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1. Assessment of bleeding events in patients receiving DOACs with or without statins to treat venous thromboembolism: insights from the RIETE registry

Author

Dominique Farge-bancel, R Marqués, M Ortiz, Paolo Prandoni, J Roa, Manuel Monreal, F Couturaud, J Gutierrez, J Pagan, Peter Verhamme, A Aujayeb, Laurent Bertoletti, P Verhamme, M Monreal, S Fonseca, S Pinto, S Soler, A Lorenzo, R Lecumberri, R Otero, P DI MICCO, F Rivera-Cívico, A Molino, P Suchon, C Grange, JA Caprini, J Osorio, Henri Bounameaux, R Valle, F Negro, A Tufano, Remedios Otero, Aitor Ballaz, G Kenet, I Francisco, F Uresandi, G Barillari, Marijan Bosevski, F García-Bragado, E Grau, D Jiménez, A Maestre, A Visonà, J Criado, R Chopard, I Weinberg, M Lumbierres, B Leclercq, H Bounameaux, Farid Rashidi, Abílio Reis, Lucia Mazzolai, P Llamas, MJ Núñez-Fernández, F Dentali, O Espitia, C Siniscalchi, Rosaria Del Giorno, Sanjiv Keller, Carmine Siniscalchi, Luciano Lopez-Jimenez, Ana Cristina Montenegro, Benjamin Brenner, Raquel Barb, Pierpaolo Di Micco, Sebastian Schellong, Inna Tzoran, Radovan Malý, Joseph A. Caprini, Hanh My Bui, MD Adarraga, A Alberich-Conesa, J Aibar, A Alda-Lozano, J Alfonso, C Amado, M Angelina-García, JI Arcelus, A Ballaz, R Barba, C Barbagelata, M Barrón, B Barrón-Andrés, F Beddar-Chaib, A Blanco-Molina, JC Caballero, J Carrillo-Alonso, G Castellanos, L Chasco, C De Ancos, J Del Toro, P Demelo-Rodríguez, C De Juana-Izquierdo, MC Díaz-Pedroche, JA Díaz-Peromingo, A Dubois-Silva, JC Escribano, C Falgá, AI Farfán-Sedano, C Fernández-Aracil, C Fernández-Capitán, B Fernández-Jiménez, JL Fernández-Reyes, MA Fidalgo, C Gabara, F Galeano-Valle, C García-González, A García-Ortega, O Gavín-Sebastián, MA Gil-De Gómez, A Gil-Díaz, C Gómez-Cuervo, A González-Munera, L Guirado, L Hernández-Blasco, L Jara-Palomares, MJ Jaras, I Jou, MD Joya, JL Lobo, L López-Jiménez, P López-Miguel, H López-Brull, JJ López-Núñez, A López-Ruiz, JB LópezSáez, O Madridano, PJ Marchena, M Marcos, M Martín del Pozo, F Martín-Martos, R Martínez-Prado, JM Maza, E Mena, MI Mercado, J Moisés, MV Morales, MS Navas, JA Nieto, M Olid, L Ordieres-Ortega, S Otálora, N Pacheco-Gómez, AC Palomeque, E Paredes, P Parra-Caballero, P Parra-Rosado, JM Pedrajas, C Pérez-Ductor, M Pérez-Pinar, MA Pérez-Jacoiste, ML Peris, ML Pesce, JA Porras, R Puchades, A Rodríguez-Cobo, M Romero-Brugera, P Ruiz-Artacho, N Ruiz-Giménez, J Ruiz-Ruiz, G Salgueiro, T Sancho, V Sendín, P Sigüenza, A Steinherr, S Suárez-Fernández, R Tirado, A TorrentsVilar, MI Torres, J Trujillo-Santos, JF Varona, A Villalobos, P Villares, C Ay, S Nopp, I Pabinger, C Van Edom, A Verstraete, Yoo HHB, AC Montenegro, SN Morales, J Hirmerova, R Malý, L Bertoletti, A BuraRiviere, J Catella, R Le Mao, I Mahé, F Moustafa, L Plaisance, G Sarlon-Bartoli, E Versini, S Schellong, B Brenner, I Tzoran, P Sadeghipour, F Rashidi, A Abenante, M Basaglia, M Bertoni, F Bilora, B Brandolin, M Ciammaichella, D Colaizzo, E Grandone, E Imbalzano, R Pesavento, A Poz, P Prandoni, B Taflaj, B Zalunardo, A Skride, D Kigitovica, J Meireles, M Bosevski, M Zdraveska, L Mazzolai, and HM Bui

Subjects
Medicine
Abstract

Objective To evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE).Design Observational cohort analysis based on a multicentre international registry.Setting Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.Participants A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.Methods Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.Results From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).Conclusions In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.

Published
2024
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2. Heart Rate and Mortality in Patients With Acute Symptomatic Pulmonary Embolism

Author

G. Pellejero, Jose Gutierrez, R. Malý, M. Basaglia, L. Chasco, P. Suchon, R. Le Mao, Laurent Bertoletti, F. Martins, J. Caprini, A. Braester, F. Galeano-Valle, Hanh My Bui, J. Alonso, Y. Sato, G. Vidal, Y. Nishimoto, C. Tolosa, E. Nofuentes-Pérez, A.M. Díaz-Brasero, N. Ait Abdallah, M.D. Adarraga, R. Sánchez-Martínez, L. Font, Raquel López-Reyes, Inna Tzoran, Karine Lacut, J. del Toro, Andris Skride, Ana Jaureguizar, Joseph A. Caprini, C. Amado, R. García de la Garza, A.M. Camon, S. Merla, Luciano López-Jiménez, G. Salgueiro, Sebastian Schellong, Alfonso Muriel, F. Bilora, S. Lainez-Justo, B. Suárez-Rodríguez, Carme Font, F. Beddar Chaib, I. Francisco, C. Jiménez-Alfaro, P. Azcarate-Agüero, Maurizio Ciammaichella, J.A. Porras, N. Vo Hong, F. Martín-Martos, Dominique Farge-Bancel, D. Farge-Bancel, José Luis Lobo, M. Giménez-Suau, E. Grau, F. García-Bragado, Ángeles Blanco-Molina, Carmen Fernández-Capitán, María del Carmen Díaz-Pedroche, C. Grange, Adriana Visonà, L. Guirado, P. Villares, P. López-Miguel, José María Pedrajas, S. Accassat, Beatriz Valero, B. Crichi, Juan J. López-Núñez, Luis Jara-Palomares, G. Sarlon-Bartoli, J. Lima, C. Bortoluzzi, Alicia Lorenzo, C. de Ancos, M.A. Fidalgo, Philippe Debourdeau, Pablo Javier Marchena, C. Rodríguez-Matute, A.I. Farfán-Sedano, José Luis Fernández-Reyes, J.C. Escribano, Juan I. Arcelus, M. Barrón, I. Quere, Remedios Otero, A. De Angelis, P. Morange, Peter Verhamme, G. Kenet, P. Prandoni, Pedro Ruiz-Artacho, C. Siniscalchi, A. Zaicenko, M. Olid-Velilla, C. García-Díaz, B. Barrón-Andrés, T. Sancho, Fernando Uresandi, Javier Trujillo-Santos, A. Muñoz-Blanco, A. Villalobos, A. Dubois-Silva, J. Moisés, J. Osorio, M.I. Mercado, J.M. Suriñach, M.A. Aibar, M.D. Joya, Cihan Ay, J.A. Díaz-Peromingo, H. Bounameaux, Diego Martínez-Urbistondo, Thomas Vanassche, L. Bertoletti, Marijan Bosevski, Farès Moustafa, M. Martín del Pozo, J.F. Sánchez-Muñoz-Torrero, H.M. Bui, Ingrid Pabinger, M.C. Olivares, M. García de Herreros, M.J. Núñez-Fernández, B. Zalunardo, J.F. Varona, Stephan Nopp, Behnood Bikdeli, B. Brandolin, B. Bikdeli, Olga Madridano, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, Abílio Reis, J. Portillo, O. Espitia, J. Catella, Aitor Ballaz, F. Esposito, R. Barba, R. Valle, H. Helfer, I. Tzoran, J.B. López-Sáez, P. Ruiz-Artacho, M.A. García, J. Aibar, C. Gómez-Cuervo, C. Gabara, A. Latorre, J. Ruiz-Ruiz, Benjamin Brenner, S. Fonseca, S. Schellong, Raffaele Pesavento, Barry M. Brenner, Silvia Soler, Paolo Prandoni, Victor F. Tapson, Ana Maestre, Pierpaolo Di Micco, M. Muñoz, J. Criado, D. Jiménez, Antonella Tufano, G. Krstevski, B. Valero, Henri Bounameaux, M.I. Torres, G. Poenou, Isabelle Mahé, Aída Gil-Díaz, A. Asuero, S. Otalora, V. Rosa, L. Vela, E. Imbalzano, C. Vandenbriele, C. Barbagelata, Jana Hirmerova, J. Meireles, David Jiménez, Lucia Mazzolai, L. Hernández-Blasco, M. Bosevski, Gili Kenet, C. Mella, M. Monreal, J.R. Vela, P. Di Micco, Carlos Zamora, K. Flores, P. Demelo-Rodríguez, Radovan Malý, J. Birzulis, J.A. Nieto, J. Castro, M.V. Di Campli, Francis Couturaud, Raquel Barba, Jaureguizar, A., Jimenez, D., Bikdeli, B., Ruiz-Artacho, P., Muriel, A., Tapson, V., Lopez-Reyes, R., Valero, B., Kenet, G., 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., Aibar, J., Aibar, M. A., Alonso, J., Amado, C., Arcelus, J. I., Asuero, A., Azcarate-Aguero, P., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Beddar Chaib, F., Camon, A. M., Castro, J., Chasco, L., Criado, J., de Ancos, C., del Toro, J., Demelo-Rodriguez, P., Diaz-Brasero, A. M., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Di Campli, M. V., Dubois-Silva, A., Escribano, J. C., Esposito, F., Farfan-Sedano, 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 de Herreros, M., Garcia de la Garza, R., Garcia-Diaz, C., Gil-Diaz, A., Gomez-Cuervo, C., Gimenez-Suau, M., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Jimenez-Alfaro, C., Joya, M. D., Lainez-Justo, S., Latorre, A., Lima, J., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Saez, J. B., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Martinez-Urbistondo, D., Mella, C., Mercado, M. I., Moises, J., Munoz, M., Munoz-Blanco, A., Nieto, J. A., Nofuentes-Perez, E., Nunez-Fernandez, M. J., Olid-Velilla, M., Olivares, M. C., Osorio, J., Otalora, S., Otero, R., Pedrajas, J. M., Pellejero, G., Porras, J. A., Portillo, J., Rodriguez-Matute, C., Rosa, V., Ruiz-Ruiz, J., Salgueiro, G., Sanchez-Martinez, R., Sanchez-Munoz-Torrero, J. F., Sancho, T., Soler, S., Suarez-Rodriguez, B., Surinach, J. M., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Valle, R., Varona, J. F., Vela, L., Vela, J. R., Vidal, G., Villalobos, A., Villares, P., Zamora, C., Ay, C., Nopp, S., Pabinger, I., Vanassche, T., Vandenbriele, C., Hirmerova, J., Accassat, S., Ait Abdallah, N., Bura-Riviere, A., Catella, J., Couturaud, F., Crichi, B., Debourdeau, P., Espitia, O., Grange, C., Helfer, H., Lacut, K., Le Mao, R., Mahe, I., Morange, P., Moustafa, F., Poenou, G., Sarlon-Bartoli, G., Suchon, P., Quere, I., Braester, A., Basaglia, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., De Angelis, A., Imbalzano, E., Merla, S., Pesavento, R., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Nishimoto, Y., Sato, Y., Birzulis, J., Skride, A., Zaicenko, A., Fonseca, S., Martins, F., Meireles, J., Krstevski, G., and Mazzolai, L.

Subjects
Male, Registrie, Pulmonary and Respiratory Medicine, medicine.medical_specialty, pulmonary embolism, Critical Care and Intensive Care Medicine, Logistic regression, Heart Rate, Internal medicine, Heart rate, medicine, In patient, Aged, Aged, 80 and over, business.industry, medicine.disease, mortality, Pulmonary embolism, Prospective Studie, Increased risk, Spain, Cardiology, Positive relationship, Female, Cardiology and Cardiovascular Medicine, business, Human
Abstract

Background: The association between heart rate (HR) and pulmonary embolism (PE) outcomes has not been well studied. Furthermore, optimal cutoffs to identify low-risk and intermediate- to high-risk patients are not well known. Research Question: Does an association exist between baseline HR and PE outcome across the continuum of HR values? Study Design and Methods: The current study included 44,331 consecutive nonhypotensive patients with symptomatic PE from the Registro Informatizado de la Enfermedad TromboEmbólica registry between 2001 and 2021. Outcomes included 30-day all-cause and PE-specific mortality. We used hierarchical logistic regression to assess the association between admission HR and outcomes. Results: A positive relationship was found between admission HR and 30-day all-cause and PE-related mortality. Considering an HR of 80 to 99 beats/min as a reference, patients in the higher HR strata showed higher rates of all-cause death (adjusted OR, 1.5 for HR of 100-109 beats/min; adjusted OR, 1.7 for HR of 110-119 beats/min; adjusted OR, 1.9 for HR of 120-139 beats/min; and adjusted OR, 2.4 for HR of ≥ 140 beats/min). Patients in the lower strata of HR showed significantly lower rates of 30-day all-cause mortality compared with the same reference group (adjusted OR, 0.6 for HR of 60-79 beats/min; and adjusted OR, 0.5 for HR of < 60 beats/min). The findings for 30-day PE-related mortality were similar. For identification of low-risk patients, a cutoff value of 80 beats/min (vs 110 beats/min) increased the sensitivity of the simplified Pulmonary Embolism Severity Index (sPESI) from 93.4% to 98.8%. For identification of intermediate- to high-risk patients, a cutoff value of 140 beats/min (vs 110 beats/min) increased the specificity of the Bova score from 93.2% to 98.0%. Interpretation: In nonhypotensive patients with acute symptomatic PE, a high HR portends an increased risk of all-cause and PE-related mortality. Modifying the HR cutoff in the sPESI and the Bova score improves prognostication of patients with PE.

Published
2022
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3. Enoxaparin versus dalteparin or tinzaparin in patients with cancer and venous thromboembolism: The RIETECAT study

Author

Trujillo-Santos J, Farge-Bancel D, Pedrajas JM, Gómez-Cuervo C, Ballaz A, Braester A, Mahé I, Villalobos A, Porras JA, Monreal M, RIETE Investigators, M D Adarraga, J Aibar, M A Aibar, C Amado, J I Arcelus, A Asuero, R Barba, C Barbagelata, M Barrón, B Barrón-Andrés, A Blanco-Molina, E Botella, A M Camon, I Casado, J Castro, M Castro, L Chasco, J Criado, C de Ancos, J Del Toro, P Demelo-Rodríguez, A M Díaz-Brasero, J A Díaz-Peromingo, M V Di Campli, A Dubois-Silva, J C Escribano, F Espósito, C Falgá, A I Farfán-Sedano, C Fernández-Capitán, J L Fernández-Reyes, M A Fidalgo, K Flores, C Font, L Font, I Francisco, C Gabara, F Galeano-Valle, M A García, F García-Bragado, M García de Herreros, R García de la Garza, C García-Díaz, R García-Hernáez, A García-Raso, A Gil-Díaz, M Giménez-Suau, E Grau, L Guirado, J Gutiérrez, L Hernández-Blasco, E Hernando, L Jara-Palomares, M J Jaras, D Jiménez, R Jiménez, C Jiménez-Alfaro, M D Joya, S Lainez-Justo, A Latorre, J Lima, P Llamas, J L Lobo, L López-Jiménez, P López-Miguel, J J López-Núñez, R López-Reyes, J B López-Sáez, A Lorenzo, O Madridano, A Maestre, P J Marchena, F Martín-Martos, D Martínez-Urbistondo, C Mella, M I Mercado, J Moisés, M V Morales, A Muñoz-Blanco, N Muñoz-Rivas, M S Navas, J A Nieto, E Nofuentes-Pérez, M J Núñez-Fernández, B Obispo, M Olid, M C Olivares, J L Orcastegui, J Osorio, S Otalora, R Otero, D Paredes, P Parra, G Pellejero, J Portillo, F Rivera-Civico, D A Rodríguez-Chiaradía, C Rodríguez-Matute, J Rogado, V Rosa, P Ruiz-Artacho, N Ruiz-Giménez, J Ruiz-Ruiz, P Ruiz-Sada, G Salgueiro, R Sánchez-Martínez, J F Sánchez-Muñoz-Torrero, T Sancho, S Soler, B Suárez-Rodríguez, J M Suriñach, R Tirado, M I Torres, C Tolosa, F Uresandi, B Valero, R Valle, J F Varona, G Vidal, P Villares, C Zamora, M Engelen, T Vanassche, P Verhamme, J Hirmerova, R Malý, N Ait Abdallah, L Bertoletti, A Bura-Riviere, J Catella, F Couturaud, B Crichi, P Debourdeau, O Espitia, N Falvo, H Helfer, K Lacut, R Le Mao, F Moustafa, G Poenou, I Quere, S Schellong, B Brenner, I Tzoran, R Nikandish, F Bilora, B Brandolin, M Ciammaichella, P Di Micco, E Imbalzano, R Maida, F Pace, R Pesavento, P Prandoni, R Quintavalla, A Rocci, C Siniscalchi, A Tufano, A Visonà, B Zalunardo, J Birzulis, A Skride, A Zaicenko, S Fonseca, F Martins, J Meireles, M Bosevski, H Bounameaux, L Mazzolai, C I Ochoa-Chaar, I Weinberg, H M Bui, J, Trujillo-Santo, D, Farge-Bancel, Jm, Pedraja, C, Gómez-Cuervo, A, Ballaz, A, Braester, I, Mahé, A, Villalobo, Ja, Porra, M, Monreal, Investigators, Riete, D Adarraga, M, Aibar, J, A Aibar, M, Amado, C, I Arcelus, J, Asuero, A, Barba, R, Barbagelata, C, Barrón, M, Barrón-Andrés, B, Blanco-Molina, A, Botella, E, M Camon, A, Casado, I, Castro, J, Castro, M, Chasco, L, Criado, J, de Ancos, C, Del Toro, J, Demelo-Rodríguez, P, M Díaz-Brasero, A, A Díaz-Peromingo, J, V Di Campli, M, Dubois-Silva, A, C Escribano, J, Espósito, F, Falgá, C, I Farfán-Sedano, A, Fernández-Capitán, C, L Fernández-Reyes, J, A Fidalgo, M, Flores, K, Font, C, Font, L, Francisco, I, Gabara, C, Galeano-Valle, F, A García, M, García-Bragado, F, García de Herreros, M, García de la Garza, R, García-Díaz, C, García-Hernáez, R, García-Raso, A, Gil-Díaz, A, Giménez-Suau, M, Grau, E, Guirado, L, Gutiérrez, J, Hernández-Blasco, L, Hernando, E, Jara-Palomares, L, J Jaras, M, Jiménez, D, Jiménez, R, Jiménez-Alfaro, C, D Joya, M, Lainez-Justo, S, Latorre, A, Lima, J, Llamas, P, L Lobo, J, López-Jiménez, L, López-Miguel, P, J López-Núñez, J, López-Reyes, R, B López-Sáez, J, Lorenzo, A, Madridano, O, Maestre, A, J Marchena, P, Martín-Martos, F, Martínez-Urbistondo, D, Mella, C, I Mercado, M, Moisés, J, V Morales, M, Muñoz-Blanco, A, Muñoz-Rivas, N, S Navas, M, A Nieto, J, Nofuentes-Pérez, E, J Núñez-Fernández, M, Obispo, B, Olid, M, C Olivares, M, L Orcastegui, J, Osorio, J, Otalora, S, Otero, R, Paredes, D, Parra, P, Pellejero, G, Portillo, J, Rivera-Civico, F, A Rodríguez-Chiaradía, D, Rodríguez-Matute, C, Rogado, J, Rosa, V, Ruiz-Artacho, P, Ruiz-Giménez, N, Ruiz-Ruiz, J, Ruiz-Sada, P, Salgueiro, G, Sánchez-Martínez, R, F Sánchez-Muñoz-Torrero, J, Sancho, T, Soler, S, Suárez-Rodríguez, B, M Suriñach, J, Tirado, R, I Torres, M, Tolosa, C, Uresandi, F, Valero, B, Valle, R, F Varona, J, Vidal, G, Villares, P, Zamora, C, Engelen, M, Vanassche, T, Verhamme, P, Hirmerova, J, Malý, R, Ait Abdallah, N, Bertoletti, L, Bura-Riviere, A, Catella, J, Couturaud, F, Crichi, B, Debourdeau, P, Espitia, O, Falvo, N, Helfer, H, Lacut, K, Le Mao, R, Moustafa, F, Poenou, G, Quere, I, Schellong, S, Brenner, B, Tzoran, I, Nikandish, R, Bilora, F, Brandolin, B, Ciammaichella, M, Di Micco, P, Imbalzano, E, Maida, R, Pace, F, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Tufano, A, Visonà, A, Zalunardo, B, Birzulis, J, Skride, A, Zaicenko, A, Fonseca, S, Martins, F, Meireles, J, Bosevski, M, Bounameaux, H, Mazzolai, L, I Ochoa-Chaar, C, Weinberg, I, and M Bui, H

Subjects
dalteparin, recurrences, tinzaparin, venous thromboembolism, cancer, enoxaparin, Hematology, cohort, LMWH
Abstract

Venous thromboembolism (VTE) is a frequent complication in patients with cancer and a leading cause of morbidity and death. The objective of the RIETECAT study was to compare the long-term effectiveness and safety of enoxaparin versus dalteparin or tinzaparin for the secondary prevention of VTE in adults with active cancer. We used the data from the multicenter, multinational RIETE registry to compare the rates of VTE recurrences, major bleeding, or death over 6 months in patients with active cancer and acute VTE using full doses of enoxaparin versus dalteparin or tinzaparin, and a multivariable Cox proportional hazard model was used to analyze the primary end point. From January 2009 to June 2018, 4451 patients with active cancer received full doses of the study drugs: enoxaparin, 3526 patients; and dalteparin or tinzaparin, 925 (754 + 171) patients. There was limited difference in VTE recurrences (2.0% vs 2.5%) and mortality rate (19% vs 17%) between the enoxaparin and dalteparin or tinzaparin subgroups. However, there was a slight numerical increase in major bleeding (3.1% vs 1.9%). Propensity score matching confirmed that there were no differences in the risk for VTE recurrences (adjusted hazard ratio [aHR], 0.81; 95% confidence interval [CI], 0.48-1.38), major bleeding (aHR, 1.40; 95% CI, 0.80-2.46), or death (aHR, 1.07; 95% CI, 0.88-1.30) between subgroups. In RIETECAT, in patients with cancer and VTE receiving full-dose enoxaparin or dalteparin or tinzaparin, no statistically significant differences were observed regarding effectiveness and safety outcomes over a 6-month period.

Published
2022

4. A prognostic score to identify women at increased risk for abnormal uterine bleeding during anticoagulation for venous thromboembolism

Author

Gabrielle Sarlon-Bartoli, Juan Criado, Saskia Middeldorp, José Antonio Nieto, María del Carmen Díaz-Pedroche, Farès Moustafa, Nuria Ruiz-Giménez, Benjamin Brenner, Manuel Monreal, Pierpaolo DI Micco, Paolo Prandoni, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Joseph A. Caprini, Hanh My Bui, M.D. Adarraga, P. Agudo, C. Amado, J.I. Arcelus, A. Ballaz, J. Bascuñana, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, F. Beddar Chaib, E. Botella, I. Cañas, R. Carrero-Arribas, I. Casado, P. Cerdá, L. Chasco, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, A.M. Díaz-Brasero, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, I.M. Domínguez, A. Dubois-Silva, J.C. Escribano, F. Espósito, A.I. Farfán-Sedano, C. Falgá, C. Fernández-Capitán, B. Fernández-Jiménez, J. Fernández-Muixi, J.L. Fernández-Reyes, C. Font, I. Francisco, F. Galeano-Valle, M.A. García, F. García-Bragado, M. García de Herreros, O. Gavín-Blanco, A. Gil-Díaz, C. Gómez-Cuervo, A.M. Gómez-Mosquera, M. Gonzalez-Moreno, E. Grau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, I. Jou, M.D. Joya, B. Lacruz, S. Lainez-Justo, Latorre A, Lima J, Lobo Jl, M. López-De la Fuente, L. López-Jiménez, M. López-Meseguer, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, P.J. Marchena, J.M. Martín-Guerra, F. Martín-Martos, M. Mellado, E. Mena, J. Moisés, M.I. Mercado, M. Monreal, A. Muñoz-Blanco, G. Muñoz-Gamito, M.V. Morales, J.A. Nieto, E. Noguera-Gras, M.J. Núñez-Fernández, M. Olid-Velilla, J. Osorio, S. Otalora, R. Otero, D. Paredes-Ruiz, P. Parra, V. Parra, J.M. Pedrajas, M. Pérez-López, M.L. Peris, M.L. Pesce, J.A. Porras, J. Poyo-Molina, R. Puchades, A. Riera-Mestre, F. Rivera-Civico, A. Rivera-Gallego, M. Roca, V. Rosa, A. Rodríguez-Cobo, C. Rodríguez-Matute, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, G. Salgueiro, T. Sancho, V. Sendín, P. Sigüenza, S. Soler, B. Suárez-Rodríguez, J.M. Suriñach, G. Tiberio, M.I. Torres, A. Torres-Sánchez, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, R. Valle, J.F. Varona, L. Vela, J.R. Vela, A. Villalobos, P. Villares, C. Ay, S. Nopp, I. Pabinger, M.M. Engelen, C. Martens, P. Verhamme, H.H.B. Yoo, J.D. Arguello, A.C. Montenegro, J. Roa, J. Hirmerova, R. Malý, S. Accassat, L. Bertoletti, A. Bura-Riviere, J. Catella, R. Chopard, F. Couturaud, O. Espitia, S. El Harake, R. Le Mao, I. Mahé, F. Moustafa, L. Plaisance, G. Sarlon-Bartoli, P. Suchon, E. Versini, S. Schellong, A. Braester, B. Brenner, G. Kenet, I. Tzoran, P. Sadeghipour, M. Basaglia, F. Bilora, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, A. De Angelis, F. Dentali, P. Di Micco, E. Imbalzano, S. Merla, R. Pesavento, P. Prandoni, C. Siniscalchi, A. Tufano, A. Visonà, N. Vo Hong, B. Zalunardo, D. Kigitovica, E. Rusa, A. Skride, S. Fonseca, M. Manuel, J. Meireles, M. Bosevski, A. Eftimova, M. Zdraveska, H. Bounameaux, L. Mazzolai, A. Aujayeb, J.A. Caprini, I. Weinberg, and H.M. Bui

Subjects
Anticoagulants, Venous thromboembolism, Uterine bleeding, Prognostic score, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Little is known about the clinical characteristics of women at increased risk for abnormal uterine bleeding (UB) during anticoagulation for venous thromboembolism (VTE). Methods: We used the RIETE registry to identify the baseline characteristics of women developing abnormal UB during anticoagulation. We used logistic regression analysis to identify independent predictors for abnormal UB. Then, we built a prognostic score to identify at-risk women. Results: From March 2001 through October 2022, there were 54,372 women with VTE. During anticoagulation (median, 181 days), 318 (0.6%) developed abnormal UB (major bleeding = 88, clinically relevant non-major (CRNM) = 230). On multivariable analysis, women aged 70 kg, with uterine cancer, recent UB, anemia, estrogen-related VTE, or receiving rivaroxaban or apixaban were at increased risk for abnormal UB. Using the prognostic score, 42,273 women (78%) were at low-risk, 8,828 (16%) intermediate-, and 3,271 (6.1%) at high-risk for abnormal UB. Their rates of abnormal UB were: 0.28 (95%CI: 0.23–0.35), 1.32 (95%CI: 1.07–1.61) and 7.12 (95%CI: 5.98–8.41) bleeds per 100 patient-years, respectively. The c-statistic was 0.80 (95%CI: 0.77–0.83). The rates of major UB were: 0.06 (95%CI: 0.04–0.09), 0.43 (95%CI: 0.30–0.60) and 1.85 (95%CI: 1.31–2.53) per 100 patient-years, respectively (c-statistic: 0.84; 95%CI: 0.80–0.89). The rates of CRNM uterine bleeding were: 0.21 (95%CI: 0.17–0.26), 0.85 (95%CI: 0.65–1.08), and 5.02 (95%CI: 4.09–6.10) bleeds per 100 patient-years, respectively (c-statistic: 0.78; 95%CI: 0.75–0.82). Conclusions: Using 7 variables easily available at admission, we built a prognostic score that reliably identified women with VTE at increased risk for abnormal UB during anticoagulation.

Published
2023
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