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

for the RIETE investigators

doi:10.3390/v14020178

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

for the RIETE investigators

Bar-Ilan University - Azrieli Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

16 Scopus citations

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.

Original language	English
Article number	178
Journal	Viruses
Volume	14
Issue number	2
DOIs	https://doi.org/10.3390/v14020178
State	Published - 18 Jan 2022

Bibliographical note

Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Funding

We express our gratitude to SANOFI Spain, LEO PHARMA, and ROVI for supporting this registry with an unrestricted educational grant. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication. Disclosures: Behnood Bikdeli reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of IVC filters. David Jiménez (PI15/00207) has been partially supported by the Instituto de Salud Carlos III (Plan Estatal de I+D+I 2013-2016) and co-financed by the European Development Regional Fund “A way to achieve Europe” (ERDF), and reports personal fees from BMS, Pfizer, Bayer, Daiichi-Sankyo, Sanofi, ROVI, and Leo-Pharma. Pablo Demelo-Rodriguez reports personal fees from Sanofi, LeoPharma, Bayer, ROVI and Menarini. Francisco Galeano reports personal fees from ROVI, Techdow and Daiichi-Sankyo. Raquel Barba reports personal fees from Sociedad Española de Medicina Interna. Ramón Lecumberri reports personal fees from Rovi, BMS, Sanofi, and Daiichi-Sankyo. Ángeles Fidalgo reports personal fees from Rovi and Sanofi. José Antonio Porras reports personal fees from Rovi, Pfizer/Bristol Myers, Daiichi Sankyo. Egidio Imbalzano reports personal fees from Amgen; Bayer Healthcare; Pfizer/Bristol Myers Squibb; Daiichi Sankyo; Servier; and Sanofi. Cihan Ay reports personal fees for participation in advisory boards and for lectures from Bayer, BMS, Pfizer, Daiichi-Sankyo, Portola/Alexion and Sanofi. Radovan Malý reports personal fees from Pfizer, Boehringer Ingelheim. Manuel Monreal reports research grants from Sanofi, Leo Pharma, and Rovi for sponsoring the RIETE registry and personal fees from Sanofi, Leo Pharma, Bristol Myers Squibb. Carmine Siniscalchi, Vladimir Rosa, and Salvador Ortiz report no personal disclosures. The rest of the authors have no disclosures to report.

Funders	Funder number
ROVI
Instituto de Salud Carlos III	I+D+I 2013-2016
European Regional Development Fund
LEO Pharma

Keywords

COVID-19
SARS-CoV-2
Vaccination
Venous thromboembolism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.3390/v14020178

Cite this

@article{b2befd30a2d1436f9ee6a6533680893d,

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

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 TromboEmb{\'o}lica (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",

author = "{for the RIETE investigators} and Behnood Bikdeli and David Jim{\'e}nez and Pablo Demelo-Rodriguez and Francisco Galeano-Valle and Porras, {Jos{\'e} Antonio} and Raquel Barba and Cihan Ay and Radovan Mal{\'y} and Andrei Braester and Egidio Imbalzano and Vladimir Rosa and Ram{\'o}n Lecumberri and Carmine Siniscalchi and {\'A}ngeles Fidalgo and Salvador Ortiz and Manuel Monreal",

note = "Publisher Copyright: {\textcopyright} 2022 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2022",

month = jan,

day = "18",

doi = "10.3390/v14020178",

language = "אנגלית",

volume = "14",

journal = "Viruses",

issn = "1999-4915",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "2",

}

TY - JOUR

T1 - Venous Thrombosis within 30 Days after Vaccination against SARS-CoV-2 in a Multinational Venous Thromboembolism Registry

AU - for the RIETE investigators

AU - Bikdeli, Behnood

AU - Jiménez, David

AU - Demelo-Rodriguez, Pablo

AU - Galeano-Valle, Francisco

AU - Porras, José Antonio

AU - Barba, Raquel

AU - Ay, Cihan

AU - Malý, Radovan

AU - Braester, Andrei

AU - Imbalzano, Egidio

AU - Rosa, Vladimir

AU - Lecumberri, Ramón

AU - Siniscalchi, Carmine

AU - Fidalgo, Ángeles

AU - Ortiz, Salvador

AU - Monreal, Manuel

PY - 2022/1/18

Y1 - 2022/1/18

N2 - 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.

AB - 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.

KW - COVID-19

KW - SARS-CoV-2

KW - Vaccination

KW - Venous thromboembolism

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VL - 14

JO - Viruses

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

Abstract

Bibliographical note

Funding

Keywords

UN SDGs

Access to Document

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