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1. Bleeding risk in hospitalized patients with COVID‐19 receiving intermediate‐ or therapeutic doses of thromboprophylaxis

Author

Pablo Demelo‐Rodriguez, Ana Isabel Farfán‐Sedano, José María Pedrajas, Pilar Llamas, Patricia Sigüenza, María Jesús Jaras, Manuel Quintana‐Diaz, Carmen Fernández‐Capitán, Behnood Bikdeli, David Jiménez, Manuel Monreal, Adarraga D, Aibar J, Baeza C, Ballaz A, Barba R, Blanco‐Molina A, Botella E, Criado J, Demelo‐Rodríguez P, Díaz‐Brasero AM, de Ancos C, del Toro J, Farfán‐Sedano AI, Fernández‐Capitán C, Fidalgo A, Flores K, Gabara C, Galeano‐Valle F, Gavín‐Sebastián O, Gil‐Díaz A, Jaras MJ, Jara‐Palomares L, Jiménez R, Lainez‐Justo S, Latorre A, Lecumberri R, Llamas P, Lobo JL, López‐Jiménez L, Loureiro B, Madridano O, Mancebo‐Plaza AB, Martín del Pozo M, Monreal M, Muñoz‐Rivas N, Núñez‐Fernández MJ, Olivera PE, Ordieres‐Ortega L, Padín‐Paz EM, Pedrajas JM, Quintana‐Díaz M, Ríos‐Prego M, Rodríguez‐Chiaradía DA, Ruiz‐Artacho P, Sigüenza P, Suriñach JM, Trujillo‐Santos J, Zamora C, Bucherini E, Di Micco P, Imbalzano E, Siniscalchi C, Bosevski M, Stevanovic M, Paz‐Rios L, and Weinberg I

Subjects
anticoagulants, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Hospitalized patients, 030204 cardiovascular system & hematology, Logistic regression, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, COVID‐19, death, Internal medicine, medicine, Humans, Retrospective Studies, SARS-CoV-2, business.industry, Mortality rate, Incidence (epidemiology), Hazard ratio, COVID-19, Venous Thromboembolism, Original Articles, Hematology, Confidence interval, Original Article, prognosis, hemorrhage, business, Cohort study
Abstract

Introduction Some local protocols suggest using intermediate or therapeutic doses of anticoagulants for thromboprophylaxis in hospitalized patients with coronavirus disease 2019 (COVID‐19). However, the incidence of bleeding, predictors of major bleeding, or the association between bleeding and mortality remain largely unknown. Methods We performed a cohort study of patients hospitalized for COVID‐19 that received intermediate or therapeutic doses of anticoagulants from March 25 to July 22, 2020, to identify those at increased risk for major bleeding. We used bivariate and multivariable logistic regression to explore the risk factors associated with major bleeding. Results During the study period, 1965 patients were enrolled. Of them, 1347 (69%) received intermediate‐ and 618 (31%) therapeutic‐dose anticoagulation, with a median duration of 12 days in both groups. During the hospital stay, 112 patients (5.7%) developed major bleeding and 132 (6.7%) had non‐major bleeding. The 30‐day all‐cause mortality rate for major bleeding was 45% (95% confidence interval [CI]: 36%‐54%) and for non‐major bleeding 32% (95% CI: 24%‐40%). Multivariable analysis showed increased risk for in‐hospital major bleeding associated with D‐dimer levels >10 times the upper normal range (hazard ratio [HR], 2.23; 95% CI, 1.38–3.59), ferritin levels >500 ng/ml (HR, 2.01; 95% CI, 1.02–3.95), critical illness (HR, 1.91; 95% CI, 1.14–3.18), and therapeutic‐intensity anticoagulation (HR, 1.43; 95% CI, 1.01–1.97). Conclusions Among patients hospitalized with COVID‐19 receiving intermediate‐ or therapeutic‐intensity anticoagulation, a major bleeding event occurred in 5.7%. Use of therapeutic‐intensity anticoagulation, critical illness, and elevated D‐dimer or ferritin levels at admission were associated with increased risk for major bleeding.

Published
2021
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2. Liver status and outcomes in patients without previous known liver disease receiving anticoagulant therapy for venous thromboembolism

Author

Martinez-Urbistondo D., de la Garza R. G., Villares-Fernandez P., Font C., Schellong S., Lopez-Nunez J. J., Gil-Diaz A., del Carmen Diaz-Pedroche M., Hirmerova J., Monreal M., Adarraga M., Aibar J., Alonso J., Amado C., Arcelus J., Asuero A., Ballaz A., Barba R., Barbagelata C., Barron M., Barron-Andres B., Blanco-Molina A., Beddar Chaib F., Botella E., Castro J., Chasco L., Criado J., de Ancos C., del Toro J., Demelo-Rodriguez P., Diaz-Brasero A., Diaz-Pedroche M., Diaz-Peromingo J., Di Campli M., Dubois-Silva A., Escribano J., Esposito F., Farfan-Sedano A., Fernandez-Capitan C., Fernandez-Reyes J., Fidalgo M., Flores K., Font L., Francisco I., Gabara C., Galeano-Valle F., Garcia M., Garcia-Bragado F., Garcia de Herreros M., de la Garza R., Garcia-Diaz C., Gomez-Cuervo C., Grau E., Guirado L., Gutierrez J., Hernandez-Blasco L., Jara-Palomares L., Jaras M., Jimenez D., Jimenez R., Jimenez-Alfaro C., Joya M., Lainez-Justo S., Lalueza A., Latorre A., Lima J., Lobo J., Lopez-Jimenez L., Lopez-Miguel P., Lopez-Nunez J., Lopez-Reyes R., Lopez-Saez J., Lorenzo A., Madridano O., Maestre A., Marchena P., Martin del Pozo M., Martin-Martos F., Mella C., Mercado M., Moises J., Munoz-Blanco A., Nieto J., Nofuentes-Perez E., Nunez-Fernandez M., Olid-Velilla M., Olivares M., Osorio J., Otalora S., Otero R., Paredes D., Pedrajas J., Porras J., Portillo J., Redondo I., Rodriguez-Matute C., Rosa V., Ruiz-Artacho P., Ruiz-Ruiz J., Salgueiro G., Sanchez-Martinez R., Sanchez-Munoz-Torrero J., Sancho T., Soler S., Suarez-Rodriguez B., Surinach J., Torres M., Torres-Sanchez A., Tolosa C., Trujillo-Santos J., Uresandi F., Valero B., Valle R., Varona J., Vela L., Vela J., Vidal G., Villalobos A., Villares P., Zamora C., Ay C., Nopp S., Pabinger I., Engelen M., Vanassche T., Verhamme P., Maly R., Accassat S., Ait Abdallah N., Bertoletti L., Bura-Riviere A., Catella J., Couturaud F., Crichi B., Debourdeau P., Espitia O., Farge-Bancel D., 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., Brenner B., Kenet G., Tzoran I., Basaglia M., Bilora F., Bortoluzzi C., Brandolin B., Ciammaichella M., De Angelis A., Di Micco P., Imbalzano E., Merla S., Pesavento R., Prandoni P., Siniscalchi C., Tufano A., Visona A., Vo Hong N., Zalunardo B., Nishimoto Y., Sato Y., Make K., Skride A., Strautmane S., Fonseca S., Martins F., Meireles J., Bosevski M., Bounameaux H., Mazzolai L., Caprini J., Bui H., Martinez-Urbistondo, D., de la Garza, R. G., Villares-Fernandez, P., Font, C., Schellong, S., Lopez-Nunez, J. J., Gil-Diaz, A., del Carmen Diaz-Pedroche, M., Hirmerova, J., Monreal, M., Adarraga, M., Aibar, J., Alonso, J., Amado, C., Arcelus, J., Asuero, A., Ballaz, A., Barba, R., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Beddar Chaib, F., Botella, E., Castro, J., Chasco, L., Criado, J., de Ancos, C., del Toro, J., Demelo-Rodriguez, P., Diaz-Brasero, A., Diaz-Pedroche, M., Diaz-Peromingo, J., Di Campli, M., Dubois-Silva, A., Escribano, J., Esposito, F., Farfan-Sedano, A., Fernandez-Capitan, C., Fernandez-Reyes, J., Fidalgo, M., Flores, K., Font, L., Francisco, I., Gabara, C., Galeano-Valle, F., Garcia, M., Garcia-Bragado, F., Garcia de Herreros, M., de la Garza, R., Garcia-Diaz, C., Gomez-Cuervo, C., Grau, E., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M., Jimenez, D., Jimenez, R., Jimenez-Alfaro, C., Joya, M., Lainez-Justo, S., Lalueza, A., Latorre, A., Lima, J., Lobo, J., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J., Lopez-Reyes, R., Lopez-Saez, J., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P., Martin del Pozo, M., Martin-Martos, F., Mella, C., Mercado, M., Moises, J., Munoz-Blanco, A., Nieto, J., Nofuentes-Perez, E., Nunez-Fernandez, M., Olid-Velilla, M., Olivares, M., Osorio, J., Otalora, S., Otero, R., Paredes, D., Pedrajas, J., Porras, J., Portillo, J., Redondo, I., Rodriguez-Matute, C., Rosa, V., Ruiz-Artacho, P., Ruiz-Ruiz, J., Salgueiro, G., Sanchez-Martinez, R., Sanchez-Munoz-Torrero, J., Sancho, T., Soler, S., Suarez-Rodriguez, B., Surinach, J., Torres, M., Torres-Sanchez, A., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Valero, B., Valle, R., Varona, J., Vela, L., Vela, J., Vidal, G., Villalobos, A., Villares, P., Zamora, C., Ay, C., Nopp, S., Pabinger, I., Engelen, M., Vanassche, T., Verhamme, P., Maly, R., Accassat, S., Ait Abdallah, N., Bertoletti, L., Bura-Riviere, A., Catella, J., Couturaud, F., Crichi, B., Debourdeau, P., Espitia, O., Farge-Bancel, D., 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., Brenner, B., Kenet, G., Tzoran, I., Basaglia, M., Bilora, F., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., De Angelis, A., Di Micco, P., Imbalzano, E., Merla, S., Pesavento, R., Prandoni, P., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Zalunardo, B., Nishimoto, Y., Sato, Y., Make, K., Skride, A., Strautmane, S., Fonseca, S., Martins, F., Meireles, J., Bosevski, M., Bounameaux, H., Mazzolai, L., Caprini, J., and Bui, H.

Subjects
medicine.medical_specialty, VTE risk assessment, Healthy individual, Elevated liver enzymes, Hemorrhage, Gastroenterology, Liver disease, Recurrence, Fibrosis, Internal medicine, Internal Medicine, medicine, Anticoagulation adverse event, Humans, In patient, Registries, Clinical VTE, business.industry, Liver Diseases, Anticoagulants, Venous Thromboembolism, medicine.disease, Im - Original, Non-invasive liver assessment, Healthy individuals, Increased risk, Anticoagulant therapy, Emergency Medicine, Anticoagulation adverse events, business, Venous thromboembolism, Major bleeding
Abstract

The association between elevated liver enzymes or FIB-4 (fibrosis index 4) and outcome in patients with venous thromboembolism (VTE) has not been evaluated. Data from patients in RIETE (Registro Informatizado Enfermedad TromboEmbólica) were used to assess the association between elevated liver enzymes or FIB-4 levels and the rates of major bleeding or death in apparent liver disease-free patients with acute VTE under anticoagulation therapy. A total of 6206 patients with acute VTE and without liver disease were included. Of them, 92 patients had major bleeding and 168 died under anticoagulation therapy. On multivariable analysis, patients with elevated liver enzymes were at increased mortality risk (HR: 1.58; 95% CI: 1.10–2.28), while those with FIB-4 levels > 2.67 points were at increased risk for major bleeding (HR: 1.69; 95% CI: 1.04–2.74). Evaluation of liver enzymes and FIB-4 index at baseline in liver disease-free patients with VTE may provide additional information on the risk for major bleeding or death during anticoagulation. Supplementary Information The online version contains supplementary material available at 10.1007/s11739-021-02858-x.

Published
2021

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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