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

Hoberstorfer, T.; Nopp, S.; Steiner, D.; Hernandez-Blasco, L.; Jou, I.; Lopez-Nunez, J. J.; Fidalgo, A.; Lopez-Miguel, P.; Monreal, M.; Ay, C.; Monreal, M.; Prandoni, P.; Brenner, B.; Farge-Bancel, D.; Barba, R.; Verhamme, P.; Yoo, H. H. B.; Maly, R.; Bertoletti, L.; Schellong, S.; Tzoran, I.; Di Micco, P.; Reis, A.; Bosevski, M.; Mazzolai, L.; Joseph, A.; Caprini,; Bui, H. M.; Adarraga, M. D.; Aibar, J.; Alberich-Conesa, A.; Alda-Lozano, A.; Alfonso, J.; Amado, C.; Angelina-Garcia, M.; Arcelus, J. I.; Ballaz, A.; Barba, R.; Barbagelata, C.; Barron, M.; Barron-Andres, B.; Bencosme-de Mendez, E. I.; Blanco-Molina, A.; Bonavila, C. S.; Caballero, J. C.; Cantarella, R. F.; Chasco, L.; Claver, G.; Crecente, P.; Criado, J.; De Ancos-Aracil, C.; De Juana-Izquierdo, C.; Del Toro, J.; Demelo-Rodriguez, P.; Diaz-Brasero, A. M.; Diaz-Pedroche, M. C.; Diaz-Peromingo, J. A.; Dubois-Silva, A.; Duran, D.; Escribano, J. C.; Farfan-Sedano, A. I.; Fernandez-Bermejo, L. A.; Fernandez-Capitan, C.; Fernandez-Reyes, J. L.; Fidalgo, M. A.; Francisco, I.; Gabara, C.; Galeano-Valle, F.; Garcia-Bragado, F.; Garcia-Ortega, A.; Gavin-Sebastian, O.; Gil-Diaz, A.; Gomez-Cepeda, C.; Gomez-Cuervo, C.; Gonzalez-Martinez, J. G.; Gonzalez-Munera, A.; Gonzalez-Olmedo, J.; Gorostidi-Perez, J.; Grau, E.; Guirado, L.; Gutierrez-Guisado, J.; Heredia-Mena, C.; Hernandez-Blasco, L.; Hernandez-Vidal, M. J.; Jara-Palomares, L.; Jimenez, D.; Jou, I.; Joya, M. D.; Lainez-Justo, S.; Lecumberri, R.; Llamas, P.; Lopez-Brull, H.; Lopez-Jimenez, L.; Lopez-Miguel, P.; Lopez-Nunez, J. J.; Lopez-Ruiz, A.; Lopez-Saez, J. B.; Lorenzo, A.; Madronal-Cerezo, E.; Maestre, A.; Marchena, P. J.; Marcos, M.; Martin-del Pozo, M.; Mas-Maresma, L.; Mercado, M. I.; Monreal, M.; Monzon, L.; Nieto, J. A.; Nunez-Fernandez, M. J.; Olivares, M. C.; Ordieres-Ortega, L.; Ortiz, M.; Otalora, S.; Otero, R.; Pagan, J.; Parra-Caballero, P.; Payro-Bisart, N.; Pedrajas, J. M.; Perez-Ductor, C.; Perez-Pinar, M.; Peris, M. L.; Pesce, M. L.; Porras, J. A.; Prieto-Ganan, L. M.; Puchades, R.; Puche, G.; Raposo, S.; Rivas, A.; Rivera-Civico, F.; Rodriguez-Cobo, A.; Ruiz-Gimenez, N.; Salgueiro, G.; Sanchez-Serrano, M.; Sancho, T.; Sendin, V.; Sole, A.; Soler, S.; Suarez-Fernandez, S.; Teres-Pueyo, L.; Tolosa, C.; Torres, M. I.; Trujillo-Santos, J.; Uresandi, F.; Valle, R.; Varona, J. F.; Vazquez, E.; Vega-Romero, E.; Vela-Moreno, J. R.; Vela-Valle, L.; Vidal, G.; Villares, P.; Ay, C.; Nopp, S.; Pabinger, I.; Van Thillo, Q.; Vanassche, T.; Verhamme, P.; Yoo, H. H. B.; Jimenez-Echandia, C. A.; Montenegro, A. C.; Roa, J.; Hirmerova, J.; Maly, R.; Accassat, S.; Bertoletti, L.; Bura-Riviere, A.; Catella, J.; Chopard, R.; Espitia, O.; Leclercq, B.; Mahe, I.; Moustafa, F.; Plaisance, L.; Poenou, G.; Quere, I.; Sarlon-Bartoli, G.; Suchon, P.; Versini, E.; Schellong, S.; Jenab, Y.; Khodayari, A.; Sadeghipour, P.; Yadangi, S.; Brenner, B.; Dally, N.; Kenet, G.; Tzoran, I.; Barillari, G.; Basaglia, M.; Bazza, A.; Bilora, F.; Bissacco, D.; Bortoluzzi, C.; Bortoluzzi, M.; Brandolin, B.; Casana, R.; Ciammaichella, M. M.; Di Micco, P.; Giorgi-Pierfranceschi, M.; Imbalzano, E.; Lambertenghi-Deliliers, D.; Pesavento, R.; Pizzuti, V.; Poz, A.; Prandoni, P.; Scandiuzzi-Piovesan, T.; Scarinzi, P.; Siniscalchi, C.; Zalunardo, B.; Cesnieks, H.; Kigitovica, D.; Skride, A.; Tazi-Mezalek, Z.; Fonseca, S.; Marques, R.; Meireles, J.; Soeiro, B.; Bosevski, M.; Barco, S.; Elbaranes, N.; Mazzolai, L.; Rimann, L.; Angiolillo, D. J.; Caprini, J. A.; Khalil, A.; Ortega-Paz, L.; Tafur, A. J.; Weinberg, I.; Bui, H. M.

doi:10.1016/j.jtha.2025.08.007

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.