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. 2025 Aug 22:S1538-7836(25)00529-X.
doi: 10.1016/j.jtha.2025.08.007. Online ahead of print.

External validation of the VTE-PREDICT score for predicting recurrence and bleeding in venous thromboembolism: results from the Registro Informatizado Enfermedad TromboEmbὀlica Registry

Timothy Hoberstorfer  1 , Stephan Nopp  2 , Daniel Steiner  2 , Luis Hernández-Blasco  3 , Inés Jou  4 , Juan José López-Núñez  5 , Ángeles Fidalgo  6 , Patricia López-Miguel  7 , Manuel Monreal  8 , Cihan Ay  9 ; RIETE Investigators
Collaborators, Affiliations
Free article

External validation of the VTE-PREDICT score for predicting recurrence and bleeding in venous thromboembolism: results from the Registro Informatizado Enfermedad TromboEmbὀlica Registry

Timothy Hoberstorfer et al. J Thromb Haemost. .
Free article

Abstract

Background: The VTE-PREDICT score predicts venous thromboembolism (VTE) recurrence and clinically relevant bleeding (CRB; major and clinically relevant nonmajor bleeding) after acute VTE.

Objectives: We aimed to externally validate the VTE-PREDICT score in the Registro Informatizado Enfermedad TromboEmbὀlica, a prospective registry of patients with VTE.

Methods: Exclusion criteria included enrollment before 2012, active cancer, and anticoagulation other than direct oral anticoagulants, vitamin K antagonists, or low-molecular-weight heparin. VTE recurrence and CRB risks were calculated using VTE-PREDICT for a prediction period of 3 months after the index VTE until the following 1 to 5 years. Predicted risks were then compared with observed risks. C-statistics and calibration plots were assessed.

Results: In total, 17 850 patients (50.3% women) were included in the final analysis, of whom 64.3% had pulmonary embolism. The median age was 67 years (IQR, 52-78). Regarding long-term anticoagulation, 21.8% of patients were treated with a direct oral anticoagulant, 39.9% with a vitamin K antagonist, and 4.8% with low-molecular-weight heparin, whereas 33.6% received no anticoagulant treatment. Cumulative incidences of VTE recurrence and CRB at 1 year were 3.7% (95% CI, 3.4%-4.0%) and 2.6% (95% CI, 2.4%-2.9%), respectively. The c-statistics of VTE-PREDICT for 1 to 5 years varied between 0.70 (95% CI, 0.67-0.72) and 0.73 (95% CI, 0.69-0.76) for VTE recurrence and between 0.65 (95% CI, 0.63-0.67) and 0.67 (95% CI, 0.64-0.70) for CRB. Calibration analysis revealed underestimation of VTE recurrence and overestimation of CRB risk.

Conclusion: VTE-PREDICT showed good discrimination for VTE recurrence and moderate discrimination for CRB, but underestimated the risk of VTE recurrence in high-risk patients.

Keywords: anticoagulants; hemorrhage; pulmonary embolism; recurrence; venous thrombosis.

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Conflict of interest statement

Declaration of competing interests T.H., S.N., D.S., L.H.-B., I.J., A.F., and P.L.-M. report no conflicts of interest. J.J.L.-N. reports honoraria for consultancy or advisory role for Pfizer, for lectures from Bayer, Pfizer/Bristol Myers Squibb, Rovi, Techdow, Sanofi, and Viatris, and personal fees from Bayer, Pfizer/Bristol Myers Squibb, Rovi, Sanofi, and Viatris. M.M. reports that he received educational grants to support the Registro Informatizado Enfermedad TromboEmbὀlica (RIETE) Registry from Sanofi, Rovi, and the Universidad Católica San Antonio de Murcia (Spain). C.A. reports honoraria for lectures from AstraZeneca, Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi, and participation in advisory boards for Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi outside the current work.

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