A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Gabrielle Sarlon-Bartoli; Juan Criado; Saskia Middeldorp; The RIETE Group; D. Kigitovica; A. Skride

doi:10.1016/j.tru.2023.100148

A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Gabrielle Sarlon-Bartoli (Corresponding Author), Juan Criado, Saskia Middeldorp, The RIETE Group, D. Kigitovica (Member of the Working Group), A. Skride (Member of the Working Group)

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

1 Citation (Scopus)

Abstract

Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE).

Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women.

Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged <50 years, weighing >70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82).

Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

Original language	English
Article number	100148
Journal	Thrombosis Update
Volume	13
DOIs	https://doi.org/10.1016/j.tru.2023.100148
Publication status	Published - Dec 2023
Externally published	Yes

Keywords*

Anticoagulants
Prognostic score
Uterine bleeding
Venous thromboembolism

Field of Science*

3.2 Clinical medicine

Publication Type*

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

UN SDGs

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

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10.1016/j.tru.2023.100148Licence: CC BY-NC-ND

Cite this

@article{559e8fc73cf348c9a13fe17305f2e48c,

title = "A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism",

abstract = "Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged <50 years, weighing >70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.",

keywords = "Anticoagulants, Prognostic score, Uterine bleeding, Venous thromboembolism",

author = "Gabrielle Sarlon-Bartoli and Juan Criado and Saskia Middeldorp and Nieto, {Jos{\'e} Antonio} and D{\'i}az-Pedroche, {M. C.} and Far{\`e}s Moustafa and Nuria Ruiz-Gim{\'e}nez and Benjamin Brenner and Manuel Monreal and {DI Micco}, Pierpaolo and {The RIETE Group} and Paolo Prandoni and Dominique Farge-Bancel and Raquel Barba and Laurent Bertoletti and Sebastian Schellong and Inna Tzoran and Abilio Reis and Marijan Bosevski and Henri Bounameaux and Radovan Mal{\'y} and Peter Verhamme and Caprini, {Joseph A.} and Bui, {Hanh My} and Adarraga, {M. D.} and P. Agudo and C. Amado and Arcelus, {J. I.} and A. Ballaz and J. Bascu{\~n}ana and R. Barba and C. Barbagelata and M. Barr{\'o}n and B. Barr{\'o}n-Andr{\'e}s and A. Blanco-Molina and {Beddar Chaib}, F. and E. Botella and I. Ca{\~n}as and R. Carrero-Arribas and I. Casado and P. Cerd{\'a} and L. Chasco and J. Criado and {de Ancos}, C. and {de Miguel}, J. and {del Toro}, J. and P. Demelo-Rodr{\'i}guez and D{\'i}az-Brasero, {A. M.} and D. Kigitovica and A. Skride",

note = "Link to the RIETE Registry participating centers https://www.riete.org/info/centros_participantes/index.php Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = dec,

doi = "10.1016/j.tru.2023.100148",

language = "English",

volume = "13",

journal = "Thrombosis Update",

issn = "2666-5727",

publisher = "Elsevier BV",

}

TY - JOUR

T1 - A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

AU - Sarlon-Bartoli, Gabrielle

AU - Criado, Juan

AU - Middeldorp, Saskia

AU - Nieto, José Antonio

AU - Díaz-Pedroche, M. C.

AU - Moustafa, Farès

AU - Ruiz-Giménez, Nuria

AU - Brenner, Benjamin

AU - Monreal, Manuel

AU - DI Micco, Pierpaolo

AU - The RIETE Group

AU - Adarraga, M. D.

AU - Blanco-Molina, A.

A2 - Prandoni, Paolo

A2 - Farge-Bancel, Dominique

A2 - Barba, Raquel

A2 - Bertoletti, Laurent

A2 - Schellong, Sebastian

A2 - Tzoran, Inna

A2 - Reis, Abilio

A2 - Bosevski, Marijan

A2 - Bounameaux, Henri

A2 - Malý, Radovan

A2 - Verhamme, Peter

A2 - Caprini, Joseph A.

A2 - Bui, Hanh My

A2 - Agudo, P.

A2 - Amado, C.

A2 - Arcelus, J. I.

A2 - Ballaz, A.

A2 - Bascuñana, J.

A2 - Barba, R.

A2 - Barbagelata, C.

A2 - Barrón, M.

A2 - Barrón-Andrés, B.

A2 - Beddar Chaib, F.

A2 - Botella, E.

A2 - Cañas, I.

A2 - Carrero-Arribas, R.

A2 - Casado, I.

A2 - Cerdá, P.

A2 - Chasco, L.

A2 - Criado, J.

A2 - de Ancos, C.

A2 - de Miguel, J.

A2 - del Toro, J.

A2 - Demelo-Rodríguez, P.

A2 - Díaz-Brasero, A. M.

A2 - Kigitovica, D.

A2 - Skride, A.

PY - 2023/12

Y1 - 2023/12

N2 - Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged <50 years, weighing >70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

AB - Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged <50 years, weighing >70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

KW - Anticoagulants

KW - Prognostic score

KW - Uterine bleeding

KW - Venous thromboembolism

UR - http://www.scopus.com/inward/record.url?scp=85176109809&partnerID=8YFLogxK

U2 - 10.1016/j.tru.2023.100148

DO - 10.1016/j.tru.2023.100148

M3 - Article

AN - SCOPUS:85176109809

SN - 2666-5727

VL - 13

JO - Thrombosis Update

JF - Thrombosis Update

M1 - 100148

ER -

A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Abstract

Keywords*

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UN SDGs

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