Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study

Luis Jara-Palomares; Behnood Bikdeli; David Jiménez; The RIETE Investigators; Andris Skride; Dana Kigitovica

doi:10.1016/j.eclinm.2024.102659

Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study

Luis Jara-Palomares (Corresponding Author), Behnood Bikdeli, David Jiménez, The RIETE Investigators, Andris Skride (Member of the Working Group), Dana Kigitovica (Member of the Working Group)

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

Abstract

Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE.

Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued.

Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences.

Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings.

Funding: Sanofi and Rovi, Sanofi Spain.

Original language	English
Article number	102659
Journal	EClinicalMedicine
Volume	73
DOIs	https://doi.org/10.1016/j.eclinm.2024.102659
Publication status	Published - Jul 2024
Externally published	Yes

Keywords*

Anticoagulation
COVID-19
Pulmonary embolism
SARS-CoV-2
Venous thromboembolism

Field of Science*

3.2 Clinical medicine

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

Access to Document

10.1016/j.eclinm.2024.102659Licence: CC BY-NC-ND

Cite this

@article{04ac90fd37aa468b8de839e12ba1daff,

title = "Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study",

abstract = "Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences.Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.",

keywords = "Anticoagulation, COVID-19, Pulmonary embolism, SARS-CoV-2, Venous thromboembolism",

author = "Luis Jara-Palomares and Behnood Bikdeli and David Jim{\'e}nez and Alfonso Muriel and Pablo Demelo-Rodr{\'i}guez and Far{\`e}s Moustafa and Aurora Villalobos and Patricia L{\'o}pez-Miguel and Luciano L{\'o}pez-Jim{\'e}nez and Sonia Ot{\'a}lora and Peris, {Mar{\'i}a Luisa} and Cristina Amado and Romain Chopard and Francisco Rivera-C{\'i}vico and Manuel Monreal and {The RIETE Investigators} and Adarraga, {Mar{\'i}a Dolores} and Conesa, {Ana Alberich} and Jes{\'u}s Aibar and Lozano, {Alicia Alda} and Joaqu{\'i}n Alfonso and Carrillo, {Jes{\'u}s Alonso} and Garc{\'i}a, {Mar{\'i}a Angelina} and Arcelus, {Juan Ignacio} and Aitor Ballaz and Raquel Barba and Hernando, {Mar{\'i}a Barca} and Cristina Barbagelata and Manuel Barr{\'o}n and Andr{\'e}s, {Bel{\'e}n Barr{\'o}n} and Chaib, {Fahd Beddar} and {Blanco Molina}, {Mar{\'i}a {\'A}ngeles} and Caballero, {Juan Carlos} and Gonzalo Castellanos and Leyre Chasco and Juan Criado and {de Ancos}, Cristina and Toro, {Jorge del} and Rodr{\'i}guez, {Pablo Demelo} and {de Juana Izquierdo}, Cristina and {D{\'i}az Brasero}, {Ana Mar{\'i}a} and {D{\'i}az Peromingo}, {Jos{\'e} Antonio} and Silva, {{\'A}lvaro Dubois} and Escribano, {Juan Carlos} and Concepci{\'o}n Falg{\'a} and {Farf{\'a}n Sedano}, {Ana Isabel} and Aracil, {Cleofe Fern{\'a}ndez} and Capit{\'a}n, {Carmen Fern{\'a}ndez} and Jim{\'e}nez, {Bego{\~n}a Fern{\'a}ndez} and Andris Skride and Dana Kigitovica",

note = "A full list of the RIETE investigators is given in the Appendix of the article. Link to the RIETE Registry participating centers: https://www.riete.org/info/centros_participantes/index.php Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

month = jul,

doi = "10.1016/j.eclinm.2024.102659",

language = "English",

volume = "73",

journal = "EClinicalMedicine",

issn = "2589-5370",

publisher = "Lancet Publishing Group",

}

TY - JOUR

T1 - Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism

T2 - a prospective multicentre cohort study

AU - Jara-Palomares, Luis

AU - Bikdeli, Behnood

AU - Jiménez, David

AU - Muriel, Alfonso

AU - Demelo-Rodríguez, Pablo

AU - Moustafa, Farès

AU - Villalobos, Aurora

AU - López-Miguel, Patricia

AU - López-Jiménez, Luciano

AU - Otálora, Sonia

AU - Peris, María Luisa

AU - Amado, Cristina

AU - Chopard, Romain

AU - Rivera-Cívico, Francisco

AU - Monreal, Manuel

AU - The RIETE Investigators

AU - Castellanos, Gonzalo

A2 - Adarraga, María Dolores

A2 - Conesa, Ana Alberich

A2 - Aibar, Jesús

A2 - Lozano, Alicia Alda

A2 - Alfonso, Joaquín

A2 - Carrillo, Jesús Alonso

A2 - García, María Angelina

A2 - Arcelus, Juan Ignacio

A2 - Ballaz, Aitor

A2 - Barba, Raquel

A2 - Hernando, María Barca

A2 - Barbagelata, Cristina

A2 - Barrón, Manuel

A2 - Andrés, Belén Barrón

A2 - Chaib, Fahd Beddar

A2 - Blanco Molina, María Ángeles

A2 - Caballero, Juan Carlos

A2 - Chasco, Leyre

A2 - Criado, Juan

A2 - de Ancos, Cristina

A2 - Toro, Jorge del

A2 - Rodríguez, Pablo Demelo

A2 - de Juana Izquierdo, Cristina

A2 - Díaz Brasero, Ana María

A2 - Díaz Peromingo, José Antonio

A2 - Silva, Álvaro Dubois

A2 - Escribano, Juan Carlos

A2 - Falgá, Concepción

A2 - Farfán Sedano, Ana Isabel

A2 - Aracil, Cleofe Fernández

A2 - Capitán, Carmen Fernández

A2 - Jiménez, Begoña Fernández

A2 - Skride, Andris

A2 - Kigitovica, Dana

N1 - A full list of the RIETE investigators is given in the Appendix of the article. Link to the RIETE Registry participating centers: https://www.riete.org/info/centros_participantes/index.php Publisher Copyright: © 2024 The Authors

PY - 2024/7

Y1 - 2024/7

N2 - Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences.Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

AB - Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences.Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

KW - Anticoagulation

KW - COVID-19

KW - Pulmonary embolism

KW - SARS-CoV-2

KW - Venous thromboembolism

UR - http://www.scopus.com/inward/record.url?scp=85193906758&partnerID=8YFLogxK

U2 - 10.1016/j.eclinm.2024.102659

DO - 10.1016/j.eclinm.2024.102659

M3 - Article

AN - SCOPUS:85193906758

SN - 2589-5370

VL - 73

JO - EClinicalMedicine

JF - EClinicalMedicine

M1 - 102659

ER -

Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study

Abstract

Keywords*

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