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

Author

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

Subjects
Long-term treatment. low molecular weight heparin. vitamin k-antagonist. venous thrombosis. pulmonary embolism. deep vein thrombosis, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: The use of low-molecular-weight heparin (LMWH) for long-term therapy of venous thromboembolism (VTE) in patients without cancer has not been consistently evaluated. Methods: We used the data in the RIETE registry to compare the 3-month outcomes (VTE recurrences, major bleeding or death) in non-cancer patients with VTE, according to long-term therapy with LMWH or vitamin K antagonists (VKAs). Results: As of March 2018, 14,582 non-cancer patients with VTE had received initial therapy with LMWH and then switched to VKAs, while 9151 were prescribed LMWH for initial and long-term therapy. Overall, 11,494 had initially presented with pulmonary embolism (PE) and 12,239 with isolated deep vein thrombosis (DVT). Among 11,494 patients initially presenting with PE, 84 had VTE recurrences, 204 major bleeding and 406 died. Among 12,239 patients with isolated DVT, 133 developed VTE recurrences, 137 bled and 289 died. On propensity score analysis, PE patients on long-term LMWH therapy were at increased risk for PE recurrences (OR: 3.30; 95%CI: 1.67–6.48), major bleeding (OR: 1.68; 95%CI: 1.21–2.32) or death (OR: 3.16; 95%CI: 2.43–4.09) compared with those receiving VKAs. In patients with DVT, those on long-term LMWH also were at increased risk for PE recurrences (OR: 2.31; 95%CI: 1.13–4.73), major bleeding (OR 2.28; 95%CI: 1.51–3.44) or death (OR: 2.32; 95%CI: 1.54–3.51). Conclusions: In the RIETE non-cancer patients with VTE, long-term therapy with VKAs was associated with a lower risk for recurrences, major bleeding or death.

Published
2020
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3. 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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4. 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

5. 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

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

Author

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

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

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

Published
2020

7. Timing and characteristics of venous thromboembolism after noncancer surgery

Author

Manuela Expósito-Ruiz, Juan Ignacio Arcelus, Joseph A. Caprini, Cristina López-Espada, Alessandra Bura-Riviere, Cristina Amado, Mónica Loring, Daniela Mastroiacovo, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Hanh My Bui, M.D. Adarraga, M. Agud, J. Aibar, M.A. Aibar, C. Amado, J.I. Arcelus, C. Baeza, A. Ballaz, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, E. Botella, A.M. Camon, S. Campos, I. Cañas, I. Casado, J. Castro, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, C. Díaz-Pedroche, J.A. Díaz-Peromingo, J. Díez-Sierra, I.M. Domínguez, J.C. Escribano, C. Falgá, A.I. Farfán, K. Fernández de Roitegui, C. Fernández-Aracil, C. Fernández-Capitán, J.L. Fernández-Reyes, M.A. Fidalgo, K. Flores, C. Font, L. Font, I. Francisco, I. Furest, C. Gabara, F. Galeano-Valle, M.A. García, F. García-Bragado, R. García-Hernáez, A. García-Raso, O. Gavín-Sebastián, A. Gil-Díaz, C. Gómez-Cuervo, J. González-Martínez, E. Grau, M. Giménez-Suau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, E. Hernando, M. Herreros, L. Jara-Palomares, M.J. Jaras, D. Jiménez, R. Jiménez, M.D. Joya, I. Jou, A. Lalueza, R. Lecumberri, 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, M. Loring, O. Madridano, A. Maestre, P.J. Marchena, M. Martín del Pozo, F. Martín-Martos, C. Mella, M. Mellado, M.I. Mercado, J. Moisés, M. Monreal, M.V. Morales, A. Muñoz-Blanco, D. Muñoz-Guglielmetti, N. Muñoz-Rivas, J.A. Nieto, A. Núñez-Ares, M.J. Núñez-Fernández, B. Obispo, M.C. Olivares, J.L. Orcastegui, M.D. Ortega-Recio, J. Osorio, S. Otalora, R. Otero, D. Paredes, P. Parra, V. Parra, J.M. Pedrajas, G. Pellejero, D. Pesántez, J.A. Porras, J. Portillo, A. Riera-Mestre, A. Rivas, F. Rivera, A. Rodríguez-Cobo, C. Rodríguez-Matute, J. Rogado, V. Rosa, C.M. Rubio, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, P. Ruiz-Sada, J.C. Sahuquillo, G. Salgueiro, A. Sampériz, J.F. Sánchez-Muñoz-Torrero, T. Sancho, P. Sigüenza, S. Soler, J.M. Suriñach, M.I. Torres, C. Tolosa, J. Trujillo-Santos, F. Uresandi, R. Valle, J.R. Vela, G. Vidal, P. Villares, C. Zamora, P. Gutiérrez, F.J. Vázquez, T. Vanassche, C. Vandenbriele, P. Verhamme, J. Hirmerova, R. Malý, 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, F. Bilora, B. Brandolin, E. Bucherini, M. Ciammaichella, D. Colaizzo, P. Di Micco, E. Grandone, D. Marchi, D. Mastroiacovo, R. Maida, F. Pace, R. Pesavento, P. Prandoni, R. Quintavalla, N. Rinzivillo, A. Rocci, C. Siniscalchi, A. Tufano, A. Visonà, B. Zalunardo, V. Gibietis, D. Kigitovica, A. Skride, M. Ferreira, S. Fonseca, F. Martins, J. Meireles, M. Bosevski, G. Krstevski, H. Bounameaux, L. Mazzolai, J.A. Caprini, A.J. Tafur, I. Weinberg, H. Wilkins, H.M. Bui, Exposito-Ruiz, M., Arcelus, J. I., Caprini, J. A., Lopez-Espada, C., Bura-Riviere, A., Amado, C., Loring, M., Mastroiacovo, D., 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., Bui, H. M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Botella, E., Camon, A. M., Campos, S., Canas, I., Casado, I., Castro, J., Criado, J., de Ancos, C., de Miguel, J., Toro, J. D., Demelo-Rodriguez, P., Diaz-Pedroche, C., Diaz-Peromingo, J. A., Diez-Sierra, J., Dominguez, I. M., Escribano, J. C., Falga, C., Farfan, A. I., Fernandez de Roitegui, K., Fernandez-Aracil, C., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Font, L., Francisco, I., Furest, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Hernaez, R., Garcia-Raso, A., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gimenez-Suau, M., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Hernando, E., Herreros, M., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, R., Joya, M. D., Jou, I., Lalueza, A., Lecumberri, R., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Munoz-Rivas, N., Nieto, J. A., Nunez-Ares, A., Nunez-Fernandez, M. J., Obispo, B., Olivares, M. C., Orcastegui, J. L., Ortega-Recio, M. D., Osorio, J., Otalora, S., Otero, R., Paredes, D., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Pesantez, D., Porras, J. A., Portillo, J., Riera-Mestre, A., Rivas, A., Rivera, F., 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., Soler, S., Surinach, J. M., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Valle, R., Vela, J. R., Vidal, G., Villares, P., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Hirmerova, J., Benzidia, I., Crichi, B., Debourdeau, P., Espitia, O., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Braester, A., Bilora, F., Brandolin, B., Bucherini, E., Ciammaichella, M., Colaizzo, D., Grandone, E., Marchi, D., Maida, R., Pace, F., Pesavento, R., Quintavalla, R., Rinzivillo, N., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Zalunardo, B., Gibietis, V., Kigitovica, D., Skride, A., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Krstevski, G., Mazzolai, L., Tafur, A. J., Weinberg, I., and Wilkins, H.

Subjects
Adult, Male, Registrie, medicine.medical_specialty, Time Factors, Time Factor, Duration of risk, 030204 cardiovascular system & hematology, Drug Administration Schedule, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Risk Factors, Deep vein thrombosi, Interquartile range, medicine, Humans, Registries, cardiovascular diseases, 030212 general & internal medicine, Aged, Venous Thrombosis, Benign disease, business.industry, Risk Factor, Incidence (epidemiology), Pulmonary embolism, Anticoagulant, Anticoagulants, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Middle Aged, equipment and supplies, medicine.disease, Thrombosis, Surgery, Time course, Thromboprophylaxi, Female, Postoperative Complication, Cardiology and Cardiovascular Medicine, business, Venous thromboembolism, Human, Surgical patients
Abstract

Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality postoperatively. The use of pharmacologic prophylaxis is effective in reducing the incidence of VTE. However, the prophylaxis is often discontinued at hospital discharge, especially for those with benign disease. The implications of this practice are not known. We assessed the data from a large, ongoing registry regarding the time course of VTE and outcomes after noncancer surgery. Methods We analyzed the RIETE (Computerized Registry on Venous Thromboembolism) registry, which includes data from consecutive patients with symptomatic confirmed VTE. In the present study, we focused on general surgical patients who had developed symptomatic postoperative VTE in the first 8 weeks after noncancer surgery. The main objective was to assess the interval between surgery and the occurrence of VTE. Additional variables included the clinical presentation associated with the event, the use of thrombosis prophylaxis, and unfavorable outcomes. Results The data from 3296 patients were analyzed. The median time from surgery to the detection of VTE was 16 days (interquartile range, 8-30 days). Of the VTE events, 77% were detected after the first postoperative week and 27% after 4 weeks. Overall, 43.9% of the patients with VTE had received pharmacologic prophylaxis after surgery for a median of 8 days (interquartile range, 5-14 days), and three quarters of the VTE events were detected after pharmacologic prophylaxis had been discontinued. Overall, 54% of the patients with VTE had presented with pulmonary embolism. For 15% of the patients, the clinical outcome was unfavorable, including 4% who had died within 90 days. Conclusions The risk of VTE after noncancer general surgery remains high for ≤2 months. More than one half of the patients had presented with symptomatic PE as the VTE event, and 15% had had unfavorable outcomes. Only 44% of these patients had received pharmacologic prophylaxis for around 1 week.

Published
2021
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8. FPGA Implementation of Low-Latency Robust Asynchronous Interfaces for GALS Systems

Author

Duarte L. Oliveira, Tiago Curtinhas, Joao B. Brandolin, and Osamu Saotome

Subjects
Reduction (complexity), Handshake, Computer science, Clock signal, Asynchronous communication, business.industry, Embedded system, Latency (audio), Latency (engineering), Hazard (computer architecture), business, Field-programmable gate array
Abstract

Complex digital systems must necessarily be based on the "System-on-Chip – SoC" concept. A natural implementation of SoC circuit uses global clock, but in DSM technology (Deep-Sub-Micron) global clock signal causes several problems. An interesting style for SoC design that reduces the problems of the global clock is the GALS (Globally Asynchronous, Locally Synchronous) paradigm. Currently, the major drawback in the design of a GALS system, shows to be the asynchronous interface. This paper proposes a novel asynchronous wrapper based on a unique port controller aiming to the point-to-point GALS style and easily generalized to multi-point GALS systems. The proposed asynchronous wrapper allows the communication between modules to be performed in the two-phase handshake protocol, which reduces the latency time when compared to the previous ones, and it is robust with respect to essential hazard. A comparison with seven wrappers found in literature shows that the proposed wrapper leads to an average reduction in latency time of 61.1% and average reduction in area of 58% in the FPGA (Field Programmable Gated array) platform.

Published
2018
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9. A Novel Architecture for Implementation of Quasi Delay Insensitive Finite State Machines

Author

Osamu Saotome, Duarte L. Oliveira, Robson L. Moreno, Orlando Verducci, Vitor L. V. Torres, and Joao B. Brandolin

Subjects
Reduction (complexity), Finite-state machine, Asynchronous system, Asynchronous communication, Computer science, Logic gate, Dynamic demand, Electronic engineering, Hardware_PERFORMANCEANDRELIABILITY, Power (physics), Electronic circuit
Abstract

Due to the increasing demand for mobile devices, the search for ultra-low-power projects is becoming a priority. One technique that allows a strong reduction of circuits dissipated power is the sub-threshold voltage operation, but it leads to some drawbacks. The QDI (Quasi Delay Insensitive) asynchronous circuits class shows to be an interesting solution to these problems, when compared to synchronous circuits and in CMOS-UDSM (Ultra Deep Sub-Micron) technology. Asynchronous finite state machines (AFSMs) are important components in an asynchronous system. This paper proposes a new architecture for QDI AFSMs described in Extended Burst-Mode specification, implemented in the dual-rail style using basic gates and memory based on RS latches. The resulting XBM_AFSMs are QDI, so they can operate in sub-threshold voltage. The architecture is presented through the case study and the obtained QDI_XBM_AFSM presents for three benchmarks an average reduction of 24.4%, and 48.3%, 49.6% and 49.2% respectively, latency time, number of LUTs, dynamic power and static power, when compared with four QDI controllers of the literature.

Published
2018
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10. A Tools Flow for Automatic Synthesis of Extended Burst-Mode Asynchronous State Machines

Author

Joao B. Brandolin, Duarte L. Oliveira, Tiago Curtinhas, Vitor L. V. Torres, and Osamu Saotome

Subjects
symbols.namesake, Finite-state machine, Computer engineering, Computer science, Asynchronous communication, symbols, Static timing analysis, Minification, Huffman coding, Clock skew, Burst mode (computing), Electronic circuit
Abstract

Asynchronous design is an interesting alternative to solve the difficulties of the synchronous counterpart related to clock, like clock skew and clock distribution problems. However, the lack of tools for automatic synthesis is a major drawback. Asynchronous Finite State Machines are widely used in the control of asynchronous digital systems and are usually implemented as Huffman machines with fed-back outputs (HMFO). However, it can be implemented as Huffman Machines (HM) which has the advantage of better interaction with fast environments, reducing the cost of timing analysis and has potential for better latency time, compared to HMFO. Interestingly, state of the art tools like 3D and SAGAAS does not synthesize asynchronous circuits in HM architecture, only HMFO. Nevertheless both uses Extended Burst-Mode (XBM) specification as its input. This paper proposes an algorithm based on genetic algorithms for state assignment of XBM_HMs, which is important step in the synthesis. This paper also proposes a tools flow for automatic synthesis of XBM specifications in the HM architecture.

Published
2018
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11. Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Author

Farès Moustafa, Matteo Giorgi Pierfranceschi, Pierpaolo Di Micco, Eugenio Bucherini, Alicia Lorenzo, Aurora Villalobos, José A. Nieto, Beatriz Valero, Ángel L. Sampériz, Manuel Monreal, Hervé Decousus, Paolo Prandoni, Benjamin Brenner, Raquel Barba, Laurent Bertoletti, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Philip Wells, Manolis Papadakis, MD Adarraga, P Agudo, MA Aibar, M Alfonso, JI Arcelus, A Ballaz, R Barba, M Barrón, B Barrón‐Andrés, J Bascuñana, A Blanco‐Molina, I Cañas, I Casado, N Chic, R del Pozo, J del Toro, MC Díaz‐Pedroche, JA Díaz‐Peromingo, C Falgá, C Fernández‐Aracil, C Fernández‐Capitán, MA Fidalgo, C Font, L Font, P Gallego, MA García, F García‐Bragado, O Gavín, C Gómez, V Gómez, J González, E Grau, A Grimón, R Guijarro, L Guirado, J Gutiérrez, G Hernández‐Comes, L Hernández‐Blasco, L Jara‐Palomares, MJ Jaras, D Jiménez, J Jiménez, MD Joya, P Llamas, JL Lobo, P López, L López‐Jiménez, R López‐Reyes, JB López‐Sáez, MA Lorente, M Lumbierres, JM Luque, PJ Marchena, F Martín‐Martos, M Mellado, S Nieto, A Núñez, MJ Núñez, S Otalora, R Otero, JM Pedrajas, G Pérez, C Pérez‐Ductor, ML Peris, I Pons, JA Porras, O Reig, A Riera‐Mestre, D Riesco, A Rivas, M Rodríguez, MA Rodríguez‐Dávila, V Rosa, E Rosillo‐Hernández, P Ruiz‐Artacho, N Ruiz‐Giménez, JC Sahuquillo, MC Sala‐Sainz, R Sánchez‐Martínez, O Sanz, S Soler, B Sopeña, JM Suriñach, C Tolosa, MI Torres, J Troya, J Trujillo‐Santos, F Uresandi, E Usandizaga, R Valle, J Vela, L Vela, MP Vicente, B Xifre, T Vanassche, P Verhamme, HHB Yoo, P Wells, J Hirmerova, R Malý, P Dulíček, E Salgado, L Bertoletti, A Bura‐Riviere, D Farge‐Bancel, A Hij, I Mahé, A Merah, A Braester, B Brenner, I Tzoran, G Antonucci, G Barillari, F Bilora, C Bortoluzzi, B Brandolin, C Cattabiani, M Ciammaichella, N Dell'Elce, F Dentali, R Duce, E Grandone, E Imbalzano, G Lessiani, R Maida, D Mastroiacovo, F Pace, R Parisi, M Pellegrinet, R Pesavento, M Pinelli, R Poggio, P Prandoni, R Quintavalla, A Rocci, E Tiraferri, D Tonello, A Tufano, A Visonà, V Gibietis, A Skride, B Vitola, M Bosevski, M Zdraveska, H Bounameaux, L Mazzolai, RIETE Investigators, Decousus, H., Prandoni, P., Brenner, B., Barba, R., Bertoletti, L., Tzoran, I., Reis, A., Bosevski, M., Bounameaux, H., Malý, R., Wells, P., Papadakis, M., Adarraga, M.D., Agudo, P., Aibar, M.A., Alfonso, M., Arcelus, J.I., Ballaz, A., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Blanco-Molina, A., Cañas, I., Casado, I., Chic, N., Del Pozo, R., Del Toro, J., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Falgá, C., Fernández-Aracil, C., Fernández-Capitán, C., Fidalgo, M.A., Font, C., Font, L., Gallego, P., García, M.A., García-Bragado, F., Gavín, O., Gómez, C., Gómez, V., González, J., Grau, E., Grimón, A., Guijarro, R., Guirado, L., Gutiérrez, J., Hernández-Comes, G., Hernández-Blasco, L., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jiménez, J., Joya, M.D., Llamas, P., Lobo, J.L., López, P., López-Jiménez, L., López-Reyes, R., López-Sáez, J.B., Lorente, M.A., Lumbierres, M., Luque, J.M., Marchena, P.J., Martín-Martos, F., Mellado, M., Nieto, S., Núñez, A., Núñez, M.J., Otalora, S., Otero, R., Pedrajas, J.M., Pérez, G., Pérez-Ductor, C., Peris, M.L., Pons, I., Porras, J.A., Reig, O., Riera-Mestre, A., Riesco, D., Rivas, A., Rodríguez, M., Rodríguez-Dávila, M.A., Rosa, V., Rosillo-Hernández, E., Ruiz-Artacho, P., Ruiz-Giménez, N., Sahuquillo, J.C., Sala-Sainz, M.C., Sánchez-Martínez, R., Sanz, O., Soler, S., Sopeña, B., Suriñach, J.M., Tolosa, C., Torres, M.I., Troya, J., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J., Vela, L., Vicente, M.P., Xifre, B., Vanassche, T., Verhamme, P., Yoo, H., Hirmerova, J., Dulíček, P., Salgado, E., Bura-Riviere, A., Farge-Bancel, D., Hij, A., Mahé, I., Merah, A., Braester, A., Antonucci, G., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Cattabiani, C., Ciammaichella, M., Dell'Elce, N., Dentali, F., Duce, R., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Pace, F., Parisi, R., Pellegrinet, M., Pesavento, R., Pinelli, M., Poggio, R., Quintavalla, R., Rocci, A., Tiraferri, E., Tonello, D., Tufano, A., Visonà, A., Gibietis, V., Skride, A., Vitola, B., Zdraveska, M., Mazzolai, L., Moustafa, F., Giorgi Pierfranceschi, M., Di Micco, P., Bucherini, E., Lorenzo, A., Villalobos, A., Nieto, J. A., Valero, B., Samperiz, A. L., Monreal, M., Maly, R., Adarraga, M. D., Aibar, M. A., Arcelus, J. I., Barron, M., Barron-Andres, B., Bascunana, J., Canas, I., del Pozo, R., del Toro, J., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Falga, C., Fernandez-Aracil, C., Fernandez-Capitan, C., Fidalgo, M. A., Garcia, M. A., Garcia-Bragado, F., Gavin, O., Gomez, C., Gomez, V., Gonzalez, J., Grimon, A., Gutierrez, J., Hernandez-Comes, G., Hernandez-Blasco, L., Jaras, M. J., Jimenez, D., Jimenez, J., Joya, M. D., Lobo, J. L., Lopez, P., Lopez-Jimenez, L., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Luque, J. M., Marchena, P. J., Martin-Martos, F., Nunez, A., Nunez, M. J., Pedrajas, J. M., Perez, G., Perez-Ductor, C., Peris, M. L., Porras, J. A., Rodriguez, M., Rodriguez-Davila, M. A., Rosillo-Hernandez, E., Ruiz-Gimenez, N., Sahuquillo, J. C., Sala-Sainz, M. C., Sanchez-Martinez, R., Sopena, B., Surinach, J. M., Torres, M. I., Vicente, M. P., Yoo, H. H. B., Dulicek, P., Mahe, I., and Visona, A.

Subjects
medicine.medical_specialty, Gastrointestinal bleeding, anticoagulants, recurrence, venous thromboembolism, hemorrhage, mortality, recurrences, Renal function, 030204 cardiovascular system & hematology, Lower risk, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, 030212 general & internal medicine, business.industry, anticoagulant, Retrospective cohort study, Hematology, Odds ratio, medicine.disease, Confidence interval, Surgery, Natural history, Original Article, business, Original Articles: Thrombosis
Abstract

Essentials Recent randomized trials suggested fewer bleeding events in fragile patients with VTE receiving DOACs.The frequency, clinical characteristics and outcome of these patients have not been reported in real life.Fragile patients with VTE had a higher risk for major bleeding or death and a lower risk for recurrences than non‐fragile. Background Subgroup analyses from randomized trials suggested favorable results for the direct oral anticoagulants in fragile patients with venous thromboembolism (VTE). The frequency and natural history of fragile patients with VTE have not been studied yet. Objectives To compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non‐fragile patients with VTE. Methods Retrospective study using consecutive patients enrolled in the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. Fragile patients were defined as those having age ≥75 years, creatinine clearance (CrCl) levels ≤50 mL/min, and/or body weight ≤50 kg. Results From January 2013 to October 2016, 15 079 patients were recruited. Of these, 6260 (42%) were fragile: 37% were aged ≥75 years, 20% had CrCl levels ≤50 mL/min, and 3.6% weighed ≤50 kg. During the first 3 months of anticoagulant therapy, fragile patients had a lower risk of VTE recurrences (0.78% vs 1.4%; adjusted odds ratio [OR]: 0.52; 95% confidence intervals [CI]: 0.37‐0.74) and a higher risk of major bleeding (2.6% vs 1.4%; adjusted OR: 1.41; 95% CI: 1.10‐1.80), gastrointestinal bleeding (0.86% vs 0.35%; adjusted OR: 1.84; 95% CI: 1.16‐2.92), haematoma (0.51% vs 0.07%; adjusted OR: 5.05; 95% CI: 2.05‐12.4), all‐cause death (9.2% vs 3.5%; adjusted OR: 2.02; 95% CI: 1.75‐2.33), or fatal PE (0.85% vs 0.35%; adjusted OR: 1.77; 95% CI: 1.10‐2.85) than the non‐fragile. Conclusions In real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non‐fragile.

Published
2017

12. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Deisy Barrios, Jeremy Chavant, David Jiménez, Laurent Bertoletti, Vladimir Rosa-Salazar, Alfonso Muriel, Alain Viallon, Carmen Fernández-Capitán, Roger D. Yusen, Manuel Monreal, Hervè Decousus, Paolo Prandoni, Benjamin Brenner, Raquel Barba, Pierpaolo Di Micco, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Philip Wells, Peter Verhamme, M.D. Adarraga, M.A. Aibar, M. Alfonso, J.I. Arcelus, P.M. Azcarate-Agüero, A. Ballaz, R. Barba, M. Barrón, B. Barrón-Andrés, J. Bascuñana, A. Blanco-Molina, G. Cañada, I. Cañas, I. Casado, N. Chic, R. del Pozo, J. del Toro, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, C. Falgá, C. Fernández-Aracil, C. Fernández-Capitán, M.A. Fidalgo, C. Font, L. Font, P. Gallego, M.A. García, F. García-Bragado, P. García-Brotons, O. Gavín, C. Gómez, V. Gómez, J. González, E. Grau, A. Grimón, L. Guirado, J. Gutiérrez, G. Hernández-Comes, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, J. Jiménez, M.D. Joya, P. Llamas, J.L. Lobo, P. López, L. López-Jiménez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, J.M. Luque, P.J. Marchena, C. Martínez, F. Martín-Martos, M. Monreal, J.A. Nieto, S. Nieto, A. Núñez, M.J. Núñez, S. Otalora, R. Otero, J.M. Pedrajas, G. Pérez, C. Pérez-Ductor, M.L. Peris, I. Pons, J.A. Porras, O. Reig, A. Riera-Mestre, D. Riesco, A. Rivas, M. Rodríguez, M.A. Rodríguez-Dávila, V. Rosa, J.C. Sahuquillo, M.C. Sala-Sainz, A. Sampériz, R. Sánchez-Martínez, O. Sanz, S. Soler, B. Sopeña, J.M. Suriñach, C. Tolosa, M.I. Torres, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, B. Valero, R. Valle, J. Vela, G. Vidal, C. Vilar, B. Xifre, T. Vanassche, P. Verhamme, H.H.B. Yoo, P. Wells, J. Hirmerova, R. Malý, E. Salgado, L. Bertoletti, A. Bura-Riviere, D. Farge-Bancel, A. Hij, I. Mahé, A. Merah, F. Moustafa, A. Braester, B. Brenner, I. Tzoran, G. Antonucci, G. Barillari, F. Bilora, A. Bonanome, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, P. De Ciantis, F. Dentali, P. Di Micco, R. Duce, M. Giorgi-Pierfranceschi, E. Grandone, E. Imbalzano, G. Lessiani, R. Maida, D. Mastroiacovo, F. Pace, R. Parisi, R. Pesavento, M. Pinelli, R. Poggio, P. Prandoni, R. Quintavalla, A. Rocci, E. Tiraferri, D. Tonello, A. Tufano, U. Venturelli, A. Visonà, V. Gibietis, A. Skride, B. Vitola, M. Bosevski, M. Zdraveska, H. Bounameaux, and L. Mazzolai

Subjects
Male, medicine.medical_specialty, Heart Diseases, medicine.medical_treatment, Hemorrhage, 030204 cardiovascular system & hematology, Lower risk, 03 medical and health sciences, Anticoagulation, 0302 clinical medicine, Reperfusion therapy, Recurrence, Internal medicine, Cause of Death, medicine, Humans, Thrombolytic Therapy, 030212 general & internal medicine, Propensity Score, Cause of death, Right heart thrombi, Aged, business.industry, Pulmonary embolism, Anticoagulants, Thrombosis, General Medicine, Thrombolysis, Middle Aged, medicine.disease, Confidence interval, Treatment, Treatment Outcome, Propensity score matching, Cardiology, Female, business, Pulmonary Embolism
Abstract

Background Evidence-based recommendations do not adequately address the treatment of right heart thrombi in patients who present with acute symptomatic pulmonary embolism. Methods This study included patients who had acute pulmonary embolism associated with right heart thrombi and participated in the Registro Informatizado de la Enfermedad TromboEmbolica registry. We assessed the effectiveness of anticoagulation versus reperfusion treatment for the outcomes of all-cause mortality, pulmonary embolism–related mortality, recurrent venous thromboembolism, and major bleeding rates through 30 days after initiation of pulmonary embolism treatment. We used propensity score matching to adjust for the likelihood of receiving reperfusion treatment. Results Of 325 patients with pulmonary embolism and right heart thrombi, 255 (78%; 95% confidence interval, 74-83) received anticoagulation and 70 (22%; 95% confidence interval, 17-26) also received reperfusion treatment. Propensity score–matched pairs analyses did not detect a statistically lower risk of all-cause death (6.2% vs 14%, P = .15) or pulmonary embolism–related mortality (4.7% vs 7.8%; P = .47) for reperfusion compared with anticoagulation. Of the patients who received reperfusion treatment, 6.2% had a recurrence during the study follow-up period, compared with 0% of those who received anticoagulation ( P = .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P = 1.00). Conclusions In patients with pulmonary embolism and right heart thrombi, no significant difference was found between reperfusion therapy and anticoagulant therapy for mortality and bleeding. The risk of recurrences was significantly higher for reperfusion therapy compared with anticoagulation. Right heart thrombi may not warrant riskier interventions than standard anticoagulation.

Published
2017

13. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score

Author

Paolo Prandoni, Antonio Pagnan, Franco Noventa, B. Brandolin, Marica Perlati, V. Rossetto, E. De Bon, Sofia Barbar, A. Ferrari, and Daniela Tormene

Subjects
Adult, Male, Risk, medicine.medical_specialty, MEDLINE, Hemorrhage, Risk Assessment, Cohort Studies, Internal medicine, Medicine, Humans, cardiovascular diseases, Prospective Studies, Prospective cohort study, Aged, Aged, 80 and over, business.industry, Hazard ratio, Hematology, Venous Thromboembolism, Middle Aged, equipment and supplies, medicine.disease, Thrombosis, Pulmonary embolism, Surgery, Hospitalization, Treatment Outcome, Italy, Female, business, Risk assessment, Venous thromboembolism, Cohort study
Abstract

Summary. Background: Prophylaxis of venous thromboembolism (VTE) in hospitalized medical patients is largely underused. We sought to assess the value of a simple risk assessment model (RAM) for the identification of patients at risk of VTE. Methods: In a prospective cohort study, 1180 consecutive patients admitted to a department of internal medicine in a 2-year period were classified as having a high or low risk of VTE according to a predefined RAM. They were followed-up for up to 90 days to assess the occurrence of symptomatic VTE complications. The primary study outcome was to assess the adjusted hazard ratio (HR) of VTE in high-risk patients who had adequate in-hospital thromboprophylaxis in comparison with those who did not, and that of VTE in the latter group in comparison with low-risk patients. Results: Four hundred and sixty-nine patients (39.7%) were labelled as having a high risk of thrombosis. VTE developed in four of the 186 (2.2%) who received thromboprophylaxis, and in 31 of the 283 (11.0%) who did not (HR of VTE, 0.13; 95% CI, 0.04–0.40). VTE developed also in two of the 711 (0.3%) low-risk patients (HR of VTE in high-risk patients without prophylaxis as compared with low-risk patients, 32.0; 95% CI, 4.1–251.0). Bleeding occurred in three of the 186 (1.6%) high-risk patients who had thromboprophylaxis. Conclusions: Our RAM can help discriminate between medical patients at high and low risk of VTE. The adoption of adequate thromboprophylaxis in high-risk patients during hospitalization leads to longstanding protection against thromboembolic events with a low risk of bleeding.

Published
2010

15. PROTOCOL AND EXPERIMENTAL DESIGN OF THE LEOGRA (LAST EVIDENCES OF GENETIC RISK FACTORS IN THE AGED) STUDY, A POPULATION-BASED GENETIC APPROACH TO CARDIOVASCULAR RISK

Author

Mario Saugo, E Sica, Ac Pessina, Edoardo Casiglia, B Brandolin, G Privato, Bortolo Martini, S Ruffatti, M Vinnicki, A Scarda, L Ngante, N Schenal, Giancarlo Basso, Alberto Mazza, Andrea Pavei, M. Martines, Tikhonoff, A Pizziol, and Francesco Guglielmi

Subjects
Protocol (science), Physiology, business.industry, Environmental health, Internal Medicine, Medicine, Population based, Genetic risk, Cardiology and Cardiovascular Medicine, business
Published
2000
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16. 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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17. Cognitive dysfunctions and cerebral microbleeds in adult patients with haemophilia A: a clinical and MRI pilot-study.

Author

Zanon E, Manara R, Milan M, Brandolin B, Mapelli D, Mardari R, Rosini S, and Amodio P

Subjects
Adult, Aged, Cardiovascular Diseases complications, Cardiovascular Diseases etiology, Cerebral Hemorrhage pathology, Cognition Disorders pathology, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Pilot Projects, Risk Factors, Young Adult, Brain blood supply, Brain pathology, Cerebral Hemorrhage complications, Cognition Disorders complications, Hemophilia A complications
Abstract

Background: Studies providing information about the cognitive profile of adult haemophiliacs are lacking., Aims: To assess the neuropsychological profile in a group of Haemophiliac patients; to detect asymptomatic cerebral microbleeds (CMBs) and any correlation between CMBs and cognitive dysfunctions; to verify how several contributing factors may determine cognitive dysfunctions and/or Magnetic Resonance Imaging (MRI) findings., Methods: Adult haemophiliacs without history of brain bleeding were prospectively enrolled on Padua Haemophilia Centre. Patients underwent: i) "Short Neuropsychological Test" assessing cognitive functions (Short Neuropsychological Examination) to obtain an overall cognitive performance (OCP) profile standardised on a cohort matched for age, sex, cultural profile; ii) MRI of the brain to evaluate areas of brain atrophy or haemorrhagic lesions. We collected information on anti-haemorrhagic treatment, cardiovascular risk profile, viral infections, birth trauma., Results: 49 adults with haemophilia (31 severe-moderate, 18 mild) were enrolled. 73% of patients presented a reduction in OCP. According to OCP, no significant difference between severe and mild haemophilia was observed though scores tended to be worse in severe haemophilia (mean Z score 0.20 ± 0.10 vs s0.15 ± 0.11). Considering risk factors, OCP correlated significantly with coronary artery disease (p=0.02). MRI findings in 44 patients, indicated CMBs were inversely related to OCP (R=-0.32 p<0.05). CMBs were associated with cardiovascular risk factors (p=0.018)., Conclusions: Adult haemophiliacs seem to present high prevalence of mild cognitive dysfunctions that doesn't correlate with the severity of haemophilia probably for the few number of patients evaluated. OCP impairment seems to be related to the presence of CMBs and of risk factors for cardiovascular disease., (Copyright © 2014. Published by Elsevier Ltd.)

Published
2014
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18. High dose of human plasma-derived FVIII-VWF as first-line therapy in patients affected by acquired haemophilia A and concomitant cardiovascular disease: four case reports and a literature review.

Author

Zanon E, Milan M, Brandolin B, Barbar S, Spiezia L, Saggiorato G, Simioni P, and Baudo F

Subjects
Aged, Hemorrhage prevention & control, Humans, Male, Recombinant Proteins administration & dosage, Cardiovascular Diseases, Factor VIII administration & dosage, Hemophilia A drug therapy, Hemostatics administration & dosage, von Willebrand Factor administration & dosage
Published
2013
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19. Complex dental extractions in a patient with severe haemophilia A and inhibitors treated with activated prothrombin complex concentrate.

Author

Zanon E, Brandolin B, Saggiorato G, and Bacci C

Subjects
Blood Coagulation Tests, Factor VIII metabolism, Hemophilia A complications, Hepatitis C etiology, Humans, Male, Middle Aged, Transfusion Reaction, Blood Coagulation Factors therapeutic use, Hemophilia A therapy, Hemorrhage prevention & control, Tooth Extraction methods
Published
2012
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20. Outcome of long-term prophylaxis after cerebral hemorrhage in a patient with severe hemophilia B.

Author

Zanon E, Sartori MT, Spiezia L, Brandolin B, Simioni P, and Manara R

Subjects
Adult, Cerebral Hemorrhage diagnostic imaging, Cerebral Hemorrhage etiology, Frontal Lobe diagnostic imaging, Hematoma, Subdural, Intracranial diagnostic imaging, Hematoma, Subdural, Intracranial etiology, Hemophilia B complications, Hemophilia B diagnostic imaging, Humans, Male, Recombinant Proteins administration & dosage, Time Factors, Tomography, X-Ray Computed, Cerebral Hemorrhage prevention & control, Factor IX administration & dosage, Hematoma, Subdural, Intracranial drug therapy, Hemophilia B drug therapy
Abstract

Reports of intracerebral hemorrhage (ICH) in patients with hemophilia B are relatively rare. We describe the first clinical results of the use of a monoclonal antibody purified factor IX (FIX) concentrate (Mononine) after an ICH and the long-term outcome of prophylaxis with this product to prevent recurrences. A 44-year-old male with severe hemophilia B was referred to our department because of nausea, vomiting, left lower limb hemiplegia, and left arm paresis. Computed tomography (CT) revealed a right frontal intraparenchymal bleed. The patient was treated with replacement therapy with FIX for 40 days. Computed tomography scans performed on day 40 after the event showed complete disappearance of the cerebral hematoma from the parenchymal tissue. Subsequently, the patient received 25.6 IU/kg(-1) of FIX twice a week. At the 48-month follow-up visit, no more major or minor bleeding events had occurred. Long-term prophylaxis after ICH is recommended.

Published
2011
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21. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score.

Author

Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, and Prandoni P

Subjects
Adult, Aged, Aged, 80 and over, Cohort Studies, Female, Hemorrhage complications, Hospitalization, Humans, Italy, Male, Middle Aged, Prospective Studies, Risk, Risk Assessment, Treatment Outcome, Venous Thromboembolism prevention & control, Venous Thromboembolism diagnosis, Venous Thromboembolism therapy
Abstract

Background: Prophylaxis of venous thromboembolism (VTE) in hospitalized medical patients is largely underused. We sought to assess the value of a simple risk assessment model (RAM) for the identification of patients at risk of VTE., Methods: In a prospective cohort study, 1180 consecutive patients admitted to a department of internal medicine in a 2-year period were classified as having a high or low risk of VTE according to a predefined RAM. They were followed-up for up to 90 days to assess the occurrence of symptomatic VTE complications. The primary study outcome was to assess the adjusted hazard ratio (HR) of VTE in high-risk patients who had adequate in-hospital thromboprophylaxis in comparison with those who did not, and that of VTE in the latter group in comparison with low-risk patients., Results: Four hundred and sixty-nine patients (39.7%) were labelled as having a high risk of thrombosis. VTE developed in four of the 186 (2.2%) who received thromboprophylaxis, and in 31 of the 283 (11.0%) who did not (HR of VTE, 0.13; 95% CI, 0.04-0.40). VTE developed also in two of the 711 (0.3%) low-risk patients (HR of VTE in high-risk patients without prophylaxis as compared with low-risk patients, 32.0; 95% CI, 4.1-251.0). Bleeding occurred in three of the 186 (1.6%) high-risk patients who had thromboprophylaxis., Conclusions: Our RAM can help discriminate between medical patients at high and low risk of VTE. The adoption of adequate thromboprophylaxis in high-risk patients during hospitalization leads to longstanding protection against thromboembolic events with a low risk of bleeding., (© 2010 International Society on Thrombosis and Haemostasis.)

Published
2010
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22. The risk of cancer progression in women with gynecological malignancies and thrombophilic polymorphisms: a pilot case-control study.

Author

Tormene D, Beltramello P, Perlati M, Brandolin B, Barbar S, De Toffoli G, and Simioni P

Subjects
Adult, Aged, Case-Control Studies, Disease Progression, Factor V metabolism, Female, Gene Frequency, Genetic Predisposition to Disease, Genital Neoplasms, Female blood, Genital Neoplasms, Female pathology, Humans, Middle Aged, Pilot Projects, Polymorphism, Genetic, Polymorphism, Single Nucleotide, Risk Factors, Venous Thromboembolism blood, Venous Thromboembolism pathology, Genital Neoplasms, Female genetics, Prothrombin genetics, Venous Thromboembolism genetics
Abstract

Cancer produces a hypercoagulable state, which might lead to thrombosis, and on contrary, unprovoked venous thromboembolism might be the manifestation of an occult cancer. In this pilot case-control study, we assessed the risk of gynecological malignant diseases related to the presence of the factor V Leiden and prothrombin G20210A polymorphisms. Fifty-two women underwent an operation for gynecological malignancy and were enrolled in the study. Women who underwent an operation for gynecological nonmalignant disease in the same days of cases were considered as controls. The presence of factor V Leiden and prothrombin G20210A was assessed in case and control groups. In all, 7 out of 52 cases were carriers of the 2 polymorphisms compared with 20 out of 198 controls (odds ratio = 1.3; 95% confidence interval, 0.6-3.0). The results were also similar when the risk was considered separately for the site of cancer. As for advanced and metastatic malignancies, the odds ratios were 2.3 (95% confidence interval, 0.9-6.0) and 3.3 (95% confidence interval, 1.0-11), respectively, compared to noncancer patients. When these 2 groups were compared to nonadvanced cancer group, the odds ratios for carriers of polymorphisms were 2.7 (95%confidence interval, 0.7-11.0) and 3.9 (95%confidence interval, 0.8-18.6) for advanced cancer and metastatic malignancies, respectively. Women with factor V Leiden or prothrombin G20210A polymorphisms who developed gynecological malignancy might present with a higher stage of cancer at the time of surgery. Larger case-control studies in similar cohort of patients are needed to confirm these findings.

Published
2009
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24. Idraparinux: review of its clinical efficacy and safety for prevention and treatment of thromboembolic disorders.

Author

Prandoni P, Tormene D, Perlati M, Brandolin B, and Spiezia L

Subjects
Animals, Antithrombins metabolism, Atrial Fibrillation blood, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Clinical Trials as Topic, Drug Administration Schedule, Drug Evaluation, Fibrinolytic Agents administration & dosage, Fibrinolytic Agents adverse effects, Fibrinolytic Agents pharmacokinetics, Fibrinolytic Agents therapeutic use, Half-Life, Humans, Oligosaccharides administration & dosage, Oligosaccharides adverse effects, Oligosaccharides pharmacokinetics, Oligosaccharides therapeutic use, Protein Binding, Thromboembolism blood, Thromboembolism drug therapy, Thromboembolism prevention & control
Abstract

Background: Idraparinux is a synthetic pentasaccharide that binds to antithrombin with high affinity. In view of its long half-life, it is suitable for once-a-week administration., Objective: To review the evidence favoring the use of idraparinux for the acute and long-term treatment of patients with venous thromboembolism (VTE) and for the prevention of thromboembolic events in patients with atrial fibrillation (AF)., Methods: All preclinical and clinical studies carried out with the use of idraparinux were sought through electronic searches of MEDLINE from January 1, 1999 up to December 31, 2007., Results: The administration of idraparinux in subcutaneous fixed doses of 2.5 mg once weekly was found to be as effective and safe as conventional antithrombotic therapy in the initial treatment of patients with deep vein thrombosis, but less effective than standard therapy in the initial treatment of patients with primary pulmonary embolism. During a 6-month extension of thromboprophylaxis, idraparinux was effective in preventing recurrent VTE but was associated with an increased risk of bleeding versus placebo. Finally, in patients with AF the long-term treatment with idraparinux was as effective as vitamin K antagonists, but caused more bleeding., Conclusions: In its current formulation, idraparinux can be recommended only for the initial treatment of patients with deep vein thrombosis. The bioequipotency of a biotinylated version of idraparinux (idrabiotaparinux), whose effects can be reversed by a neutralizing agent (avidin), is under investigation in the treatment of VTE at present, as is the use of lower doses in patients with AF.

Published
2008
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