TY - JOUR
T1 - A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism
AU - Coordinator of the RIETE Registry
AU - RIETE Steering Committee Members
AU - RIETE National Coordinators
AU - RIETE Registry Coordinating Center: S & H Medical Science Service
AU - Members of the RIETE Group
AU - Sarlon-Bartoli, Gabrielle
AU - Criado, Juan
AU - Middeldorp, Saskia
AU - Nieto, José Antonio
AU - Díaz-Pedroche, María del Carmen
AU - Moustafa, Farès
AU - Ruiz-Giménez, Nuria
AU - Brenner, Benjamin
AU - Monreal, Manuel
AU - DI Micco, Pierpaolo
AU - Prandoni, Paolo
AU - Farge-Bancel, Dominique
AU - Barba, Raquel
AU - Bertoletti, Laurent
AU - Schellong, Sebastian
AU - Tzoran, Inna
AU - Reis, Abilio
AU - Bosevski, Marijan
AU - Bounameaux, Henri
AU - Malý, Radovan
AU - Verhamme, Peter
AU - Caprini, Joseph A.
AU - Bui, Hanh My
AU - Adarraga, M. D.
AU - Agudo, P.
AU - Amado, C.
AU - Arcelus, J. I.
AU - Ballaz, A.
AU - Bascuñana, J.
AU - Barba, R.
AU - Barbagelata, C.
AU - Barrón, M.
AU - Barrón-Andrés, B.
AU - Blanco-Molina, A.
AU - Beddar Chaib, F.
AU - Botella, E.
AU - Cañas, I.
AU - Carrero-Arribas, R.
AU - Casado, I.
AU - Cerdá, P.
AU - Chasco, L.
AU - Criado, J.
AU - de Ancos, C.
AU - de Miguel, J.
AU - del Toro, J.
AU - Demelo-Rodríguez, P.
AU - Díaz-Brasero, A. M.
AU - Díaz-Pedroche, M. C.
AU - Díaz-Peromingo, J. A.
AU - Domínguez, I. M.
N1 - Funding Information: We express our gratitude to Sanofi Spain, LEO PHARMA and ROVI for supporting this Registry with an unrestricted educational grant. We also thank the RIETE Registry Coordinating Center, S&H Medical Science Service, for their quality control data, logistic and administrative support. Publisher Copyright: © 2023
PY - 2023/12/1
Y1 - 2023/12/1
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 - https://doi.org/10.1016/j.tru.2023.100148
DO - https://doi.org/10.1016/j.tru.2023.100148
M3 - Article
SN - 2666-5727
VL - 13
JO - Thrombosis Update
JF - Thrombosis Update
M1 - 100148
ER -