Thrombosis with thrombocytopenia syndrome following adenovirus vector-based vaccines to prevent COVID-19: Epidemiology and clinical presentation in Spain

D García-Azorín; E Lázaro; D Ezpeleta; R Lecumberri; R de la Cámara; M Castellanos; C Iñiguez Martínez; L Quiroga-González; G Elizondo Rivas; A Sancho-López; P Rayón Iglesias; E Segovia; C Mejías; D Montero Corominas

doi:10.1016/j.nrleng.2024.10.001

Thrombosis with thrombocytopenia syndrome following adenovirus vector-based vaccines to prevent COVID-19: Epidemiology and clinical presentation in Spain

Neurologia (Engl Ed). 2024 Oct 31:S2173-5808(24)00082-8. doi: 10.1016/j.nrleng.2024.10.001. Online ahead of print.

Authors

Affiliations

¹ Servicio de Neurología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. Electronic address: [email protected].
² División de Farmacoepidemiología y Farmacovigilancia, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
³ Servicio de Neurología, Hospital Universitario Quirónsalud Madrid, Pozuelo de Alarcón, Madrid, Spain.
⁴ Servicio de Hematología, Clínica Universidad de Navarra, Pamplona, Navarra, Spain; CIBER-CV, Instituto de Salud Carlos III, Madrid, Spain.
⁵ Servicio de Hematología, Hospital de la Princesa, Madrid, Spain.
⁶ Servicio de Neurología, Complejo Hospitalario Universitario/Instituto de Investigación Biomédica de Coruña, Coruña, Spain; Instituto de Salud Carlos III, Madrid, Spain.
⁷ Servicio de Neurología, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza, Spain.
⁸ Centro de Farmacovigilancia de Navarra, Departamento de Salud, Gobierno de Navarra, Pamplona, Navarra, Spain; Comité Técnico del Sistema Español de Farmacovigilancia, Spain.
⁹ Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain; Sociedad Española de Farmacología Clínica (SECF), Spain; Grupo de Vacunas de FACME, Madrid, Spain.

PMID: 39488251
DOI: 10.1016/j.nrleng.2024.10.001

Abstract

Background: We describe the epidemiological and clinical characteristics of thrombosis with thrombocytopenia syndrome (TTS) cases reported in Spain.

Methods: We included all venous or arterial thrombosis with thrombocytopenia following adenovirus vector-based vaccines (AstraZeneca or Janssen) to prevent COVID-19 disease between February 1st and September 26th, 2021. We describe the crude rate and the standardized morbidity ratio. We assessed the predictors of mortality.

Results: Sixty-one cases were reported and 45 fulfilled eligibility criteria, 82% women. The crude TTS rate was 4/1,000,000 doses and 14-15/1,000,000 doses between 30-49 years. The number of observed cases of cerebral venous thrombosis was 6-18 higher than the expected in patients younger than 49 years. Symptoms started 10 (interquartile range (IQR): 7-14) days after vaccination. Eighty percent (95% confidence interval (CI): 65-90%) had thrombocytopenia at the time of the emergency department visit, and 65% (95% CI: 49-78%) had D-dimer >2000 ng/mL. Patients had multiple location thrombosis in 36% and fatal outcome in 24% cases. A platelet nadir <50,000/μL (odds ratio (OR): 7.4; CI 95%: 1.2-47.5) and intracranial hemorrhage (OR: 7.9; IC95%: 1.3-47.0) were associated with fatal outcome.

Conclusion: TTS must be suspected in patients with symptoms 10 days after vaccination and thrombocytopenia and/or D-dimer increase.

Keywords: Blood platelet disorders; COVID-19; Drug-related side effects and adverse reactions; Efectos adversos de medicamentos y reacciones adversas; Embolia y trombosis; Embolism and thrombosis; MeSH Terms; Trastornos plaquetarios; Vaccines; Vacunas.