Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry

• Published in: Viruses 2022-01, Vol.14 (2), p.178
• Main Authors: Bikdeli, Behnood, Jiménez, David, Demelo-Rodriguez, Pablo, Galeano-Valle, Francisco, Porras, José Antonio, Barba, Raquel, Ay, Cihan, Malý, Radovan, Braester, Andrei, Imbalzano, Egidio, Rosa, Vladimir, Lecumberri, Ramón, Siniscalchi, Carmine, Fidalgo, Ángeles, Ortiz, Salvador, Monreal, Manuel, For The Riete Investigators
• Format: Article
• Language: English
• Subjects: 2019-nCoV Vaccine mRNA-1273 - administration & dosage; 2019-nCoV Vaccine mRNA-1273 - adverse effects; Aged; Aged, 80 and over; Bleeding; BNT162 Vaccine - administration & dosage; BNT162 Vaccine - adverse effects; ChAdOx1 nCoV-19 - administration & dosage; ChAdOx1 nCoV-19 - adverse effects; Coronaviruses; COVID-19; COVID-19 - prevention & control; Embolism; Female; Humans; Immunization; Male; Middle Aged; Mortality; mRNA; Outcome Assessment, Health Care; Patients; Prospective Studies; Registries; Risk Factors; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Thrombocytopenia; Thrombocytopenia - etiology; Thromboembolism; Thrombosis; Time Factors; Vaccination; Vaccination - adverse effects; Vaccination - mortality; venous thromboembolism; Venous Thromboembolism - etiology
• ISSN: 1999-4915; 1999-4915
• DOI: 10.3390/v14020178

Venous thromboembolism (VTE)-including deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis (CVST)-may occur early after vaccination against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We sought to describe the site, clinical characteristics, and outcomes of VTE after vaccination against SARS-CoV-2. In a prospective study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) platform, patients with VTE 4-30 days after vaccination against SARS-CoV-2 (1 February 2021 through 30 April 2021) were included. VTE patients recruited from the same centers into RIETE in the same months in 2018-2019 were selected as the reference group. All-cause mortality and major bleeding were the main study outcomes. As of 30 April 2020, 102 patients with post-vaccination VTEs had been identified (28 after adenovirus-based vaccination [ChAdOx1 nCov-19; AstraZeneca] and 74 after mRNA-based vaccination [mRNA-1273; Moderna, and BNT162b2; Pfizer]). Compared with 911 historical controls, patients with VTE after adenovirus-based vaccination more frequently had CVST (10.7% vs. 0.4%, < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, < 0.001), and had higher 14-day mortality (14.3% vs. 0.7%; odds ratio [OR]: 25.1; 95% confidence interval [CI]: 6.7-94.9) and major bleeding rates (10.3% vs. 1.0%, OR: 12.03, 95% CI: 3.07-47.13). The site of thrombosis, accompanying thrombocytopenia, and 14-day mortality rates were not significantly different for patients with VTE after mRNA-based vaccination, compared with historical controls. Compared with historical controls, VTE after adenovirus-based vaccination against SARS-CoV-2 is accompanied by thrombocytopenia, occurs in unusual sites, and is associated with worse clinical outcomes.