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1. Validation of a prognostic score for hidden cancer in unprovoked venous thromboembolism.

Author

Luis Jara-Palomares, Remedios Otero, David Jimenez, Juan Manuel Praena-Fernandez, Carme Font, Conxita Falga, Silvia Soler, David Riesco, Peter Verhamme, Manuel Monreal, and RIETE Registry

Subjects
Medicine, Science
Abstract

The usefulness of a diagnostic workup for occult cancer in patients with venous thromboembolism (VTE) is controversial. We used the RIETE (Registro Informatizado Enfermedad Trombo Embólica) database to perform a nested case-control study to validate a prognostic score that identifies patients with unprovoked VTE at increased risk for cancer. We dichotomized patients as having low- (≤2 points) or high (≥3 points) risk for cancer, and tried to validate the score at 12 and 24 months. From January 2014 to October 2016, 11,695 VTE patients were recruited. Of these, 1,360 with unprovoked VTE (11.6%) were eligible for the study. At 12 months, 52 patients (3.8%; 95%CI: 2.9-5%) were diagnosed with cancer. Among 905 patients (67%) scoring ≤2 points, 22 (2.4%) had cancer. Among 455 scoring ≥3 points, 30 (6.6%) had cancer (hazard ratio 2.8; 95%CI 1.6-5; p

Published
2018
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2. Prognostic Significance of Concomitant Superficial Vein Thrombosis in Patients with Deep Vein Thrombosis of the Lower Limbs

Author

Carmine Siniscalchi, Isabelle Quéré, Manuel Monreal, Carmen Mella, Patricia Piñeiro-Parga, Jose-Maria Surinach, Jerónimo Ramón Vela, Conxita Falga, Raimundo Tirado, Álvaro Dubois-Silva, Cristina Barbagelata-López, and Iria Francisco

Subjects
Male, medicine.medical_specialty, anticoagulants, Time Factors, pulmonary embolism, Superficial vein thrombosis, Deep vein, Hemorrhage, 030204 cardiovascular system & hematology, Rate ratio, Risk Assessment, deep vein thrombosis, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Risk Factors, Internal medicine, superficial vein thrombosis, Medicine, Humans, In patient, 030212 general & internal medicine, Registries, Stroke, Aged, Aged, 80 and over, Venous Thrombosis, recurrences, business.industry, Hazard ratio, Hematology, Middle Aged, medicine.disease, Prognosis, Thrombosis, medicine.anatomical_structure, Concomitant, Cardiology, Female, business, Pulmonary Embolism
Abstract

Background The prognostic significance of concomitant superficial vein thrombosis (SVT) in patients with lower-limb deep vein thrombosis (DVT) has not been consistently evaluated. Methods We used the RIETE (Registro Informatizado de Enfermedad TromboEmbólica) registry to compare the rates of subsequent pulmonary embolism (PE), recurrent DVT, major bleeding or death in patients with lower-limb DVT, according to the presence or absence of concomitant SVT. Results From March 2015 to May 2020, there were 8,743 patients with lower-limb DVT. Of these, 745 (8.5%) had concomitant SVT. Most patients (97.4% in both subgroups) received anticoagulant therapy (median duration: 138 vs. 147 days). During follow-up (median: 193 vs. 210 days), 156 (1.8%) patients developed subsequent PE, 336 (3.8%) had recurrent DVT, 201 (2.3%) had major bleeding and 844 (9.7%) died. Patients with concomitant SVT had a higher rate of subsequent PE (rate ratio [RR]: 2.11; 95% confidence interval [95%CI]: 1.33–3.24) than those with isolated DVT, with no significant differences in the rates of recurrent DVT (RR: 0.80; 95%CI: 0.50–1.21), major bleeding (RR: 0.77; 95%CI: 0.41–1.33) or death (RR: 0.81; 95%CI: 0.61–1.06). On multivariable analysis, patients with DVT and SVT concomitantly were at increased risk of subsequent PE during anticoagulation (adjusted hazard ratio [HR]: 2.23; 95%CI: 1.22–4.05) and also during the entire follow-up period (adjusted HR: 2.33; 95%CI: 1.49–3.66). Conclusion Patients with lower-limb DVT and SVT concomitantly are at increased risk of developing PE. Further studies are needed to externally validate our findings and to determine if these patients could benefit from a different management strategy.

Published
2021

3. 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

4. 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

5. Outcomes after venous thromboembolism in patients with gastric cancer: Analysis of the RIETE Registry

Author

Adriana Visonà, Riete Investigators, Jorge Del Toro, Ido Weinberg, Pierpaolo Di Micco, Joan Carles Sahuquillo, Iva Golemi, Alfonso Tafur, Kaushal Majmudar, Manuel Alejandro Lorente, Conxita Falga, Antonella Tufano, Manuel Monreal, Majmudar, K., Golemi, I., Tafur, A. J., Toro, J. D., Visona, A., Falga, C., Sahuquillo, J. C., Lorente, M. A., Tufano, A., Weinberg, I., Di Micco, P., and Monreal, M.

Subjects
Registrie, Male, Time Factors, Databases, Factual, 030204 cardiovascular system & hematology, Gastroenterology, Hemoglobins, 0302 clinical medicine, Recurrence, Risk Factors, thrombosi, Registries, Aged, 80 and over, education.field_of_study, Hazard ratio, Anemia, Venous Thromboembolism, Middle Aged, Prognosis, Thrombosis, Venous thrombosis, Deep vein thrombosis (DVT), 030220 oncology & carcinogenesis, Cohort, pulmonary embolism (PE), Female, Cardiology and Cardiovascular Medicine, Human, medicine.medical_specialty, Time Factor, Prognosi, Population, Hemorrhage, Risk Assessment, 03 medical and health sciences, Stomach Neoplasm, Stomach Neoplasms, Internal medicine, deep vein thrombosis (DVT), medicine, Humans, Hemoglobin, education, thrombosis, Aged, business.industry, gastric cancer, Risk Factor, Cancer, Biomarker, medicine.disease, bleeding, business, Biomarkers
Abstract

Gastric cancer is the fifth most common malignancy worldwide. Venous thromboembolism is an independent predictor of death among patients with gastric cancer. We aimed to describe the factors associated with mortality, thrombosis recurrence, and bleeding complications in patients with gastric cancer who develop venous thromboembolism. We included 612 patients with gastric cancer and venous thromboembolism in the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry from 2001 to 2018. We used Cox proportional hazard ratios and a Fine–Gray model to define factors associated with outcomes. The overall mortality at 6 months was 44.4%. Factors associated with increased 6-month mortality included immobility (HR 1.8, 95% CI 1.3–2.4; p < 0.001), anemia (HR 1.4, 95% CI 1.1–1.8; p < 0.02), and leukocytosis (HR 1.8, 95% CI 1.4–2.3; p < 0.001). Recurrent thrombosis occurred in 6.5% of patients and major bleeding complications in 8.5% of the cohort. Male sex was the main factor associated with thrombosis recurrence (HR 2.1, 95% CI 1.1–4.0; p < 0.02) and hemoglobin below 10 g/dL (HR 1.6, 95% CI 1.05–2.50; p = 0.03) the main factor associated with bleeding. In conclusion, patients with gastric cancer who develop venous thrombosis have a very high likelihood of death. Low hemoglobin in this population is associated with poor outcomes.

Published
2020

6. Outcome after discontinuing anticoagulant therapy in women with venous thromboembolism during hormonal use

Author

Ángeles Blanco-Molina, Raffaele Pesavento, C. Tolosa, Ángel Sampériz, Javier Trujillo-Santos, Lucia Mazzolai, Rita Duce, Conxita Falga, Manuel Monreal, and Vladimir Rosa

Subjects
Adult, medicine.medical_specialty, Hormone Replacement Therapy, medicine.medical_treatment, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Risk Factors, Internal medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Gynecology, Pregnancy, business.industry, Anticoagulants, Cancer, Hormone replacement therapy (menopause), Venous Thromboembolism, Hematology, Middle Aged, equipment and supplies, medicine.disease, Pulmonary embolism, Treatment Outcome, Anticoagulant therapy, Hormonal therapy, Female, business, Venous thromboembolism, Follow-Up Studies, Hormone
Abstract

Introduction Whether women developing venous thromboembolism (VTE) while using hormonal therapy should be classified as having “unprovoked” or “provoked” VTE is controversial. Methods We used the RIETE (Registro Informatizado Enfermedad TromboEmbolica) database to compare the rate of symptomatic VTE recurrences after discontinuing anticoagulation in 3 subgroups of women aged ≤ 50 years without cancer, pregnancy or puerperium: (1) those with hormonal therapy and no additional risk factors (hormonal users only); (2) those with unprovoked VTE; and (3) those with additional risk factors, with or without hormonal therapy. Results As of March 2016, 1513 women had been followed-up for at least one month after discontinuing anticoagulation. Of these, 654 (43%) were hormonal users only, 390 (26%) had unprovoked VTE and 469 (31%) had transient risk factors with or without hormonal therapy. After discontinuing anticoagulation, the rate of VTE recurrences in women with hormonal use only (2.44 per 100 patient-years; 95% CI: 1.53–3.69) was significantly lower than in those with unprovoked VTE (6.03; 95% CI: 3.97–8.77) and similar to those with transient risk factors (2.58; 95% CI: 1.50–4.13). Interestingly, the rate of VTE recurrences presenting as pulmonary embolism in women with hormonal use only (0.55 per 100 patient-years; 95% CI: 0.18–1.29) was similar to those with transient risk factors (0.46; 95% CI: 0.09–1.33) and 4-fold lower than in women with unprovoked VTE (2.23; 95% CI: 1.07–4.10). Conclusions After discontinuing anticoagulation, the rate of VTE recurrences in hormonal users only was significantly lower than in women with unprovoked VTE and similar to the rate in women with additional risk factors.

Published
2017

7. The Clinical Course of Venous Thromboembolism May Differ According to Cancer Site

Author

Alicia Lorenzo, E. Tiraferri, J.M. Martín-Antorán, I. Mahé, Bernardo Sopeña, Luciano López-Jiménez, Carmen Fernández-Capitán, M.L. Peris, M.A. Rodríguez-Dávila, Carme Font, Luca Calanca, Lidia Luciana Rota, A. Merah, C. Font, Lucia Mazzolai, J.M. Suriñach, M.A. Aibar, J. Vela, Daniela Mastroiacovo, Juan I. Arcelus, I. Casado, Elvira Grandone, Inna Tzoran, Laurent Bertoletti, Maria Luisa Peris, J.A. Nieto, C. Pérez, Adriana Visonà, L. Guirado, J. González, L. Bertoletti, G. Candeloro, J. Villalta, A. Riera, Ángeles Blanco-Molina, J. del Toro, J.L. Ribeiro, A. Belovs, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, Javier Trujillo-Santos, Vladimir Rosa, S. Otalora, G. Pérez, Fernando Uresandi, L. Ramírez, V. Gómez, Jean Chidiac, G. Tiberio, David Jiménez, Radovan Malý, T. Tomko, Aitor Ballaz, J. Hirmerova, Pablo Javier Marchena, C. Tolosa, Jose Gutierrez, Peter Verhamme, A. Grimón, M. Monreal, N. Ruiz-Giménez, E. Grau, G. Hernández, I. Suarez, M.V. Morales, Andris Skride, Raquel López-Reyes, Ángel Sampériz, Giovanni Barillari, Cristina Perez Ductor, R. Valle, M.S. Sousa, J.A. Porras, D. Farge-Bancel, Conxita Falga, P. García-Brotons, P. Malfante, Madalena Moreira, F. Martín-Martos, P. Gallego, O. Sanz, Santiago Nieto, B. Pagán, Hervé Decousus, O. Reig, L. Font, Corrado Lodigiani, F. García-Bragado, Maurizio Ciammaichella, A. Alatri, Isabelle Mahé, M. Pinelli, Philip S. Wells, Remedios Otero, Henri Bounameaux, José María Pedrajas, V. Isern, Manolis Papadakis, Pedro Ruiz-Artacho, B. Barrón-Andrés, F. Pace, E. Salgado, Beatriz Lacruz, Raquel Barba, A. Apollonio, J.B. López-Sáez, J. Bascuñana, M.A. Lorente, M.J. Núñez, Antonella Tufano, E. Grandone, A. Braester, Dolores Nauffal, Agustina Rivas, Barry M. Brenner, Silvia Soler, Paolo Prandoni, P. Di Micco, S. Nieto, J.C. Serrano, Abílio Reis, T. Bueso, Paola Ferrazzi, Luis Jara-Palomares, C. Ruiz-Martínez, Gianfranco Lessiani, José Luis Lobo, M. Zdraveska, Marijan Bosevski, C. Sala, J. de Miguel, L. Hernández-Blasco, A. Hij, Ramón Lecumberri, A. Culla, Olga Madridano, J.A. Díaz-Peromingo, M. Barrón, and J. Trujillo-Santos

Subjects
Male, Oncology, medicine.medical_specialty, Lung Neoplasms, Colorectal cancer, medicine.drug_class, Breast Neoplasms, Hemorrhage, 030204 cardiovascular system & hematology, Gastroenterology, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Recurrence, Prostate, Neoplasms, Internal medicine, medicine, Humans, Registries, Lung cancer, Aged, business.industry, Anticoagulant, Anticoagulants, Prostatic Neoplasms, Cancer, Venous Thromboembolism, General Medicine, Middle Aged, medicine.disease, Primary tumor, Confidence interval, Treatment Outcome, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Disease Progression, Female, Colorectal Neoplasms, business
Abstract

Background We hypothesized that the clinical course of venous thromboembolism in patients with active cancer may differ according to the specificities of primary tumor site. Aim and Methods We used data from RIETE (international registry of patients with venous thromboembolism) to compare the clinical venous thromboembolism-related outcomes during the course of anticoagulation in patients with one of the 4 more frequent cancers (breast, prostate, colorectal, or lung cancer). Results As of September 2014, 3947 cancer patients were recruited, of whom 938 had breast, 629 prostate, 1189 colorectal, and 1191 lung cancer. Overall, 55% had metastatic disease (42%, 36%, 53%, and 72%, respectively). During the course of anticoagulant therapy (mean duration, 139 days), the rate of thromboembolic recurrences was similar to the rate of major bleeding in patients with breast (5.6 [95% confidence interval (CI), 3.8-8.1] vs 4.1 [95% CI, 2.7-5.9] events per 100 patient-years) or colorectal cancer (10 [95% CI, 7.6-13] vs 12 [95% CI, 9.4-15] per 100 patient-years). In contrast, in patients with prostate cancer, the rate of venous thromboembolic recurrences was half the rate of major bleeding (6.9 [95% CI, 4.4-10] vs 13 [95% CI, 9.2-17] events per 100 patient-years), whereas in those with lung cancer, the rate of thromboembolic recurrences was twofold higher than the rate of major bleeding (27 [95% CI, 22-23] vs 11 [95% CI, 8.6-15] per 100 patient-years). Conclusions Significant differences in the clinical profile of venous thromboembolic-related outcomes were observed according to the site of cancer. These findings suggest the development of cancer-specific anticoagulant strategies as an area for further research.

Published
2017

8. Impact of Thrombus Sidedness on Presentation and Outcomes of Patients with Proximal Lower Extremity Deep Vein Thrombosis

Author

Lucia Mazzolai, Bavand Bikdeli, Luciano López-Jiménez, Manuel Monreal, Juan Francisco Sánchez Muñoz Torrero, R. Valle, Conxita Falga, Peter Verhamme, Antoni Riera-Mestre, Behnood Bikdeli, Babak Sharif-Kashani, and Philip S. Wells

Subjects
Male, medicine.medical_specialty, pulmonary embolism, Deep vein, 030204 cardiovascular system & hematology, Article, Disease-Free Survival, deep vein thrombosis, 03 medical and health sciences, 0302 clinical medicine, left, right, medicine, Humans, 030212 general & internal medicine, cardiovascular diseases, Trombosi, Registries, Thrombus, Survival rate, bilateral, Aged, Retrospective Studies, Embòlia pulmonar, Aged, 80 and over, Venous Thrombosis, business.industry, Anticoagulants, Retrospective cohort study, Thrombosis, Hematology, Middle Aged, medicine.disease, Review article, Surgery, Pulmonary embolism, Survival Rate, medicine.anatomical_structure, Lower Extremity, Female, Presentation (obstetrics), Cardiology and Cardiovascular Medicine, business
Abstract

Small studies have suggested differences in demographics and outcomes between left- and right-sided deep vein thrombosis (DVT), and also unilateral versus bilateral DVT. We investigated the clinical presentation and outcomes of patients with DVT based on thrombus sidedness. The authors used the data from the Registro Informatizado Enfermedad TromboEmbólica (RIETE) database (2001–2016) to identify patients with symptomatic proximal lower-extremity DVT. Main outcomes included cumulative 90-day symptomatic pulmonary embolism (PE) and 1-year mortality. Overall, 30,445 patients were included. The majority of DVTs occurred in the left leg (16,421 left-sided, 12,643 right-sided, and 1,390 bilateral; p

Published
2018

9. Analysis of noncatheter-associated upper extremity deep venous thrombosis from the RIETE registry

Author

C. Pérez-Ductor, Raffaele Pesavento, Barry M. Brenner, Silvia Soler, Paolo Prandoni, Luciano López-Jiménez, Pierpaolo Di Micco, S. Nieto, Renzo Poggio, Inna Tzoran, T. Bueso, Alicia Lorenzo, Carmen Fernández-Capitán, F. García-Bragado, D. Riesco, Thomas Vanassche, M. Papadakis, J. del Toro, N. Ruiz-Giménez, M.J. Núñez, F. Martín-Martos, Mark M. Levy, Benjamin Brenner, J.A. Porras, G. Vidal, V. Gómez, A. Braester, Cristina Perez Ductor, R. Barba, R. Valle, Bernardo Sopeña, Lidia Luciana Rota, J.C. Sahuquillo, E. Tiraferri, J.M. Martín-Antorán, M.S. Sousa, Conxita Falga, Jose Gutierrez, Ángeles Blanco-Molina, J.M. Suriñach, H. Bounameaux, Isabelle Mahé, María del Carmen Díaz-Pedroche, Philip S. Wells, B. Pagán, Agustina Rivas, J. Bascuñana, G. Antonucci, Carme Font, Antonella Tufano, Maurizio Ciammaichella, S. Otalora, Ángel Sampériz, J. González, R. Maida, Giovanni Barillari, Andris Skride, P. Di Micco, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, F. Pace, Diego Tonello, Remedios Otero, R. Malý, L. Bertoletti, R. Lecumberri, M.A. Aibar, K. Champion, D. Kigitovica, J. Binetti, M.L. Peris, M.A. Rodríguez-Dávila, Adriana Visonà, L. Guirado, Miguel Martín, Abílio Reis, P. Gallego, O. Reig, G. Pérez, Hervé Decousus, Daniel H. Newton, E. Salgado, P. Prandoni, Laurent Bertoletti, Peter Verhamme, Luke G. Wolfe, Javier Trujillo-Santos, M.A. García, M.A. Fidalgo, Paola Ferrazzi, Pablo Javier Marchena, J. Villalta, M.A. Lorente, Elvira Grandone, O. Sanz, M.C. Sala-Sainz, F. Bilora, M. Bosevski, I. Cañas, Vladimir Rosa, David Jiménez, Juan I. Arcelus, E. Grau, B. Zalunardo, Beatriz Valero, Luis Jara-Palomares, Manuel Monreal Bosch, José María Pedrajas, Pedro Ruiz-Artacho, B. Barrón-Andrés, Fernando Uresandi, E. Rosillo-Hernández, M.D. Joya, Rita Duce, L. Font, C. Tolosa, Francesco Dentali, I. Manrique-Abos, F. Carmona, Andreas Erdmann, Antoni Riera-Mestre, L. Hernández-Blasco, Nuria Chic, J.B. López-Sáez, J. Vela, J. Hirmerova, A. Grimón, G. Hernández-Comes, D. Farge-Bancel, C. Fernández-Aracil, Raquel López-Reyes, Raúl Sánchez, Michael F. Amendola, J.A. Nieto, A. Merah, I. Tzoran, J.L. Ribeiro, E. Drucka, Lucia Mazzolai, Radovan Malý, María Belén Alfonso, José Luis Lobo, M. Zdraveska, I. Pérez, Marijan Bosevski, Manolis Papadakis, Raquel Barba, R. Aranda, A.R. Ramos, R. del Pozo, M. Barrón, A. Hij, R. Agüero, Ramón Lecumberri, Corrado Lodigiani, Henri Bounameaux, A. Culla, A. Núñez, J.A. Díaz-Peromingo, and Barbara Ney

Subjects
Adult, Male, medicine.medical_specialty, Multivariate analysis, Adolescent, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Catheterization, Peripheral, 03 medical and health sciences, Immobilization, Young Adult, 0302 clinical medicine, Recurrence, Aged, Aged, 80 and over, Catheterization, Peripheral, Female, Humans, Middle Aged, Neoplasms, Pulmonary Embolism, Registries, Upper Extremity Deep Vein Thrombosis, Venous Thromboembolism, 80 and over, Medicine, cardiovascular diseases, Young adult, Prospective cohort study, business.industry, Odds ratio, medicine.disease, Thrombosis, Confidence interval, Surgery, Pulmonary embolism, Venous thrombosis, 030228 respiratory system, Cardiology and Cardiovascular Medicine, business
Abstract

We sought to determine the risk factors for subsequent bleeding and recurrent venous thromboembolism (VTE) events following isolated noncatheter-associated upper extremity deep venous thrombosis (non-CA-UEDVT) to better inform future treatment decisions for this group of patients.The RIETE registry (Registro Informatizado de Enfermedad TromboEmbólica [Computerized Registry of Patients with Venous Thromboembolism]) is a prospective international registry of patients with objectively confirmed symptomatic VTE. Patients with a symptomatic, isolated, proximal UEDVT from March 2001 through March 2015 were analyzed. Any patient with an indwelling catheter or pacemaker lead at the DVT site and at the time of thrombosis was considered to have a CA-UEDVT and was excluded. Patient and treatment characteristics such as age, gender, comorbidities, VTE risk factors, treatment drug, and duration were collected. Outcomes examined included recurrent DVT, subsequent pulmonary embolism (PE), and hemorrhage. Multivariate analysis was performed using stepwise logistic regression.Of the 1100 patients who met the study criteria, 580 (53%) were male. The mean age of the patients was 50 ± 20 years, and overall patient survival at 1 year was 85%. Recurrent VTE occurred in 59 patients (5.4%). Of these, 46 patients (4%) had recurrent DVT, 10 (0.9%) had a PE following UEDVT diagnosis, and 3 (0.3%) had both. PE was fatal in three patients (0.3%). Bleeding occurred in 50 patients (4.5%), major bleeding in 19 patients (1.7%), and fatal bleeding in 6 patients (0.5%). On multivariate analysis, malignant disease was associated with VTE recurrence (odds ratio [OR], 2.00; 95% confidence interval [CI], 1.04-3.45; P .04), whereas hemorrhage was associated with age (OR, 1.03; 95% CI, 1.01-1.05; P = .002) and malignant disease (OR, 2.53; 95% CI, 1.34-4.76; P .005). Hemorrhage and recurrent VTE were also significantly associated (OR, 2.79; 95% CI, 1.16-6.76; P .03).PE following non-CA-UEDVT is rare. Malignant disease was associated with VTE recurrence. Age and malignant disease were associated with hemorrhage, and VTE recurrence was associated with hemorrhage. Further prospective studies should be undertaken to best determine length of anticoagulation treatment for the varied populations of patients with UEDVT.

Published
2017

10. Venous thromboembolism in nonagenarians

Author

Beatriz Vasco, Luciano López-Jiménez, Manuel Monreal, Joan Carles Villalba, Javier Trujillo-Santos, Julio Montes, and Conxita Falga

Subjects
medicine.medical_specialty, business.industry, Vascular disease, Acute infection, Hematology, medicine.disease, Pulmonary embolism, Surgery, Venous thrombosis, Internal medicine, Heart failure, medicine, Risk factor, business, Survival rate, Venous thromboembolism
Abstract

SummaryThe balance between the efficacy and safety of anticoagulant therapy in patients aged ≥90 years with venous thromboembolism (VTE) is uncertain. RIETE is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic VTE. We evaluated the efficacy and safety of anticoagulant therapy during the first three months in all patients aged ≥90 years. In addition, we tried to identify those at a higher risk for VTE. Of 21,873 patients enrolled from March 2001 to February 2008, 610 (2.8%) were aged ≥90 years. Of these, 307 (50%) presented with pulmonary embolism (PE), 240 (39%) had immobility ≥4 days, and 271 (44%) had abnormal creatinine levels. During the first three months of therapy, 140 patients aged ≥90 years (23%) died. Of these, 45 (32%) died of PE (34 of the initial episode, 11 of recurrent PE), 18 (13%) had fatal bleeding. Recent im-mobility ≥4 days was the most common risk factor for VTE (240 of 610 patients, 39%), but only 54 of them (22%) had received thromboprophylaxis. The most frequent causes for immobility were senile dementia, acute infection, trauma or decompen-sated heart failure. The duration of immobility was

Published
2009

11. Venous Thromboembolism in Patients with Renal Insufficiency: Findings from the RIETE Registry

Author

Ana Maestre, Raquel Barba, Juan Bosco, R. Valle, Conxita Falga, José Luís Beato, and Manuel Monreal

Subjects
Male, medicine.medical_specialty, Renal function, Gastroenterology, Thromboembolism, Internal medicine, Humans, Medicine, Registries, Renal Insufficiency, Aged, Retrospective Studies, business.industry, Vascular disease, Incidence, Incidence (epidemiology), General Medicine, Heparin, medicine.disease, Pulmonary embolism, Surgery, Venous thrombosis, Female, Renal vein, business, Kidney disease, medicine.drug
Abstract

Background Current guidelines make no specific recommendations for venous thromboembolism (VTE) treatment in patients with renal insufficiency, but some experts recommend some reduction in heparin dose. Methods Registro Informatizado de Enfermedad TromboEmbolica (RIETE) is an ongoing, prospective registry of consecutively enrolled patients with objectively confirmed, symptomatic, acute VTE. In this analysis we retrospectively analyzed the effect of renal insufficiency on the incidence of fatal pulmonary embolism (PE) and fatal bleeding within 15 days of diagnosis. Results Up to March 2005, 10,526 patients with acute VTE were enrolled in RIETE, of whom 9234 (88%) had a creatinine clearance (CrCl) greater than 60 mL/min, 704 (6.7%) had a CrCl 30 to 60 mL/min, and 588 (5.6%) had a CrCl less than 30 mL/min. The incidence of fatal PE during the study period was 1.0%, 2.6%, and 6.6%, respectively. Fatal bleeding occurred in 0.2%, 0.3%, and 1.2% of the patients, respectively. On multivariate analysis, patients with a CrCl less than 30 mL/min were independently associated with an increased risk for fatal PE and fatal bleeding. In addition, initial diagnosis of PE, immobility for 4 days or more, cancer, and initial therapy with unfractionated heparin were independent predictors of fatal PE; whereas immobility for 4 days or more and cancer were independent predictors of fatal bleeding. Conclusions Patients with VTE who have renal insufficiency had an increased incidence of both fatal PE and fatal bleeding, but the risk of fatal PE far exceeded that of fatal bleeding. Our data support the use of full-dose anticoagulant therapy, even in patients with a CrCl less than 30 mL/min.

Published
2006

12. Fatal pulmonary embolism and fatal bleeding in cancer patients with venous thromboembolism: findings from the RIETE registry

Author

C. Tolosa, Manuel Monreal, F Gabriel, Conxita Falga, Mariano Valdes, Juan Francisco Jordán Montes, Riete Investigators, and Carmen Suárez

Subjects
Male, medicine.medical_specialty, Hemorrhage, Disease, Immobilization, Risk Factors, Neoplasms, Internal medicine, medicine, Humans, Registries, Neoplasm Metastasis, Risk factor, Aged, Venous Thrombosis, business.industry, Cancer, Hematology, Middle Aged, medicine.disease, Pulmonary embolism, Surgery, Venous thrombosis, Increased risk, Female, Kidney Diseases, Pulmonary Embolism, business, Venous thromboembolism, Major bleeding
Abstract

Summary. Objectives: To examine the clinical characteristics and outcomes of cancer patients with venous thromboembolism (VTE) in order to identify factors that place these patients at an increased risk for fatal pulmonary embolism (PE) or fatal bleeding. Patients and methods: Registro Informatizado de la Enfermedad Trombo Embolica (RIETE) is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. Results: Up to January 2006, a total of 14 391 patients with symptomatic acute VTE were enrolled in RIETE, of whom 2945 (20%) had cancer. During the 3-month follow-up period the frequency of fatal PE in cancer patients was 2.6%, and that of fatal bleeding 1.0%. These frequencies were significantly higher than in VTE patients without cancer (1.4% and 0.3%, respectively). In patients with cancer, abnormal renal function, metastatic disease, recent major bleeding and recent immobility for ≥ 4 days (42% of the 108 patients who died from PE or bleeding had recent immobility) were factors independently associated with an increased risk for both fatal PE and fatal bleeding. In addition, PE diagnosis on admission was an independent risk factor for fatal PE, while body weight

Published
2006

13. Subsequent arterial ischemic events in patients receiving anticoagulant therapy for venous thromboembolism

Author

S. Hernández-Huerta, J. del Toro, J.L. Ogea, I. Tzinieris, Juan I. Arcelus, Fernando Uresandi, Rita Duce, M. Monreal, Laurent Bertoletti, Diego Tonello, Mar Martín, Alicia Lorenzo, J. Villalta, M. Ciammaichella, C. Piovella, María Teresa Martín, Jorge Gómez Cerezo, José María Pedrajas, Inna Tzoran, O. Madridano, F. del Molino, Luca Calanca, N. Ruiz-Giménez, A. Alatri, M.J. Núñez, Daniel Mosquera, L. Hernández, Ángeles Blanco-Molina, Adriana Visonà, R.M. Tilvan, F.J. Muñoz, A. Braester, Isabelle Mahé, Ángel Sampériz, B. Valero, B. Barrón-Andrés, M.D. Nauffal, P. Prandoni, M. Macià, Jorge Del Toro, R. Maida, J. Bascuñana, Agustina Rivas, P. Gallego, Antonella Tufano, Barry M. Brenner, Ana Maestre, Silvia Soler, Paolo Prandoni, M. Saraiva, F. Gonçalves, L. Rota, J. Ruiz, P. Bedate, T. Bueso, M. Valdés, D. Kovacevic, Henri Bounameaux, P. Di Micco, J. Trujillo, Luis Hernández, A. Schenone, Vladimir Rosa, E. Salgado, David Jiménez, E. Grau, M. Fernandes, J.F. Sánchez Muñoz-Torrero, David Zeltser, Giovanni Barillari, P. Román, I. Casado, Pablo Javier Marchena, M.A. Lorente, M.L. Peris, M.A. Rodríguez-Dávila, B. Zalunardo, M.I. Fuentes, G. Vidal, J.A. Nieto, E. Tiraferri, Carme Font, D. Aujeski, M. Guil, Antoni Riera-Mestre, C. Vilar, G. Tiberio, D. Farge-Bancel, Manolis Papadakis, R. Guijarro, Remedios Otero, Raquel Barba, A. Lorenzo, E. González-Bachs, Luis Jara-Palomares, J. Hirmerova, D. Babalis, R. Poggio, Isabelle Quéré, Lucia Mazzolai, F. Dalla Valle, R. Valle, Conxita Falga, M. Arroyo, J.M. Mora, A. Merah, M. Santos, J.B. López-Sáez, O. Gavín, V. Gómez, C. Tolosa, J. Vela, Ramón Lecumberri, Radovan Malý, Olga Madridano, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, J.M. Luque, Sebastian Schellong, Roberto Quintavalla, José Luis Lobo, R. Sousa, Aitor Ballaz, Marijan Bosevski, Luciano López-Jiménez, F. García-Bragado, Carmen Fernández-Capitán, M. Barrón, Aurora Villalobos, J.C. Sahuquillo, J.M. Suriñach, A. Ruiz-Gamietea, J.J. Martín-Villasclaras, J. González, J. Gutiérrez, M. Miklo sová, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), and Université Montpellier 1 (UM1)-Université de Montpellier (UM)

Subjects
medicine.medical_specialty, Anemia, Myocardial Infarction, Hemorrhage, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Diabetes mellitus, Internal medicine, medicine, Humans, Myocardial infarction, Stroke, business.industry, Hazard ratio, Anticoagulants, Venous Thromboembolism, Cardiology and Cardiovascular Medicine, Surgery, medicine.disease, 3. Good health, Pulmonary embolism, Venous thrombosis, Mesenteric ischemia, Cardiology, business, Pulmonary Embolism
Abstract

International audience; OBJECTIVE:Patients with acute venous thromboembolism (VTE) are at increased risk for the development of subsequent arterial ischemic events unrelated to the diagnosis of VTE. Accurate identification of VTE patients at increased risk for ischemic events during the course of anticoagulation may help to select those who would potentially benefit from concomitant therapy with anticoagulants and antiplatelets.METHODS:We used the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) Registry to assess the rate and severity of subsequent ischemic events (ie, stroke, myocardial infarction, lower limb amputation, or mesenteric ischemia) appearing during the course of anticoagulant therapy and tried to identify risk factors for these events.RESULTS:From February 2009 to March 2014, 23,370 patients were recruited: 12,397 initially presenting with pulmonary embolism (PE) and 10,973 with deep venous thrombosis. During the course of anticoagulation (mean, 9.2 months), 597 patients developed recurrent VTE, 652 bled, 162 had ischemic events (stroke, 86; myocardial infarction, 53; limb amputation, 13; mesenteric ischemia, 11), and 2063 died. Of these, 29 patients died of recurrent PE, 83 of bleeding, and 53 of the ischemic events. On multivariable analysis, cancer (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.21-2.61), chronic lung disease (HR, 1.54; 95% CI, 1.05-2.26), renal insufficiency (HR, 1.72; 95% CI, 1.25-2.36), anemia (HR, 1.54; 95% CI, 1.11-2.14), prior artery disease (HR, 1.84; 95% CI, 1.29-2.64), and diabetes (HR, 1.58; 95% CI, 1.10-2.27) independently predicted the risk for ischemic events. Most of these variables also predicted major bleeding (cancer, chronic lung disease, renal insufficiency, anemia, and prior artery disease) or recurrent PE (cancer, chronic lung disease, anemia, and prior artery disease).CONCLUSIONS:In patients receiving anticoagulation for VTE, the mortality due to PE recurrences was lower than the mortality due to ischemic events. Most independent predictors for ischemic events were also predictors for major bleeding and for recurrent PE.

Published
2014

14. A prognostic score to identify low-risk outpatients with acute deep vein thrombosis in the lower limbs

Author

S. Pasca, M.D. Adarraga, Manuel Monreal, M.J. Jaras, Sebastian Schellong, R. Maida, C. Piovella, Dolores Adarraga, F. García-Bragado, Ramón Lecumberri, J.A. Nieto, M. Mellado, Remedios Otero, Isabelle Quéré, Lucia Mazzolai, Radovan Malý, P. Malfante, V. Rosa, M. Farès, M. Alcalde, M. Kaletova, L. López-Jiménez, R. Pesavento, S. Almeida, R. Duce, F. Conget, M.L. Peris, J.M. Luque, B. Pagán, M.A. Rodríguez-Dávila, E. González-Bachs, I. Casado, T. Tomko, Peter Verhamme, J. Ruiz, A. Alatri, A. Apollonio, D. Zeltser, J.A. Porras, Olga Madridano, J.B. López-Sáez, Henri Bounameaux, Giovanni Barillari, Laurent Bertoletti, David Jiménez, A. Merah, N. Ruiz-Giménez, J. Gutiérrez, R. Guijarro, J.M. Suriñach, L. López-Montes, R. Jiménez, Jorge Del Toro, V. Andújar, J. del Toro, I. Pons, J. Trujillo-Santos, Alicia Lorenzo, P. Gallego, Jana Hirmerova, G. Pérez-Rus, E. Grau, M. Guil, M. Monreal, Manuel Alejandro Lorente, J.L. Ogea, Dolores Nauffal, Barry M. Brenner, J. González, L. Calanca, L. Mazzolai, A. Bura-Riviere, M.A. Lorente, Antoni Riera-Mestre, Inna Tzoran, G. Tiberio, J. Hirmerova, Silvia Soler, Paolo Prandoni, C. Grange, V. Gómez, Francisco Lozano, J.M. Martín-Antorán, F. Leal-Seabra, Adriana Visonà, A. Braester, Juan I. Arcelus, Luis Jara-Palomares, J.M. Pedrajas, F. del Molino, A. Blanco-Molina, J.C. Serrano, P.J. Marchena, A. Tufano, J. Vela, B. Valero, R. Poggio, Diego Tonello, M.J. Núñez, L. Rota, Agustina Rivas, José Luis Lobo, T. Bueso, Raquel López-Reyes, Javier Trujillo-Santos, P. Di Micco, Marijan Bosevski, Raúl Sánchez, J. Bascuñana, Isabelle Mahé, M. Barrón, Fernando Uresandi, L. Font, Philip S. Wells, A. Guida, E. Tiraferri, G. Barillari, P. Román, M. Ciammaichella, B. Zalunardo, Ángel Sampériz, Carmen Fernández-Capitán, F. Pace, Manolis Papadakis, R. Valle, M.S. Sousa, P. Sabio, Conxita Falga, A. Climent, A. Villalobos, Raquel Barba, M.V. Morales, K. Peerlinck, B. Barrón-Andrés, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Trujillo-Santos, J., Lozano, F., Lorente, M. A., Adarraga, D., Hirmerova, J., Toro, J. D., Mazzolai, L., Barillari, G., Barron, M., Monreal, M., Alcalde, M., Andujar, V., Arcelus, J. I., Barba, R., Barron-Andres, B., Bascunana, J., Blanco-Molina, A., Bueso, T., Casado, I., Climent, A., Conget, F., Del, M. F., Falga, C., Fernandez-Capitan, C., Font, L., Gallego, P., Garcia-Bragado, F., Gomez, V., Gonzalez, J., Gonzalez-Bachs, E., Grau, E., Guijarro, R., Guil, M., Gutierrez, J., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, R., Lecumberri, R., Lobo, J. L., Lopez-Jimenez, L., Lopez-Montes, L., Lopez-Reyes, R., Lopez-Saez, J. B., Lorenzo, A., Luque, J. M., Madridano, O., Marchena, P. J., Martin-Antoran, J. M., Mellado, M., Morales, M. V., Nauffal, D., Nieto, J. A., Nunez, M. J., Ogea, J. L., Otero, R., Pagan, B., Pedrajas, J. M., Perez-Rus, G., Peris, M. L., Porras, J. A., Pons, I., Riera-Mestre, A., Rivas, A., Rodriguez-Davila, M. A., Roman, P., Rosa, V., Ruiz-Gimenez, N., Ruiz, J., Sabio, P., Samperiz, A., Sanchez, R., Soler, S., Surinach, J. M., Tiberio, G., Uresandi, F., Valero, B., Valle, R., Vela, J., Villalobos, A., Malfante, P., Verhamme, P., Peerlinck, K., Wells, P., Maly, R., Kaletova, M., Tomko, T., Bertoletti, L., Bura-Riviere, A., Fares, M., Grange, C., Mahe, I., Merah, A., Quere, I., Schellong, S., Papadakis, M., Braester, A., Brenner, B., Tzoran, I., Zeltser, D., Apollonio, A., Ciammaichella, M., Di, M. P., Duce, R., Guida, A., Maida, R., Pace, F., Pasca, S., Piovella, C., Pesavento, R., Poggio, R., Prandoni, P., Rota, L., Tiraferri, E., Tonello, D., Tufano, A., Visona, A., Zalunardo, B., Almeida, S., Leal-Seabra, F., Sousa, M. S., Bosevski, M., Alatri, A., Bounameaux, H., Calanca, L., and Serrano, J. C.

Subjects
Adult, Male, medicine.medical_specialty, Deep vein, Anticoagulant therapy, Deep venous thrombosis, Home, Hospital, Outcome, Aged, Aged, 80 and over, Ambulatory Care, Anticoagulants, Female, Humans, Lower Extremity, Middle Aged, Outpatients, Prognosis, Risk Assessment, Venous Thrombosis, Prognostic score, 80 and over, medicine, Adverse effect, Deep venous thrombosi, business.industry, Cancer, General Medicine, medicine.disease, Thrombosis, Confidence interval, 3. Good health, Surgery, Pulmonary embolism, medicine.anatomical_structure, Heart failure, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; BACKGROUND:No prior studies have identified which patients with deep vein thrombosis in the lower limbs are at a low risk for adverse events within the first week of therapy.METHODS:We used data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) to identify patients at low risk for the composite outcome of pulmonary embolism, major bleeding, or death within the first week. We built a prognostic score and compared it with the decision to treat patients at home.RESULTS:As of December 2013, 15,280 outpatients with deep vein thrombosis had been enrolled. Overall, 5164 patients (34%) were treated at home. Of these, 12 (0.23%) had pulmonary embolism, 8 (0.15%) bled, and 4 (0.08%) died. On multivariable analysis, chronic heart failure, recent immobility, recent bleeding, cancer, renal insufficiency, and abnormal platelet count independently predicted the risk for the composite outcome. Among 11,430 patients (75%) considered to be at low risk, 15 (0.13%) suffered pulmonary embolism, 22 (0.19%) bled, and 8 (0.07%) died. The C-statistic was 0.61 (95% confidence interval [CI], 0.57-0.65) for the decision to treat patients at home and 0.76 (95% CI, 0.72-0.79) for the score (P = .003). Net reclassification improvement was 41% (P < .001). Integrated discrimination improvement was 0.034 for the score and 0.015 for the clinical decision (P < .001).CONCLUSIONS:Using 6 easily available variables, we identified outpatients with deep vein thrombosis at low risk for adverse events within the first week. These data may help to safely treat more patients at home. This score, however, should be validated.

Published
2014

15. Low-molecular-weight or unfractionated heparin in venous thromboembolism: the influence of renal function

Author

Javier Trujillo Santos, Sebastian, Schellong, Conxita, Falga, Vanessa, Zorrilla, Pedro, Gallego, Manuel, Barrón, Manuel, Monreal, Arcelus, Ji, Ballaz, A, Barba, R, Barragán, Jm, Barrón, M, Barrón Andrés, B, Bascuñana, J, Blanco Molina, A, Bosco, J, Cañas, I, Casado, I, Conget, F, Chaves, E, de Miguel, J, del Campo, R, del Molino, F, del Toro, J, Falgá, C, Fernández, M, Fernández Capitán, C, Fuentes, L, Gabriel, F, Gallego, P, García Bragado, F, Gómez, V, González, J, Guil, M, Gutiérrez, J, Hernández, L, Hernández, Hd, Jaras, Mj, Jiménez, D, Jiménez, S, Lobo, Jl, López Jiménez, L, Lorenzo, A, Macià, M, Madridano, O, Marchena, Pj, Martín, M, Martín Villasclaras JJ, Monreal, M, Morales, M, Nauffal, Md, Nieto, Ja, Núñez, Mj, Ogea, Jl, Otero, R, Pedrajas, Jm, Riera Mestre, A, Román, P, Rodríguez, Em, Román Bernal, B, Royo, C, Ruiz Martínez, C, Ruíz, J, Ruiz Gamietea, A, Ruiz Giménez, N, Sahuquillo, Jc, Sánchez, R, Sánchez Muñoz Torrero JF, Soler, S, Soto, Mj, Tiberio, G, Tolosa, C, Trujillo, J, Uresandi, F, Valdés, M, Valle, R, Vela, J, Vidal, G, Villalta, J, Zorrilla, V, Barillari, G, Ciammaichella, M, Di Micco, P, Dalla Valle, F, Duce, R, Maida, R, Orlandini, F, Pasca, S, Piovella, C, Poggio, R, Prandoni, Paolo, Quintavalla, R, Rota, L, Schenone, A, Tiraferri, E, Tonello, D, Visonà, A, Zalunardo, B, Bertoletti, L, Bura Riviere, A, Debourdeau, P, Farge Bancel, D, Lamuraglia, M, Mahe, I, Quere, I, Brenner, B, Alatri, A, Bounameaux, H, Calanca, L, Mazzolai, L, Malý, R, Hirmerova, J, Tomko, T, Schellong, S, Papadakis, M, Bosevski, M, Salgado, E, La Regina, M, and Rodríguez Dávila MA

Subjects
Adult, Male, medicine.medical_specialty, medicine.drug_class, Low molecular weight heparin, Renal function, Kidney, Kidney Function Tests, Gastroenterology, Internal medicine, medicine, Humans, Renal Insufficiency, Intensive care medicine, Aged, business.industry, Heparin, General Medicine, Odds ratio, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Middle Aged, medicine.disease, Confidence interval, Pulmonary embolism, Treatment Outcome, Propensity score matching, Female, business, Venous thromboembolism, medicine.drug, Follow-Up Studies
Abstract

In patients with acute venous thromboembolism and renal insufficiency, initial therapy with unfractionated heparin may have some advantages over low-molecular-weight heparin.We used the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) Registry data to evaluate the 15-day outcome in 38,531 recruited patients. We used propensity score matching to compare patients treated with unfractionated heparin with those treated with low-molecular-weight heparin in 3 groups stratified by creatinine clearance levels at baseline:60 mL/min, 30 to 60 mL/min, or30 mL/min.Patients initially receiving unfractionated heparin therapy (n = 2167) more likely had underlying diseases than those receiving low-molecular-weight heparin (n = 34,665). Propensity score-matched groups of patients with creatinine clearance levels60 mL/min (n = 1598 matched pairs), 30 to 60 mL/min (n = 277 matched pairs), and30 mL/min (n = 210 matched pairs) showed an increased 15-day mortality for unfractionated heparin compared with low-molecular-weight heparin (4.5% vs 2.4% [P = .001], 5.4% vs 5.8% [P = not significant], and 15% vs 8.1% [P = .02], respectively), an increased rate of fatal pulmonary embolism (2.8% vs 1.2% [P = .001], 3.2% vs 2.5% [P = not significant], and 5.7% vs 2.4% [P = .02], respectively), and a similar rate of fatal bleeding (0.3% vs 0.3%, 0.7% vs 0.7%, and 0.5% vs 0.0%, respectively). Multivariate analysis confirmed that patients treated with unfractionated heparin were at increased risk for all-cause death (odds ratio, 1.8; 95% confidence interval, 1.3-2.4) and fatal pulmonary embolism (odds ratio, 2.3; 95% confidence interval, 1.5-3.6).In comparison with low-molecular-weight heparin, initial therapy with unfractionated heparin was associated with a higher mortality and higher rate of fatal pulmonary embolism in patients with creatinine clearance levels60 mL/min or30 mL/min, but not in those with levels between 30 and 60 mL/min.

Published
2012

16. Clinical outcome of patients with venous thromboembolism and renal insufficiency. Findings from the RIETE registry

Author

Silvia Soler, Ramón Rabuñal, Manuel Monreal, Juan Francisco Sánchez Muñoz-Torrero, Pedro Gallego, Josep Antón Capdevila, and Conxita Falga

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.drug_class, Deep vein, Hemorrhage, Recurrence, Risk Factors, medicine, Humans, Registries, Renal Insufficiency, Aged, Vascular disease, business.industry, Anticoagulant, Anticoagulants, Hematology, Venous Thromboembolism, Middle Aged, medicine.disease, Thrombosis, Surgery, Pulmonary embolism, Venous thrombosis, medicine.anatomical_structure, Treatment Outcome, Creatinine, Female, Renal vein, business, Kidney disease
Abstract

SummaryThere is little information on the clinical outcome of patients with venous thromboembolism and renal insufficiency. RIETE is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE). In this analysis we analyzed the three-month outcome in patients with creatinine clearance (CrCl) 30 ml/min. Of the 579 patients presenting with clinically overt PE, 52 (9.0%) died of the initial PE, 13 (2.2%) of recurrent PE, and nine (1.6%) died of bleeding complications. During the first 15 days of therapy the 10% incidence of fatal PE was 10-fold their 1.0% of fatal bleeding. From day 16 to 90, the 1.0% rate of fatal PE was not significantly higher than the 0.5% of fatal bleeding. Of the 458 DVT patients with CrCl

Published
2007

17. A RIETE registry analysis of recurrent thromboembolism and hemorrhage in patients with catheter-related thrombosis

Author

A. Hij, C. Piovella, Ramón Lecumberri, José Luis Lobo, M. Zdraveska, F.J. Muñoz, F. Valle, Marijan Bosevski, P. Verhamme, N. Ruiz-Giménez, Olga Madridano, Steven Greenberg, A. Apollonio, J.F. Benítez, J.A. Porras, R. Maida, L. Bertoletti, G. Pérez-Rus, P. Román, R. Malý, M.J. Soto, J.M. Suriñach, H. Bounameaux, S. Pasca, J. González, B. Zalunardo, A. Merah, J. Caprini, J. Gutiérrez, I. Tzoran, M. Ciammaichella, A. García, Alicia Lorenzo, Manuel Monreal Bosch, R. Re, Abílio Reis, R. Valle, Lucia Mazzolai, M. Alcalde, Laurent Bertoletti, Peter Verhamme, Diego Tonello, J.B. López-Sáez, Juan I. Arcelus, Vladimir Rosa, D. Farge-Bancel, Isabelle Quéré, V. Vilella-Tomas, R. Jiménez, José María Pedrajas, J.M. Martín-Antorán, O. Sanz, P. Malfante, David Jiménez, L. López-Montes, B. Pagán, Inna Tzoran, J. Bascuñana, Beatriz Valero, E. Grau, Adriana Visonà, Francisco José Muñoz, M. Gómez-Durán, R. Guijarro, Antonella Tufano, A. Guida, J. Villalta, Luca Calanca, M.A. Lorente, M.J. Núñez, F. Conget, Lauren Cote, F. del Molino, M. Barrón, L. Rota, P. Prandoni, A. Braester, Raquel Barba, Radovan Malý, Ajla Alibalic, J. del Toro, I. Pons, Luis Jara-Palomares, B. Barrón-Andrés, Javier Trujillo-Santos, Fernando Uresandi, F. García-Bragado, P. Gallego, J. Malheiro, J. Vela, Henri Bounameaux, S. Hernández-Huerta, L. Hernández, P. Ferrazzi, Thomas Vanassche, Agustina Rivas, Giovanni Barillari, Farès Moustafa, J.A. Díaz, Ángeles Blanco-Molina, Pablo Javier Marchena, Benjamin Brenner, J. Hirmerova, M. Monreal, Raúl Sánchez, Aurora Villalobos, M.V. Morales, P. Di Micco, V. Gómez, Bernardo Sopeña, Ángel Sampériz, Antoni Riera-Mestre, Raquel López-Reyes, L. Font, M. Bosevski, Philip S. Wells, Joseph A. Caprini, I. Casado, R. Tirado, R. Barba, M.S. Sousa, Conxita Falga, J.A. Nieto, Remedios Otero, Lisa Baumann Kreuziger, Hervé Decousus, J.L. Ribeiro, G. Tiberio, M.L. Peris, M.A. Rodríguez-Dávila, A. Alatri, Isabelle Mahé, F. Pace, Luciano López-Jiménez, Sebastian Schellong, Carmen Fernández-Capitán, P. Sabio, Manuel Monreal, M.J. Jaras, Alessandra Bura-Rivière, F. Martín-Martos, S. Jiménez, Teresa Auguet, M. Macià, Dolores Nauffal, Barry M. Brenner, Silvia Soler, Paolo Prandoni, Pierpaolo Di Micco, J.C. Serrano, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), and Université Montpellier 1 (UM1)-Université de Montpellier (UM)

Subjects
medicine.medical_specialty, Catheters, Hemorrhage, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Recurrent thromboembolism, medicine, Humans, Registries, Risk factor, Venous Thrombosis, business.industry, Thrombosis, Odds ratio, medicine.disease, 3. Good health, Surgery, Pulmonary embolism, Catheter, Venous thrombosis, 030220 oncology & carcinogenesis, Concomitant, Pulmonary Embolism, Cardiology and Cardiovascular Medicine, business
Abstract

International audience; BACKGROUND:Few studies have investigated the treatment and the outcomes of patients with catheter-related thrombosis (CRT).METHODS:The RIETE registry (Registro Informatizado de Enfermedad TromboEmbólica [Computerized Registry of Patients with Venous Thromboembolism]) is a prospective international registry of consecutive patients with objectively confirmed venous thromboembolism (VTE). We analyzed the characteristics, treatment, and outcomes of patients with CRT.RESULTS:Of 558 patients with CRT, 45 (8%) presented with a pulmonary embolism (PE) concomitantly. More patients had central line-associated thrombosis compared with port systems, but catheter type did not influence the risk of presenting with a PE. Patients with only CRT were more often prescribed low-molecular-weight heparin for the duration of their anticoagulant treatment compared with patients presenting with concomitant PE. VTE recurrences and major bleeding events occurred frequently during treatment with anticoagulation (7 per 100 patient-years and 8.9 per 100 patient years, respectively). The rates of fatal PE recurrences (1.85 per 100 patient-years) and fatal bleeding (2.32 per 100 patient-years) were similar. Patients with an additional transient risk factor for VTE had the lowest risk for VTE recurrences (odds ratio [OR], 0.07; 90% confidence interval [CI], 0.01-0.45) compared with patients with CRT and no additional transient risk factors. PE at presentation increased the risk of recurrent thrombosis by 2.4 times. Renal insufficiency was also an independent predictor of recurrent thrombosis (OR, 3.93; 90% CI, 2.0-7.7). The odds of recurrent thrombosis was decreased by 77% in patients who received anticoagulation therapy for >90 days compared with patients with a shorter treatment (OR, 0.23; 90% CI, 0.1-0.56).CONCLUSIONS:Concomitant PE occurs less frequently in CRT than lower extremity deep venous thrombosis, but it is associated with a worse outcome. CRT occurs in high-risk patients, and duration of anticoagulation must be predicated on balancing these risks.

Published
2015

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