tetano
Editor, Senior Moderator
Viruses
. 2022 Jan 18;14(2):178.
doi: 10.3390/v14020178.
Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry
Behnood Bikdeli[SUP] 1 2 3 [/SUP], David Jiménez[SUP] 4 5 [/SUP], Pablo Demelo-Rodriguez[SUP] 6 7 8 [/SUP], Francisco Galeano-Valle[SUP] 6 7 8 [/SUP], José Antonio Porras[SUP] 9 [/SUP], Raquel Barba[SUP] 10 [/SUP], Cihan Ay[SUP] 11 [/SUP], Radovan Malý[SUP] 12 [/SUP], Andrei Braester[SUP] 13 [/SUP], Egidio Imbalzano[SUP] 14 [/SUP], Vladimir Rosa[SUP] 15 [/SUP], Ramón Lecumberri[SUP] 16 17 [/SUP], Carmine Siniscalchi[SUP] 18 [/SUP], Ángeles Fidalgo[SUP] 19 [/SUP], Salvador Ortiz[SUP] 20 21 [/SUP], Manuel Monreal[SUP] 22 [/SUP], For The Riete Investigators
Affiliations
Abstract
Background: 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.
Methods: 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.
Results: 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%, p < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p < 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.
Conclusions: 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.
Keywords: COVID-19; SARS-CoV-2; vaccination; venous thromboembolism.
. 2022 Jan 18;14(2):178.
doi: 10.3390/v14020178.
Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry
Behnood Bikdeli[SUP] 1 2 3 [/SUP], David Jiménez[SUP] 4 5 [/SUP], Pablo Demelo-Rodriguez[SUP] 6 7 8 [/SUP], Francisco Galeano-Valle[SUP] 6 7 8 [/SUP], José Antonio Porras[SUP] 9 [/SUP], Raquel Barba[SUP] 10 [/SUP], Cihan Ay[SUP] 11 [/SUP], Radovan Malý[SUP] 12 [/SUP], Andrei Braester[SUP] 13 [/SUP], Egidio Imbalzano[SUP] 14 [/SUP], Vladimir Rosa[SUP] 15 [/SUP], Ramón Lecumberri[SUP] 16 17 [/SUP], Carmine Siniscalchi[SUP] 18 [/SUP], Ángeles Fidalgo[SUP] 19 [/SUP], Salvador Ortiz[SUP] 20 21 [/SUP], Manuel Monreal[SUP] 22 [/SUP], For The Riete Investigators
Affiliations
- PMID: 35215771
- DOI: 10.3390/v14020178
Abstract
Background: 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.
Methods: 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.
Results: 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%, p < 0.001) or thrombosis at multiple sites (17.9% vs. 1.3%, p < 0.001), more frequently had thrombocytopenia (40.7% vs. 14.7%, p < 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.
Conclusions: 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.
Keywords: COVID-19; SARS-CoV-2; vaccination; venous thromboembolism.