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1. Comparative clinical prognosis of massive and non‐massive pulmonary embolism: A registry‐based cohort study

Author

Blondon, Marc, Jimenez, David, Robert‐Ebadi, Helia, Del Toro, Jorge, Lopez‐Jimenez, Luciano, Falga, Conxita, Skride, Andris, Font, Llorenç, Vazquez, Fernando Javier, Bounameaux, Henri, Monreal, Manuel, Prandoni, Paolo, Brenner, Benjamin, Farge‐Bancel, Dominique, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Schellong, Sebastian, Tzoran, Inna, Reis, Abilio, Bosevski, Marijan, Malý, Radovan, Verhamme, Peter, Caprini, Joseph A, My Bui, Hanh, Adarraga, MD, Agud, M, Aibar, J, Aibar, MA, Alfonso, J, Amado, C, Arcelus, JI, Baeza, C, Ballaz, A, Barba, R, Barbagelata, C, Barrón, M, Barrón‐Andrés, B, Blanco‐Molina, A, Botella, E, Camon, AM, Castro, J, Caudevilla, MA, Cerdà, P, Chasco, L, Criado, J, de Ancos, C, de Miguel, J, Demelo‐Rodríguez, P, Díaz‐Peromingo, JA, Díez‐Sierra, J, Díaz‐Simón, R, Domínguez, IM, Encabo, M, Escribano, JC, Falgá, C, Farfán, AI, Fernández‐Capitán, C, Fernández‐Reyes, JL, Fidalgo, MA, Flores, K, Font, C, Francisco, I, Gabara, C, Galeano‐Valle, F, García, MA, García‐Bragado, F, García‐Mullor, MM, Gavín‐Blanco, O, Gavín‐Sebastián, O, Gil‐Díaz, A, Gómez‐Cuervo, C, González‐Martínez, J, Grau, E, Guirado, L, Gutiérrez, J, Hernández‐Blasco, L, Jara‐Palomares, L, Jaras, MJ, Jiménez, D, Joya, MD, Jou, I, Lacruz, B, Lecumberri, R, Lima, J, Lobo, JL, López‐Brull, H, López‐Jiménez, L, López‐Miguel, P, López‐Núñez, JJ, López‐Reyes, R, López‐Sáez, JB, Lorente, MA, Lorenzo, A, Loring, M, Madridano, O, Maestre, A, Marchena, PJ, Martín del Pozo, M, Martín‐Martos, F, Martínez‐Baquerizo, C, Mella, C, Mellado, M, Mercado, MI, Moisés, J, Morales, MV, Muñoz‐Blanco, A, Muñoz‐Guglielmetti, D, Muñoz‐Rivas, N, Nart, E, Nieto, JA, Núñez, MJ, Olivares, MC, Ortega‐Michel, C, Ortega‐Recio, MD, Osorio, J, Otalora, S, Otero, R, Parra, P, Parra, V, Pedrajas, JM, Pellejero, G, Pérez‐Jacoiste, A, Peris, ML, Pesántez, D, Porras, JA, Portillo, J, Reig, L, Riera‐Mestre, A, Rivas, A, Rodríguez‐Cobo, A, Rodríguez‐Matute, C, Rogado, J, Rosa, V, Rubio, CM, Ruiz‐Artacho, P, Ruiz‐Giménez, N, Ruiz‐Ruiz, J, Ruiz‐Sada, P, Sahuquillo, JC, Salgueiro, G, Sampériz, A, Sánchez‐Muñoz‐Torrero, JF, Sancho, T, Sigüenza, P, Sirisi, M, Soler, S, Suárez, S, Suriñach, JM, Tiberio, G, Torres, MI, Tolosa, C, Trujillo‐Santos, J, Uresandi, F, Usandizaga, E, Valle, R, Vela, JR, Vidal, G, Vilar, C, Villares, P, Zamora, C, Gutiérrez, P, Vázquez, FJ, Vanassche, T, Vandenbriele, C, Verhamme, P, Hirmerova, J, Malý, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura‐Riviere, A, Crichi, B, Debourdeau, P, Espitia, O, Farge‐Bancel, D, Helfer, H, Mahé, I, Moustafa, F, Poenou, G, Schellong, S, Braester, A, Brenner, B, Tzoran, I, Amitrano, M, Bilora, F, Bortoluzzi, C, Brandolin, B, Ciammaichella, M, Colaizzo, D, Dentali, F, Di Micco, P, Giammarino, E, Grandone, E, Mangiacapra, S, Mastroiacovo, D, Maida, R, Mumoli, N, Pace, F, Pesavento, R, Pomero, F, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Tufano, A, Visonà, A, Vo Hong, N, Zalunardo, B, Kalejs, RV, Maķe, K, Ferreira, M, Fonseca, S, Martins, F, Meireles, J, Bosevski, M, Zdraveska, M, Mazzolai, L, Caprini, JA, Tafur, AJ, Weinberg, I, Wilkins, H, and Bui, HM

Published
2021
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2. Incidence of major adverse cardiovascular events among patients with provoked and unprovoked venous thromboembolism: Findings from the Registro Informatizado de Enfermedad Tromboembólica Registry

Author

Monreal, Manuel, Prandoni, Paolo, Brenner, Benjamin, Farge-Bancel, Dominique, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Tzoran, Inna, Reis, Abilio, Bounameaux, Henri, Malý, Radovan, Verhamme, Peter, Bosevski, Marijan, Caprini, Joseph A., Bui, Hanh My, Adarraga, M.D., Aibar, M.A., Aibar, J., Amado, C., Arcelus, J.I., Azcarate, P.M., Ballaz, A., Barba, R., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Blanco-Molina, A., Camon, A.M., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Díaz-Simón, R., Encabo, M., Falgá, C., Farfán, A.I., Fernández-Capitán, C., Fernández-Criado, M.C., Fidalgo, M.A., Font, C., Font, L., García, M.A., García-Bragado, F., García-Morillo, M., García-Raso, A., Gavín, O., Gaya, I., Gayol, M.C., Gil-Díaz, A., Guirado, L., Gómez, V., González-Martínez, J., Grau, E., Gutiérrez, J., Hernández Blasco, L.M., Iglesias, M., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jou, I., Joya, M.D., Lalueza, A., Lima, J., Llamas, P., Lobo, J.L., López-Jiménez, L., López-Miguel, P., López-Nuñez, J.J., López-Reyes, R., López-Sáez, J.B., Lorente, M.A., Lorenzo, A., Loring, M., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P.J., Martín-Guerra, J.M., Martín Fernández, M., Mellado, M., Monreal, M., Morales, M.V., Nieto, J.A., Núñez, M.J., Olivares, M.C., Otalora, S., Otero, R., Pedrajas, J.M., Pellejero, G., Pérez-Pinar, M., Pérez-Rus, G., Peris, M.L., Pesce, M.L., Porras, J.A., Rivas, A., Rodríguez-Dávila, M.A., Rodríguez-Fernández, L., Rodríguez-Hernández, A., Rodríguez-Martín, C., Rubio, C.M., Ruiz-Alcaraz, S., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J.C., Salazar, V., Sampériz, A., Sánchez-Muñoz-Torrero, J.F., Sancho, T., Sanoja, I., Soler, S., Soto, M.J., Suriñach, J.M., Tolosa, C., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vidal, G., Gutiérrez, P., Vázquez, F.J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Verhamme, P., Hirmerova, J., Malý, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Debourdeau, P., Falvo, N., Farge-Bancel, D., Hij, A., Mahé, I., Moustafa, F., Braester, A., Brenner, B., Ellis, M., Tzoran, I., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Mumoli, N., Vo Hong, N., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visonà, A., Skride, A., Sablinskis, K., Sablinskis, M., Bosevski, M., Zdraveska, M., Bounameaux, H., Fresa, M., Ney, B., Mazzolai, L., Caprini, J., Tafur, A., Bui, H.M., Golemi, Iva, Cote, Lauren, Iftikhar, Omer, Tafur, Alfonso, Bikdeli, Behnood, Fernández-Capitán, Carmen, Pedrajas, José María, Otero, Remedios, and Quintavalla, Roberto

Published
2020
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3. Edoxaban for the Long‐Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised?

Author

Camporese, G., Simioni, P., Di Micco, P., Fernandez-Capitan, C., Rivas, A., Font, C., Sahuquillo, J. C., Villares, P., Prandoni, P., Monreal, M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Arcelus, J. I., Baeza, C., Ballaz, A., Barba, R., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Castro, J., Caudevilla, M. A., Cerda, P., Chasco, L., Criado, J., de Ancos, C., de Miguel, J., del Toro, J., Demelo-Rodriguez, P., Diaz-Peromingo, J. A., Diez-Sierra, J., Dominguez, I. M., Encabo, M., Escribano, J. C., Falga, C., Farfan, A. I., Fernandez de Roitegui, K., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, L., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Mullor, M. M., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Joya, M. D., Jou, I., Lacruz, B., Lalueza, A., Lecumberri, R., Lima, J., Lobo, J. L., Lopez-Brull, H., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Martinez-Baquerizo, C., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Munoz-Rivas, N., Nart, E., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Recio, M. D., Osorio, J., Otalora, S., Otero, R., Paredes, D., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Peris, M. L., Pesantez, D., Porras, J. A., Portillo, J., Ramos, E., Reig, L., Riera-Mestre, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rogado, J., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Siguenza, P., Sirisi, M., Soler, S., Suarez, S. Surinach J. M., Tiberio, G., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vidal, G., Vilar, C., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Verhamme, P., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Crichi, B., Debourdeau, P., Espitia, O., Farge-Bancel, D., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Schellong, S., Braester, A., Brenner, B., Tzoran, I., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., Colaizzo, D., Dentali, F., Giammarino, E., Grandone, E., Mangiacapra, S., Mastroiacovo, D., Maida, R., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Make, K., Meilanden, K., Skride, A., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Caprini, J. A., Tafur, A. J., Weinberg, I., Wilkins, H., Bui, H. M., and UAM. Departamento de Medicina

Subjects
Male, medicine.medical_specialty, Time Factors, Dose, Medicina, Pyridines, Hemorrhage, General Biochemistry, Genetics and Molecular Biology, Article, chemistry.chemical_compound, Edoxaban, Recurrence, Internal medicine, medicine, Humans, Prospective Studies, Registries, General Pharmacology, Toxicology and Pharmaceutics, Long term therapy, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Drug Tapering, business.industry, lcsh:Public aspects of medicine, General Neuroscience, Mortality rate, Research, lcsh:RM1-950, Hazard ratio, Anticoagulants, lcsh:RA1-1270, General Medicine, Articles, Venous Thromboembolism, Middle Aged, Confidence interval, Thiazoles, lcsh:Therapeutics. Pharmacology, chemistry, Practice Guidelines as Topic, Dose reduction, Female, business, Venous thromboembolism, Follow-Up Studies
Abstract

Edoxaban is used for venous thromboembolism (VTE) treatment. Real-life data are lacking about its use in long-term therapy. We aimed to assess the efficacy and the safety of edoxaban for long-term VTE treatment in a real-life setting. Patients with VTE included in the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry, receiving edoxaban 60 or 30 mg daily were prospectively followed up to validate the benefit of using different dosages. The main outcome was the composite of VTE recurrences or major bleeding in patients with or without criteria for dose reduction. Multivariable analysis to identify predictors for the composite outcome was performed. From October 2015 to November 2019, 562 patients received edoxaban for long-term therapy. Most (94%) of the 416 patients not meeting criteria for dose reduction received 60 mg daily, and 92 patients meeting criteria (63%) received 30 mg daily. During treatment, two patients developed recurrent VTE, six had major bleeding and nine died (2 from fatal bleeding). Among patients not meeting criteria for dose reduction, those receiving 30 mg daily had a higher rate of the composite event (hazard ratio (HR) 8.37; 95% confidence interval (CI) 1.12–42.4) and a significant higher mortality rate (HR 31.1; 95% CI 4.63–262) than those receiving 60 mg. Among patients meeting criteria for dose reduction, those receiving 60 mg daily had no events, and a nonsignificantly higher mortality rate (HR 5.04; 95% CI 0.54–133) than those receiving 30 mg daily. In conclusion, edoxaban seems to be effective and safe for long-term VTE treatment in real life. Criteria for dose reduction should be reformulated., No funding was received for this work

Published
2020

4. Real-Time Dissemination of Aggregate Data on Presentation and Outcomes of Patients With Venous Thromboembolism: The RIETE Infographics Project

Author

Tafur, A., Bikdeli, B., Weinberg, I., Jimenez, D., Monreal, A., Barba, R., Mira, E., Macrinici, V., Krumholz, H. M., Hawkins, M., Monreal, M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Arcelus, J. I., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Canas, I., Castro, J., Cerda, P., Criado, J., de Ancos, C., de Miguel, J., del Toro, J., Demelo-Rodriguez, P., Diaz-Peromingo, J. A., Diez-Sierra, J., Diaz-Simon, R., Dominguez, I. M., Encabo, M., Escribano, J. C., Falga, C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Font, L., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Mullor, M. M., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Joya, M. D., Jou, I., Lacruz, B., Lecumberri, R., Lima, J., Lobo, J. L., Lopez-Brull, H., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Guerra, J. M., Martin-Martos, F., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Michel, C., Ortega-Recio, M. D., Osorio, J., Otero, R., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Perez-Jacoiste, A., Peris, M. L., Pesantez, D., Porras, J. A., Ramos, E., Reig, L., Riera-Mestre, A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Soler, S., Suarez, S., Surinach, J. M., Tiberio, G., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vidal, G., Villares, P., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Verhamme, P., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Crichi, B., Debourdeau, P., Espitia, O., Farge-Bancel, D., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Schellong, S., Braester, A., Brenner, B., Tzoran, I., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Colaizzo, D., Dentali, F., Di Micco, P., Giammarino, E., Grandone, E., Mangiacapra, S., Mastroiacovo, D., Maida, R., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Gibietis, V., Kigitovica, D., Skride, A., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Caprini, J. A., Tafur, A. J., Wilkins, H., Bui, H. M., Tafur, A., Bikdeli, B., Weinberg, I., Jimenez, D., Monreal, A., Barba, R., Mira, E., Macrinici, V., Krumholz, H. M., Hawkins, M., Monreal, M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Arcelus, J. I., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Canas, I., Castro, J., Cerda, P., Criado, J., de Ancos, C., de Miguel, J., del Toro, J., Demelo-Rodriguez, P., Diaz-Peromingo, J. A., Diez-Sierra, J., Diaz-Simon, R., Dominguez, I. M., Encabo, M., Escribano, J. C., Falga, C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Font, L., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Mullor, M. M., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Joya, M. D., Jou, I., Lacruz, B., Lecumberri, R., Lima, J., Lobo, J. L., Lopez-Brull, H., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Guerra, J. M., Martin-Martos, F., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Michel, C., Ortega-Recio, M. D., Osorio, J., Otero, R., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Perez-Jacoiste, A., Peris, M. L., Pesantez, D., Porras, J. A., Ramos, E., Reig, L., Riera-Mestre, A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Soler, S., Suarez, S., Surinach, J. M., Tiberio, G., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vidal, G., Villares, P., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Verhamme, P., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Crichi, B., Debourdeau, P., Espitia, O., Farge-Bancel, D., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Schellong, S., Braester, A., Brenner, B., Tzoran, I., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Colaizzo, D., Dentali, F., Di Micco, P., Giammarino, E., Grandone, E., Mangiacapra, S., Mastroiacovo, D., Maida, R., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Gibietis, V., Kigitovica, D., Skride, A., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Caprini, J. A., Tafur, A. J., Wilkins, H., and Bui, H. M.

Subjects
Male, 0301 basic medicine, lcsh:Diseases of the circulatory (Cardiovascular) system, pulmonary embolism, Patient Empowerment, media_common.quotation_subject, 030204 cardiovascular system & hematology, Data Aggregation, 03 medical and health sciences, Presentation, 0302 clinical medicine, thrombosis, pulmonary embolism, risk assessment, Humans, Medicine, Prospective Studies, Registries, cardiovascular diseases, thrombosis, media_common, business.industry, Infographic, risk assessment, Venous Thromboembolism, Hematology, General Medicine, Precision medicine, medicine.disease, Treatment Outcome, 030104 developmental biology, lcsh:RC666-701, Female, Original Article, Aggregate data, Medical emergency, business, Risk assessment, Venous thromboembolism
Abstract

In the current era of patient empowerment and precision medicine, access to timely information is critical to decision-making. Unfortunately, we currently lack patient-specific, real-time data about clinical presentation, risk of thrombotic or hemorrhagic events, key risk factors, and adverse outcomes in patients with venous thromboembolism (VTE). Accordingly, the Registro Informatizado Enfermedad TromboEmbólica (RIETE) investigators developed a tool to provide an open-source, real-time graphic representation of VTE-related data derived from over 90 000 patients with confirmed VTE. This information is intended to facilitate discussion in the informed decision-making process. The current article describes the aims, rationale, methods, and ongoing and future efforts of the real-time VTE infographics developed by the RIETE registry collaborators.

Published
2020

5. Venous Thromboembolism in Patients With Autoimmune Disorders: Findings From the RIETE Registry

Author

Sada, PR, Lopez-Nunez, JJ, Samperiz, A, Soto, MJ, Pedrajas, JM, Porras, JA, Peris, ML, Debourdeau, P, Pace, F, Monreal, M, Adarraga, MD, Agud, M, Aibar, MA, Alfonso, J, Amado, C, Arcelus, JI, Ballaz, A, Barba, R, Barbagelata, C, Barron, M, Barron-Andres, B, Blanco-Molina, A, Camon, AM, Canas, I, Carrasco, C, Castro, J, Cerda, P, de Ancos, C, del Toro, J, Demelo, P, Diaz-Pedroche, C, Diaz-Peromingo, JA, Diaz-Simon, R, Encabo, M, Escribano, JC, Esposito, F, Falga, C, Farfan, I, Fernandez-Capitan, C, Fernandez-Criado, MC, de Roitegui, KF, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Raso, A, Gavin-Blanco, O, Gavin-Sebastian, O, Gayol, MC, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grau, E, Gutierrez, J, Hernandez-Blasco, LM, Iglesias, M, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jimenez, R, Joya, MD, Jou, I, Lecumberri, R, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Madridano, O, Maestre, A, Marchena, PJ, del Pozo, MM, Martin-Fortea, P, Martin-Martos, F, Martin-Romero, M, Martinez-Baquerizo, C, Martinez-Garcia, MA, Martinez-Gonzalez, L, Mella, C, Mellado, M, Montesa, C, Morales, MV, Nieto, JA, Nunez, MJ, Olivares, MC, Olivera, PE, Otalora, S, Otero, R, Panadero-Macia, M, Pellejero, G, Perez-Ductor, C, Perez-Rus, G, Riera-Mestre, A, Rivas, A, Rodriguez-Cobo, A, Rodriguez-Hernandez, A, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Sahuquillo, JC, Sala-Sainz, MC, Salgueiro, G, Saanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Suarez, S, Surinach, JM, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Valle, R, Vela, JR, Vidal, G, Vilar, C, Villares, P, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Verhamme, P, Hirmerova, J, Maly, R, Celis, G, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Farge-Bancel, D, Helfer, H, Hij, A, Mahe, I, Moustafa, F, Schellong, S, Braester, A, Brenner, B, Tzoran, I, Sharif-Kashani, B, Barillari, G, Bilora, F, Bortoluzzi, C, Brandolin, B, Ceccanti, G, Ciammaichella, M, Dentali, F, Di Micco, P, Imbalzano, E, Landolfi, R, Lessiani, G, Maida, R, Mastroiacovo, D, Pesavento, R, Pomero, F, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Tufano, A, Visona, A, Hong, NV, Zalunardo, B, Gibietis, V, Kigitovica, D, Skride, A, Bosevski, M, Zdraveska, M, Bounameaux, H, Fresa, M, Mazzolai, L, Ney, B, Reis, A, Caprini, JA, and Bui, HM

Subjects
recurrences, anticoagulant therapy, venous thromboembolism, bleeding, autoimmune disorders
Abstract

Patients with autoimmune disorders are at an increased risk of venous thromboembolism (VTE), but this association has not been consistently evaluated. We used the RIETE (Registro Informatizado Enfermedad Trombo Embolica) database to compare the rates of VTE recurrences, major bleeding, and death during the course of anticoagulation, according to the presence or absence of autoimmune disorders. Of 71 625 patients with VTE recruited in February 2018, 1800 (2.5%) had autoimmune disorders. Median duration of anticoagulant therapy was slightly longer in patients with autoimmune disorders (median, 190 vs 182 days; P = .001). On multivariable analysis, patients with autoimmune disorders had a similar risk of VTE recurrences (hazard ratio [HR]: 0.93; 95% confidence interval [CI]: 0.68-1.27) or major bleeding (HR: 1.07; 95% CI: 0.82-1.40) and a lower risk to die (HR: 0.66; 95% CI: 0.54-0.81) than those without autoimmune disorders. Patients with giant cell arteritis had the highest rates of major bleeding (8.6 events per 100 patient-years) and the lowest rate of recurrences (zero). In other subgroups, the rates of both events were more balanced. During anticoagulation, patients with or without autoimmune disorders had similar rates of VTE recurrences or major bleeding. However, there were some differences between subgroups of patients with autoimmune disorders.

Published
2020

6. First three months of anticoagulation for venous thromboembolism in non-cancer patients: LMWH VS. VKAs. Findings from the RIETE registry

Author

Núñez Fernández, Manuel J., primary, Martínez Reglero, Cristina, additional, Nieto Rodríguez, José Antonio, additional, Chouza Piñeiro, Ana, additional, Barcia Sixto, Laura, additional, Maestre Peiró, Ana, additional, Trujillo Santos, Javier, additional, Visonà, Adriana, additional, Fernández-Reyes, José Luis, additional, Monreal Bosch, Manuel, additional, Adarraga, M.D., additional, Agud, M., additional, Aibar, J., additional, Aibar, M.A., additional, Amado, C., additional, Arcelus, J.I., additional, Baeza, C., additional, Ballaz, A., additional, Barba, R., additional, Barbagelata, C., additional, Barrón, M., additional, Barrón-Andrés, B., additional, Bernal, M., additional, Blanco-Molina, A., additional, Botella, E., additional, Camon, A.M., additional, Cañas, I., additional, Casado, I., additional, Castro, J., additional, Chasco, L., additional, Criado, J., additional, de Ancos, C., additional, de Miguel, J., additional, del Toro, J., additional, Demelo-Rodríguez, P., additional, Díaz-Peromingo, J.A., additional, Di Campli, M.V., additional, Díez-Sierra, J., additional, Domínguez, I.M., additional, Encabo, M., additional, Escribano, J.C., additional, Falgá, C., additional, Farfán-Sedano, A.I., additional, Fernández de Roitegui, K., additional, Fernández-Capitán, C., additional, Fernández-Reyes, J.L., additional, Fidalgo, M.A., additional, Flores, K., additional, Font, C., additional, Font, L., additional, Francisco, I., additional, Furest, I., additional, Gabara, C., additional, Galeano-Valle, F., additional, García, M.A., additional, García-Bragado, F., additional, García de Herreros, M., additional, García-Hernáez, R., additional, García-Mullor, M.M., additional, García-Raso, A., additional, Gavín-Sebastián, O., additional, Gil-Díaz, A., additional, Gómez-Cuervo, C., additional, González-Martínez, J., additional, Grau, E., additional, Giménez-Suau, M., additional, Guirado, L., additional, Gutiérrez, J., additional, Hernández-Blasco, L., additional, Hernando, E., additional, Jara-Palomares, L., additional, Jaras, M.J., additional, Jiménez, D., additional, Joya, M.D., additional, Jou, I., additional, Lima, J., additional, Llamas, P., additional, Lobo, J.L., additional, López-Jiménez, L., additional, López-Miguel, P., additional, López-Núñez, J.J., additional, López-Reyes, R., additional, López-Sáez, J.B., additional, Lorenzo, A., additional, Loring, M., additional, Madridano, O., additional, Maestre, A., additional, Marchena, P.J., additional, Martín del Pozo, M., additional, Martín-Martos, F., additional, Mella, C., additional, Mellado, M., additional, Mercado, M.I., additional, Moisés, J., additional, Monreal, M., additional, Morales, M.V., additional, Muñoz-Blanco, A., additional, Muñoz-Guglielmetti, D., additional, Muñoz-Rivas, N., additional, Navas, M.S., additional, Nieto, J.A., additional, Núñez-Ares, A., additional, Núñez-Fernández, M.J., additional, Obispo, B., additional, Olid, M., additional, Olivares, M.C., additional, Orcastegui, J.L., additional, Ortega-Recio, M.D., additional, Osorio, J., additional, Otalora, S., additional, Otero, R., additional, Parra, P., additional, Parra, V., additional, Pedrajas, J.M., additional, Peinado, A., additional, Pellejero, G., additional, Pérez-Jacoiste, A., additional, Porras, J.A., additional, Portillo, J., additional, Riera-Mestre, A., additional, Rivas, A., additional, Rivera, F., additional, Rodríguez-Chiaradía, D.A., additional, Rodríguez-Cobo, A., additional, Rodríguez-Matute, C., additional, Rogado, J., additional, Rojo, R., additional, Rosa, V., additional, Ruiz-Artacho, P., additional, Ruiz-Giménez, N., additional, Ruiz-Ruiz, J., additional, Ruiz-Sada, P., additional, Sahuquillo, J.C., additional, Salgueiro, G., additional, Sampériz, A., additional, Sánchez-Martínez, R., additional, Sánchez-Muñoz-Torrero, J.F., additional, Sancho, T., additional, Soler, S., additional, Suriñach, J.M., additional, Tirado, R., additional, Torres, M.I., additional, Tolosa, C., additional, Trujillo-Santos, J., additional, Uresandi, F., additional, Valero, B., additional, Valle, R., additional, Vela, J.R., additional, Vidal, G., additional, Villares, P., additional, Zamora, C., additional, Gutiérrez, P., additional, Vázquez, F.J., additional, Engelen, M., additional, Vanassche, T., additional, Vehamme, P., additional, Hirmerova, J., additional, Malý, R., additional, Ait Abdallah, N., additional, Bertoletti, L., additional, Bura-Riviere, A., additional, Crichi, B., additional, Debourdeau, P., additional, Espitia, O., additional, Farge-Bancel, D., additional, Helfer, H., additional, Mahé, I., additional, Moustafa, F., additional, Poenou, G., additional, Schellong, S., additional, Braester, A., additional, Brenner, B., additional, Tzoran, I., additional, Bilora, F., additional, Brandolin, B., additional, Bucherini, E., additional, Ciammaichella, M., additional, Colaizzo, D., additional, Di Micco, P., additional, Grandone, E., additional, Imbalzano, E., additional, Maida, R., additional, Mastroiacovo, D., additional, Pace, F., additional, Pesavento, R., additional, Prandoni, P., additional, Quintavalla, R., additional, Rocci, A., additional, Siniscalchi, C., additional, Tufano, A., additional, Visonà, A., additional, Zalunardo, B., additional, Skride, A., additional, Strautmane, S., additional, Zaicenko, A., additional, Ferreira, M., additional, Fonseca, S., additional, Martins, F., additional, Meireles, J., additional, Bosevski, M., additional, Bounameaux, H., additional, Mazzolai, L., additional, Caprini, J.A., additional, Tafur, A.J., additional, Weinberg, I., additional, Wilkins, H., additional, and Bui, H.M., additional

Published
2020
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7. Incidence of major adverse cardiovascular events among patients with provoked and unprovoked venous thromboembolism: Findings from the Registro Informatizado de Enfermedad Tromboembólica Registry

Author

Golemi, Iva, primary, Cote, Lauren, additional, Iftikhar, Omer, additional, Brenner, Benjamin, additional, Tafur, Alfonso, additional, Bikdeli, Behnood, additional, Fernández-Capitán, Carmen, additional, Pedrajas, José María, additional, Otero, Remedios, additional, Quintavalla, Roberto, additional, Monreal, Manuel, additional, Prandoni, Paolo, additional, Farge-Bancel, Dominique, additional, Barba, Raquel, additional, Di Micco, Pierpaolo, additional, Bertoletti, Laurent, additional, Tzoran, Inna, additional, Reis, Abilio, additional, Bounameaux, Henri, additional, Malý, Radovan, additional, Verhamme, Peter, additional, Bosevski, Marijan, additional, Caprini, Joseph A., additional, Bui, Hanh My, additional, Adarraga, M.D., additional, Aibar, M.A., additional, Aibar, J., additional, Amado, C., additional, Arcelus, J.I., additional, Azcarate, P.M., additional, Ballaz, A., additional, Barba, R., additional, Barrón, M., additional, Barrón-Andrés, B., additional, Bascuñana, J., additional, Blanco-Molina, A., additional, Camon, A.M., additional, Carrasco, C., additional, Castro, J., additional, de Ancos, C., additional, del Toro, J., additional, Demelo, P., additional, Díaz-Pedroche, M.C., additional, Díaz-Peromingo, J.A., additional, Díaz-Simón, R., additional, Encabo, M., additional, Falgá, C., additional, Farfán, A.I., additional, Fernández-Capitán, C., additional, Fernández-Criado, M.C., additional, Fidalgo, M.A., additional, Font, C., additional, Font, L., additional, García, M.A., additional, García-Bragado, F., additional, García-Morillo, M., additional, García-Raso, A., additional, Gavín, O., additional, Gaya, I., additional, Gayol, M.C., additional, Gil-Díaz, A., additional, Guirado, L., additional, Gómez, V., additional, González-Martínez, J., additional, Grau, E., additional, Gutiérrez, J., additional, Hernández Blasco, L.M., additional, Iglesias, M., additional, Jara-Palomares, L., additional, Jaras, M.J., additional, Jiménez, D., additional, Jou, I., additional, Joya, M.D., additional, Lalueza, A., additional, Lima, J., additional, Llamas, P., additional, Lobo, J.L., additional, López-Jiménez, L., additional, López-Miguel, P., additional, López-Nuñez, J.J., additional, López-Reyes, R., additional, López-Sáez, J.B., additional, Lorente, M.A., additional, Lorenzo, A., additional, Loring, M., additional, Lumbierres, M., additional, Madridano, O., additional, Maestre, A., additional, Marchena, P.J., additional, Martín-Guerra, J.M., additional, Martín Fernández, M., additional, Mellado, M., additional, Monreal, M., additional, Morales, M.V., additional, Nieto, J.A., additional, Núñez, M.J., additional, Olivares, M.C., additional, Otalora, S., additional, Otero, R., additional, Pedrajas, J.M., additional, Pellejero, G., additional, Pérez-Pinar, M., additional, Pérez-Rus, G., additional, Peris, M.L., additional, Pesce, M.L., additional, Porras, J.A., additional, Rivas, A., additional, Rodríguez-Dávila, M.A., additional, Rodríguez-Fernández, L., additional, Rodríguez-Hernández, A., additional, Rodríguez-Martín, C., additional, Rubio, C.M., additional, Ruiz-Alcaraz, S., additional, Ruiz-Artacho, P., additional, Ruiz-Ruiz, J., additional, Ruiz-Sada, P., additional, Sahuquillo, J.C., additional, Salazar, V., additional, Sampériz, A., additional, Sánchez-Muñoz-Torrero, J.F., additional, Sancho, T., additional, Sanoja, I., additional, Soler, S., additional, Soto, M.J., additional, Suriñach, J.M., additional, Tolosa, C., additional, Torres, M.I., additional, Trujillo-Santos, J., additional, Uresandi, F., additional, Usandizaga, E., additional, Valle, R., additional, Vidal, G., additional, Gutiérrez, P., additional, Vázquez, F.J., additional, Vilaseca, A., additional, Vanassche, T., additional, Vandenbriele, C., additional, Verhamme, P., additional, Hirmerova, J., additional, Malý, R., additional, Salgado, E., additional, Benzidia, I., additional, Bertoletti, L., additional, Bura-Riviere, A., additional, Debourdeau, P., additional, Falvo, N., additional, Farge-Bancel, D., additional, Hij, A., additional, Mahé, I., additional, Moustafa, F., additional, Braester, A., additional, Brenner, B., additional, Ellis, M., additional, Tzoran, I., additional, Barillari, G., additional, Bilora, F., additional, Bortoluzzi, C., additional, Brandolin, B., additional, Bucherini, E., additional, Ciammaichella, M., additional, Dentali, F., additional, Di Micco, P., additional, Grandone, E., additional, Imbalzano, E., additional, Lessiani, G., additional, Maida, R., additional, Mastroiacovo, D., additional, Mumoli, N., additional, Vo Hong, N., additional, Pace, F., additional, Parisi, R., additional, Pesavento, R., additional, Pinelli, M., additional, Prandoni, P., additional, Quintavalla, R., additional, Rocci, A., additional, Siniscalchi, C., additional, Tufano, A., additional, Visonà, A., additional, Skride, A., additional, Sablinskis, K., additional, Sablinskis, M., additional, Bosevski, M., additional, Zdraveska, M., additional, Bounameaux, H., additional, Fresa, M., additional, Ney, B., additional, Mazzolai, L., additional, Caprini, J., additional, Tafur, A., additional, and Bui, H.M., additional

Published
2020
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8. Prediction of early mortality in patients with cancer-associated thrombosis in the RIETE Database

Author

Fuentes, HE, Tafur, AJ, Caprini, JA, Alatri, A, Trujillo-santos, J, Farge-bancel, D, Rosa, V, Font, L, Vilaseca, A, Monreal, M, Adarraga, MD, Aibar, MA, Aibar, J, Amado, C, Aranda, C, Arcelus, JI, Ballaz, A, Barba, R, Barillari, G, Barron, M, Barron-Andres, B, Bascunana, J, Benzidia, I, Bertoletti, L, Blanco-Molina, A, Bilora, F, Bortoluzzi, C, Bosevski, M, Bounameaux, H, Braester, A, Brandolin, B, Brenner, B, Bucherini, E, Bui, HM, Bura-Riviere, A, Camon, AM, Carrasco, C, Castro, J, Cesta, A, Ciammaichella, M, Cruz, JA, de Ancos, C, del Toro, J, Demelo, P, Dentali, F, Diaz-pedroche, MD, Diaz-Peromingo, JA, Di Micco, P, Di Pangrazio, M, Ellis, M, Encabo, M, Falga, C, Falvo, N, Farfan, AI, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Fresa, M, Furest, I, Garcia, MA, Garcia-Braoado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grandone, E, Grau, E, Guijarro, R, Gutierrez, J, Gutierrez, P, Hernandez-Blasco, L, Hu, A, Hirmerova, J, Imbalzano, E, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jou, I, Joya, MD, Krstevski, G, Lessiani, G, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Mahe, I, Maida, R, Maly, R, Manrique-Abos, I, Marchena, PJ, Martin-Fernandez, M, Martin-Guerra, JM, Martin-Romero, M, Mastroiacovo, D, Mazzolai, L, Mellado, M, Merah, A, Morales, MD, Moustafa, F, Ney, B, Nieto, JA, Nunez, MJ, Olivares, MD, Otalora, S, Otero, R, Pace, F, Parisi, R, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Jacoiste, A, Perez-Rus, G, Peris, ML, Pesavento, R, Pesce, ML, Porras, JA, Prandoni, P, Quinta-Valla, R, Riesco, D, Rivas, A, Rocci, A, Rodriguez-Davila, MA, Rodriguez-Hernandez, A, Rubio, CM, Ruiz-Alcaraz, S, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Ruiz-Torregrosa, P, Sahuquillo, JC, Sala-Sainz, C, Salgado, E, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Sanoja, ID, Siniscalchi, C, Skride, A, Soler, S, Sotgiu, P, Soto, MJ, Surinach, JM, Tiraferri, E, Tonello, D, Torres, MI, Tufano, A, Tzoran, I, Uresandi, F, Usandizaga, E, Valle, R, Vanassche, T, Vandenbriele, C, Vazquez, FJ, Verhamme, P, Villalobos, A, Visona, A, Hong, NV, Yoo, HH, and Zdraveska, M

Subjects
Neoplasms, Thrombosis, Mortality, premature
Abstract

Background: Proper risk stratification of patients for early mortality after cancer-associated thrombosis may lead to personalized anticoagulation protocols. Therefore, we aimed to derive and validate a scoring system to predict early mortality in this population. To this end, we selected patients with active cancer and thrombosis from the Computerized Registry of Patients with Venous Thromboembolism database. Methods: The main outcome was all cause mortality within the month following a thrombotic event. We used a simple random selection to split arc data in a derivation and a validation cohort. In the derivation cohort, we used recursive partitioning and binary logistic regression to identify groups at risk and to determine the likelihood of the primary outcome. The risk score was developed based on odds ratios from the final multivariate model, and then tested in the validation cohort. Results: In 10,025 eligible patients, we identified 6 predictors of 30-day mortality: leukocytosis >= 11.5x109/L; platelet count = 7). The AUC for the overall score was 0.74, and using a cutoff >= 7 points, the model had a negative predictive value of 94.4%, a positive predictive value of 23.1%, a sensitivity of 73.3%, and a specificity of 64.6% in the validation cohort. Conclusions: Our validated risk model may assist physicians in the selection of patients for outpatient management, and perhaps anticoagulant, considering expanding anticoagulation options.

Published
2019

9. Frequency and prognostic impact of acute kidney injury in patients with acute pulmonary embolism. Data from the RIETE registry

Author

Murgier, M, Darmon, M, Zeni, F, Valle, R, Del Toro, J, Llamas, P, Mazzolai, L, Villalobos, A, Monreal, M, Brenner, B, Farge-Bancel, D, Barba, R, Di Micco, P, Bertoletti, L, Tzoran, I, Reis, A, Bounameaux, H, Maly, R, Verhamme, P, Bosevski, M, Caprini, JA, Adarraga, MD, Aibar, MA, Aibar, J, Alfonso, M, Amado, C, Aranda, C, Arcelus, JI, Ballaz, A, Barron, M, Barron-Andres, B, Bascunana, J, Blanco-Molina, A, Camon, AM, Carrasco, C, Cruz, AJ, del Pozo, R, del Toro, J, Diaz-Pedroche, MC, Diaz-Peromingo, JA, Encabo, M, Falga, C, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gomez, V, Gonzalez-Martinez, J, Grau, E, Guijarro, R, Gutierrez, J, Isern, V, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jimenez, J, Jou, I, Joya, MD, Lalueza, A, Lima, J, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Madridano, O, Marchena, PJ, Martin-Martos, F, Martin-Romero, M, Morales, MV, Nieto, JA, Nunez, A, Nunez, MJ, Olivares, MC, Otalora, S, Otero, R, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Peris, ML, Pesce, ML, Porras, JA, Riesco, D, Rivas, A, Rodriguez-Davila, MA, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Sahuquillo, JC, Sala-Sainz, MC, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Soto, MJ, Surinach, JM, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Usandizaga, E, Vela, J, Vidal, G, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Hirmerova, J, Salgado, E, Benzidia, I, Bura-Riviere, A, Hij, A, Merah, A, Mahe, I, Moustafa, F, Braester, A, EllisM, Bilora, F, Bortoluzzi, C, Brandolin, B, Bucherini, E, Cattabiani, C, Ciammaichella, M, Dentali, F, DiMicco, P, Giorgi-Pierfranceschi, M, Grandone, E, Imbalzano, E, Maida, R, Mastroiacovo, D, Ngoc, V, Pace, F, Pallotti, G, Parisi, R, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Romualdi, R, Siniscalchi, C, Sotgiu, P, Tiraferri, E, Tonello, D, Tufano, A, Visona, A, Skride, A, Krstevski, G, Zdraveska, M, and Caprini, J

Subjects
Risk, Pulmonary embolism, Bleeding, Mortality, Biomarkers, Acute kidney injury
Abstract

Rationale: Acute kidney injury (AKI) is associated with a poor outcome. Although pulmonary embolism(PE) may promote AKI through renal congestion and/or hemodynamic instability, its frequency and influence on outcome in patients with acute PE have been poorly studied. Methods: The frequency of AKI (defined according to the "Kidney Disease: Improving Global Outcomes" definition) at baseline and its influence on the 30-day mortality was evaluated in patients with acute PE from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. We used multivariate analysis to assess whether the presence of AKI influenced the risk for 30-day death. Results: The study included 21,131 patients, of whom 6222 (29.5%) had AKI at baseline: 4385 patients (21%) in stage 1, 1385 (6.5%) in stage 2 and 452 (2%) in stage 3. The proportion of patients with high-risk PE in those with no AKI, AKI stage 1, AKI stage 2 or AKI stage 3 was: 2.8%, 5.3%, 8.8% and 12%, respectively (p < 0.001). After 30 days, 1236 patients (5.9%) died. Overall mortality was 4% in patients with no AKI, 8.4% in AKI stage 1, 14% in AKI stage 2 and 17% in AKI stage 3 (all p < 0.001). AKI was independently associated with an increased risk of all-cause death at 30 days (odds ratio = 1.25; 95% CI: 1.02-1.54). Conclusions: One in every 3-4 patients with acute PE had AKI at baseline. The presence of AKI independently predicted 30-day mortality. This study suggests that AKI may deserve to be evaluated as a prognostic factor in patients with acute PE. (C) 2019 Elsevier B.V. All rights reserved.

Published
2019

10. Venous thromboembolism in young adults: Findings from the RIETE registry

Author

Lacruz, B, Tiberio, G, Latorre, A, Villalba, JC, Bikdeli, B, Hirmerova, J, Lorenzo, A, Mellado, M, Canas, I, Monreal, M, Adarraga, MD, Agud, M, Agudo, P, Aibar, MA, Aibar, J, Amado, C, Arcelus, JI, Ballaz, A, Barba, R, Barron, M, Barron-Andres, B, Bascunana, J, Bolado, C, Blanco-Molina, A, Camon, AM, Carrasco, C, Castro, J, de Ancos, C, del Toro, J, Demelo, P, Diaz-Simon, R, Diaz-Peromingo, JA, Encabo, M, Falga, C, Farfan, AI, Fernandez-Capitan, C, Fernandez-Criado, MC, Fernandez-Ovalle, H, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gaya-Manso, I, Gayol, MC, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grau, E, Gutierrez, J, Hernandez-Blasco, LM, Iglesias, M, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jou, I, Joya, MD, Lalueza, A, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Loring, M, Madridano, O, Maestre, A, Marchena, PJ, Martin, M, Martin-Fortea, MP, Martin-Guerra, JM, Martinez-Gonzalez, L, Melia, C, Montesa, C, Morales, MV, Nieto, MA, Nieto, JA, Nunez, MJ, Olivares, MC, Otalora, S, Otero, R, Ovejero, A, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Pinar, M, Perez-Rus, G, Penis, ML, Porras, JA, Redrado, J, Rivas, A, Rodriguez-Galan, I, Rodriguez-Hernandez, A, Rubio, CM, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Sahuquillo, JC, Sala-Sainz, MC, Salazar, V, Salgueiro, G, Samperiz, A, Sanchez-Camara, S, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Surinach, JM, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Valle, R, Vidal, G, Villares, P, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Verhamme, P, Yoo, HHB, Maly, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Debourdeau, P, Farge-Bancel, D, Hij, A, Mahe, I, Merah, A, Moustafa, F, Schellong, S, Braester, A, Brenner, B, Ellis, M, Tzoran, I, Sharif-Kashani, B, Barillari, G, Bilora, F, Bortoluzzi, C, Brandolin, B, Ciammaichella, M, Dentali, F, Di Micco, P, Grandone, E, Maida, R, Mastroiacovo, D, Pace, F, Parisi, R, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Sotgiu, P, Tufano, A, Visona, A, Hong, NV, Gibietis, V, Kigitovica, D, Skride, A, Bosevski, M, Bounameaux, H, Mazzolai, L, Caprini, J, Bui, HM, and Pham, KQ

Subjects
Young, Anticoagulants, Outcomes, Venous thromboembolism
Abstract

Background: Little is known on the clinical characteristics, risk factors and outcomes during anticoagulation in young patients with acute venous thromboembolism (VTE). Methods: We used data from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to assess the clinical characteristics, risk factors and outcomes during anticoagulation in VTE patients aged 10-24 years. Data were separately analyzed according to initial presentation and gender. Results: Of 76,719 patients with VTE, 1571 (2.0%) were aged 10-24 years. Of these, 989 (63%) were women and 669 (43%) presented with pulmonary embolism (PE). Most women were using estrogens (680, 69%) or were pregnant (101, 10%), while 59% of men had unprovoked VTE. Women were more likely to present with PE (48% vs. 34%). The majority (87%) of PE patients had Sat O-2 levels >= 90% at baseline. The vast majority (97%) of PE patients were at low risk according to the PESI score, many (90%) at very low risk. During the course of anticoagulation (median, 192 days), 40 patients had VTE recurrences, 17 had major bleeding and 10 died (3 died of PE). Women had as many VTE recurrences as major bleeds (15 vs. 14 events), while men had many more VTE recurrences than major bleeding (25 vs. 3 events). Conclusions: VTE is associated with low risk of short-term mortality in young adults. Noticeable gender differences exist in the risk factor profile and the risk of VTE recurrences and major bleeding in the course of anticoagulation.

Published
2019

11. Statin and all-cause mortality in patients receiving anticoagulant therapy for venous thromboembolism. Data from the RIETE registry

Author

Siniscalchi, C, Quintavalla, R, Rocci, A, Riera-Mestre, A, Trujillo-Santos, J, Surinach, JM, Jara-Palomares, L, Bikdeli, B, Moustafa, F, Monreal, M, Adarraga, MD, Agud, M, Aibar, MA, Alfonso, J, Amado, C, Arcelus, JI, Ballaz, A, Barba, R, Barbagelata, C, Barron, M, Barron-Andres, B, Blanco-Molina, A, Camon, AM, Canas, I, Carrasco, C, Castro, J, Chasco, L, Cerda, P, Demelo, P, Diaz-Peromingo, JA, Elias-Hernandez, T, Encabo, M, Escribano, JC, Falga, C, Farfan, AI, Fernandez-Capitan, C, Fernandez-Criado, MC, Fidalgo, MA, Font, C, Font, L, Furest, I, Galian, JD, Garcia, MA, Garcia-Bragado, F, Garcia-Raso, A, Gavin, O, Gayol, MC, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grau, E, Gutierrez, J, Hernandez-Blasco, LM, Iglesias, M, Jaras, MJ, Jimenez, D, Jimenez, R, Joya, MD, Jou, I, Lalueza, A, Lecumberri, R, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Madridano, O, Maestre, A, Marchena, PJ, del Pozo, MM, Martin-Fortea, P, Martin-Martos, F, Martinez-Garcia, MA, Martinez-Gonzalez, L, Mella, C, Mellado, M, Montesa, C, Morales, MV, Nieto, JA, Nunez, MJ, Olivares, MC, Olivera, PE, Ortega-Michel, C, Otalora, S, Otero, R, Panadero-Macia, M, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Jacoiste, A, Perez-Rus, G, Penis, ML, Pesantez, D, Porras, JA, Rivas, A, Rodriguez-Cobo, A, Rodriguez-Hernandez, A, Rubio, CM, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Sahuquillo, JC, Sala-Sainz, MC, Salazar, V, Salgueiro, G, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Suarez, S, Tolosa, C, Torres, MI, Uresandi, F, Valle, R, Vela, JR, Vidal, G, Villares, P, de Ancos, C, del Toro, J, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Verhamme, P, Yoo, HHB, Hirmerova, J, Maly, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Debourdeau, P, Farge-Bancel, D, Helfer, H, Hij, A, Mahe, I, Schellong, S, Braester, A, Brenner, B, Tzoran, I, Sharif-Kashani, B, Barillari, G, Bilora, F, Bortoluzzi, C, Brandolin, B, Ciammaichella, M, Dentali, F, Di Micco, P, Imbalzano, E, Landolfi, R, Maida, R, Mastroiacovo, D, Pace, F, Pesavento, R, Pomero, F, Prandoni, P, Tufano, A, Ventresca, A, Visona, A, Hong, NV, Zalunardo, B, Gibietis, V, Kigitovica, D, Skride, A, Bosevski, M, Bounameaux, H, Mazzolai, L, Caprini, J, and Bui, HM

Subjects
Venous thomboembolism, Fatal bleeding, Statins, Death all-causes, Fatal pulmonary embolism
Abstract

Background: The clinical outcomes during the course of anticoagulation in patients with venous thromboem-bolism (VTE) using statins remain controversial. Methods: We used the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to compare the risk for VTE recurrences, major bleeding or death during anticoagulation, according to the use of statins at baseline. We used propensity score-matching (PSM) to adjust for confounding variables. Results: From February 2009 to January 2018, 32,062 VTE patients were included. Of these, 7,085 (22%) were using statins. Statin users were 10 years older (73 +/- 11 vs. 63 +/- 19 years, respectively) and more likely to have comorbidities or to be using antiplatelets or corticosteroids at baseline than non-users. During the course of anticoagulation (median, 177 days), 694 patients developed VTE recurrences, 848 bled and 3,169 died (fatal pulmonary embolism 176, fatal bleeding 121). Statin users had a similar rate of VTE recurrences (hazard ratio [HR]: 0.98; 95%CI: 0.82-1.17), a higher rate of major bleeding (HR: 1.29; 95%CI: 1.11-1.50) and a similar mortality rate (HR: 1.01; 95%CI: 0.93-1.10) than non-users. On PSM analysis, statin users had a significantly lower risk for death (HR: 0.62; 95%CI: 0.48-0.79) and a similar risk for VTE recurrences (HR: 0.98; 95%CI: 0.61-1.57) or major bleeding (HR: 0.85; 95%CI: 0.59-1.21) than non-users. Conclusions: During anticoagulation for VTE, patients using statins at baseline had a lower risk to die than nonusers.

Published
2019

12. Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

Author

Mellado, M, Trujillo-Santos, J, Bikdeli, B, Jimenez, D, Nunez, MJ, Ellis, M, Marchena, PJ, Vela, JR, Clara, A, Moustafa, F, Monreal, M, Adarraga, MD, Aibar, MA, Alfonso, M, Arcelus, JI, Ballaz, A, Banos, P, Barba, R, Barron, M, Bascunana, J, Blanco-Molina, A, Camon, AM, Carrasco, C, Chasco, L, Cruz, AJ, Del, PR, Del, TJ, Diaz-Pedroche, MC, Diaz-Peromingo, JA, Encabo, M, Falga, C, Fernandez-Aracil, C, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Raso, A, Garcia-Sanchez, I, Gavin, O, Gomez, C, Gomez, V, Gonzalez, J, Grau, E, Guijarro, R, Guirado, L, Gutierrez, J, Hernandez-Blasco, L, Hernando, E, Isern, V, Jara-Palomares, L, Jaras, MJ, Joya, MD, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Madridano, O, Maestre, A, Martin, M, Martin-Martos, F, Morales, MV, Nieto, JA, Olivares, MC, Otalora, S, Otero, R, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Peris, ML, Pons, I, Porras, JA, Riera-Mestre, A, Rivas, A, Rodriguez-Davila, MA, Rodriguez-Galan, I, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Sahuquillo, JC, Sala-Sainz, MC, Samperiz, A, Sanchez-Artola, B, Sanchez-Martinez, R, Sancho, T, Soler, S, Soto, MJ, Surinach, JM, Tolosa, C, Torres, MI, Uresandi, F, Usandizaga, E, Valero, B, Valle, R, Vela, J, Vidal, G, Villalobos, A, Xifre, B, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Verhamme, P, Yoo, HHB, Wells, P, Hirmerova, J, Maly, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Falvo, N, Farge-Bancel, D, Hij, A, Merah, A, Mahe, I, Quere, I, Braester, A, Brenner, B, Tzoran, I, Antonucci, G, Bilora, F, Bucherini, E, Cattabiani, C, Ciammaichella, M, Dentali, F, Di Micco, P, Doddi, M, Duce, R, Giorgi-Pierfranceschi, M, Grandone, E, Imbalzano, E, Lessiani, G, Maggi, F, Maida, R, Mastroiacovo, D, Pace, F, Pesavento, R, Poggio, R, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Tiraferri, E, Tonello, D, Visona, A, Zalunardo, B, Gibietis, V, Skride, A, Vitola, B, Zdraveska, M, Bounameaux, H, Calanca, L, Fresa, M, and Mazzolai, L

Subjects
Male, medicine.medical_specialty, Vena Cava Filters, Inferior vena cava filter, Hemorrhage, 030204 cardiovascular system & hematology, Lower risk, Statistics, Nonparametric, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Thromboembolism, Anticoagulants, Bleeding, Mortality, Vena cava filter, Venous thromboembolism, Internal Medicine, medicine, Humans, Registries, 030212 general & internal medicine, Aged, Retrospective Studies, Aged, 80 and over, business.industry, Mortality rate, Heparin, Middle Aged, Surgery, Clinical trial, Treatment Outcome, Propensity score matching, Emergency Medicine, Female, business, Major bleeding, medicine.drug
Abstract

The association between inferior vena cava filter (IVC) use and outcome in patients presenting with major bleeding during anticoagulation for venous thromboembolism (VTE) has not been thoroughly investigated. We used the RIETE registry to compare the 30-day outcomes (death, major re-bleeding or VTE recurrences) in VTE patients who bled during the first 3 months of therapy, regarding the insertion of an IVC filter. A propensity score matched (PSM) analysis was performed to adjust for potential confounders. From January 2001 to September 2016, 1065 VTE patients had major bleeding during the first 3 months of anticoagulation (gastrointestinal 370; intracranial 124). Of these, 122 patients (11%) received an IVC filter. Patients receiving a filter restarted anticoagulation later (median, 4 vs. 2 days) and at lower doses (95 +/- 52 IU/kg/day vs. 104 +/- 55 of low-molecular-weight heparin) than those not receiving a filter. During the first 30 days after bleeding (after excluding 246 patients who died within the first 24 h), 283 patients (27%) died, 63 (5.9%) had non-fatal re-bleeding and 19 (1.8%) had recurrent pulmonary embolism (PE). In PSM analysis, patients receiving an IVC filter (n = 122) had a lower risk for all-cause death (HR 0.49; 95% CI 0.31-0.77) or fatal bleeding (HR 0.16; 95% CI 0.07-0.49) and a similar risk for re-bleeding (HR 0.55; 95% CI 0.23-1.40) or PE recurrences (HR 1.57; 95% CI 0.38-6.36) than those not receiving a filter (n = 429). In VTE patients experiencing major bleeding during the first 3 months, use of an IVC filter was associated with reduced mortality rates. Clinical Trial Registration NCT02832245.

Published
2019

13. Clinical characteristics and 3-month outcomes in cancer patients with incidental versus clinically suspected and confirmed pulmonary embolism

Author

Peris, M., Lopez-Nunez, J. J., Maestre, A., Jimenez, D., Muriel, A., Bikdeli, B., Weinberg, I., Ay, C., Mazzolai, L., Lorenzo, A., Monreal, M., Monreel, M., Prandoni, P., Brenner, B., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Schellong, S., Tzoran, I., Reis, A., Bosevski, M., Bounameaux, H., Maly, R., Verhamme, P., Caprini, J. A., Bui, H. M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Aramberri, M., Arcelus, J. I., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Canas, I., Cerda, P., Criado, J., de Ancos, C., de Miguel, J., del Toro, J., Demelo-Rodriguez, P., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Diez-Sierra, J., Dominguez, I. M., Encabo, M., Escribano, J. C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Reyes, J. L., de Roitegui, F. K., Fidalgo, M. A., Flores, K., Font, C., Font, L., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Raso, A., Gavin-Blanco, O., Gavin-Sebastian, O., Gayol, M. C., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L., Iglesias, M., Jara-Palomares, L., Jaras, M. J., Joya, M. D., Jou, I., Lacruz, B., Lalueza, A., Lecumberri, R., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Loring, M., Lumbierres, M., Madridano, O., Manrique-Abos, I., Marchena, P. J., Martin-Asenjo, M., Martin-Fernandez, M., Martin-Guerra, J. M., Martin-Martos, F., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Recio, M. D., Osorio, J., Otero, R., Paredes, D., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Perez-Ductor, C., Perez-Jacoiste, M. A., Peris, M. L., Pesantez, D., Porras, J. A., Portillo, J., Ramos, E., Reig, L., Riera-Mestre, A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Fernandez, L., Rodriguez-Galan, I., Rodriguez-Matute, C., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Ruiz-Torregrosa, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Sanmartin, R., Soler, S., Suarez, S., Surinach, J. M., Tiberio, G., Tolosa, C., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, Vidal, G., Villares, P., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Crichi, B., Debourdeau, P., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Braester, A., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Colaizzo, D., Dentali, F., Giammarino, E., Grandone, E., Maida, R., Mangiacapra, S., Mastroiacovo, D., Pace, F., Pesavento, R., Pomero, F., Quintavalla, R., Rocci, A., Siniscalchi, C., Tiraferri, E., Tufano, A., Ventresca, A., Visona, A., Vo Hong, N., Zalunardo, B., Kigitovica, D., Make, K., Skride, A., Ferreira, M., Meireles, J., Zdraveska, M., Tafur, A. J., and Wilkins, H.

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, business.industry, Mortality rate, Cancer, 030204 cardiovascular system & hematology, medicine.disease, Lower risk, Asymptomatic, Optimal management, Pulmonary embolism, Natural history, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Medicine, In patient, medicine.symptom, business
Abstract

BackgroundCurrent guidelines suggest treating cancer patients with incidental pulmonary embolism (PE) similarly to those with clinically suspected and confirmed PE. However, the natural history of these presentations has not been thoroughly compared.MethodsWe used the data from the RIETE (Registro Informatizado de Enfermedad TromboEmbólica) registry to compare the 3-month outcomes in patients with active cancer and incidental PE versus those with clinically suspected and confirmed PE. The primary outcome was 90-day all-cause mortality. Secondary outcomes were PE-related mortality, symptomatic PE recurrences and major bleeding.ResultsFrom July 2012 to January 2019, 946 cancer patients with incidental asymptomatic PE and 2274 with clinically suspected and confirmed PE were enrolled. Most patients (95% versus 90%) received low-molecular-weight heparin therapy. During the first 90 days, 598 patients died, including 42 from PE. Patients with incidental PE had a lower all-cause mortality rate than those with suspected and confirmed PE (11% versus 22%; OR 0.43, 95% CI 0.34–0.54). Results were consistent for PE-related mortality (0.3% versus 1.7%; OR 0.18, 95% CI 0.06–0.59). Multivariable analysis confirmed that patients with incidental PE were at lower risk of death (adjusted OR 0.43, 95% CI 0.34–0.56). Overall, 29 (0.9%) patients developed symptomatic PE recurrences, and 122 (3.8%) had major bleeding. There were no significant differences in PE recurrences (OR 0.62, 95% CI 0.25–1.54) or major bleeding (OR 0.78, 95% CI 0.51–1.18).ConclusionsCancer patients with incidental PE had a lower mortality rate than those with clinically suspected and confirmed PE. Further studies are required to validate these findings, and to explore optimal management strategies in these patients.

Published
2020

14. Comparative clinical prognosis of massive and non-massive pulmonary embolism: A registry-based cohort study

Author

Marc Blondon, David Jimenez, Helia Robert‐Ebadi, Jorge Del Toro, Luciano Lopez‐Jimenez, Conxita Falga, Andris Skride, Llorenç Font, Fernando Javier Vazquez, Henri Bounameaux, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge‐Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Radovan Malý, Peter Verhamme, Joseph A Caprini, Hanh My Bui, MD Adarraga, M Agud, J Aibar, MA Aibar, J Alfonso, C Amado, JI Arcelus, C Baeza, A Ballaz, R Barba, C Barbagelata, M Barrón, B Barrón‐Andrés, A Blanco‐Molina, E Botella, AM Camon, J Castro, MA Caudevilla, P Cerdà, L Chasco, J Criado, C de Ancos, J de Miguel, P Demelo‐Rodríguez, JA Díaz‐Peromingo, J Díez‐Sierra, R Díaz‐Simón, IM Domínguez, M Encabo, JC Escribano, C Falgá, AI Farfán, C Fernández‐Capitán, JL Fernández‐Reyes, MA Fidalgo, K Flores, C Font, I Francisco, C Gabara, F Galeano‐Valle, MA García, F García‐Bragado, MM García‐Mullor, O Gavín‐Blanco, O Gavín‐Sebastián, A Gil‐Díaz, C Gómez‐Cuervo, J González‐Martínez, E Grau, L Guirado, J Gutiérrez, L Hernández‐Blasco, L Jara‐Palomares, MJ Jaras, D Jiménez, MD Joya, I Jou, B Lacruz, R Lecumberri, J Lima, JL Lobo, H López‐Brull, L López‐Jiménez, P López‐Miguel, JJ López‐Núñez, R López‐Reyes, JB López‐Sáez, MA Lorente, A Lorenzo, M Loring, O Madridano, A Maestre, PJ Marchena, M Martín del Pozo, F Martín‐Martos, C Martínez‐Baquerizo, C Mella, M Mellado, MI Mercado, J Moisés, MV Morales, A Muñoz‐Blanco, D Muñoz‐Guglielmetti, N Muñoz‐Rivas, E Nart, JA Nieto, MJ Núñez, MC Olivares, C Ortega‐Michel, MD Ortega‐Recio, J Osorio, S Otalora, R Otero, P Parra, V Parra, JM Pedrajas, G Pellejero, A Pérez‐Jacoiste, ML Peris, D Pesántez, JA Porras, J Portillo, L Reig, A Riera‐Mestre, A Rivas, A Rodríguez‐Cobo, C Rodríguez‐Matute, J Rogado, V Rosa, CM Rubio, P Ruiz‐Artacho, N Ruiz‐Giménez, J Ruiz‐Ruiz, P Ruiz‐Sada, JC Sahuquillo, G Salgueiro, A Sampériz, JF Sánchez‐Muñoz‐Torrero, T Sancho, P Sigüenza, M Sirisi, S Soler, S Suárez, JM Suriñach, G Tiberio, MI Torres, C Tolosa, J Trujillo‐Santos, F Uresandi, E Usandizaga, R Valle, JR Vela, G Vidal, C Vilar, P Villares, C Zamora, P Gutiérrez, FJ Vázquez, T Vanassche, C Vandenbriele, P Verhamme, J Hirmerova, R Malý, E Salgado, I Benzidia, L Bertoletti, A Bura‐Riviere, B Crichi, P Debourdeau, O Espitia, D Farge‐Bancel, H Helfer, I Mahé, F Moustafa, G Poenou, S Schellong, A Braester, B Brenner, I Tzoran, M Amitrano, F Bilora, C Bortoluzzi, B Brandolin, M Ciammaichella, D Colaizzo, F Dentali, P Di Micco, E Giammarino, E Grandone, S Mangiacapra, D Mastroiacovo, R Maida, N Mumoli, F Pace, R Pesavento, F Pomero, P Prandoni, R Quintavalla, A Rocci, C Siniscalchi, A Tufano, A Visonà, N Vo Hong, B Zalunardo, RV Kalejs, K Maķe, M Ferreira, S Fonseca, F Martins, J Meireles, M Bosevski, M Zdraveska, L Mazzolai, JA Caprini, AJ Tafur, I Weinberg, H Wilkins, HM Bui, Blondon, M., Jimenez, D., Robert-Ebadi, H., Del Toro, J., Lopez-Jimenez, L., Falga, C., Skride, A., Font, L., Vazquez, F. J., Bounameaux, H., Monreal, M., Prandoni, P., Brenner, B., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Schellong, S., Tzoran, I., Reis, A., Bosevski, M., Maly, R., Verhamme, P., Caprini, J. A., My Bui, H., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Alfonso, J., Amado, C., Arcelus, J. I., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Botella, E., Camon, A. M., Castro, J., Caudevilla, M. A., Cerda, P., Chasco, L., Criado, J., de Ancos, C., de Miguel, J., Demelo-Rodriguez, P., Diaz-Peromingo, J. A., Diez-Sierra, J., Diaz-Simon, R., Dominguez, I. M., Encabo, M., Escribano, J. C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Mullor, M. M., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Joya, M. D., Jou, I., Lacruz, B., Lecumberri, R., Lima, J., Lobo, J. L., Lopez-Brull, H., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Martinez-Baquerizo, C., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Munoz-Rivas, N., Nart, E., Nieto, J. A., Nunez, M. J., Olivares, M. C., Ortega-Michel, C., Ortega-Recio, M. D., Osorio, J., Otalora, S., Otero, R., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Perez-Jacoiste, A., Peris, M. L., Pesantez, D., Porras, J. A., Portillo, J., Reig, L., Riera-Mestre, A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rogado, J., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Siguenza, P., Sirisi, M., Soler, S., Suarez, S., Surinach, J. M., Tiberio, G., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vidal, G., Vilar, C., Villares, P., Zamora, C., Gutierrez, P., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Crichi, B., Debourdeau, P., Espitia, O., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Braester, A., Amitrano, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., Colaizzo, D., Dentali, F., Giammarino, E., Grandone, E., Mangiacapra, S., Mastroiacovo, D., Maida, R., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Kalejs, R. V., Maie, K., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Zdraveska, M., Mazzolai, L., Tafur, A. J., Weinberg, I., Wilkins, H., and Bui, H. M.

Subjects
Registrie, medicine.medical_specialty, pulmonary embolism, Prognosi, Hemodynamics, 030204 cardiovascular system & hematology, Cohort Studies, 03 medical and health sciences, Clinical prognosis, 0302 clinical medicine, Recurrence, Internal medicine, Case fatality rate, medicine, Humans, hemorrhage, mortality, prognosis, thrombolytic therapy, Registries, cardiovascular diseases, business.industry, Anticoagulant, Anticoagulants, Hematology, Venous Thromboembolism, Prognosis, medicine.disease, Confidence interval, Pulmonary embolism, Discontinuation, Cohort Studie, business, Venous thromboembolism, Cohort study, Human
Abstract

Aims Little is known about the prognosis of patients with massive pulmonary embolism (PE) and its risk of recurrent venous thromboembolism (VTE) compared with non-massive PE, which may inform clinical decisions. Our aim was to compare the risk of recurrent VTE, bleeding, and mortality after massive and non-massive PE during anticoagulation and after its discontinuation. Methods and results We included all participants in the RIETE registry who suffered a symptomatic, objectively confirmed segmental or more central PE. Massive PE was defined by a systolic hypotension at clinical presentation (

Published
2021

15. Incidence of major adverse cardiovascular events among patients with provoked and unprovoked venous thromboembolism: Findings from the Registro Informatizado de Enfermedad Tromboembólica Registry

Author

Fernando J. Vazquez, Hanh My Bui, R. Maida, Alicia Lorenzo, Iva Golemi, Remedios Otero, R. Otero, G. Pellejero, Pilar Llamas, M.J. Soto, J. del Toro, Inna Tzoran, K. Sablinskis, Carmine Siniscalchi, E. Bucherini, G. Vidal, Juan J. López-Núñez, N. Mumoli, J.M. Suriñach, S. Ruiz-Alcaraz, H. Bounameaux, Jose Gutierrez, E. Salgado, C. Carrasco, I. Gaya, R. Parisi, M.D. Adarraga, Peter Verhamme, Meritxell Mellado, N. Vo Hong, I. Jou, M.C. Gayol, M. García-Morillo, Marco Fresa, Luis Jara-Palomares, Daniela Mastroiacovo, M. Sablinskis, A. Rodríguez-Hernández, R. Díaz-Simón, Miguel Ángel Aibar, David Jiménez, Ángel Sampériz, Raquel López-Reyes, Isabelle Mahé, P. Ruiz-Sada, Martin Ellis, J.A. Porras, Omer Iftikhar, Ángeles Blanco-Molina, J. Aibar, R. Malý, M. Pérez-Pinar, Adriana Visonà, L. Guirado, Carme Font, M. Encabo, M.A. Lorente, María del Carmen Díaz-Pedroche, F. García-Bragado, Gianfranco Lessiani, P. Prandoni, T. Sancho, I. Sanoja, A. Tafur, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, Javier Trujillo-Santos, E. Grau, J. Castro, E. Imbalzano, P. Demelo, A.M. Camon, P. López-Miguel, R. Quintavalla, Alfonso Tafur, Laurent Bertoletti, N. Falvo, J. Ruiz-Ruiz, M. Pinelli, M.A. Fidalgo, Pablo Javier Marchena, Anna Rocci, Aitor Ballaz, José González-Martínez, Andrei Braester, J.F. Sánchez-Muñoz-Torrero, J. Bascuñana, Philippe Debourdeau, J.M. Pedrajas, Giovanni Barillari, C. Vandenbriele, H.M. Bui, M. Iglesias, M. Bosevski, Raffaele Pesavento, Barry M. Brenner, Antonella Tufano, Silvia Soler, F. Pace, Paolo Prandoni, L. Font, L. Bertoletti, A. García-Raso, G. Pérez-Rus, V. Salazar, Juan I. Arcelus, Barbara Ney, Lauren Cote, Raquel Barba, B. Brandolin, Luciano López-Jiménez, Pierpaolo Di Micco, C. Fernández-Capitán, M. Martín Fernández, M.A. García, R. Barba, R. Valle, Carmen Fernández-Capitán, M.L. Pesce, J.M. Martín-Guerra, D. Farge-Bancel, Conxita Falga, M. Lumbierres, Fernando Uresandi, Benjamin Brenner, Elvira Grandone, Mónica Loring, Dominique Farge-Bancel, A. Lalueza, Cristiano Bortoluzzi, M.J. Núñez, M.C. Olivares, Maurizio Ciammaichella, M.D. Joya, Agustina Rivas, Joan Carles Sahuquillo, C.M. Rubio, Abílio Reis, A. Vilaseca, P. Di Micco, Jana Hirmerova, M. Monreal, José María Pedrajas, M.L. Peris, M.A. Rodríguez-Dávila, S. Otalora, F. Bilora, E. Usandizaga, C. Amado, Pedro Ruiz-Artacho, Roberto Quintavalla, B. Barrón-Andrés, P.M. Azcarate, I. Benzidia, Lucia Mazzolai, P. Gutiérrez, Jorge Lima, O. Gavín, Thomas Vanassche, Farès Moustafa, V. Gómez, Andris Skride, Joseph A. Caprini, A. Gil-Díaz, Behnood Bikdeli, A. Hij, L. Rodríguez-Fernández, Olga Madridano, C. Rodríguez-Martín, C. de Ancos, Ana Maestre, M.C. Fernández-Criado, Henri Bounameaux, M.I. Torres, Radovan Malý, A.I. Farfán, I. Tzoran, J.A. Díaz-Peromingo, J.B. López-Sáez, M. Barrón, C. Tolosa, José Luis Lobo, Francesco Dentali, M. Zdraveska, Marijan Bosevski, L.M. Hernández Blasco, J.A. Nieto, Ma Morales, J. Caprini, Golemi, I., Cote, L., Iftikhar, O., Brenner, B., Tafur, A., Bikdeli, B., Fernandez-Capitan, C., Pedrajas, J. M., Otero, R., Quintavalla, R., Monreal, M., Prandoni, P., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Tzoran, I., Reis, A., Bounameaux, H., Maly, R., Verhamme, P., Bosevski, M., Caprini, J. A., Bui, H. M., Adarraga, M. D., Aibar, M. A., Aibar, J., Amado, C., Arcelus, J. I., Azcarate, P. M., Ballaz, A., Barron, M., Barron-Andres, B., Bascunana, J., Blanco-Molina, A., Camon, A. M., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Diaz-Simon, R., Encabo, M., Falga, C., Farfan, A. I., Fernandez-Criado, M. C., Fidalgo, M. A., Font, C., Font, L., Garcia, M. A., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Gavin, O., Gaya, I., Gayol, M. C., Gil-Diaz, A., Guirado, L., Gomez, V., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez Blasco, L. M., Iglesias, M., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jou, I., Joya, M. D., Lalueza, A., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Loring, M., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P. J., Martin-Guerra, J. M., Martin Fernandez, M., Mellado, M., Morales, M. V., Nieto, J. A., Nunez, M. J., Olivares, M. C., Otalora, S., Pellejero, G., Perez-Pinar, M., Perez-Rus, G., Peris, M. L., Pesce, M. L., Porras, J. A., Rivas, A., Rodriguez-Davila, M. A., Rodriguez-Fernandez, L., Rodriguez-Hernandez, A., Rodriguez-Martin, C., Rubio, C. M., Ruiz-Alcaraz, S., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salazar, V., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Sanoja, I., Soler, S., Soto, M. J., Surinach, J. M., Tolosa, C., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vidal, G., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Debourdeau, P., Falvo, N., Hij, A., Mahe, I., Moustafa, F., Braester, A., Ellis, M., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Dentali, F., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Mumoli, N., Vo Hong, N., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Skride, A., Sablinskis, K., Sablinskis, M., Zdraveska, M., Fresa, M., Ney, B., Mazzolai, L., and Caprini, J.

Subjects
Registrie, Male, Time Factors, Databases, Factual, Major adverse cardiovascular event, 030204 cardiovascular system & hematology, Coronary artery disease, 0302 clinical medicine, Retrospective Studie, Cardiovascular Disease, Major adverse limb events, Medicine, Registries, 030212 general & internal medicine, Myocardial infarction, Stroke, Incidence, Incidence (epidemiology), Hazard ratio, Major adverse limb event, Heart Disease Risk Factor, Middle Aged, Prognosis, Cardiovascular Diseases, Major adverse cardiovascular events, Female, VTE, Cardiology and Cardiovascular Medicine, Human, Provoked, Venous thromboembolism, medicine.medical_specialty, Time Factor, Prognosi, Risk Assessment, 03 medical and health sciences, Internal medicine, Humans, cardiovascular diseases, Aged, Retrospective Studies, business.industry, Unstable angina, medicine.disease, equipment and supplies, Confidence interval, Heart Disease Risk Factors, Surgery, business, Mace
Abstract

Registro Informatizado de Enfermedad Tromboembólica Investigators., [Objective] Overlap exists between the risk factors for coronary artery disease and venous thromboembolism (VTE). However, a paucity of data is available on the incidence of major acute cardiovascular events (MACE) and major adverse limb events (MALE) among patients presenting with VTE. Moreover, it is unknown whether the rate of cardiovascular outcomes differs among patients with unprovoked vs provoked VTE., [Methods] We analyzed the data from 2009 to 2017 in the Registro Informatizado de Enfermedad Tromboembólica registry, an ongoing, multicenter, international registry of consecutive patients with a diagnosis of objectively confirmed VTE. The query was restricted it to patients with data entry for the arterial outcomes. The baseline prevalence of coronary artery disease risk factors was compared between patients with provoked (ie, immobility, cancer, surgery, travel >6 hours, hormonal causes) and unprovoked VTE. After the initial VTE event, we followed up patients for the composite primary outcome of incident MACE (ie, stroke, myocardial infarction, unstable angina) and/or MALE (ie, major limb events). We used the χ2 test for baseline associations and a Cox proportional hazard for multivariate analysis. We used IBM SPSS, version 24 (IBM Corp, Armonk, NY) for statistical analysis. A P value of, [Results] We analyzed the data from 41,259 patients with VTE, of whom 22,633 (55.6%) had experienced a provoked VTE. During follow-up, the patients with provoked VTE were more likely to develop MACE or MALE than were patients with unprovoked VTE (hazard ratio [HR], 1.3; 95% confidence interval [CI], 1.1-1.5). The association of arterial events with recent immobility (HR, 1.4; 95% CI, 1.5-12.1) and cancer (HR, 1.7; 95% CI, 1.4-1.9) was strong. After adjusting for multiple conventional cardiovascular risk factors, provoked VTE, compared with unprovoked VTE, was significantly associated with an increased hazard for MACE (HR, 1.4; 95% CI, 1.1-1.7). Cancer remained a significant adjusted predictor for both MACE (HR, 1.7; 95% CI, 1.4-2.1) and MALE (HR, 2.1; 95% CI 1.01-4.6) in those with provoked VTE., [Conclusions] Among patients with VTE, provoked cases, specifically those with cancer-associated VTE, have an increased risk of major arterial events.

Published
2020

16. Monocyte distribution width (MDW) as an infection indicator in severe patients attending in the Emergency Department: a pilot study.

Author

Encabo M, Hernández-Álvarez E, Oteo D, García-Álvarez A, Martínez-Novillo González M, Sanz-Casla MT, and González-Del Castillo J

Subjects
Humans, Male, Aged, Female, Pilot Projects, Prospective Studies, Biomarkers, Emergency Service, Hospital, Monocytes, Sepsis diagnosis
Abstract

Objective: The aim of the present study was to evaluate the diagnostic performance of monocyte distribution width (MDW) as a biomarker for sepsis diagnosis in severe patients attended in the Emergency Department for different conditions and not only infections., Methods: We performed an observational study in a consecutive prospective cohort including severe patients attending the Emergency Department with different conditions. MDW and other biomarkers were determined from samples obtained during the first care of patients. The diagnostic performance of the different biomarkers was determined based on the final diagnosis at patient discharge., Results: One hundred two patients, with a mean age of 76.7 (SD 16.5) years were included, 53 being (51.9%) male. Among the patients included, 65 (63.7%) had an infectious disease while the remaining had other different conditions. A MDW cut-off of 20.115 provided the best accuracy to identify infected patients, with a sensitivity of 89.2 (95% CI 79.4-94.7), a specificity of 89.2 (95% CI 75.3-95.7), a positive predictive value of 93.5 (95% CI 84.6-97.5), a negative predictive value of 82.5% (95% CI 68.0-91.3), a positive likelihood ratio of 8.25 (3.26-20.91), and a negative likelihood ratio of 0.12 (0.06-0.24). The area under the receiver operating characteristic curve for infection according to MDW was 0.943 (95% CI 0.897-0.989; p<0.001)., Conclusions: A MDW > 20.115 may be associated with infection and could help to distinguish between infected and non-infected patients in severe patients. These results must be confirmed in new studies due to the limited patient sample included., (©The Author 2023. Published by Sociedad Española de Quimioterapia. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)(https://creativecommons.org/licenses/by-nc/4.0/).)

Published
2023
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17. COVID-19 in donation and transplant.

Author

Candel FJ, Pardo Rey C, Torres-González JI, Fernández-Vega P, Fragiel M, Oteo D, Del Toro E, Vega-Bayol M, Outon C, Encabo M, García-Marugán A, Resino S, Parra D, Matesanz M, and Del Rio Gallegos FJ

Subjects
Humans, SARS-CoV-2, Pandemics, Tissue Donors, COVID-19, Organ Transplantation
Abstract

SARS-CoV-2 infection has had a major impact on donation and transplantation. Since the cessation of activity two years ago, the international medical community has rapidly generated evidence capable of sustaining and increasing this neccesary activity. This paper analyses the epidemiology and burden of COVID-19 in donation and transplantation, the pathogenesis of the infection and its relationship with graft-mediated transmission, the impact of vaccination on donation and transplantation, the evolution of donation in Spain throughout the pandemic, some lessons learned in SARS-CoV-2 infected donor recipients with positive PCR and the applicability of the main therapeutic tools recently approved for treatment among transplant recipients., (©The Author 2022. Published by Sociedad Española de Quimioterapia. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)(https://creativecommons.org/licenses/by-nc/4.0/).)

Published
2022
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18. Single-dose pharmacokinetics of co-crystal of tramadol-celecoxib: Results of a four-way randomized open-label phase I clinical trial in healthy subjects.

Author

Videla S, Lahjou M, Vaqué A, Sust M, Encabo M, Soler L, Sans A, Sicard E, Gascón N, Encina G, and Plata-Salamán C

Subjects
Administration, Oral, Adolescent, Adult, Analgesics, Opioid blood, Analgesics, Opioid chemistry, Area Under Curve, Celecoxib chemistry, Cross-Over Studies, Crystallization, Cyclooxygenase 2 Inhibitors blood, Cyclooxygenase 2 Inhibitors chemistry, Drug Administration Schedule, Drug Combinations, Drug Compounding, Female, Half-Life, Healthy Volunteers, Humans, Male, Metabolic Clearance Rate, Middle Aged, Models, Biological, Quebec, Tramadol chemistry, Young Adult, Analgesics, Opioid administration & dosage, Analgesics, Opioid pharmacokinetics, Celecoxib administration & dosage, Celecoxib pharmacokinetics, Cyclooxygenase 2 Inhibitors administration & dosage, Cyclooxygenase 2 Inhibitors pharmacokinetics, Tramadol administration & dosage, Tramadol pharmacokinetics
Abstract

Aims: Co-crystal of tramadol-celecoxib (CTC) is a novel co-crystal molecule containing two active pharmaceutical ingredients under development by Esteve (E-58425) and Mundipharma Research (MR308). This Phase I study compared single-dose pharmacokinetics (PK) of CTC with those of the individual reference products [immediate-release (IR) tramadol and celecoxib] alone and in open combination., Methods: Healthy adults aged 18-55 years were orally administered four treatments under fasted conditions (separated by 7-day wash-out period): 200 mg IR CTC (equivalent to 88 mg tramadol and 112 mg celecoxib; Treatment 1); 100 mg IR tramadol (Treatment 2); 100 mg celecoxib (Treatment 3); and 100 mg IR tramadol and 100 mg celecoxib (Treatment 4). Treatment sequence was assigned using computer-generated randomization. PK parameters were calculated using noncompartmental analysis with parameters for CTC adjusted according to reference product dose (100 mg)., Results: Thirty-six subjects (28 male, mean age 36 years) participated. Tramadol PK parameters for Treatments-1, -2 and -4, respectively, were 263, 346 and 349 ng ml -1 (mean maximum plasma concentration); 3039, 2979 and 3119 ng h ml -1 (mean cumulative area under the plasma concentration-time curve); and 2.7, 1.8 and 1.8 h (median time to maximum plasma concentration). For Treatments 1, 3 and 4, the respective celecoxib PK parameters were 313, 449 and 284 ng ml -1 ; 2183, 3093 and 2856 ng h ml -1 ; and 1.5, 2.3 and 3.0 h. No unexpected adverse events were reported., Conclusion: PK parameters of each API in CTC were modified by co-crystallization compared with marketed formulations of tramadol, celecoxib, and their open combination., (© 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Published
2017
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19. Pharmacokinetic dose proportionality between two strengths (12.5 mg and 25 mg) of doxylamine hydrogen succinate film-coated tablets in fasting state: a single-dose, randomized, two-period crossover study in healthy volunteers.

Author

Videla S, Cebrecos J, Lahjou M, Wagner F, Guibord P, Xu Z, Cabot A, Encabo M, Encina G, Sicard E, and Sans A

Subjects
Adult, Biological Availability, Cross-Over Studies, Dose-Response Relationship, Drug, Doxylamine administration & dosage, Doxylamine adverse effects, Doxylamine blood, Doxylamine pharmacokinetics, Fasting blood, Female, Healthy Volunteers, Histamine H1 Antagonists adverse effects, Histamine H1 Antagonists blood, Humans, Male, Medication Adherence, Middle Aged, Tablets, Doxylamine analogs & derivatives, Histamine H1 Antagonists pharmacokinetics
Abstract

Background: Doxylamine succinate, an ethanolamine-based antihistamine, is used in the short-term management of insomnia because of its sedative effects. No data on the dose proportionality of the pharmacokinetics of doxylamine are available, although this drug has been marketed in European countries for more than 50 years., Objective: The objective of this study was to evaluate and compare the dose proportionality between two marketed strengths (12.5 mg and 25 mg) of doxylamine hydrogen succinate after a single oral dose administration under fasting conditions in healthy human subjects., Study Design: This was a single-center, randomized, single dose, laboratory-blinded, two-period, two-sequence, crossover study., Setting: The study was conducted in a phase I clinical unit., Subjects and Methods: A single oral dose of doxylamine hydrogen succinate of 12.5 mg (equivalent to 8.7 mg of doxylamine base) or 25 mg (equivalent to 17.4 mg of doxylamine base) was administered to healthy volunteers under fasting conditions in each study period. The drug administrations were separated by a wash-out period of 7 calendar days. Blood samples were collected for up to 60 h post-dose, and plasma doxylamine levels were determined by an ultra high-performance liquid chromatography method with tandem mass spectrometry detection. Pharmacokinetic parameters were calculated using non-compartmental analysis. Dose proportionality was assessed based on the parameter area under the concentration-time curve (AUCt normalized). Safety was evaluated through assessment of adverse events, standard laboratory evaluations, vital signs and 12-lead electrocardiogram (ECG)., Results: In total, 12 healthy volunteers (3 male; 9 female) were included in the study. Mean maximum observed plasma concentration (Cmax) and area under the concentration-time curve from time zero to time t (AUCt ) of doxylamine hydrogen succinate 12.5 mg and 25 mg tablets increased linearly and dose-dependently [12.5 mg: mean Cmax 61.94 ng/mL, coefficient of variation (CV) 23.2%; mean AUCt 817.33 ng·h/mL, CV 27.4%; and 25 mg: mean Cmax 124.91 ng/mL, CV 18.7%; mean AUCt 1630.85 ng·h/mL, CV 22.8%]. Mean AUCt normalized was 815.43 ng·h/mL, CV 22.8% for 25 mg. The dose-normalized geometric mean ratio (%, 12.5 mg/25 mg) of AUCt was 98.92 (90% CI: 92.46, 105.83). The most common adverse event was somnolence., Conclusions: Exposure to doxylamine was proportional over the therapeutic dose range of 12.5-25 mg in healthy volunteers. Based on the results, a predictable and linear increase in systemic exposure can be expected. Doxylamine hydrogen succinate was safe and well tolerated.

Published
2013
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