Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism

Cristina Gabara; Jesus Aibar; Yuji Nishimoto; Yugo Yamashita; Paolo Prandoni; Geoffrey D Barnes; Behnood Bikdeli; David Jiménez; Pablo Demelo-Rodríguez; Ma Luisa Peris; Son Truong Nguyen; Manuel Monreal; RIETE Investigators; Andris Skride; Dana Kigitovica

doi:10.1016/j.jtha.2024.05.007

Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism

Cristina Gabara, Jesus Aibar (Corresponding Author), Yuji Nishimoto, Yugo Yamashita, Paolo Prandoni, Geoffrey D Barnes, Behnood Bikdeli, David Jiménez, Pablo Demelo-Rodríguez, Ma Luisa Peris, Son Truong Nguyen, Manuel Monreal, 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 duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding.

OBJECTIVES: Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation.

PATIENTS/METHODS: We compared the rates and CFRs in patients of the RIETE and COMMAND-VTE registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding.

RESULTS: Of 8,261 patients with unprovoked VTE in RIETE, 4,012 (48.6%) had isolated deep vein thrombosis (DVT) and 4,250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The COMMAND VTE registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding, were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio (HR): 3.03; 95%CI: 2.49-3.69), dementia (HR: 1.47; 95%CI: 1.01-2.13), and anemia (HR: 0.72; 95%CI: 0.57-0.91) predicted recurrent PE, whereas older age (HR: 2.11; 95%CI: 1.15-3.87), inflammatory bowel disease (HR: 4.39; 95%CI: 1.00-19.3) and anemia (HR: 2.24; 95%CI: 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with c-statistics of 0.63 for recurrent PE and 0.69 for major bleeding.

CONCLUSIONS: Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. Contrary, major bleeding was rare, but had high CFR (24%). A few clinical factors may predict these outcomes.

Original language	English
Pages (from-to)	2234-2246
Number of pages	13
Journal	Journal of Thrombosis and Haemostasis
Volume	22
Issue number	8
DOIs	https://doi.org/10.1016/j.jtha.2024.05.007
Publication status	Published - Aug 2024
Externally published	Yes

Keywords*

recurrence
unprovoked
bleeding
venous thromboembolism
mortality

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.jtha.2024.05.007

Cite this

Gabara, C., Aibar, J., Nishimoto, Y., Yamashita, Y., Prandoni, P., Barnes, G. D., Bikdeli, B., Jiménez, D., Demelo-Rodríguez, P., Peris, M. L., Nguyen, S. T., Monreal, M., RIETE Investigators, Skride, A., & Kigitovica, D. (2024). Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism. Journal of Thrombosis and Haemostasis, 22(8), 2234-2246. https://doi.org/10.1016/j.jtha.2024.05.007

@article{f0a06d44d28a4ff9a5f5919520a7e8d8,

title = "Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism",

abstract = "BACKGROUND: The duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding.OBJECTIVES: Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation.PATIENTS/METHODS: We compared the rates and CFRs in patients of the RIETE and COMMAND-VTE registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding.RESULTS: Of 8,261 patients with unprovoked VTE in RIETE, 4,012 (48.6%) had isolated deep vein thrombosis (DVT) and 4,250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The COMMAND VTE registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding, were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio (HR): 3.03; 95%CI: 2.49-3.69), dementia (HR: 1.47; 95%CI: 1.01-2.13), and anemia (HR: 0.72; 95%CI: 0.57-0.91) predicted recurrent PE, whereas older age (HR: 2.11; 95%CI: 1.15-3.87), inflammatory bowel disease (HR: 4.39; 95%CI: 1.00-19.3) and anemia (HR: 2.24; 95%CI: 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with c-statistics of 0.63 for recurrent PE and 0.69 for major bleeding.CONCLUSIONS: Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. Contrary, major bleeding was rare, but had high CFR (24%). A few clinical factors may predict these outcomes.",

keywords = "recurrence, unprovoked, bleeding, venous thromboembolism, mortality",

author = "Cristina Gabara and Jesus Aibar and Yuji Nishimoto and Yugo Yamashita and Paolo Prandoni and Barnes, {Geoffrey D} and Behnood Bikdeli and David Jim{\'e}nez and Pablo Demelo-Rodr{\'i}guez and Peris, {Ma Luisa} and Nguyen, {Son Truong} and Manuel Monreal and {RIETE Investigators} and Andris Skride and Dana Kigitovica",

note = "Link to the RIETE Registry participating centers https://www.riete.org/info/centros_participantes/index.php Copyright {\textcopyright} 2024 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.",

year = "2024",

month = aug,

doi = "10.1016/j.jtha.2024.05.007",

language = "English",

volume = "22",

pages = "2234--2246",

journal = "Journal of Thrombosis and Haemostasis",

issn = "1538-7933",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "8",

}

Gabara, C, Aibar, J, Nishimoto, Y, Yamashita, Y, Prandoni, P, Barnes, GD, Bikdeli, B, Jiménez, D, Demelo-Rodríguez, P, Peris, ML, Nguyen, ST, Monreal, M, RIETE Investigators, Skride, A & Kigitovica, D 2024, 'Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism', Journal of Thrombosis and Haemostasis, vol. 22, no. 8, pp. 2234-2246. https://doi.org/10.1016/j.jtha.2024.05.007

TY - JOUR

T1 - Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism

AU - Gabara, Cristina

AU - Aibar, Jesus

AU - Nishimoto, Yuji

AU - Yamashita, Yugo

AU - Prandoni, Paolo

AU - Barnes, Geoffrey D

AU - Bikdeli, Behnood

AU - Jiménez, David

AU - Demelo-Rodríguez, Pablo

AU - Peris, Ma Luisa

AU - Nguyen, Son Truong

AU - Monreal, Manuel

AU - RIETE Investigators

A2 - Skride, Andris

A2 - Kigitovica, Dana

N1 - Link to the RIETE Registry participating centers https://www.riete.org/info/centros_participantes/index.php Copyright © 2024 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.

PY - 2024/8

Y1 - 2024/8

N2 - BACKGROUND: The duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding.OBJECTIVES: Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation.PATIENTS/METHODS: We compared the rates and CFRs in patients of the RIETE and COMMAND-VTE registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding.RESULTS: Of 8,261 patients with unprovoked VTE in RIETE, 4,012 (48.6%) had isolated deep vein thrombosis (DVT) and 4,250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The COMMAND VTE registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding, were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio (HR): 3.03; 95%CI: 2.49-3.69), dementia (HR: 1.47; 95%CI: 1.01-2.13), and anemia (HR: 0.72; 95%CI: 0.57-0.91) predicted recurrent PE, whereas older age (HR: 2.11; 95%CI: 1.15-3.87), inflammatory bowel disease (HR: 4.39; 95%CI: 1.00-19.3) and anemia (HR: 2.24; 95%CI: 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with c-statistics of 0.63 for recurrent PE and 0.69 for major bleeding.CONCLUSIONS: Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. Contrary, major bleeding was rare, but had high CFR (24%). A few clinical factors may predict these outcomes.

AB - BACKGROUND: The duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding.OBJECTIVES: Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation.PATIENTS/METHODS: We compared the rates and CFRs in patients of the RIETE and COMMAND-VTE registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding.RESULTS: Of 8,261 patients with unprovoked VTE in RIETE, 4,012 (48.6%) had isolated deep vein thrombosis (DVT) and 4,250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The COMMAND VTE registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding, were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio (HR): 3.03; 95%CI: 2.49-3.69), dementia (HR: 1.47; 95%CI: 1.01-2.13), and anemia (HR: 0.72; 95%CI: 0.57-0.91) predicted recurrent PE, whereas older age (HR: 2.11; 95%CI: 1.15-3.87), inflammatory bowel disease (HR: 4.39; 95%CI: 1.00-19.3) and anemia (HR: 2.24; 95%CI: 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with c-statistics of 0.63 for recurrent PE and 0.69 for major bleeding.CONCLUSIONS: Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. Contrary, major bleeding was rare, but had high CFR (24%). A few clinical factors may predict these outcomes.

KW - recurrence

KW - unprovoked

KW - bleeding

KW - venous thromboembolism

KW - mortality

UR - https://www-webofscience-com.db.rsu.lv/wos/alldb/full-record/MEDLINE:38762019

UR - http://www.scopus.com/inward/record.url?scp=85195279838&partnerID=8YFLogxK

U2 - 10.1016/j.jtha.2024.05.007

DO - 10.1016/j.jtha.2024.05.007

M3 - Article

C2 - 38762019

SN - 1538-7933

VL - 22

SP - 2234

EP - 2246

JO - Journal of Thrombosis and Haemostasis

JF - Journal of Thrombosis and Haemostasis

IS - 8

ER -

Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism

Abstract

Keywords*

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