine; Cardiology; ChAdOx1 nCoV-19; Coronaviruses; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Etiology; Hematology; Humans; Immunization; Immunoassay; Malignancy; Medicine; Medicine & Public Health; mRNA; Platelets; Purpura, Thrombocytopenic, Idiopathic; Retrospective Studies; Severe acute respiratory syndrome coronavirus 2; Thrombocytopenia; Thrombocytopenia - chemically induced; Thromboembolism; Thrombosis; Vaccination - adverse effects
• ISSN: 1573-742X; 0929-5305; 1573-742X
• DOI: 10.1007/s11239-022-02764-9

Vaccination against COVID-19 reduces infection-related mortality. Unfortunately, reports of vaccine-induced immune thrombotic thrombocytopenia (VITT) in individuals administered adenovirus-vector-based vaccines (ChAdOx1 nCoV-19 and Ad26.COV2.S) have spurred side effect concerns. To address vaccine hesitancy related to this, it is essential to determine the incidence of VITT (defined by a 50% decrease in platelet count and positive anti-PF4 immunoassay within 4–28 days after vaccination) among patients administered two doses of an mRNA-based COVID-19 vaccination. We identified a retrospective cohort of 223,345 patients in the Cleveland Clinic Enterprise administered a COVID-19 vaccine at any location in Northeast Ohio and Florida from 12/4/2020 to 6/6/2021. 97.3% of these patients received an mRNA-based vaccination. Patients with: (1) a serial complete blood count both before and after vaccination and (2) a decrease in platelet count of ≥ 50% were selected for chart review. The primary outcome was the incidence of thrombotic events, including venous thromboembolism (VTE) and arterial thrombosis, 4–28 days post vaccination. Of 74 cohort patients with acute thrombosis, 72 (97.3%) demonstrated clear etiologies, such as active malignancy. Of two patients with unprovoked thrombosis, only one had findings concerning for VITT, with a strongly positive anti-PF4 antibody assay. In this large, multi-state, retrospective cohort, of 223,345 patients (97.2% of whom received the mRNA-based mRNA-1273 or BNT162b2 vaccines), we detected a single case that was concerning for VITT in a patient who received an mRNA vaccine. The overwhelming majority of patients with a thrombotic event 4–28 days following vaccination demonstrated clear etiologies. Key points Vaccine-induced immune thrombotic thrombocytopenia (VITT) is recognized as a triad of (1) arterial/venous thrombosis in the setting of (2) thrombocytopenia (with initial case series reporting counts ranging from 10 to 113 × 109/L) and (3) a positive anti-PF4 immunoassay in the 4-28 days after vaccination. We reviewed a multi-state, prospective, observational registry of patients administered a COVID-19 mRNA vaccination for thrombotic events in the setting of thrombocytopenia in the 4-28 days after their vaccination. The overwhelming majority of patients with a thrombotic event 4-28 days following vaccination demonstrated very clear etiologies for thrombosis, the most common of which was active malignancy (40.5%). In a large