Author: "Pomero, F" / Topic: medicine - Searchworks@Jio Institute Digital Library Search Results

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17 results on '"Pomero, F"'

1. 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

2. 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

3. Natural history of patients with venous thromboembolism and hereditary hemorrhagic telangiectasia. Findings from the RIETE registry

Author: Riera-Mestre, A, Mora-Lujan, JM, Trujillo-Santos, J, Del Toro, J, Nieto, JA, Pedrajas, JM, Lopez-Reyes, R, Soler, S, Ballaz, A, Cerda, P, Monreal, 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, JA, Bui, HM, Adarraga, MD, Agud, M, Aibar, MA, Alcalde-Manero, M, Alfonso, J, Amado, C, Arcelus, JI, Barbagelata, C, Barron, M, Barron-Andres, B, Blanco-Molina, A, Camon, AM, Canas, I, Castro, J, de Miguel, J, del Toro, J, Demelo, P, Diaz-Pedroche, C, Diaz-Peromingo, JA, Dominguez, I, Escribano, JC, Falga, C, Fernandez-Capitan, C, Fernandez-Criado, MC, Fidalgo, MA, Flores, K, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Raso, A, Gavin-Bianco, O, Gavin-Sebastian, O, Gil-Diaz, A, Godoy-Diaz, D, Gomez, V, Gomez-Cuelvo, C, Gonzalez-Martinez, J, Grau, E, Guirado, L, Gutierrez, J, Hernandez-Blasco, LM, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Joya, MD, Jou, I, Lalueza, A, Lecumberri, R, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Meseguer, M, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Saez, JB, Lorente, MA, Loring, M, Lumbierres, M, Madridano, O, Maestre, A, Marchena, PJ, Martin-Martos, F, Martinez-Baquerizo, C, Martinez-Garcia, MA, Mellado, M, Moises, J, Morales, MV, Munoz-Bianco, A, Nunez, MJ, Olivares, MC, Olivera, PE, Ortega, C, Osorio, J, Otalora, S, Otero, R, Panadero-Macia, M, Parra, V, Pellejero, G, Perez-Ductor, C, Perez-Rus, G, Penis, ML, Pesantez, D, Porras, JA, Rivas, A, Rodriguez-Cobo, A, Rodriguez-Matute, C, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Ruiz-Sada, P, Sahuquillo, JC, Sala-Sainz, MC, Salgueiro, G, Samperiz, A, Sanchez-Martinez, R, Sanchez-Munoz-Torrero, JF, Segui, E, Suarez, S, Surinach, JM, Tolosa, C, Torres, MI, Uresandi, F, Valero, B, Valle, R, Vidal, G, Aar, C, Villares, P, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Hirmerova, J, Salgado, E, Benzidia, I, Bura-Riviere, A, Debourdeau, P, Courtois, MC, Helfer, H, Hij, A, Mahe, I, Moustafa, F, Braester, A, Bilora, F, Bortoluzzi, C, Ciammaichella, M, Dentali, F, Fermi, P, Imbaizano, E, Lodigiani, C, Maida, R, Mastroiacovo, D, Mumoli, N, Pace, F, Pesavento, R, Pomero, F, Quintavalla, R, Rocci, A, Rota, L, Siniscalchi, C, Tiraferri, E, Tufano, A, Visona, A, Hong, NV, Zalunardo, B, Kalejs, RV, Kigitovica, D, Skride, A, Zdraveska, M, Mazzola, L, Capnini, JA, Tafur, AJ, Vanassche, T, Verhamme, P, Riera-Mestre, A., Mora-Lujan, J. M., Trujillo-Santos, J., Del Toro, J., Nieto, J. A., Pedrajas, J. M., Lopez-Reyes, R., Soler, S., Ballaz, A., Cerda, P., Monreal, 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, M. A., Alcalde-Manero, M., Alfonso, J., Amado, C., Arcelus, J. I., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Canas, I., Castro, J., De Miguel, J., Demelo, P., Diaz-Pedroche, C., Diaz-Peromingo, J. A., Dominguez, I. M., Escribano, J. C., Falga, C., Fernandez-Capitan, C., Fernandez-Criado, M. C., Fidalgo, M. A., Flores, K., Font, C., Font, L., Furest, I., Garcia, M. A., Garcia-Bragado, F., Garcia-Raso, A., Gavin-Blanco, O., Gavin-Sebastian, O., Gil-Diaz, A., Godoy-Diaz, D., Gomez, V., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L. M., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Joya, M. D., Jou, I., Lalueza, A., Lecumberri, R., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Meseguer, M., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Saez, J. B., Lorente, M. A., Loring, M., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P. J., Martin-Martos, F., Martinez-Baquerizo, C., Martinez-Garcia, M. A., Mellado, M., Moises, J., Morales, M. V., Munoz-Blanco, A., Nunez, M. J., Olivares, M. C., Olivera, P. E., Ortega, C., Osorio, J., Otalora, S., Otero, R., Panadero-Macia, M., Parra, V., Pellejero, G., Perez-Ductor, C., Perez-Rus, G., Peris, M. L., Pesantez, D., Porras, J. A., Rivas, A., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Sada, P., Sahuquillo, J. C., Sala-Sainz, M. C., Salgueiro, G., Samperiz, A., Sanchez-Martinez, R., Sanchez-Munoz-Torrero, J. F., Segui, E., Suarez, S., Surinach, J. M., Tolosa, C., Torres, M. I., Uresandi, F., Valero, B., Valle, R., Vidal, G., Vilar, C., Villares, P., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Hirmerova, J., Salgado, E., Benzidia, I., Bura-Riviere, A., Debourdeau, P., Courtois, M. C., Helfer, H., Hij, A., Mahe, I., Moustafa, F., Braester, A., Bilora, F., Bortoluzzi, C., Ciammaichella, M., Dentali, F., Ferrazzi, P., Imbalzano, E., Lodigiani, C., Maida, R., Mastroiacovo, D., Mumoli, N., Pace, F., Pesavento, R., Pomero, F., Quintavalla, R., Rocci, A., Rota, L., Siniscalchi, C., Tiraferri, E., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Kalejs, R. V., Kigitovica, D., Skride, A., Zdraveska, M., Mazzolai, L., and Tafur, A. J.
Subjects: 0301 basic medicine, Registrie, lcsh:Medicine, 030105 genetics & heredity, Research & Experimental Medicine, THERAPY, 0302 clinical medicine, Pharmacology (medical), Registries, Telangiectasia, EPISTAXIS, Genetics (clinical), Venous Thrombosis, Embòlia pulmonar, Genetics & Heredity, OUTCOMES, FACTOR-VIII, General Medicine, Heparin, Hemorrhagic hereditary telangiectasia, Middle Aged, Pulmonary embolism, Rare diseases, Natural history, Venous thrombosis, Medicine, Research & Experimental, Deep venous thrombosis, Telangiectasia, Hereditary Hemorrhagic, medicine.symptom, Malalties rares, Life Sciences & Biomedicine, medicine.drug, Human, Venous thromboembolism, Adult, medicine.medical_specialty, Hemorrhage, Therapeutics, HHT, 03 medical and health sciences, Internal medicine, medicine, Humans, cardiovascular diseases, Risk factor, Deep venous thrombosi, Aged, Tromboflebitis, Bleeding episodes, Science & Technology, business.industry, Research, lcsh:R, Thrombophlebitis, medicine.disease, Terapèutica, equipment and supplies, business, Rare disease, 030217 neurology & neurosurgery, RENDU-OSLER-WEBER
Abstract: BACKGROUND: Limited data exist about the clinical presentation, ideal therapy and outcomes of patients with hereditary hemorrhagic telangiectasia (HHT) who develop venous thromboembolism (VTE). METHODS: We used the data in the RIETE Registry to assess the clinical characteristics, therapeutic approaches and clinical outcomes during the course of anticoagulant therapy in patients with HHT according to initial presentation as pulmonary embolism (PE) or deep venous thrombosis (DVT). RESULTS: Of 51,375 patients with acute VTE enrolled in RIETE from February 2009 to January 2019, 23 (0.04%) had HHT: 14 (61%) initially presented with PE and 9 (39%) with DVT alone. Almost half (47.8%) of the patients with VTE had a risk factor for VTE. Most PE and DVT patients received low-molecular-weight heparin for initial (71 and 100%, respectively) and long-term therapy (54 and 67%, respectively). During anticoagulation for VTE, the rate of bleeding events (major 2, non-major 6) far outweighed the rate of VTE recurrences (recurrent DVT 1): 50.1 bleeds per 100 patient-years (95%CI: 21.6-98.7) vs. 6.26 recurrences (95%CI: 0.31-30.9; p = 0.020). One major and three non-major bleeding were epistaxis. No patient died of bleeding. One patient died shortly after being diagnosed with acute PE. CONCLUSIONS: During anticoagulation for VTE in HHT patients, there were more bleeding events than VTE recurrences. Most bleeding episodes were non-major epistaxis. ispartof: ORPHANET JOURNAL OF RARE DISEASES vol:14 issue:1 ispartof: location:England status: published
Published: 2019

4. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

Author: Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Koshlia, V., Fraiz, J., Krakhmalova, O., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.
Subjects: Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract: Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.
Published: 2017
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5. Systolic blood pressure and mortality in acute symptomatic pulmonary embolism

Author: Quezada, A, Jimenez, D, Bikdeli, B, Moores, L, Porres-Aguilar, M, Aramberri, M, Lima, J, Ballaz, A, Yusen, RD, Monreal, 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, JA, Bui, HM, Adarraga, MD, Agud, M, Aibar, MA, Alfonso, J, Amado, C, Arcelus, JI, Azcarate-Aguero, P, Barbagelata, C, Barron, M, Barron-Andres, B, Blanco-Molina, A, Camon, AM, Canas, I, Carrasco, C, Castro, J, Cerda, P, Chasco, L, de Ancos, C, del Toro, J, Demelo, P, Diaz-Peromingo, JA, Diaz-Simon, R, Elias-Hernandez, T, Escribano, JC, Falga, C, Farfan, AI, Fernandez-Capitan, C, Fernandez-Criado, MC, de Roitegui, F, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, 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, Joya, MD, Jou, I, Lacruz, B, Lecumberri, R, 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, M, Martin-Fortea, P, Martin-Martos, F, Martinez-Garcia, MA, Martinez-Gonzalez, L, Mellado, M, Moises, J, Montesa, C, Morales, MV, Nieto, JA, Nunez, MJ, Olivares, MC, Olivera, PE, Otalora, S, Otero, R, Panadero-Macia, M, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Jacoiste, A, Perez-Rus, G, Peris, ML, Porras, JA, 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, Samperiz, A, Sanchez-Camara, S, Sanchez-Martinez, R, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Suarez, S, Surinach, JM, Tiberio, G, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Valero, B, Valle, R, Vela, JR, Vidal, G, Villares, P, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Hirmerova, J, Salgado, E, Benzidia, I, Bura-Riviere, A, Debourdeau, P, Helfer, H, Hij, A, Mahe, I, Moustafa, F, Braester, A, Sharif-Kashani, B, Barillari, G, Bilora, F, Bortoluzzi, C, Brandolin, B, Ciammaichella, M, Dentali, F, Imbalzano, E, Landolfi, R, Maida, R, Mastroiacovo, D, Mumoli, N, Pace, F, Pesavento, R, Pomero, F, Quintavalla, R, Rocci, A, Siniscalchi, C, Tufano, A, Visona, A, Hong, NV, Zalunardo, B, Kalejs, RV, Skride, A, Strautmane, S, Zdraveska, M, Mazzolai, L, Caprini, J, Tafur, AJ, and RIETE Investigators
Subjects: Male, Cardiac & Cardiovascular Systems, Blood Pressure, 030204 cardiovascular system & hematology, GUIDELINES, THERAPY, 0302 clinical medicine, Cause of Death, EPIDEMIOLOGY, 030212 general & internal medicine, Prospective Studies, Registries, RISK, Aged, 80 and over, OUTCOMES, Pulmonary embolism, Survival Rate, Systolic blood pressure, Acute Disease, Cardiology, Female, Cardiology and Cardiovascular Medicine, Life Sciences & Biomedicine, Major bleeding, circulatory and respiratory physiology, medicine.medical_specialty, Canada, Systole, DIAGNOSIS, 03 medical and health sciences, Internal medicine, MANAGEMENT, medicine, Humans, In patient, cardiovascular diseases, Mortality, Aged, VENOUS THROMBOEMBOLISM, Science & Technology, business.industry, Odds ratio, medicine.disease, Confidence interval, United States, THROMBOSIS, Increased risk, Blood pressure, Spain, Cardiovascular System & Cardiology, PROGNOSTICATION, Pulmonary Embolism, business, Venous thromboembolism
Abstract: BACKGROUND: The optimal cutoff for systolic blood pressure (SBP) level to define high-risk pulmonary embolism (PE) remains to be defined. METHODS: To evaluate the relationship between SBP levels on admission and mortality in patients with acute symptomatic PE, the current study included 39,257 consecutive patients with acute symptomatic PE from the RIETE registry between 2001 and 2018. Primary outcomes included all-cause and PE-specific 30-day mortality. Secondary outcomes included major bleeding and recurrent venous thromboembolism (VTE). RESULTS: There was a linear inverse relationship between admission SBP and 30-day all-cause and PE-related mortality that persisted after multivariable adjustment. Patients in the lower SBP strata had higher rates of all-cause death (reference: SBP 110-129 mmHg) (adjusted odds ratio [OR] 2.9; 95% confidence interval [CI], 2.0-4.2 for SBP 190 mmHg). Consistent findings were also observed for 30-day PE-related death. CONCLUSIONS: In patients with acute symptomatic PE, a low SBP portends an increased risk of all-cause and PE-related mortality. The highest mortality was observed in patients with SBP
Published: 2019

6. 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
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7. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author: Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.
Subjects: Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract: Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.
Published: 2017

8. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

Author: Raymuno, S., Ramacciotti, E., Manenti, E., Freire, A., Fiss, E., Bizzacchi, J. Annichino, Lienart, F., Dive, A., Delforge, M., Blockmans, D., Soroka, N., Kamenova, Z., Kostadinova, M., Milanova, M., Pencheva, G., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Polonetsy, L., Pimanov, S., Mitkovskaya, N., Tokmakova, M., Dhar, A., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Douketis, J., Konig, J., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M. Arias, Lazcano, M. Opazo, Cardenas, S. Potthoff, Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Marusic, S., Vagic, J. Sikic, Skerk, V., Cermak, O., Gibson, C. Michael, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Arbetter, Douglas F., Yee, Megan K., Chlumsky, J., Chochola, J., Cizek, V., Goldhaber, Samuel Z., Hull, Russel, Hernandez, Adrian F., Huber, K., Lu, Shiao-ping, Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Nazliel, BİJEN, Bandman, Olga, Leeds, Janet M., Gold, Alex, Harrington, Robert A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Poy, C., Baker, R., Lang, P., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Coughlin, P., Finfer, S., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Rubinfeld, A., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Paleiron, N., Payot, L., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pernod, G., Pearl, R., Parthiban, K., Ortel, T., Ohaju, V., Pottier, P., Proust, A., Quere, I., Roy, P-M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Grandes, J., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Cepeda, J. M., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Van Dyk, C., Mitha, I., Engelbrecht, J., Breedt, J., Basson, M., Adler, D., Spisakova, M., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Amann, B., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Lupkovics, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Kalpachki, R., Grigorov, M., Dimov, B., Rocha, A., Goloshchekin, B., Berrouschot, J., Laszlo, Z., Rees, C., Overcash, J., Prokop, D., and Cohen, Alexander T.
Subjects: Relative risk reduction, Male, Pyridines, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Randomized controlled trial, Double-Blind Method, law, Medicine, Humans, 030212 general & internal medicine, Dosing, Enoxaparin, education, Aged, Aged, 80 and over, Venous Thrombosis, education.field_of_study, business.industry, Absolute risk reduction, Anticoagulants, Venous Thromboembolism, Hospitalization, chemistry, Concomitant, Betrixaban, Anesthesia, Benzamides, Female, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, Factor Xa Inhibitors
Abstract: The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients. The 80-mg betrixaban dose was halved to 40 mg among subjects with severe renal insufficiency and those receiving a concomitant strong P-glycoprotein inhibitor.This analysis assessed the pharmacokinetics, efficacy, and safety of full- (80 mg) and reduced-dose (40 mg) betrixaban relative to enoxaparin in the APEX trial.The median concentration of betrixaban among subjects administered the 80-mg dose was higher than that of the 40-mg dose (19 ng/mL vs 11 ng/mL, P.001). In the primary analysis cohort 1 (d-dimer ≥2× upper limit of normal), the primary efficacy outcome (asymptomatic proximal deep vein thrombosis, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism, or venous thromboembolism-related death) was significantly reduced among subjects treated with 80 mg of extended-duration betrixaban versus enoxaparin (6.27% [95/1516] vs 8.39% [130/1549], relative risk reduction=0.26 [0.04-0.42], P=.023), and similarly in the entire primary efficacy outcome population (4.87% [122/2506] vs 7.06% [181/2562], relative risk reduction=0.30 [0.13-0.44], P=.001). There was no difference in the primary outcome for subjects treated with 40 mg betrixaban vs enoxaparin across cohorts. In addition, there was no excess of major bleeding associated with either betrixaban dose compared with enoxaparin.The 80-mg betrixaban dose achieves higher plasma concentrations than the 40-mg dose and, in contrast to the 40-mg dose, is associated with improved efficacy across all cohorts relative to standard-dose enoxaparin without an excess risk of major bleeding in the management of medically ill subjects.
Published: 2016

9. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Author: Engelbrecht, J., Finfer, S., Van Dyk, C., Cohen, Alexander, Grandes, J., Cepeda, J. M., NAZLIEL, BİJEN, Cohen, Alexander T., Efrati, S., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Alekniene, B., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Mitha, I., Breedt, J., Basson, M., Adler, D., Spisakova, M., Prokop, D., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Goloshchekin, B., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Harrington, Robert A., Goldhaber, Samuel Z., Hull, Russell D., Popescu, M., Wiens, Brian L., Gold, Alex, Hernandez, Adrian F., Gibson, C. Michael, Harrington, Robert, Hull, Russell, Goldhaber, Samuel, Hernandez, Adrian, Ceresetto, Jose Manuel, Colquhoun, David, Pilger, Ernst, Polonetsky, Leonid, Podoleanu, C., Musetescu, R., Marin, I., Bojinca, M., Motte, Serge, Saraiva, Jose Francisco, Balogh, Z. E., Wrzesinski, K., Waldemar, K., Walasek, L., Raev, Dimitar, Mincheva, Valentina, Kahn, Susan, Sulik, P., Canon, Claudia Olivares, Malojcic, Branko, Mayer, Otto, Husted, Steen, Marandi, Toomas, Lassila, Riitta, Mottier, Dominique, Shaburishvili, Tamaz, Bauersachs, Rupert, Zeymer, Uwe, Hajko, Erik, Sobkowicz, B., Zeltser, David, Ageno, Walter, Krievins, Dainis, Bagdonas, Alfredas, Osores, Juan Lema, Tomkowski, Witold, Mot, Stefan, Panchenko, Elizaveta, Tan, Ru San, Gaspar, Ludovit, Jacobson, Barry, Monreal, Manuel, Ongen, Gul, Parkhomenko, Alexander, Uprichard, James, Pulkowski, G., Mirek-Bryniarska, E., Kucharski, L., Jastrzebski, D., Yusen, Roger, Grzelakowski, P., Merli, Geno, Gruenpeter, P., Gorecka, D., Gniot, J., Gaciong, Z., Fryze, W., Peacock, Frank, Schellong, Sebastian, Januzzi, James, Piovella, Franco, Cochet, Madeleine, Michalak, Nathan, Stepanchak, Maria, Spielman, Kathryn, Neal, Brandon, Florea, Ana, Chi, Gerald, Szlosek, Donald, Jain, Purva, Popma, Christopher, Korjian, Serge, Daaboul, Yazan, Halaby, Rim, Yanez, L. Toche, Lemor, Alejandro, Zacarkim, Marcelo, Romero, Gonzalo, Hernandez Elenes, Jesus Rosario, Alvarado, Alonso, Susheela, Ammu, Leitao, Meghan, Salas, M., Bandman, Olga, Horna, M., Strumph, Peter, Vinh, Nancy, Visona, A., Kostadinova, M., Vance, Annemarie, Moia, M., Wiens, Brian, Orlandini, F., Parisi, R., Pontaga, N., Smoak, Carey, Storgaard, M., Molteni, M., Castelino, Rennie, Goodman, Shelly, Stukena, I., Leeds, Janet, al-Khalidi, Hussein, Milanova, M., Karlo, L. Farjardo, Leimberger, Jeffrey, Phillips, Thomas, Rizos, T., Pencheva, G., Pomero, F., Francis, Charles, Novo, S., Pereyra, R. Cotrina, Tiefenbacher, C., Buller, Harry, Roberts, Robin, Prins, Martin, Weimar, C., Tuxen, C., Urhammer, S., Lember, M., Runev, N., Uuetoa, T., Spyropoulos, Alex, Carrier, Marc, Alkonyi, B., Lopes, Renato D., Horacek, T., Airaksinen, J., Honkaniemi, J., Pottier, P., Falukozy, J., Kaaja, R., Stoeva, N., Saarinen, J., Stoyanov, M., Pizzini, A., Devor, Adam, Tatlisumak, T., Kolls, Bradley, Dedrick, Joseph, Todd, Jamie, Jones, William Schuyler, Vikman, S., Agraou, B., Futo, L., Castillo Leon, R., Eapen, Zubin, Katona, A., Proust, A., Quere, I., Kirschner, R., Syulemzova, S., Valavicius, A., Todorov, G., Tokmakova, M., Dhar, A., Klimpe, S., Ahmad, Tariq, Brenna, J. Matthew, Douketis, J., Le Gal, G., Pearce, M., Susinskiene, D., Brito, Flavio, Provencher, S., Rozitis, V., Roy, P-M., Kroning, R., Gulack, Brian, Schmidt, J., Meza, James, Parikh, Kishan, Cooper, Lauren, Poskiene, R., Aquilanti, S., Lapp, H., Kristof, P., Lakatos, F., Laszlo, Z., Belhassane, A., Petrauskiene, R., Pagidipati, Neha, Simoneau, G., Verreault, S., Guimaraes, Patricia, Brisot, D., Perkins, Lynn M., De Geeter, G., Debourdeau, P., Alarcon, M. Arias, Lupkovics, G., Norviliene, R., Wilson, Matthew, Merkely, B., Lazcano, M. Opazo, Collier, Jeannie, Andras, C. Nagy, Cardenas, S. Potthoff, Butkovic-Soldo, S., Norvaisiene, R., Decoulx, E., Hayden, Nikieia, El Kouri, D., Car, S., Nemeth, L., Leizorovicz, Alain, Ciglenecki, N., Naudziunas, A., Datikashvili-David, I., Francetic, I., Jakopovic, M., Becker, Francois, Jennings, Lisa, Khabeishvili, G., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Griskeviciene, V., Kalinic-Grgorinic, H., Falvo, N., Khintibidze, I., Grange, C., Kobulia, B., Knezevic, A., Megreladze, I., Marusic, S., Papp, A., Pagava, Z., Lawall, H., Oliva, M., Paposhvili, K., Parody, M., Amann, B., Soltesz, P., Sudar, Z., Butkiene, Z., Szabo, G., Vagic, J. Sikic, Szegedi, N., Poy, C., Timar, G., Skerk, V., Cermak, O., Valco, J., Baker, R., Coughlin, P., Vertes, A., Rubinfeld, A., Elias, M., Berrouschot, J., Gafter, A., Hayek, T., Chlumsky, J., Lacroix, P., Messas, E., Chochola, J., Cizek, V., Basijokiene, V., Hussein, O., Dunaj, M., Dusek, J., Huber, K., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Francek, L., Havelka, J., Konig, J., Beyer-Westendorf, J., Herold, M., Holaj, R., Imberti, D., Landolfi, R., Blessing, E., Mathies, R., Schoenerr, H., Adzerikho, I., Koryk, V., Licka, M., Martinova, V., Horny, I., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Bizzacchi, J. Annichino, Fiss, E., Mismetti, P., Freire, A., Hubac, J., Jajtner, P., Manenti, E., Ramacciotti, E., Lembo, G., Raymuno, S., Rocha, A., Kolman, P., Lang, P., Bott, M., Dengler, T., Mikulova, J., Dimov, B., Podpera, I., Reiterer, P., Dziewas, R., Montaclair, K., Genth-Zotz, S., Hamann, F., Paleiron, N., Spacek, R., Payot, L., Vejvoda, J., Vyhnanek, M., Christensen, H., Salvi, A., Lodigiani, C., Pernod, G., Grigorov, M., Lassen, M., Mumoli, N., Kalpachki, R., Kamenova, Z., Schenone, A., Guy's and St Thomas' Hospital [London], Stanford Medicine, Stanford University, Brigham and Women's Hospital [Boston], Thrombosis Research Unit, University of Calgary, Portola Pharmaceuticals (Portola), PORTOLA PHARMACEUTICALS, Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute (DCRI - DURHAM), Duke University [Durham], Beth Israel Deaconess Medical Center [Boston, USA], Harvard Medical School [Boston] (HMS), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)
Subjects: Male, Pyridines, Medizin, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Ultrasonography, Venous Thrombosis, Factors de risc en les malalties, Medicine (all), Acute Disease, Adult, Aged, Benzamides, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Fibrin Fibrinogen Degradation Products, Hemorrhage, Hospitalization, Humans, Middle Aged, Pulmonary Embolism, Venous Thromboembolism, General Medicine, 3. Good health, Pulmonary embolism, Venous thrombosis, Cohort, medicine.medical_specialty, Patients, Risk factors in diseases, Placebo, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, Thromboembolism, medicine, Pacients, Betrixaban, Thromboprophylaxis, Acutely Ill Medical Patients, Tromboembolisme, business.industry, Settore MED/09 - MEDICINA INTERNA, ta3121, Population cohort, medicine.disease, Surgery, chemistry, Once daily, business
Abstract: Background\ud Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.\ud \ud Methods\ud Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.\ud \ud Results\ud A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).\ud \ud Conclusions\ud Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.)
Published: 2016
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10. Clinical course of isolated distal deep vein thrombosis in patients with active cancer: a multicenter cohort study

Author: Serena M. Passamonti, Stefano Barco, Giovanni Barillari, Michelangelo Sartori, Federica Bagna, Daniela Mastroiacovo, S. Pegoraro, Walter Ageno, Raffaella Benedetti, Francesco Dentali, Corrado Lodigiani, Nicola Mumoli, Mariasanta Napolitano, M. Di Nisio, M. N. D. Di Minno, Fulvio Pomero, Dentali, F, Pegoraro, S, Barco, S, DI MINNO, Matteo, Mastroiacovo, D, Pomero, F, Lodigiani, C, Bagna, F, Sartori, M, Barillari, G, Mumoli, N, Napolitano, M, Passamonti, S. M, Benedetti, R, Ageno, W, Di Nisio, M., Dentali, F., Pegoraro, S., Barco, S., di Minno, M., Mastroiacovo, D., Pomero, F., Lodigiani, C., Bagna, F., Sartori, M., Barillari, G., Mumoli, N., Napolitano, M., Passamonti, S., Benedetti, R., and Ageno, W.
Subjects: Male, medicine.medical_specialty, distal deep vein thrombosis, mortality, neoplasm, observational study, venous thromboembolism, Hematology, Time Factors, Deep vein, Hemorrhage, 030204 cardiovascular system & hematology, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Risk Factors, Neoplasms, Internal medicine, medicine, Humans, 030212 general & internal medicine, Aged, Proportional Hazards Models, Retrospective Studies, Venous Thrombosis, business.industry, Incidence, Clinical course, Anticoagulants, Cancer, distal deep vein thrombosi, Venous Thromboembolism, Heparin, Middle Aged, medicine.disease, Thrombosis, Surgery, Treatment Outcome, medicine.anatomical_structure, Italy, Female, Pulmonary Embolism, business, Venous thromboembolism, Distal deep vein thrombosis, Mortality, Neoplasm, Observational study, medicine.drug, Cohort study
Abstract: Essentials Isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer. No study has specifically evaluated the long-term clinical course of cancer-associated IDDVT. Patients with cancer-associated IDDVT are at very high risk of symptomatic recurrence and death. We observed low rates of major bleeding during anticoagulation. SummaryBackground Although isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer, no study has specifically evaluated the long-term clinical course of IDDVT in this setting. Aim To provide data on the rate of recurrent venous thromboembolism (VTE), major bleeding events and death in IDDVT patients with active cancer. Patients and Methods Consecutive patients with active cancer and an objective IDDVT diagnosis (January 2011 to September 2014) were included from our files. We collected information on baseline characteristics, IDDVT location and extension, VTE risk factors, and type and duration of anticoagulant treatment. Results A total of 308 patients (mean age 66.2 [standard deviation (SD), 13.2 years]; 57.1% female) with symptomatic IDDVT and a solid (n = 261) or hematologic (n = 47) cancer were included at 13 centers. Cancer was metastatic in 148 (48.1%) patients. All but three (99.0%) patients received anticoagulant therapy, which consisted of low-molecular-weight heparin in 288 (93.5%) patients. Vitamin K antagonists were used for the long-term treatment in 46 (14.9%) patients, whereas all others continued the initial parenteral agent for a mean treatment duration of 4.2 months (SD, 4.6 months). During a total follow-up of 355.8 patient-years (mean, 13.9 months), there were 47 recurrent objectively diagnosed VTEs for an incidence rate of 13.2 events per 100 patient-years. During anticoagulant treatment, the annual incidence of major bleeding was 2.0 per 100 patient-years. Conclusions Cancer patients with IDDVT have a high risk of VTE recurrence. Additional studies are warranted to investigate the optimal intensity and duration of anticoagulant treatment for these patients.
Published: 2017
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11. Residual vein obstruction in patients diagnosed with acute isolated distal deep vein thrombosis associated with active cancer

Author: M. N. D. Di Minno, S. Pegoraro, F. Bagna, Serena M. Passamonti, Nicola Mumoli, Stefano Barco, Giovanni Barillari, Walter Ageno, Corrado Lodigiani, Mariasanta Napolitano, Daniela Mastroiacovo, Francesco Dentali, M. Di Nisio, Raffaella Benedetti, Fulvio Pomero, Michelangelo Sartori, Dentali, F., Barco, S., Pegoraro, S., Di Minno, M. N. D., Mastroiacovo, D., Pomero, F., Lodigiani, C., Bagna, F., Sartori, M., Barillari, G., Mumoli, N., Napolitano, M., Passamonti, S. M., Benedetti, R., Ageno, W., Di Nisio, M., Dentali F., Barco S., Pegoraro S., Di Minno M.N.D., Mastroiacovo D., Pomero F., Lodigiani C., Bagna F., Sartori M., Barillari G., Mumoli N., Napolitano M., Passamonti S.M., Benedetti R., Ageno W., and Di Nisio M.
Subjects: Adult, Male, medicine.medical_specialty, medicine.drug_class, Deep vein, 030204 cardiovascular system & hematology, Compression ultrasound, Distal deep vein thrombosis, Recurrence, Residual vein obstruction, Venous thromboembolism, Hematology, Cardiology and Cardiovascular Medicine, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Neoplasms, medicine, Humans, In patient, Distal deep vein thrombosi, Aged, Ultrasonography, Venous Thrombosis, business.industry, Risk Factor, Anticoagulant, Cancer, Anticoagulants, Venous Thromboembolism, Middle Aged, medicine.disease, Thrombosis, Surgery, Discontinuation, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Acute Disease, Neoplasm, Female, business, Human, Cohort study
Abstract: After acute proximal deep vein thrombosis (DVT) the thrombotic mass decreases, especially during the first months of anticoagulation. The persistence of residual vein obstruction (RVO) may predict future recurrence in patients with cancer-associated DVT. We aimed to evaluate the proportion of patients with RVO after an episode of cancer associated isolated distal DVT (IDDVT), to identify variables associated with RVO, and to provide initial evidence of its association with recurrent VTE. We performed a post-hoc analysis of a multicenter cohort study of patients with isolated cancer-associated acute IDDVT. We included patients who underwent a control ultrasonography at the end of the anticoagulant treatment between day 30 and day 365 after index IDDVT, given that no recurrent VTE had already occurred on anticoagulant treatment. A total of 153 patients had ultrasonographic follow-up after a median of 92 days from index IDDVT: 45.8% had RVO and 54.2% exhibited complete recanalization. Female sex, Body Mass Index > 30Kg/m2 and involvement of axial calf veins showed the strongest association with RVO. The risk of recurrence was twofold higher in patients with (versus without) RVO. RVO persisted in approximately half of patients with an episode of cancer-associated IDDVT at anticoagulant discontinuation. Patients with RVO appeared to be at a higher risk for recurrent events.
Published: 2018

12. 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

13. Incidence rates and case-fatality rates of cerebral vein thrombosis: A population-based study

Author: Jonathan M. Coutinho, Aldo Bonaventura, Walter Ageno, Matteo Bonzini, Roberta Re, Emanuele Rezoagli, Alessandro Squizzato, Vera Gessi, Francesco Dentali, Alessandra Vecchié, Fulvio Pomero, Neurology, ACS - Atherosclerosis & ischemic syndromes, ANS - Neurovascular Disorders, Rezoagli, E, Bonaventura, A, Coutinho, J, Vecchie, A, Gessi, V, Re, R, Squizzato, A, Pomero, F, Bonzini, M, Ageno, W, and Dentali, F
Subjects: Adult, Male, Pediatrics, medicine.medical_specialty, venous thrombosi, Cerebrovascular disorders, Epidemiology, Population, intracranial thrombosi, Cerebral vein thrombosis, Cerebral hemorrhage, Incidence, Intracranial thrombosis, Mortality, Venous thrombosis, Risk Factors, Case fatality rate, Humans, Medicine, Hospital Mortality, education, cerebrovascular disorder, Advanced and Specialized Nursing, education.field_of_study, business.industry, Incidence (epidemiology), Middle Aged, medicine.disease, Cerebral Veins, Population based study, Intracranial Thrombosis, Italy, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business
Abstract: Background and Purpose: Cerebral vein thrombosis (CVT) incidence is estimated to be >10 per 1 000 000 per year. Few population-based studies investigating case-fatality rates (CFRs) and pyogenic/nonpyogenic CVT incidence are available. We assessed trends in CVT incidence between 2002 and 2012, as well as adjusted in-hospital CFRs and incidence of hospital admissions for pyogenic/nonpyogenic CVT in a large Northwestern Italian epidemiological study. Methods: Primary and secondary discharge diagnoses of pyogenic/nonpyogenic CVT were identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes 325, 671.5, and 437.6. Age, sex, vital status at discharge, length of hospital stay, and up to 5 secondary discharge diagnoses were collected. Concomitant presence of intracerebral hemorrhage (ICH) was registered, and comorbidities were assessed through the Charlson comorbidity index. Results: A total of 1718 patients were hospitalized for CVT (1147 females—66.8%; 810 pyogenic and 908 nonpyogenic CVT, 47.1% and 52.9%, respectively), with 134 patients (7.8%) experiencing a concomitant ICH. The overall incidence rate for CVT was 11.6 per 1 000 000 inhabitants with a sex-specific rate of 15.1 and 7.8 per 1 000 000 in females and males, respectively. CVT incidence significantly increased in women during time of observation ( P =0.007), with the highest incidence being at 40 to 44 years (27.0 cases per 1 000 000). In-hospital CFR was 3%, with no difference between pyogenic/nonpyogenic CVT. Patients with concomitant ICH had a higher in-hospital CFR compared with patients without ICH (7.5% versus 2.7%; odds ratio, 2.96 [95% CI, 1.45–6.04]). In-hospital CFR progressively increased with increasing Charlson comorbidity index ( P =0.003). Age (odds ratio, 1.03 [95% CI, 1.02–1.05]), Charlson comorbidity index ≥4 (odds ratio, 4.33 [95% CI, 1.29–14.52]), and ICH (odds ratio, 3.05 [95% CI, 1.40–6.62]) were independent predictors of in-hospital mortality. Conclusions: In a large epidemiological study, CVT incidence was found to be comparable to the one registered in population-based studies reported after the year 2000. CVT incidence increased among women over time. In-hospital CFR was low, but not negligible, in patients with concomitant ICH. Age, ICH, and a high number of comorbidities were independent predictors of in-hospital mortality. Pyogenic CVT was not a predictor of in-hospital CFR, although its high proportion was not confirmed by internal validation.
Published: 2021

14. Clinical course of patients with symptomatic isolated superficial vein thrombosis: the ICARO follow‐up study

Author: G. Di Minno, Walter Ageno, Giovanni Barillari, Francesco Dentali, Samantha Pasca, Sergio Siragusa, Luigi Fenoglio, Fulvio Pomero, E. Tamborini Permunian, Stefano Barco, Alessandra Malato, M. N. D. Di Minno, Barco, S., Pomero, F., Di Minno, M. N. D., Tamborini Permunian, E., Malato, A., Pasca, S., Barillari, G., Fenoglio, L., Siragusa, S., Di Minno, G., Ageno, W., and Dentali, F.
Subjects: Male, Time Factors, Superficial vein thrombosis, Deep vein, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, 0302 clinical medicine, Recurrence, Risk Factors, Interquartile range, cohort study, death, major bleeding, superficial vein thrombosis, venous thromboembolism, Adult, Aged, Anticoagulants, Cause of Death, Female, Hemorrhage, Humans, Incidence, Italy, Longitudinal Studies, Lower Extremity, Middle Aged, Multivariate Analysis, Neoplasms, Odds Ratio, Proportional Hazards Models, Pulmonary Embolism, Retrospective Studies, Sex Factors, Treatment Outcome, Venous Thrombosis, superficial vein thrombosi, Cause of death, Anticoagulant, Hematology, Thrombosis, Pulmonary embolism, Venous thrombosis, medicine.anatomical_structure, 030220 oncology & carcinogenesis, medicine.medical_specialty, medicine.drug_class, 03 medical and health sciences, Internal medicine, medicine, business.industry, medicine.disease, Surgery, business
Abstract: Essentials Late sequelae of isolated superficial vein thrombosis (iSVT) have rarely been investigated. We studied 411 consecutive outpatients with acute iSVT with a median follow-up of three years. Male sex and cancer are risk factors for future deep vein thrombosis or pulmonary embolism. Patients without cancer appear to be at a negligible risk for death. SUMMARY Background Studies of long-term thromboembolic complications and death following acute isolated superficial vein thrombosis (iSVT) of the lower extremities are scarce. Objectives To investigate the course of iSVT in the setting of an observational multicenter study. Methods We collected longitudinal data of 411 consecutive outpatients with acute, symptomatic, objectively diagnosed iSVT who were previously included in the cross-sectional ICARO study. Four patients followed for < 30 days and 79 with concomitant deep vein thrombosis (DVT) or pulmonary embolism (PE) were excluded from the present analysis. The primary outcome was symptomatic DVT or PE. The safety outcomes were major bleeding and all-cause death. Results The median follow-up time was 1026 days (interquartile range 610-1796). Symptomatic DVT/PE occurred in 52 (12.9%) patients, giving annualized rates of 1.3% (95% confidence interval [CI] 0.3-3.9%) on anticoagulant treatment and 4.4% (95% CI 3.2-5.8%) off anticoagulant treatment. Male sex (adjusted hazard ratio [HR] 2.03 [95% CI 1.16-3.54]) and active solid cancer (adjusted HR 3.14 [95% CI 1.11-8.93]) were associated with future DVT/PE, whereas prior DVT/PE failed to show significance, most likely because of bias resulting from prolonged anticoagulant treatment. Three major bleeding events occurred on treatment, giving an annualized rate of 1.4% (95 CI 0.3-4.0%). Death was recorded in 16 patients (annualized rate: 1.1% [95% CI 0.6-1.7%]), and was attributable to cancer (n = 8), PE (n = 1), cardiovascular events (n = 3), or other causes (n = 4). Conclusions The long-term risk of DVT/PE after anticoagulant discontinuation for acute iSVT is clinically relevant, especially in males and in the presence of active cancer. The risk of death appears to be negligible in patients without cancer.
Published: 2017
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15. Antiphospholipid Syndrome During Septic Shock: Hyper- or Hypocoagulability?: A Case Report

Author: Francesco Dentali, Mark Crowther, Nicoletta Barzaghi, Fulvio Pomero, Emanuele Rezoagli, Rezoagli, E, Barzaghi, N, Crowther, M, Dentali, F, and Pomero, F
Subjects: Ischemia, Fatal Outcome, Antiphospholipid syndrome, Anticoagulants, Blood Coagulation, Blood Coagulation Disorders, Cellulitis, Extremities, Female, Heparin, Humans, Middle Aged, Antiphospholipid Syndrome, Shock, Septic, Thrombelastography, medicine, In patient, Blood Coagulation Disorder, medicine.diagnostic_test, business.industry, Septic shock, Septic, Anticoagulant, Shock, General Medicine, medicine.disease, Thromboelastography, Discontinuation, Anesthesia, business, Extremitie, medicine.drug, Celluliti, Human
Abstract: We report the clinical case of a septic patient with antiphospholipid syndrome who developed ischemia in all 4 limbs, despite a normal systemic blood pressure. Prolonged coagulation times suggested a hemorrhagic diathesis, requiring transfusion of fresh-frozen plasma and discontinuation of heparin infusion. In contrast, the study of the viscoelastic properties of the clot by thromboelastography suggested an uncontrolled activation of the coagulation cascade. This observation led to the reintroduction of heparin with improvement in the patient's laboratory findings. Anesthesiologists should consider thromboelastography to correct coagulopathies in patients with septic shock in the presence of antiphospholipid antibodies.
Published: 2019

16. A clinical score to rule out the concomitant presence of deep vein thrombosis in patients presenting with superficial vein thrombosis: The ICARO study

Author: Giovanni Barillari, Luigi Fenoglio, M. N. D. Di Minno, Francesco Dentali, Samantha Pasca, Sergio Siragusa, E. Tamburini Premunian, G. Di Minno, Fulvio Pomero, Alessandra Malato, Walter Ageno, Pomero, F., DI MINNO, Matteo, Tamburini Premunian, E., Malato, A., Pasca, S., Barillari, G., Fenoglio, L., Siragusa, S., DI MINNO, Giovanni, Ageno, W., and Dentali, F.
Subjects: Male, medicine.medical_specialty, Superficial vein thrombosis, Deep vein, Cohort Studies, Medicine, Pulmonary embolism, Risk factors, Saphenous vein, Ultrasonography, Venous thrombosis, Humans, cardiovascular diseases, Retrospective Studies, Venous Thrombosis, business.industry, Retrospective cohort study, Hematology, Female, Middle Aged, Risk Factors, medicine.disease, Venous thrombosi, Thrombosis, medicine.anatomical_structure, Concomitant, Radiology, Risk factor, business, Cohort study
Abstract: Superficial vein thrombosis (SVT) is commonly encountered in clinical practice. Recent studies have suggested that the concomitant presence of deep vein thrombosis (DVT) or pulmonary embolism (PE) at the time of SVT diagnosis is not uncommon, thus increasing the interest on this disease. Whether this coexistence is predicted by specific risk factors remains unknown.To evaluate potential risk factors for DVT coexistence in patients presenting with acute objectively diagnosed SVT of the lower limbs and to develop a simple score entirely based on clinical variables to define the pre-test probability of DVT in these patients.A multicenter, retrospective cohort study on SVT patients was conducted. Information was collected on clinical signs and on risk factors for venous thrombosis.494 patients (mean age 56.3 ± 17.9 years, 64.2% women) were included. Concomitant DVT was found in 16.0% of patients. After multivariate analysis, we identified 5 independent variables that were used to develop the ICARO score: active malignancy (1.5 points), limb edema (1.5 points), rope-like sign (-1 point), age ≥ 50 years (1 point), unprovoked SVT (-1 point). The prevalence of concomitant DVT was 1.1% in the low-probability category (0 points), 12.0% in the intermediate-probability category (0 to 1 points), and 32.3% in the high probability category (≥ 1.5 points).The concomitant presence of major DVT is not negligible in patients with SVT. Our prediction score entirely based on simple clinical variables may be useful in assessing the risk of concomitant DVT in these patients.
Published: 2015

17. OC-01 - Clinical history of cancer patients with isolated distal deep vein thrombosis: a multicenter cohort study

Author: Corrado Lodigiani, M. N. D. Di Minno, Nicola Mumoli, Daniela Mastroiacovo, Mariasanta Napolitano, M. Di Nisio, S. Pegoraro, Serena M. Passamonti, Walter Ageno, Raffaella Benedetti, Fulvio Pomero, Stefano Barco, Giovanni Barillari, Michelangelo Sartori, Francesco Dentali, F. Bagna, Dentali, F., Pegoraro, S., Barco, S., di Minno, M., Mastroiacovo, D., Pomero, F., Lodigiani, C., Bagna, F., Sartori, M., Barillari, G., Mumoli, N., Napolitano, M., Passamonti, S., Benedetti, R., Ageno, W., and Nisio, M.
Subjects: medicine.medical_specialty, medicine.drug_class, Deep vein, Population, Low molecular weight heparin, 030204 cardiovascular system & hematology, Lower risk, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, cancer, Vein, education, Thrombosis history, distal deep vein thrombosis, education.field_of_study, business.industry, distal deep vein thrombosi, Hematology, medicine.disease, Thrombosis, Pulmonary embolism, Surgery, Venous thrombosis, medicine.anatomical_structure, 030220 oncology & carcinogenesis, business
Abstract: Introduction Isolated distal deep vein thrombosis (IDDVT) accounts for one-fourth to one-half of all deep vein thrombosis (DVT) of the leg. Patients with IDDVT are frequently treated for a shorter period of time compared to patients with proximal DVT and/or pulmonary embolism (PE) due to a perceived lower risk of recurrence. About 10-20% of patients with venous thromboembolic events (VTEs) have concomitant cancer. Guidelines recommend long-term anticoagulant treatment in this group of patients due to their high risk of VTE recurrence. Unfortunately, information on the clinical history of IDDVT patients is limited and, to date, no study has evaluated the long-term risk of VTE recurrence in IDDVT patients with cancer. Aim To provide information on the clinical history of IDDVT patients with active cancer. Materials and Methods A multicenter, cohort study including active-cancer patients with an objective diagnosis of IDDVT (between January 2011 and September 2014) was conducted. Information on baseline characteristics, thrombosis location and extension, concomitant risk factors, type and duration of treatment was collected. All patients were followed for a minimum of 12 months and up to 24 months. During follow-up, VTE recurrence, major bleeding episodes and death were registered. Potential risk factors for VTE recurrence were evaluated. Results 308 patients (mean age 66.2 ± 13.2 years, female 57.1%) in 13 centers were included, Table 1; 261 patients had solid cancer and 47 patients hematologic cancer. At the time of IDDVT diagnosis, the disease was metastatic in 148 patients (48.1%); 99.0% of patients received anticoagulant treatment: 288 patients (93.5%) were initially treated with low molecular weight heparin, 15 with fondaparinux (5.2%) and 1 with unfractionated heparin; vitamin K antagonists were used in 46 patients (14.9%) only. Total follow-up was 389 patient-years, mean follow-up 15.2 months. Mean duration of treatment was 4.2 months. During the study period there were 47 episodes of VTE recurrence (36 proximal DVT or PE) for a incidence rate of 13.2 events per 100 patient-years; 7 patients had major bleeding (2.3%) and 137 died (44.5%). At multivariate analysis, previous VTE was associated with an increased risk of recurrence (OR 2.10; 95% 1.06, 4.14), whereas patients with gastrointestinal cancer had a lower risk of recurrence (OR 0.26; 95% CI 0.08, 0.86). Table 1 . Baseline characteristics of the population Number of patients 308 Age (years), mean ± SD 66.2 ± 13.2 Women 176 (57.1%) Men 132 (42.9%) Body-mass index > 30 Kg/m 2 25 (8.1%) Concomitant risk factors for VTE Recent surgery or trauma 79 (25.6%) In-patients/immobilization 45 (14.6%) Prolonged bed rest 47 (15.3%) Local or systemic infections 19 (6.2%) Qualifying distal venous thrombosis Axial calf veins 135 (43.8%) Muscolar calf veins 149 (48.4%) Medial gastrocnemius veins 113 (36.7%) Lateral gastrocnemius veins 45 (14.6%) Soleal veins 73 (23.7%) Bilateral venous thrombosis 22 (7.1%) More than one vein involved 127 (41.2%) Previous history of VTE 45 (14.6%) Family history of VTE 16 (5.2%) Primary cancer site Breast 54 (17.5%) Gastrointestinal 51 (16.6%) Pancreas 18 (5.8%) Hepatic 9 (2.9%) Lung 44 (14.3%) Hematologic 47 (15.3%) Prostate 17 (5.5%) Brain 15 (4.9%) Other 53 (17.2%) Metastases 148 (48.1%) Cancer therapy Systemic chemotherapy 174 (56.5%) Radiotherapy 20 (6.5%) Hormonal therapy 36 (11.7%) Anticoagulant therapy 305 (99%) Low-molecular-weight heparin 288 (93.5%) Fondaparinux 16 (5.2%) Unfractionated heparin 1 (0.3%) Heparin-Vitamin K antagonists 46 (14.9%) VTE = venous thromboembolism. Conclusions Cancer patients with IDDVT have a high risk of VTE recurrence. Other studies are warranted to address the adequate management of these patients.
Published: 2016
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17 results on '"Pomero, F"'

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

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

3. Natural history of patients with venous thromboembolism and hereditary hemorrhagic telangiectasia. Findings from the RIETE registry

4. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

5. Systolic blood pressure and mortality in acute symptomatic pulmonary embolism

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

7. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

8. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

9. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

10. Clinical course of isolated distal deep vein thrombosis in patients with active cancer: a multicenter cohort study

11. Residual vein obstruction in patients diagnosed with acute isolated distal deep vein thrombosis associated with active cancer

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

13. Incidence rates and case-fatality rates of cerebral vein thrombosis: A population-based study

14. Clinical course of patients with symptomatic isolated superficial vein thrombosis: the ICARO follow‐up study

15. Antiphospholipid Syndrome During Septic Shock: Hyper- or Hypocoagulability?: A Case Report

16. A clinical score to rule out the concomitant presence of deep vein thrombosis in patients presenting with superficial vein thrombosis: The ICARO study

17. OC-01 - Clinical history of cancer patients with isolated distal deep vein thrombosis: a multicenter cohort study

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