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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

Monreal, Manuel, Prandoni, Paolo, Brenner, Benjamin, Farge-Bancel, Dominique, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Tzoran, Inna, Reis, Abilio, Bounameaux, Henri, Malý, Radovan, Verhamme, Peter, Bosevski, Marijan, Caprini, Joseph A., Bui, Hanh My, Adarraga, M.D., Aibar, M.A., Aibar, J., Amado, C., Arcelus, J.I., Azcarate, P.M., Ballaz, A., Barba, R., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Blanco-Molina, A., Camon, A.M., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Díaz-Pedroche, M.C., Díaz-Peromingo, J.A., Díaz-Simón, R., Encabo, M., Falgá, C., Farfán, A.I., Fernández-Capitán, C., Fernández-Criado, M.C., Fidalgo, M.A., Font, C., Font, L., García, M.A., García-Bragado, F., García-Morillo, M., García-Raso, A., Gavín, O., Gaya, I., Gayol, M.C., Gil-Díaz, A., Guirado, L., Gómez, V., González-Martínez, J., Grau, E., Gutiérrez, J., Hernández Blasco, L.M., Iglesias, M., Jara-Palomares, L., Jaras, M.J., Jiménez, D., Jou, I., Joya, M.D., Lalueza, A., Lima, J., Llamas, P., Lobo, J.L., López-Jiménez, L., López-Miguel, P., López-Nuñez, J.J., López-Reyes, R., López-Sáez, J.B., Lorente, M.A., Lorenzo, A., Loring, M., Lumbierres, M., Madridano, O., Maestre, A., Marchena, P.J., Martín-Guerra, J.M., Martín Fernández, M., Mellado, M., Monreal, M., Morales, M.V., Nieto, J.A., Núñez, M.J., Olivares, M.C., Otalora, S., Otero, R., Pedrajas, J.M., Pellejero, G., Pérez-Pinar, M., Pérez-Rus, G., Peris, M.L., Pesce, M.L., Porras, J.A., Rivas, A., Rodríguez-Dávila, M.A., Rodríguez-Fernández, L., Rodríguez-Hernández, A., Rodríguez-Martín, C., Rubio, C.M., Ruiz-Alcaraz, S., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J.C., Salazar, V., Sampériz, A., Sánchez-Muñoz-Torrero, J.F., Sancho, T., Sanoja, I., Soler, S., Soto, M.J., Suriñach, J.M., Tolosa, C., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vidal, G., Gutiérrez, P., Vázquez, F.J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Verhamme, P., Hirmerova, J., Malý, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Debourdeau, P., Falvo, N., Farge-Bancel, D., Hij, A., Mahé, I., Moustafa, F., Braester, A., Brenner, B., Ellis, M., Tzoran, I., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Mumoli, N., Vo Hong, N., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visonà, A., Skride, A., Sablinskis, K., Sablinskis, M., Bosevski, M., Zdraveska, M., Bounameaux, H., Fresa, M., Ney, B., Mazzolai, L., Caprini, J., Tafur, A., Bui, H.M., Golemi, Iva, Cote, Lauren, Iftikhar, Omer, Tafur, Alfonso, Bikdeli, Behnood, Fernández-Capitán, Carmen, Pedrajas, José María, Otero, Remedios, and Quintavalla, Roberto

Published
2020
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5. Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

Author

Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., Protti G., Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., and Protti G.

Abstract

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's

Published
2023

7. Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism

Author

Moustafa, Farès, Giorgi Pierfranceschi, Matteo, Di Micco, Pierpaolo, Bucherini, Eugenio, Lorenzo, Alicia, Villalobos, Aurora, Nieto, José A., Valero, Beatriz, Sampériz, Ángel L., Monreal, Manuel, Decousus, Hervé, Prandoni, Paolo, Brenner, Benjamin, Barba, Raquel, Bertoletti, Laurent, Tzoran, Inna, Reis, Abilio, Bosevski, Marijan, Bounameaux, Henri, Malý, Radovan, Wells, Philip, Papadakis, Manolis, Adarraga, MD, Agudo, P, Aibar, MA, Alfonso, M, Arcelus, JI, Ballaz, A, Barba, R, Barrón, M, Barrón‐Andrés, B, Bascuñana, J, Blanco‐Molina, A, Cañas, I, Casado, I, Chic, N, del Pozo, R, del Toro, J, Díaz‐Pedroche, MC, Díaz‐Peromingo, JA, Falgá, C, Fernández‐Aracil, C, Fernández‐Capitán, C, Fidalgo, MA, Font, C, Font, L, Gallego, P, García, MA, 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, MJ, Jiménez, D, Jiménez, J, Joya, MD, Llamas, P, Lobo, JL, López, P, López‐Jiménez, L, López‐Reyes, R, López‐Sáez, JB, Lorente, MA, Lumbierres, M, Luque, JM, Marchena, PJ, Martín‐Martos, F, Mellado, M, Nieto, S, Núñez, A, Núñez, MJ, Otalora, S, Otero, R, Pedrajas, JM, Pérez, G, Pérez‐Ductor, C, Peris, ML, Pons, I, Porras, JA, Reig, O, Riera‐Mestre, A, Riesco, D, Rivas, A, Rodríguez, M, Rodríguez‐Dávila, MA, Rosa, V, Rosillo‐Hernández, E, Ruiz‐Artacho, P, Ruiz‐Giménez, N, Sahuquillo, JC, Sala‐Sainz, MC, Sánchez‐Martínez, R, Sanz, O, Soler, S, Sopeña, B, Suriñach, JM, Tolosa, C, Torres, MI, Troya, J, Trujillo‐Santos, J, Uresandi, F, Usandizaga, E, Valle, R, Vela, J, Vela, L, Vicente, MP, Xifre, B, Vanassche, T, Verhamme, P, Yoo, HHB, Wells, P, Hirmerova, J, Malý, R, Dulíček, P, Salgado, E, Bertoletti, L, Bura‐Riviere, A, Farge‐Bancel, D, Hij, A, Mahé, I, Merah, A, Braester, A, Brenner, B, Tzoran, I, 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, Prandoni, P, Quintavalla, R, Rocci, A, Tiraferri, E, Tonello, D, Tufano, A, Visonà, A, Gibietis, V, Skride, A, Vitola, B, Bosevski, M, Zdraveska, M, Bounameaux, H, and Mazzolai, L

Published
2017
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8. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Monreal, Manuel, Decousus, Hervè, Prandoni, Paolo, Brenner, Benjamin, Barba, Raquel, Di Micco, Pierpaolo, Bertoletti, Laurent, Tzoran, Inna, Reis, Abilio, Bosevski, Marijan, Bounameaux, Henri, Malý, Radovan, Wells, Philip, Verhamme, Peter, Adarraga, M.D., Aibar, M.A., Alfonso, M., Arcelus, J.I., Azcarate-Agüero, P.M., Ballaz, A., Barba, R., Barrón, M., Barrón-Andrés, B., Bascuñana, J., Blanco-Molina, A., Cañada, G., 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., García-Brotons, P., Gavín, O., Gómez, C., Gómez, V., González, J., Grau, E., Grimón, A., 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., Lorenzo, A., Luque, J.M., Marchena, P.J., Martínez, C., Martín-Martos, F., Monreal, M., Nieto, J.A., 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., Sahuquillo, J.C., Sala-Sainz, M.C., Sampériz, A., Sánchez-Martínez, R., Sanz, O., Soler, S., Sopeña, B., Suriñach, J.M., Tolosa, C., Torres, M.I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valero, B., Valle, R., Vela, J., Vidal, G., Vilar, C., Xifre, B., Vanassche, T., Verhamme, P., Yoo, H.H.B., Wells, P., Hirmerova, J., Malý, R., Salgado, E., Bertoletti, L., Bura-Riviere, A., Farge-Bancel, D., Hij, A., Mahé, I., Merah, A., Moustafa, F., Braester, A., Brenner, B., Tzoran, I., Antonucci, G., Barillari, G., Bilora, F., Bonanome, A., Bortoluzzi, C., Brandolin, B., Ciammaichella, M., De Ciantis, P., Dentali, F., Di Micco, P., Duce, R., Giorgi-Pierfranceschi, M., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Poggio, R., Prandoni, P., Quintavalla, R., Rocci, A., Tiraferri, E., Tonello, D., Tufano, A., Venturelli, U., Visonà, A., Gibietis, V., Skride, A., Vitola, B., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Barrios, Deisy, Chavant, Jeremy, Jiménez, David, Rosa-Salazar, Vladimir, Muriel, Alfonso, Viallon, Alain, Fernández-Capitán, Carmen, and Yusen, Roger D.

Published
2017
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11. Are all people with diabetes and cardiovascular risk factors or microvascular complications at very high risk? Findings from the Risk and Prevention Study

Author

Marzona, Irene, Avanzini, Fausto, Lucisano, Giuseppe, Tettamanti, Mauro, Baviera, Marta, Nicolucci, Antonio, Roncaglioni, Maria Carla, Tombesi, M., Tognoni, G., Massa, E., Marrocco, W., Micalella, M., Caimi, V., Longoni, P., Avanzini, F., Franzosi, M. G., Roncaglioni, M. C., Marzona, I., Baviera, M., Monesi, L., Pangrazzi, I., Barlera, S., Milani, V., Nicolis, E., Casola, C., Clerici, F., Palumbo, A., Sgaroni, G., Marchioli, R., Silletta, M. G., Pioggiarella, R., Scarano, M., Marfisi, R. M., Flamminio, A., Macino, L., Ferri, B., Pera, C., Polidoro, A., Abbatino, D., Acquati, M., Addorisio, G., Adinolfi, D., Adreani, L., Agistri, M. R., Agneta, A., Agnolio, M. L., Agostini, N., Agostino, G., Airò, A., Alaimo, N., Albano, M., Albano, N., Alecci, G., Alemanno, S., Alexanian, A., Alfarano, M., Alfè, L., Alonzo, N., Alvino, S., Ancora, A., Andiloro, S., Andreatta, E., Angeli, S., Angiari, F., Angilletti, V., Annicchiarico, C., Anzivino, M., Aprea, R., Aprile, A., Aprile, E., Aprile, I., Aprile, L., Armellani, V., Arnetoli, M., Aronica, A., Autiero, V., Bacca, G., Baccalaro, A. M., Bacci, M., Baglio, G., Bagnani, M., Baiano, A., Baldari, A., Ballarini, L., Banchi, G., Bandera, R., Bandini, F., Baratella, M., Barbieri, A., Barbieri Vita, A., Bardi, M., Barlocchi, M., Baron, P., Bartoli, M., Basile, A., Basile, F., Basile, S., Battaggia, A., Battaglia, A., Baù, A., Beconcini, G., Beggio, R., Belfiore, P. A., Belicchi, M., Bellamoli, S., Bellini, C., Bellomo, M., Benetollo, C., Benetti, R., Beretta, E., Bertalero, P., Bertaso, F. G., Bertolani, U., Bettelli, G., Biagiotti, G., Bianchi, S., Bianco, G., Biccari, F., Bigioli, F., Bindi, M., Bisanti, G., Bitetti, E. M., Blasetti, M. P., Blesi, F., Boato, V., Boga, S., Boidi, E., Boldrin, G., Bollati, A., Bolzan, L., Bolzonella, S., Bonardi, P., Bonato, G. B., Bonci, M., Bonfitto, G., Bonincontro, E., Boninsegna, F., Bonissone, D., Bono, L., Bonollo, E., Borghi, M., Borioli, N., Borsatto, M., Bosco, T., Bosisio Pioltelli, M., Botarelli, C., Botassis, S., Bottini, F., Bottos, C., Bova, G., Bova, V., Bozzani, A., Bozzetto, R. M., Braga, V. T., Braglia, M., Bramati, E., Brazzoli, C., Breglia, G., Brescia, A., Briganti, D., Brigato, G., Brocchi, A., Brosio, F. A., Bruni, E., Buscaglia, E., Bussini, M. D., Bussotti, A., Buzzaccarini, F., Buzzatti, A., Caccamo, G., Cacciavillani, C., Caggiano, G., Caimi, V., Calciano, F. P., Calderisi, M., Calienno, S., Caltagirone, P., Calzolari, I., Cammisa, M., Campanaro, M., Campanella, G. B., Campese, F., Canali, G., Candiani, D. E. L., Canepa, R., Canini, D., Canino, A., Cantoro, E. A., Capilupi, V., Capotosto, P., Cappelli, B., Capraro, G., Carafa, F. A., Carano, Q., Carcaterra, V., Carriero, D., Carrozzo, G., Cartanese, M., Casalena, M., Casarola, M., Caso, C., Casotto, M., Castaldi, F., Castegnaro, R., Castellani, G., Castri, S., Catalano, E., Catinello, N., Caturano, G., Cavallaro, R., Cavallo, A. M., Cavallo, G., Cavion, M. T., Cavirani, G., Cazzaniga, F., Cazzetta, D., Cecconi, V., Cefalo, A., Celebrano, M., Celora, A., Centonze, P., Cerati, D., Cesaretti, D., Checchia, G., Checchin, A., Cherubini, M., Chianese, L., Chiappa, A., Chiappa, M. V., Chiariello, G., Chiavini, G., Chicco, M., Chiumeo, F., Ciacciarelli, A., Ciaci, D., Ciancaglini, R., Cicale, C., Cicale, S., Cipolla, A., Ciruolo, A., Citeri, A. L., Citterio, G., Clerici, M., Coazzoli, E., Collecchia, G., Colletta, F., Colombo, I., Colorio, P., Coluccia, S., Comerio, M., Comoretto, P., Compagni, M., Conte, O., Contri, S., Contrisciani, A., Coppetti, T., Corasaniti, F., Corradi, M. T., Corsano, A., Corsini, A., Corti, N., Costantini, G., Costantino, A., Cotroneo, S., Cozzi, D., Cravello, M. G., Cristiano, E., Cucchi, R., Cusmai, L., D’Errico, G. B., D’Agostino, P., Dal Bianco, L., Dal Mutto, U., Dal Pozzo, G., Dallapiccola, P., Dallatorre, G., Dalle Molle, G., Dalloni, E., D’Aloiso, A., D’Amicis, G., Danese, R., Danieli, D., Danisi, G., D’Anna, M. A., Danti, G., D’Ascanio, S., Davidde, G., De Angeli, D., De Bastiani, R., De Battisti, A., De Bellis, A., De Berardinis, G., De Carlo, F., De Giorgi, D., De Gobbi, R., De Lorenzis, E., De Luca, P., De Martini, G., De Marzi, M., De Matteis, D., De Padova, S., De Polo, P., De Sabato, N., De Stefano, T., De Vita, M. T., De Vito, U., De Zolt, V., Debernardi, F., Del Carlo, A., Del Re, G., Del Zotti, F., D’Elia, R., Della Giovanna, P., Dell’Acqua, L., Dell’Orco, R. L., Demaria, G., Di Benedetto, M. G., Di Chiara, G., Di Corcia, V., Di Domizio, O., Di Donato, P., Di Donato, S., Di Fermo, G., Di Franco, M., Di Giovannantonio, G., Di Lascio, G., Di Lecce, G., Di Lorenzo, N., Di Maro, T., Di Mattia, Q., Di Michele, E., Di Modica, R. S., Di Murro, D., Di Noi, M. C., Di Paoli, V., Di Santi, M., Di Sanzo, A., Di Turi, C., Diazzi, A., Dileo, I., D’Ingianna, A. P., Dolci, A., Donà, G., Donato, C., Donato, P., Donini, A., Donna, M. E., Donvito, T. V., Esposito, L., Esposito, N., Evangelista, M., Faita, G., Falco, M., Falcone, D. A., Falorni, F., Fanciullacci, A., Fanton, L., Fasolo, L., Fassina, R., Fassone, A., Fatarella, P., Fedele, F., Fera, I., Fera, L., Ferioli, S., Ferlini, M. G., Ferlino, R., Ferrante, G., Ferrara, F. N., Ferrarese, M. F., Ferrari, G., Ferrari, O., Ferreri, A., Ferroni, M., Fezzi, G., Figaroli, C., Fina, M. G., Fioretta, A., Fiorucci, C., Firrincieli, R., Fischetti, M., Fischietti, G., Fiume, D. C., Flecchia, G., Forastiere, G., Fossati, B., Franceschi, P. L., Franchi, L., Franzoso, F., Frapporti, G., Frasca, G., Frisotti, A., Fumagalli, G., Fusco, D., Gabriele, P., Gabrieli, A., Gagliano, D., Galimberti, G., Galli, A., Gallicchio, N., Gallio, F., Gallipoli, T., Gallo, P., Galopin, T., Gambarelli, L., Garbin, A., Garozzo, G. M., Gasparri, R., Gastaldo, M., Gatti, E., Gazzaniga, P., Gennachi, N., Gentile, R. V., Germani, P., Gesualdi, F., Gherardi, E., Ghezzi, C., Ghidini, M. G., Ghionda, F., Giacci, L., Gialdini, D., Giampaolo, C., Giancane, R., Giannanti, A., Giannese, S., Giannini, L., Giaretta, M., Giaretta, R., Giavardi, L., Giordano, P., Giordano, E., Giordano, B., Gioria, G. M., Giugliano, R., Grassi, E. A., Greco, A., Greco, L., Grilletti, N., Grimaldi, N., Grisetti, G., Groppelli, G., Gualtieri, L., Guarducci, M., Guastella, G., Guerra, M., Guerrini, F., Guglielmini, A., Guido, A., Gulotta, P., Iacono, E., Iadarola, G., Ianiro, G., Iarussi, V., Ieluzzi, M. L., Ierardi, C., Ingaldi, F., Interlandi, S., Iocca, M., Iorno, A., Ioverno, E., Iurato, R., La Pace, L., La Piscopia, C., La Selva, R., Lafratta, M., Lamparelli, M., Lanaro, G., Lancerotto, R., Larcher, M., Lassandro, M., Lattuada, G., Laurino, P., Lefons, C., Legrottaglie, F., Lemma, A., Leone, D., Leone, F., Leso, A., Leuzzi, G., Levato, G., Libardi, L., Libralesso, N., Licini, P. I., Licursi, G., Lidonnici, F., Lillo, C., Liveri, L., Livio, A., Loiero, R. A., Loison, M., Lombardo, G., Lombardo, T., Lomunno, V., Lomuscio, S., Lonedo, A., Longo, E., Longoni, P., Lora, L., Lotterio, A., Lucatello, L., Luongo, A., Lupoli, M., Macchia, C., Macri, G., Mafessanti, M., Maggialetti, V., Maggioni, A., Magnani, M., Maiellaro, G., Mancuso, A., Maniglio, A. R., Mannari, G. L., Manni, A., Manocchio, B., Mao, M., Maranò, A., Maraone, E., Marascio, D., Marcheselli, P., Marchetto, B., Marchetto, S., Marchi, A., Marchi, G. L., Mariano, C., Marinacci, S., Marinelli, S., Marini, G., Marra, V. C., Marrali, F., Marseglia, C., Martello, G., Martino, C., Martino, G., Martino, M., Marulli, C. F., Maruzzi, G., Marzotti, A., Mascheroni, G., Mascolo, P., Masoch, G., Masone, R., Massa, E., Massa, L., Massafra, M., Massi, M., Massignani, D. M., Matarese, A. M., Matini, G., Mauro, R., Mazzi, M., Mazzillo, A., Mazzocato, E., Mazzoleni, N. S., Mazzone, A., Melacci, A., Mele, E., Meliota, P., Menaspà, S., Meneghello, F., Merola, G., Merone, L., Metrucci, A., Mezzina, V., Micchi, A., Michielon, A., Migliore, N., Minero, G., Minotta, F., Mirandola, C., Mistrorigo, S., Modafferi, L., Moitre, R., Mola, E., Monachese, C., Mongiardini, C., Montagna, F., Montani, M., Montemurno, I., Montolli, R., Montorsi, S., Montresor, M., Monzani, M. G., Morabito, F., Mori, G., Moro, A., Mosca, M. F., Motti, F., Muddolon, L., Mugnai, M., Muscas, F., Naimoli, F., Nanci, G., Nargi, E., Nasorri, R., Nastrini, G., Negossi, M., Negrini, A., Negroni, A., Neola, V., Niccolini, F., Niro, C. M., Nosengo, C., Novella, G., Nuti, C., Obici, F., Olita, C., Oliverio, S. S., Olivieri, I., Oriente, S., Orlando, G., Paci, C., Pagano, G., Pagliara, C., Paita, G., Paladini, G., Paladino, G., Palano, T., Palatella, A., Palermo, P., Palmisano, M., Pando, P., Panessa, P., Panigo, F., Panozzo, G., Panvini, F., Panzieri, F., Panzino, A., Panzitta, F., Paoli, N., Papagna, R., Papaleo, M. G., Papalia, G., Parisi, R., Parotti, N., Parravicini, D., Passarella, P., Pastore, G. A., Patafio, M., Pavone, P., Pedroli, W., Pedroni, M., Pelligra, G., Pellizzari, M., Penati, A., Perlot, M., Perrone, A., Perrone, G., Peruzzi, P., Peselli, C., Petracchini, L., Petrera, L., Petrone, S., Peverelli, C., Pianorsi, F., Piazza, G. P., Piazzolla, G., Picci, A., Pienabarca, G., Pietronigro, T. P., Pignocchino, P., Pilone, R., Pinto, D., Pirovano, E., Pirrotta, D., Pisante, V., Pitotto, P., Pittari, L., Piva, A., Pizzoglio, A., Plantera, O. R., Plebani, W., Plessi, S., Podrecca, D., Poerio, V., Poggiani, F., Pogliani, W., Poli, L., Poloni, F. G., Porcelli, R., Porto, S., Pranzo, L., Prevedello, C., Profeta, C., Profico, D., Punzi, A., Quaglia, G. M., Racano, M., Raccone, A., Radice, F., Raho, C. A., Raimondi, R., Rainò, M., Ramponi, R., Ramunni, A., Ramunni, A. L., Ravasio, F., Ravera, M., Re Sartò, G., Rebustello, G., Regazzoli, S., Restelli, C., Rezzonico, M., Ricchiuto, F., Rigo, S., Rigon, G., Rigon, R., Rinaldi, O. V., Rinaldi, M., Risplendente, P. G., Rispoli, M., Riundi, R., Riva, M. G., Rizzi, A. L., Rizzi, D., Rizzo, L. D., Rocchi, L., Rondinone, B., Rosa, B., Rosati, F., Roselli, F., Rossetti, A., Rossetti, C., Rossi, R., Rossi, P. R., Rossi, A., Rossi, C. L., Rossitto, A., Ruffini, R., Ruffo, A., Ruggio, S., Ruo, M., Russo, B., Russo, L., Russo, R., Russo, S., Russo, U., Russo, V., Ruta, G., Sacchi, F., Sacco Botto, F., Saia, A., Salladini, G., Salmoiraghi, S., Saluzzo, F., Salvatore, C., Salvatori, E., Salvio, G., Sandri, P., Sandrini, T., Sangermano, V., Santoni, N., Saracino, A. D., Saracino, A., Sarasin, P., Sardo Infirri, C., Sarrì, B., Sartori, G., Sartori, N., Sauro, C., Scaglioni, M., Scalfi, C., Scamardella, A. M., Scandale, G., Scandone, L., Scannavini, G., Scarati, R., Scardi, A., Scarpa, F. M., Scazzi, P., Schifone, A., Schiroso, G., Scigliano, G., Scilla, A., Sciortino, M., Scolaro, G., Scollo, E., Scorretti, G., Sellitti, R., Selmo, A., Selvaggio, G., Sempio, A., Seren, F., Serio, L., Serra, C., Serra, L., Siciliano, D., Sideri, A., Sighele, M., Signore, R., Siliberto, F., Silvestro, M., Simioni, G., Simmini, G., Simonato, L., Sinchetto, F., Sizzano, E., Smajato, G., Smaldone, M., Sola, G., Sordillo, L., Sovran, C. S., Spagnul, P., Spanò, F., Sproviero, S., Squintani, A., Stella, L., Stilo, V., Stocchiero, B., Stornello, M. C., Stracka, G., Strada, S., Stranieri, G., Stucci, N., Stufano, N., Suppa, A., Susca, V. G., Sutti, M., Taddei, M., Tagliabue, E., Tagliente, G., Talato, F., Talerico, P., Talia, R., Taranto, R., Tartaglia, M., Tauro, N., Tedesco, A., Tieri, P., Tirelli, M., Tocci, L., Todesco, P., Tognolo, M., Tomba, A., Tonello, P., Tonon, R., Toscano, L., Tosi, A., Tosi, G., Toso, S., Travaglio, P., Tremul, L., Tresso, C., Triacchini, P., Triggiano, L., Trigilio, A., Trimeloni, J., Tripicchio, G., Tritto, G. S., Trono, F., Trotta, E., Trotta, G., Tubertini, A., Turri, C., Turri, L., Tuttolani, M. P., Urago, M., Ursini, G., Valcanover, F., Valente, L., Valenti, M., Valentini, F., Vallone, G., Valz, P., Valzano, L., Vanin, V., Vatteroni, M., Vegetti, L., Vendrame, D., Veramonti, I., Veronelli, G., Vesco, A., Vicariotto, G., Vignale, G., Villa, P. L., Vinciguerra, R., Visco, A., Visentin, G., Visonà, E., Vitali, E., Vitali, S., Vitti, F., Volpone, D. A., Zambon, N., Zammarrelli, A., Zanaboni, A., Zane, D., Zanetti, B., Zanibellato, R., Zappetti, M., Zappone, P., Zerilli, G., Zirino, V., Zoccali, R., Zuin, F., Altomonte, M., Anelli, N., Angiò, F., Annale, P., Antonacci, S., Anzilotta, R., Bano, F., Basadonna, O., Beduschi, L., Becagli, P., Bellotti, G., Blotta, C., Bruno, G., Cappuccini, A., Caramatti, S., Cariolato, M. P., Castellana, M., Castellani, L., Catania, R., Chielli, A., Chinellato, A., Ciaccia, A., Clerici, E., Cocci, A., Costanzo, G., D’Ercole, F., De Stefano, G., Decè, F., Di Cicco, N., Di Marco, A., Donati Sarti, C., Draghi, E., Dusi, G., Esposito, V., Ferraro, L., Ferretti, A., Ferri, E., Foggetti, L., Foglia, A., Fonzi, E., Frau, G., Fuoco, M. R., Furci, G., Gallo, L., Garra, V., Giannini, A., Gris, A., Iacovino, R., Interrigi, R., Joppi, R., Laner, B., La Fortezza, G., La Padula, A., Lista, M. R., Lupi, G., Maffei, D., Maggioni, G., Magnani, L., Marrazzo, E., Marcon, L., Marinò, V., Maroni, A., Martinelli, C., Mastandrea, E., Mastropierro, F., Meo, A. T., Mero, P., Minesso, E., Moschetta, V., Mosele, E., Nanni, C., Negretti, A., Nisticò, C., Orsini, A., Osti, M., Pacilli, M. C., Pennestre, C., Picerno, G., Piol, K., Pivano, L., Pizzuti, E., Poggi, L., Poidomani, I., Pozzetto, M., Presti, M. L., Ravani, R., Recalenda, V., Romagnuolo, F., Rossignoli, S., Rossin, E., Sabatella, C., Sacco, F., Sanità, F., Sansone, E., Servadei, F., Sisto, M. T., Sorio, A., Sorrentino, A., Spinelli, E., Spolaor, A., Squillacioti, A., Stella, P., Talerico, A., Todisco, C., Vadino, M., Zuliani, C., and Risk & Prevention Collaborative Group

Published
2017
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12. Tissue Plasminogen Activator Levels and Risk of Breast Cancer in a Case-Cohort Study on Italian Women: Results from the Moli-sani Study

Author

Costanzo, S, Parisi, R, De Curtis, A, Gamba, S, Russo, L, Persichillo, M, Panzera, T, Marchetti, M, Cerletti, C, De Gaetano, G, Falanga, A, Donati, M, Iacoviello, L, Costanzo S., Parisi R., De Curtis A., Gamba S., Russo L., Persichillo M., Panzera T., Marchetti M., Cerletti C., De Gaetano G., Falanga A., Donati M. B., Iacoviello L., Costanzo, S, Parisi, R, De Curtis, A, Gamba, S, Russo, L, Persichillo, M, Panzera, T, Marchetti, M, Cerletti, C, De Gaetano, G, Falanga, A, Donati, M, Iacoviello, L, Costanzo S., Parisi R., De Curtis A., Gamba S., Russo L., Persichillo M., Panzera T., Marchetti M., Cerletti C., De Gaetano G., Falanga A., Donati M. B., and Iacoviello L.

Abstract

Background Elevated levels of key enzymes of the fibrinolytic system, such as tissue plasminogen activator (tPA), are reported as predictors of poor outcome in cancer patients. Limited information is available about their potential predictive value for breast cancer (BC) risk in the general population. Aim We examined the association of tPA levels with BC risk in a case-cohort study including women from the prospective Moli-sani cohort. Methods A sample of 710 women (mean age: 54.6 ± 12.1 years) was selected as a subcohort and compared with 84 BC cases, in a median follow-up of 4.2 years. Incident cases of BC were validated through medical records. tPA plasma levels were measured using an enzyme-linked immunosorbent assay kit. Hazard ratio (HR) and 95% confidence interval (CI), adjusted for relevant covariates, were estimated by a Cox regression model using the Prentice method. Results Compared with the lowest quartile (<4.9 ng/mL), women in the highest quartile of tPA (>11.2 ng/mL) had increased risk of BC (HR IVvsI: 2.20, 95% CI: 1.13-4.28) after adjusted for age, smoking, education, menopause, and residence. Further adjustment for biochemical markers did not modify this association. The risk of BC increased by 34% for each increase in 1 standard deviation of log-transformed tPA levels (p = 0.046). Elevated levels of tPA were associated mainly with estrogen-receptor-positive BC (2.08, 95% CI: 1.18-3.66). Conclusion Higher levels of tPA, reported to predict cardiovascular risk, are a potential biomarker for BC risk, supporting the hypothesis of a common soil linking the pathogenic mechanisms of hormone-dependent tumors and cardiovascular disease.

Published
2021

14. D-dimer and reduced-dose apixaban for extended treatment after unprovoked venous thromboembolism: the Apidulcis study

Author

Palareti, G., Poli, D., Pesavento, R., Legnani, C., Antonucci, E., Bucherini, E., Testa, S., Paoletti, O., Chistolini, A., Ceccato, D., Martinelli, I., Bucciarelli, P., Falanga, A., Tosetto, A., Sarti, L., Mastroiacovo, D., Cosmi, B., Visona, A., Santoro, R. C., Zanatta, N., Grandone, E., Bertu, L., Pengo, V., Caiano, L., Prandoni, P., Lotti, E., Crudele, F., Ageno, W., Abenante, A., Colombo, G., Guarascio, M., Cancellieri, E., Morandini, R., Zambelli, S., Martini, S., Vastola, M., Serrao, A., Abbattista, M., Artoni, A., Capecchi, M., Gianniello, F., Scimeca, B., Barcella, L., Gamba, S., Lerede, T., Maggioni, A., Schieppati, F., Russo, L., Zunino, F., Artuso, A., Bellesso, S., Cadau, J., Carli, G., Nichele, I., Perbellini, O., Caronna, A., Gabrielli, F., Lami, F., Nicolini, A., Scaglioni, F., Pinelli, M., Desideri, G., Borgese, L., Favaretto, E., Libra, A., Migliaccio, L., Sartori, M., Panzavolta, C., Scandiuzzi, T., Zalunardo, B. -M., Ierardi, A., Leotta, M., Strangio, A., Guzzon, S., Colaizzo, D., Favuzzi, G., Lombardi, M. R., Ferrini, P. M., Tassoni, M. I., Corradini, S., Iotti, M., Lambertini, I., Veropalumbo, M. R., Lessiani, G., Parisi, R., Bortoluzzi, C., Vo, H. N., Chiarugi, P., Casini, M., Violo, C., Nuti, M., Angeloni, L., Carrozzi, L., Pancani, R., Chimera, D., Conti, V., Meschi, C., Cattaneo, M., Podda, G., Birocchi, S., Cuppini, S., Marzolo, M., Milan, M., Martini, G., Merelli, S., Pontoglio, S., Portesi, N., Villalta, S., De Lucchi, L., Sponghiado, A., Becattini, C., Giustozzi, M., Vinci, A., Pignatelli, P., Bucci, T., Menichelli, D., Pastori, D., Pomero, F., Casalis, S., Galli, E., Ciammaichella, M., Maida, R., De Cristofaro, Raimondo, Alberelli, M. A., Basso, M. R., De Candia, Erica, Di Gennaro, Leonardo, Mumoli, N., Capra, R., Orlando, M., Porta, C., Rotiroti, G., Demarco, M., Petrillo, P., Rossi, E., Bartolomei, Francesca, Soldati, D., Russo, U., Burgo, I., Ziliotti, M., Pataccini, C., Terroni, L., Ugolotti, M. C., Di Giorgio, A., Cavagna, L., Mete, F., Gino, M., Santoro, A., De Carlo, A., Cappelli, R., Bicchi, M., Dyrmo, L., Grifoni, E., Masotti, L., Ria, L., Spagnolo, M., Rupoli, S., Federici, I., Morsia, E., Scortechini, A. R., Torre, E., Franchini, M., Montorsi, P., Galgano, G., De Luca, A., Muiesan, M. L., Paini, A., Stassaldi, D., Denas, G., De Cristofaro R. (ORCID:0000-0002-8066-8849), De Candia E. (ORCID:0000-0003-0942-2819), Di Gennaro L., Bartolomei F., Palareti, G., Poli, D., Pesavento, R., Legnani, C., Antonucci, E., Bucherini, E., Testa, S., Paoletti, O., Chistolini, A., Ceccato, D., Martinelli, I., Bucciarelli, P., Falanga, A., Tosetto, A., Sarti, L., Mastroiacovo, D., Cosmi, B., Visona, A., Santoro, R. C., Zanatta, N., Grandone, E., Bertu, L., Pengo, V., Caiano, L., Prandoni, P., Lotti, E., Crudele, F., Ageno, W., Abenante, A., Colombo, G., Guarascio, M., Cancellieri, E., Morandini, R., Zambelli, S., Martini, S., Vastola, M., Serrao, A., Abbattista, M., Artoni, A., Capecchi, M., Gianniello, F., Scimeca, B., Barcella, L., Gamba, S., Lerede, T., Maggioni, A., Schieppati, F., Russo, L., Zunino, F., Artuso, A., Bellesso, S., Cadau, J., Carli, G., Nichele, I., Perbellini, O., Caronna, A., Gabrielli, F., Lami, F., Nicolini, A., Scaglioni, F., Pinelli, M., Desideri, G., Borgese, L., Favaretto, E., Libra, A., Migliaccio, L., Sartori, M., Panzavolta, C., Scandiuzzi, T., Zalunardo, B. -M., Ierardi, A., Leotta, M., Strangio, A., Guzzon, S., Colaizzo, D., Favuzzi, G., Lombardi, M. R., Ferrini, P. M., Tassoni, M. I., Corradini, S., Iotti, M., Lambertini, I., Veropalumbo, M. R., Lessiani, G., Parisi, R., Bortoluzzi, C., Vo, H. N., Chiarugi, P., Casini, M., Violo, C., Nuti, M., Angeloni, L., Carrozzi, L., Pancani, R., Chimera, D., Conti, V., Meschi, C., Cattaneo, M., Podda, G., Birocchi, S., Cuppini, S., Marzolo, M., Milan, M., Martini, G., Merelli, S., Pontoglio, S., Portesi, N., Villalta, S., De Lucchi, L., Sponghiado, A., Becattini, C., Giustozzi, M., Vinci, A., Pignatelli, P., Bucci, T., Menichelli, D., Pastori, D., Pomero, F., Casalis, S., Galli, E., Ciammaichella, M., Maida, R., De Cristofaro, Raimondo, Alberelli, M. A., Basso, M. R., De Candia, Erica, Di Gennaro, Leonardo, Mumoli, N., Capra, R., Orlando, M., Porta, C., Rotiroti, G., Demarco, M., Petrillo, P., Rossi, E., Bartolomei, Francesca, Soldati, D., Russo, U., Burgo, I., Ziliotti, M., Pataccini, C., Terroni, L., Ugolotti, M. C., Di Giorgio, A., Cavagna, L., Mete, F., Gino, M., Santoro, A., De Carlo, A., Cappelli, R., Bicchi, M., Dyrmo, L., Grifoni, E., Masotti, L., Ria, L., Spagnolo, M., Rupoli, S., Federici, I., Morsia, E., Scortechini, A. R., Torre, E., Franchini, M., Montorsi, P., Galgano, G., De Luca, A., Muiesan, M. L., Paini, A., Stassaldi, D., Denas, G., De Cristofaro R. (ORCID:0000-0002-8066-8849), De Candia E. (ORCID:0000-0003-0942-2819), Di Gennaro L., and Bartolomei F.

Abstract

D-dimer assay is used to stratify patients with unprovoked venous thromboembolism (VTE) for the risk of recurrence. However, this approach was never evaluated since direct oral anticoagulants are available. With this multicenter, prospective cohort study, we aimed to assess the value of an algorithm incorporating serial D-dimer testing and administration of reduced-dose apixaban (2.5 mg twice daily) only to patients with a positive test. A total of 732 outpatients aged 18 to 74 years, anticoagulated for ≥12 months after a first unprovoked VTE, were included. Patients underwent D-dimer testing with commercial assays and preestablished cutoffs. If the baseline D-dimer during anticoagulation was negative, anticoagulation was stopped and testing repeated after 15, 30, and 60 days. Patients with serially negative results (286 [39.1%]) were left without anticoagulation. At the first positive result, the remaining 446 patients (60.9%) were given apixaban for 18 months. All patients underwent follow-up planned for 18 months. The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval [CI], 4.5-11.2), including symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) recurrence, death for VTE, and major bleeding occurring in patients off anticoagulation vs that in those receiving apixaban (1.1%; 95% CI, 0.4-2.6; adjusted hazard ratio [HR], 8.2; 95% CI, 3.2-25.3). In conclusion, in patients anticoagulated for ≥1 year after a first unprovoked VTE, the decision to further extend anticoagulation should not be based on D-dimer testing. The results confirmed the high efficacy and safety of reduced-dose apixaban against recurrences. This trial was registered at www.clinicaltrials.gov as #NCT03678506.

Published
2022

18. Examining the effect of evaluation sample size on the sensitivity and specificity of COVID-19 diagnostic tests in practice: a simulation study

Author

Sammut-Powell, C, Reynard, C, Allen, J, McDermott, J, Braybrook, J, Parisi, R, Lasserson, D, Body, R, Hayward, G, Buckle, P, Dark, P, Davis, K, Cook, E, Gordon, A, Halstead, A, Lewington, A, Nicholson, B, Perera-Salazar, R, Simpson, J, Turner, P, Prestwich, G, Riley, B, Tate, V, and Wilcox, M

Abstract

Background In response to the global COVID-19 pandemic, many in vitro diagnostic (IVD) tests for SARS-CoV-2 have been developed. Given the urgent clinical demand, researchers must balance the desire for precise estimates of sensitivity and specificity against the need for rapid implementation. To complement estimates of precision used for sample size calculations, we aimed to estimate the probability that an IVD will fail to perform to expected standards after implementation, following clinical studies with varying sample sizes. Methods We assumed that clinical validation study estimates met the ‘desirable’ performance (sensitivity 97%, specificity 99%) in the target product profile (TPP) published by the Medicines and Healthcare products Regulatory Agency (MHRA). To estimate the real-world impact of imprecision imposed by sample size we used Bayesian posterior calculations along with Monte Carlo simulations with 10,000 independent iterations of 5,000 participants. We varied the prevalence between 1 and 15% and the sample size between 30 and 2,000. For each sample size, we estimated the probability that diagnostic accuracy would fail to meet the TPP criteria after implementation. Results For a validation study that demonstrates ‘desirable’ sensitivity within a sample of 30 participants who test positive for COVID-19 using the reference standard, the probability that real-world performance will fail to meet the ‘desirable’ criteria is 10.7–13.5%, depending on prevalence. Theoretically, demonstrating the 'desirable' performance in 90 positive participants would reduce that probability to below 5%. A marked reduction in the probability of failure to hit ‘desirable’ specificity occurred between samples of 100 (19.1–21.5%) and 160 (4.3–4.8%) negative participants. There was little further improvement above sample sizes of 160 negative participants. Conclusion Based on imprecision alone, small evaluation studies can lead to the acceptance of diagnostic tests which are likely to fail to meet performance targets when deployed. There is diminished return on uncertainty surrounding an accuracy estimate above a total sample size of 250 (90 positive and 160 negative).

Published
2021

22. D-dimer levels and risk of recurrence following provoked venous thromboembolism: findings from the RIETE registry

Author

Avnery, O., Martin, M., Bura-Riviere, A., Barillari, G., Mazzolai, L., Mahe, I., Marchena, P. J., Verhamme, P., Monreal, M., Ellis, M. H., Adarraga, M. D., Aibar, M. A., Aibar, J., Amado, C., Arcelus, J. I., Ballaz, A., Barba, R., Barron, M., Barron-Andres, B., Bascunana, J., Ina, A., Camon, A. M., Canas, I., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Diaz-Peromingo, J. A., Falga, C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Criado, M. C., Fernandez-Nunez, S., Fidalgo, M. A., Font, C., Font, L., Freire, M., Gallego, M., Garcia, M. A., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Gavin, O., Gayol, M. C., Gil-Diaz, A., Gomez, V., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L. M., Iglesias, M., Jara-Palomares, L., Jaras, M. J., Jimenez, R., Jimenez-Castro, D., Jimenez-Lopez, J., Joya, M. D., 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., Madridano, O., Maestre, A., Martin del Pozo, M., Martin-Guerra, J. M., Martin-Romero, M., Mellado, M., Morales, M. V., Munoz, N., Nieto-Cabrera, M. A., Nieto-Rodriguez, J. A., Nunez-Ares, A., Nunez, M. J., Olivares, M. C., Otalora, S., Otero, R., Pedrajas, J. M., Pellejero, G., Perez-Rus, G., Peris, M. L., Porras, J. A., Rivas, A., Rodriguez-Davila, M. A., Rodriguez-Hernandez, A., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Torregrosa, P., Ruiz-Sada, P., Sahuquillo, J. C., Salazar, V., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Soler, S., Sopena, B., Surinach, J. M., Tolosa, C., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Valle, R., Vidal, G., Villares, P., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Debourdeau, P., Farge-Bancel, D., Hij, A., Moustafa, F., Schellong, S., Braester, A., Brenner, B., Tzoran, I., Sharif-Kashani, B., Bilora, F., Bortoluzzi, C., Bucherini, E., Ciammaichella, M., Dentali, F., Di Micco, P., Di Pangrazio, M., Maida, R., Mastroiacovo, D., Pace, F., Pallotti, G., Parisi, R., Pesavento, R., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Gibietis, V., Skride, A., Strautmane, S., Bosevski, M., Zdraveska, M., Bounameaux, H., Fresa, M., Ney, B., Caprini, J., Bui, H. M., Pham, K. Q., Avnery, O., Martin, M., Bura-Riviere, A., Barillari, G., Mazzolai, L., Mahe, I., Marchena, P. J., Verhamme, P., Monreal, M., Ellis, M. H., Adarraga, M. D., Aibar, M. A., Aibar, J., Amado, C., Arcelus, J. I., Ballaz, A., Barba, R., Barron, M., Barron-Andres, B., Bascunana, J., Ina, A., Camon, A. M., Canas, I., Carrasco, C., Castro, J., de Ancos, C., del Toro, J., Demelo, P., Diaz-Peromingo, J. A., Falga, C., Farfan, A. I., Fernandez-Capitan, C., Fernandez-Criado, M. C., Fernandez-Nunez, S., Fidalgo, M. A., Font, C., Font, L., Freire, M., Gallego, M., Garcia, M. A., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Gavin, O., Gayol, M. C., Gil-Diaz, A., Gomez, V., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L. M., Iglesias, M., Jara-Palomares, L., Jaras, M. J., Jimenez, R., Jimenez-Castro, D., Jimenez-Lopez, J., Joya, M. D., 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., Madridano, O., Maestre, A., Martin del Pozo, M., Martin-Guerra, J. M., Martin-Romero, M., Mellado, M., Morales, M. V., Munoz, N., Nieto-Cabrera, M. A., Nieto-Rodriguez, J. A., Nunez-Ares, A., Nunez, M. J., Olivares, M. C., Otalora, S., Otero, R., Pedrajas, J. M., Pellejero, G., Perez-Rus, G., Peris, M. L., Porras, J. A., Rivas, A., Rodriguez-Davila, M. A., Rodriguez-Hernandez, A., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Torregrosa, P., Ruiz-Sada, P., Sahuquillo, J. C., Salazar, V., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Soler, S., Sopena, B., Surinach, J. M., Tolosa, C., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Valle, R., Vidal, G., Villares, P., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Debourdeau, P., Farge-Bancel, D., Hij, A., Moustafa, F., Schellong, S., Braester, A., Brenner, B., Tzoran, I., Sharif-Kashani, B., Bilora, F., Bortoluzzi, C., Bucherini, E., Ciammaichella, M., Dentali, F., Di Micco, P., Di Pangrazio, M., Maida, R., Mastroiacovo, D., Pace, F., Pallotti, G., Parisi, R., Pesavento, R., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Vo Hong, N., Gibietis, V., Skride, A., Strautmane, S., Bosevski, M., Zdraveska, M., Bounameaux, H., Fresa, M., Ney, B., Caprini, J., Bui, H. M., and Pham, K. Q.

Subjects
0301 basic medicine, Male, Registrie, Multivariate analysis, Enfermedad cardiovascular, 030204 cardiovascular system & hematology, 0302 clinical medicine, Risk Factors, Recurrence, Tromboembolia, Age Factor, Registries, venous thromboembolism recurrence, d-dimer, Hazard ratio, Age Factors, Venous Thromboembolism, Middle Aged, Prognosis, provoked venous thromboembolism, Proteínas, Female, Human, medicine.medical_specialty, Prognosi, Cardiología, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, Internal medicine, D-dimer, Internal Medicine, medicine, Humans, In patient, Risk factor, Sistema cardiovascular, Pregnancy, business.industry, Risk Factor, Anticoagulant, Anticoagulants, medicine.disease, 030104 developmental biology, Increased risk, Proteína, business, Venous thromboembolism, Fibrin Fibrinogen Degradation Product
Abstract

Background Patients with venous thromboembolism (VTE) secondary to transient risk factors may develop VTE recurrences after discontinuing anticoagulation. Identifying at‐risk patients could help to guide the duration of therapy. Methods We used the RIETE database to assess the prognostic value of d‐dimer testing after discontinuing anticoagulation to identify patients at increased risk for recurrences. Transient risk factors were classified as major (postoperative) or minor (pregnancy, oestrogen use, immobilization or recent travel). Results In December 2018, 1655 VTE patients with transient risk factors (major 460, minor 1195) underwent d‐dimer measurements after discontinuing anticoagulation. Amongst patients with major risk factors, the recurrence rate was 5.74 (95% CI: 3.19–9.57) events per 100 patient‐years in those with raised d‐dimer levels and 2.68 (95% CI: 1.45–4.56) in those with normal levels. Amongst patients with minor risk factors, the rates were 7.79 (95% CI: 5.71–10.4) and 3.34 (95% CI: 2.39–4.53), respectively. Patients with major risk factors and raised d‐dimer levels (n = 171) had a nonsignificantly higher rate of recurrences (hazard ratio [HR]: 2.14; 95% CI: 0.96–4.79) than those with normal levels. Patients with minor risk factors and raised d‐dimer levels (n = 382) had a higher rate of recurrences (HR: 2.34; 95% CI: 1.51–3.63) than those with normal levels. On multivariate analysis, raised d‐dimers (HR: 1.74; 95% CI: 1.09–2.77) were associated with an increased risk for recurrences in patients with minor risk factors, not in those with major risk factors. Conclusions Patients with raised d‐dimer levels after discontinuing anticoagulant therapy for VTE provoked by a minor transient risk factor were at an increased risk for recurrences. Sin financiación 8.989 JCR (2020) Q1, 12/167 Medicine, General & Internal 2.625 SJR (2020) Q1, 9/131 Internal Medicine No data IDR 2020 UEM

Published
2020

25. Rates of turnover among general practitioners: a retrospective study of all English general practices between 2007 and 2019.

Author

Parisi, R, Lau, Y-S, Bower, P, Checkland, K, Rubery, J, Sutton, M, Giles, SJ, Esmail, A, Spooner, S, Kontopantelis, E, Parisi, R, Lau, Y-S, Bower, P, Checkland, K, Rubery, J, Sutton, M, Giles, SJ, Esmail, A, Spooner, S, and Kontopantelis, E

Abstract

OBJECTIVE: To quantify general practitioners' (GPs') turnover in England between 2007 and 2019, describe trends over time, regional differences and associations with social deprivation or other practice characteristics. DESIGN: A retrospective study of annual cross-sectional data. SETTING: All general practices in England (8085 in 2007, 6598 in 2019). METHODS: We calculated turnover rates, defined as the proportion of GPs leaving a practice. Rates and their median, 25th and 75th percentiles were calculated by year and region. The proportion of practices with persistent high turnover (>10%) over consecutive years were also calculated. A negative binomial regression model assessed the association between turnover and social deprivation or other practice characteristics. RESULTS: Turnover rates increased over time. The 75th percentile in 2009 was 11%, but increased to 14% in 2019. The highest turnover rate was observed in 2013-2014, corresponding to the 75th percentile of 18.2%. Over time, regions experienced increases in turnover rates, although it varied across English regions. The proportion of practices with high (10% to 40%) turnover within a year almost doubled from 14% in 2009 to 27% in 2019. A rise in the number of practices with persistent high turnover (>10%) for at least three consecutive years was also observed, from 2.7% (2.3%-3.1%) in 2007 to 6.3% (5.7%-6.9%) in 2017. The statistical analyses revealed that practice-area deprivation was moderately associated with turnover rate, with practices in the most deprived area having higher turnover rates compared with practices in the least deprived areas (incidence rate ratios 1.09; 95% CI 1.06 to 1.13). CONCLUSIONS: GP turnover has increased in the last decade nationally, with regional variability. Greater attention to GP turnover is needed, in the most deprived areas in particular, where GPs often need to deal with more complex health needs. There is a large cost associated with GP turnover and practices with v

Published
2021

26. Heparin in COVID-19 Patients Is Associated with Reduced In-Hospital Mortality: the Multicenter Italian CORIST Study

Author

Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, Iacoviello, Licia, Di Castelnuovo, A, Costanzo, S, Antinori, A, Berselli, N, Blandi, L, Bonaccio, M, Cauda, R, Guaraldi, G, Menicanti, L, Mennuni, M, Parruti, G, Patti, G, Santilli, F, Signorelli, C, Vergori, A, Abete, P, Ageno, W, Agodi, A, Agostoni, P, Aiello, L, Al Moghazi, S, Arboretti, R, Astuto, M, Aucella, F, Barbieri, G, Bartoloni, A, Bonfanti, P, Cacciatore, F, Caiano, L, Carrozzi, L, Cascio, A, Ciccullo, A, Cingolani, A, Cipollone, F, Colomba, C, Colombo, C, Crosta, F, Danzi, G, D'Ardes, D, de Gaetano Donati, K, Di Gennaro, F, Di Tano, G, D'Offizi, G, Fantoni, M, Fusco, F, Gentile, I, Gianfagna, F, Grandone, E, Graziani, E, Grisafi, L, Guarnieri, G, Larizza, G, Leone, A, Maccagni, G, Madaro, F, Maitan, S, Mancarella, S, Mapelli, M, Maragna, R, Marcucci, R, Maresca, G, Marongiu, S, Marotta, C, Marra, L, Mastroianni, F, Mazzitelli, M, Mengozzi, A, Menichetti, F, Meschiari, M, Milic, J, Minutolo, F, Molena, B, Montineri, A, Mussini, C, Musso, M, Niola, D, Odone, A, Olivieri, M, Palimodde, A, Parisi, R, Pasi, E, Pesavento, R, Petri, F, Pinchera, B, Poletti, V, Ravaglia, C, Rognoni, A, Rossato, M, Rossi, M, Sangiovanni, V, Sanrocco, C, Scorzolini, L, Sgariglia, R, Simeone, P, Taddei, E, Torti, C, Vettor, R, Vianello, A, Vinceti, M, Virano, A, Vocciante, L, De Caterina, R, Iacoviello, L, Di Castelnuovo, Augusto, Costanzo, Simona, Antinori, Andrea, Berselli, Nausicaa, Blandi, Lorenzo, Bonaccio, Marialaura, Cauda, Roberto, Guaraldi, Giovanni, Menicanti, Lorenzo, Mennuni, Marco, Parruti, Giustino, Patti, Giuseppe, Santilli, Francesca, Signorelli, Carlo, Vergori, Alessandra, Abete, Pasquale, Ageno, Walter, Agodi, Antonella, Agostoni, Piergiuseppe, Aiello, Luca, Al Moghazi, Samir, Arboretti, Rosa, Astuto, Marinella, Aucella, Filippo, Barbieri, Greta, Bartoloni, Alessandro, Bonfanti, Paolo, Cacciatore, Francesco, Caiano, Lucia, Carrozzi, Laura, Cascio, Antonio, Ciccullo, Arturo, Cingolani, Antonella, Cipollone, Francesco, Colomba, Claudia, Colombo, Crizia, Crosta, Francesca, Danzi, Gian Battista, D'Ardes, Damiano, de Gaetano Donati, Katleen, Di Gennaro, Francesco, Di Tano, Giuseppe, D'Offizi, Gianpiero, Fantoni, Massimo, Fusco, Francesco Maria, Gentile, Ivan, Gianfagna, Francesco, Grandone, Elvira, Graziani, Emauele, Grisafi, Leonardo, Guarnieri, Gabriella, Larizza, Giovanni, Leone, Armando, Maccagni, Gloria, Madaro, Ferruccio, Maitan, Stefano, Mancarella, Sandro, Mapelli, Massimo, Maragna, Riccardo, Marcucci, Rossella, Maresca, Giulio, Marongiu, Silvia, Marotta, Claudia, Marra, Lorenzo, Mastroianni, Franco, Mazzitelli, Maria, Mengozzi, Alessandro, Menichetti, Francesco, Meschiari, Marianna, Milic, Jovana, Minutolo, Filippo, Molena, Beatrice, Montineri, Arturo, Mussini, Cristina, Musso, Maria, Niola, Daniela, Odone, Anna, Olivieri, Marco, Palimodde, Antonella, Parisi, Roberta, Pasi, Emanuela, Pesavento, Raffaele, Petri, Francesco, Pinchera, Biagio, Poletti, Venerino, Ravaglia, Claudia, Rognoni, Andrea, Rossato, Marco, Rossi, Marianna, Sangiovanni, Vincenzo, Sanrocco, Carlo, Scorzolini, Laura, Sgariglia, Raffaella, Simeone, Paola Giustina, Taddei, Eleonora, Torti, Carlo, Vettor, Roberto, Vianello, Andrea, Vinceti, Marco, Virano, Alexandra, Vocciante, Laura, De Caterina, Raffaele, and Iacoviello, Licia

Abstract

INTRODUCTION: A hypercoagulable condition was described in patients with coronavirus disease 2019 (COVID-19) and proposed as a possible pathogenic mechanism contributing to disease progression and lethality.AIM: We evaluated if in-hospital administration of heparin improved survival in a large cohort of Italian COVID-19 patients.METHODS: In a retrospective observational study, 2,574 unselected patients hospitalized in 30 clinical centers in Italy from February 19, 2020 to June 5, 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus-2 infection were analyzed. The primary endpoint in a time-to event analysis was in-hospital death, comparing patients who received heparin (low-molecular-weight heparin [LMWH] or unfractionated heparin [UFH]) with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatment weighting by propensity scores.RESULTS: Out of 2,574 COVID-19 patients, 70.1% received heparin. LMWH was largely the most used formulation (99.5%). Death rates for patients receiving heparin or not were 7.4 and 14.0 per 1,000 person-days, respectively. After adjustment for propensity scores, we found a 40% lower risk of death in patients receiving heparin (hazard ratio=0.60; 95% confidence interval: 0.49-0.74; E-value=2.04). This association was particularly evident in patients with a higher severity of disease or strong coagulation activation.CONCLUSION: In-hospital heparin treatment was associated with a lower mortality, particularly in severely ill COVID-19 patients and in those with strong coagulation activation. The results from randomized clinical trials are eagerly awaited to provide clear-cut recommendations.

Published
2021

28. Predictors of active cancer thromboembolic outcomes

Author

Tafur, A. J., Caprini, J. A., Cote, L., Trujillo-Santos, J., del Toro, J., Garcia-Bragado, F., Tolosa, C., Barillari, G., Visona, A., Monreal, M., Adarraga, M. D., Aibar, M. A., Alfonso, M., Arcelus, J. I., Ballaz, A., Barba, R., Barron, M., Barrn-Andres, B., Bascunana, J., Blanco-Molina, A., Canas, I., Chic, N., del Pozo, R., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Falga, C., Fernandez-Aracil, C., Fernandez-Capitan, C., Fidalgo, M. A., Font, C., Font, L., Gallego, P., Garcia, I., Garcia, M. A., Garcia-Rodenas, M., Gavin, O., Gomez, C., Gomez, V., Gonzalez, J., Grau, E., Grimon, A., Guijarro, R., Guirado, L., Gutierrez, J., Hernandez-Comes, G., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, J., Joya, M. D., Llamas, P., Lobo, J. L., Lopez, P., Lopez-Jimenez, L., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Lumbierres, M., Marchena, P. J., Martin-Martos, F., Mellado, M., Nieto, J. A., Nieto, S., Nunez, A., Nunez, M. J., Otalora, S., Otero, R., Ovejero, A., Pedrajas, J. M., Perez, G., Perez-Ductor, C., Peris, M. L., Pons, I., Porras, J. A., Reig, O., Riera-Mestre, A., Riesco, D., Rivas, A., Rodriguez, M., Rodriguez-Davila, M. A., Rosa, V., Ruiz-Artacho, P., Ruiz-Gimenez, N., Sahuquillo, J. C., Sala-Sainz, M. C., Samperiz, A., Sanchez-Martinez, R., Sanz, O., Soler, S., Sopena, B., Surinach, J. M., Torres, M. I., Uresandi, F., Usandizaga, E., Valero, B., Valle, R., Vela, J., Velez-Mendizabal, E., Vidal, G., Vila, M., Villalobos, A., Xifre, B., Vanassche, T., Verhamme, P., Yoo, H. H. B., Wells, P., Hirmerova, J., Maly, R., Salgado, E., Bertoletti, L., Bura-Riviere, A., Falvo, N., Farge-Bancel, D., Hij, A., Mahe, I., Moustafa, F., Braester, A., Brenner, B., Tzoran, I., Antonucci, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Candeloro, G., Cattabiani, C., Ciammaichella, M., Dentali, F., Di Micco, P., Duce, R., Giorgi-Pierfranceschi, M., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Pace, F., Parisi, R., Pellegrinet, M., Pesavento, R., Pinelli, M., Poggio, R., Prandoni, P., Quintavalla, R., Rocci, A., Tiraferri, E., Tonello, D., Tufano, A., Gibietis, V., Skride, A., Vitola, B., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Tafur, A. J., Caprini, J. A., Cote, L., Trujillo-Santos, J., del Toro, J., Garcia-Bragado, F., Tolosa, C., Barillari, G., Visona, A., Monreal, M., Adarraga, M. D., Aibar, M. A., Alfonso, M., Arcelus, J. I., Ballaz, A., Barba, R., Barron, M., Barrn-Andres, B., Bascunana, J., Blanco-Molina, A., Canas, I., Chic, N., del Pozo, R., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Falga, C., Fernandez-Aracil, C., Fernandez-Capitan, C., Fidalgo, M. A., Font, C., Font, L., Gallego, P., Garcia, I., Garcia, M. A., Garcia-Rodenas, M., Gavin, O., Gomez, C., Gomez, V., Gonzalez, J., Grau, E., Grimon, A., Guijarro, R., Guirado, L., Gutierrez, J., Hernandez-Comes, G., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, J., Joya, M. D., Llamas, P., Lobo, J. L., Lopez, P., Lopez-Jimenez, L., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Lumbierres, M., Marchena, P. J., Martin-Martos, F., Mellado, M., Nieto, J. A., Nieto, S., Nunez, A., Nunez, M. J., Otalora, S., Otero, R., Ovejero, A., Pedrajas, J. M., Perez, G., Perez-Ductor, C., Peris, M. L., Pons, I., Porras, J. A., Reig, O., Riera-Mestre, A., Riesco, D., Rivas, A., Rodriguez, M., Rodriguez-Davila, M. A., Rosa, V., Ruiz-Artacho, P., Ruiz-Gimenez, N., Sahuquillo, J. C., Sala-Sainz, M. C., Samperiz, A., Sanchez-Martinez, R., Sanz, O., Soler, S., Sopena, B., Surinach, J. M., Torres, M. I., Uresandi, F., Usandizaga, E., Valero, B., Valle, R., Vela, J., Velez-Mendizabal, E., Vidal, G., Vila, M., Villalobos, A., Xifre, B., Vanassche, T., Verhamme, P., Yoo, H. H. B., Wells, P., Hirmerova, J., Maly, R., Salgado, E., Bertoletti, L., Bura-Riviere, A., Falvo, N., Farge-Bancel, D., Hij, A., Mahe, I., Moustafa, F., Braester, A., Brenner, B., Tzoran, I., Antonucci, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Candeloro, G., Cattabiani, C., Ciammaichella, M., Dentali, F., Di Micco, P., Duce, R., Giorgi-Pierfranceschi, M., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Pace, F., Parisi, R., Pellegrinet, M., Pesavento, R., Pinelli, M., Poggio, R., Prandoni, P., Quintavalla, R., Rocci, A., Tiraferri, E., Tonello, D., Tufano, A., Gibietis, V., Skride, A., Vitola, B., Bosevski, M., Zdraveska, M., Bounameaux, H., and Mazzolai, L.

Subjects
Male, Risk, medicine.medical_specialty, 030204 cardiovascular system & hematology, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Recurrence, Neoplasms, Thromboembolism, Internal medicine, Venous thrombosis, medicine, Humans, Cancer associated thrombosis, Recurrences, Registries, Mortality, Aged, Cancer, Aged, 80 and over, Prediction, Framingham Risk Score, business.industry, Mortality rate, Hematology, Middle Aged, Prognosis, medicine.disease, Survival Analysis, Predictive value, Thrombosis, United States, Surgery, Patient Outcome Assessment, Research Design, 030220 oncology & carcinogenesis, Cohort, Female, business, Biomarkers
Abstract

SummaryEven though the Khorana risk score (KRS) has been validated to predict against the development of VTE among patients with cancer, it has a low positive predictive value. It is also unknown whether the score predicts outcomes in patients with cancer with established VTE. We selected a cohort of patients with active cancer from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to assess the prognostic value of the KRS at inception in predicting the likelihood of VTE recurrences, major bleeding and mortality during the course of anticoagulant therapy. We analysed 7948 consecutive patients with cancer-associated VTE. Of these, 2253 (28 %) scored 0 points, 4550 (57 %) 1–2 points and 1145 (14 %) scored ≥3 points. During the course of anticoagulation, amongst patient with low, moderate and high risk KRS, the rate of VTE recurrences was of 6.21 (95 %CI: 4.99–7.63), 11.2 (95 %CI: 9.91–12.7) and 19.4 (95 %CI: 15.4–24.1) events per 100 patient-years; the rate of major bleeding of 5.24 (95 %CI: 4.13–6.56), 10.3 (95 %CI: 9.02–11.7) and 19.4 (95 %CI: 15.4–24.1) bleeds per 100 patient-years and the mortality rate of 25.3 (95 %CI: 22.8–28.0), 58.5 (95 %CI: 55.5–61.7) and 120 (95 %CI: 110–131) deaths per 100 patient-years, respectively. The C-statistic was 0.53 (0.50–0.56) for recurrent VTE, 0.56 (95 %CI: 0.54–0.59) for major bleeding and 0.54 (95 %CI: 0.52–0.56) for death. In conclusion, most VTEs occur in patients with low or moderate risk scores. The KRS did not accurately predict VTE recurrence, major bleeding, or mortality among patients with cancer-associated thrombosis.

Published
2017

33. Il sistema di finanziamento dei servizi sociali

Author

Contigiani, N, Molaschi, V, Parisi, R, Albanese, AS, La Porta, S, Morzenti Pellegrini, R, Berlingò, V, Molgora, M, Grazioli, P, Monzani, S, Genuessi, I, Di Lascio, A, Ghisalberti, T, Manganaro, F, Siclari, D, Contigiani, N, Molaschi, V, Parisi, R, Albanese, AS, La Porta, S, Morzenti Pellegrini, R, Berlingò, V, Molgora, M, Grazioli, P, Monzani, S, Genuessi, I, Di Lascio, A, Ghisalberti, T, Manganaro, F, and Siclari, D

Abstract

Lo scritto è una sostanziale riscrittura di una precedente edizione di otto anni fa ed espone - con rilievi critici - il sistema di finanziamento dei servizi sociali, anche con riferimento alla giurisprudenza costituzionale ed alla dottrina in materia. In tale contesto, sono esaminati anche i recenti provvedimenti adottati per contrastare gli effetti negativi che la pandemia da COVID-19 ha prodotto in ambito sociale. Il sistema di finanziamento dei servizi sociali e analizzato anche alla luce dei rapporti tra Stato, Regioni ed enti locali, anche tenendo conto dei provvedimenti sul “federalismo fiscale” e tenendo conto del dibattito sul cosiddetto “regionalismo differenziato”., The paper is a substantial rewriting of a previous edition of eight years ago and exposes - with critical remarks - the system of financing of social services, also with reference to constitutional jurisprudence and the doctrine on the subject. In this context, the recent measures adopted to counter the negative effects that the COVID-19 pandemic has produced in the social field are also examined. The financing system of social services is also analyzed in the light of the relations between the State, Regions and local authorities, also taking into account the provisions on “fiscal federalism” and taking into account the debate on the so-called “differentiated regionalism”.

Published
2020

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

Author

Golemi, Iva, primary, Cote, Lauren, additional, Iftikhar, Omer, additional, Brenner, Benjamin, additional, Tafur, Alfonso, additional, Bikdeli, Behnood, additional, Fernández-Capitán, Carmen, additional, Pedrajas, José María, additional, Otero, Remedios, additional, Quintavalla, Roberto, additional, Monreal, Manuel, additional, Prandoni, Paolo, additional, Farge-Bancel, Dominique, additional, Barba, Raquel, additional, Di Micco, Pierpaolo, additional, Bertoletti, Laurent, additional, Tzoran, Inna, additional, Reis, Abilio, additional, Bounameaux, Henri, additional, Malý, Radovan, additional, Verhamme, Peter, additional, Bosevski, Marijan, additional, Caprini, Joseph A., additional, Bui, Hanh My, additional, Adarraga, M.D., additional, Aibar, M.A., additional, Aibar, J., additional, Amado, C., additional, Arcelus, J.I., additional, Azcarate, P.M., additional, Ballaz, A., additional, Barba, R., additional, Barrón, M., additional, Barrón-Andrés, B., additional, Bascuñana, J., additional, Blanco-Molina, A., additional, Camon, A.M., additional, Carrasco, C., additional, Castro, J., additional, de Ancos, C., additional, del Toro, J., additional, Demelo, P., additional, Díaz-Pedroche, M.C., additional, Díaz-Peromingo, J.A., additional, Díaz-Simón, R., additional, Encabo, M., additional, Falgá, C., additional, Farfán, A.I., additional, Fernández-Capitán, C., additional, Fernández-Criado, M.C., additional, Fidalgo, M.A., additional, Font, C., additional, Font, L., additional, García, M.A., additional, García-Bragado, F., additional, García-Morillo, M., additional, García-Raso, A., additional, Gavín, O., additional, Gaya, I., additional, Gayol, M.C., additional, Gil-Díaz, A., additional, Guirado, L., additional, Gómez, V., additional, González-Martínez, J., additional, Grau, E., additional, Gutiérrez, J., additional, Hernández Blasco, L.M., additional, Iglesias, M., additional, Jara-Palomares, L., additional, Jaras, M.J., additional, Jiménez, D., additional, Jou, I., additional, Joya, M.D., additional, Lalueza, A., additional, Lima, J., additional, Llamas, P., additional, Lobo, J.L., additional, López-Jiménez, L., additional, López-Miguel, P., additional, López-Nuñez, J.J., additional, López-Reyes, R., additional, López-Sáez, J.B., additional, Lorente, M.A., additional, Lorenzo, A., additional, Loring, M., additional, Lumbierres, M., additional, Madridano, O., additional, Maestre, A., additional, Marchena, P.J., additional, Martín-Guerra, J.M., additional, Martín Fernández, M., additional, Mellado, M., additional, Monreal, M., additional, Morales, M.V., additional, Nieto, J.A., additional, Núñez, M.J., additional, Olivares, M.C., additional, Otalora, S., additional, Otero, R., additional, Pedrajas, J.M., additional, Pellejero, G., additional, Pérez-Pinar, M., additional, Pérez-Rus, G., additional, Peris, M.L., additional, Pesce, M.L., additional, Porras, J.A., additional, Rivas, A., additional, Rodríguez-Dávila, M.A., additional, Rodríguez-Fernández, L., additional, Rodríguez-Hernández, A., additional, Rodríguez-Martín, C., additional, Rubio, C.M., additional, Ruiz-Alcaraz, S., additional, Ruiz-Artacho, P., additional, Ruiz-Ruiz, J., additional, Ruiz-Sada, P., additional, Sahuquillo, J.C., additional, Salazar, V., additional, Sampériz, A., additional, Sánchez-Muñoz-Torrero, J.F., additional, Sancho, T., additional, Sanoja, I., additional, Soler, S., additional, Soto, M.J., additional, Suriñach, J.M., additional, Tolosa, C., additional, Torres, M.I., additional, Trujillo-Santos, J., additional, Uresandi, F., additional, Usandizaga, E., additional, Valle, R., additional, Vidal, G., additional, Gutiérrez, P., additional, Vázquez, F.J., additional, Vilaseca, A., additional, Vanassche, T., additional, Vandenbriele, C., additional, Verhamme, P., additional, Hirmerova, J., additional, Malý, R., additional, Salgado, E., additional, Benzidia, I., additional, Bertoletti, L., additional, Bura-Riviere, A., additional, Debourdeau, P., additional, Falvo, N., additional, Farge-Bancel, D., additional, Hij, A., additional, Mahé, I., additional, Moustafa, F., additional, Braester, A., additional, Brenner, B., additional, Ellis, M., additional, Tzoran, I., additional, Barillari, G., additional, Bilora, F., additional, Bortoluzzi, C., additional, Brandolin, B., additional, Bucherini, E., additional, Ciammaichella, M., additional, Dentali, F., additional, Di Micco, P., additional, Grandone, E., additional, Imbalzano, E., additional, Lessiani, G., additional, Maida, R., additional, Mastroiacovo, D., additional, Mumoli, N., additional, Vo Hong, N., additional, Pace, F., additional, Parisi, R., additional, Pesavento, R., additional, Pinelli, M., additional, Prandoni, P., additional, Quintavalla, R., additional, Rocci, A., additional, Siniscalchi, C., additional, Tufano, A., additional, Visonà, A., additional, Skride, A., additional, Sablinskis, K., additional, Sablinskis, M., additional, Bosevski, M., additional, Zdraveska, M., additional, Bounameaux, H., additional, Fresa, M., additional, Ney, B., additional, Mazzolai, L., additional, Caprini, J., additional, Tafur, A., additional, and Bui, H.M., additional

Published
2020
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39. Edoxaban for the treatment of cancer-associated venous thromboembolism

Author

Raskob, GE, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, MA, Kakkar, AK, Kovacs, MJ, Mercuri, MF, Meyer, G, Segers, A, Shi, M, Wang, TF, Yeo, E, Zhang, G, Zwicker, JI, Weitz, JI, Büller, HR, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, PW, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, JW, Crowther, M, Roberts, RS, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, JC, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, MI, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, HM, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, CM, Shah, V, Smith, W, Wun, T, Xiang, Z, Raskob, G, van Es, N, Verhamme, P, Carrier, M, Di Nisio, M, Garcia, D, Grosso, M, Kakkar, A, Kovacs, M, Mercuri, M, Meyer, G, Segers, A, Shi, M, Wang, T, Yeo, E, Zhang, G, Zwicker, J, Weitz, J, Büller, H, Beyer-Westendorf, J, Boda, Z, Chlumsky, Y, Gibbs, H, Kamphuizen, P, Monreal, M, Ockleford, P, Pabinger-Fasching, I, Sinnaeve, P, Beenen, L, Gerdes, V, Laleman, W, Larrey, D, van Mechelen, R, Roos, Y, Scheerder, M, Slagboom, T, Thijs, V, Eikelboom, J, Crowther, M, Roberts, R, Vanassche, T, Vandenbriele, C, Debaveye, B, Dani, V, Schwocho, L, Duggal, A, Baker, R, Carroll, P, Chan, N, Coughlin, P, Crispin, P, Gallus, A, Hugman, A, Tran, H, Brodmann, M, Mathies, R, Rossmann, D, Deeren, D, Hainaut, P, Jochmans, K, Vercauter, P, Wautrecht, J, Champion, P, Gross, P, Lee, A, Shivakumar, S, Tagalakis, V, Zed, E, Kovarova, K, Lastuvka, J, Matoska, P, Prosecky, R, Achkar, A, Aquilanti, S, Chatellain, P, Cony-Makhoul, P, Del Piano, F, Elias, A, Falvo, N, Ferrari, E, Mahé, I, Merle, P, Mismetti, P, Muron, T, Pernod, G, Quere, I, Schmidt, J, Stephan, D, Espinola-Klein, C, Horacek, T, Kröning, R, Oettler, W, Schellong, S, Schön, N, Zwemmrich, C, Farkas, K, Gurzo, M, Nyirati, G, Pecsvarady, Z, Riba, M, Becattini, C, Cattaneo, M, Falanga, A, Ghirarduzzi, A, Imberti, D, Lodigiani, C, Parisi, R, Porreca, E, Squizzato, A, Tassoni, M, Villalta, S, Visonà, A, Beeker, A, Boersma, W, Brouwer, R, Dees, A, Huisman, M, Kuijer, P, Mairuhu, R, Meijer, K, Middeldorp, S, Otten, H, van Marwijk-Kooy, M, van Wissen, S, Westerweel, P, Harper, P, Merriman, E, Ockelford, P, Royle, G, Smith, M, Cereto Castro, F, de Oña Navarrete, R, Font Puig, C, Gallardo Díaz, E, Garcia-Bragado Dalmau, F, Ruiz Artacho, P, Santamaria, A, Baumann Kreuziger, L, De Sancho, M, Gaddh, M, Metjian, A, Rojas Hernandez, C, Shah, V, Smith, W, Wun, T, Xiang, Z, Graduate School, CCA - Cancer Treatment and Quality of Life, Vascular Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, Other Research, Other departments, Neurology, APH - Societal Participation & Health, APH - Quality of Care, Coronel Institute of Occupational Health, ARD - Amsterdam Reproduction and Development, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, and ACS - Microcirculation

Subjects
Adult, Dalteparin, Male, Randomization, Pyridines, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Edoxaban, Neoplasms, medicine, Humans, Aged, Intention-to-treat analysis, Heparin, business.industry, Standard treatment, Low-Molecular-Weight, Anticoagulants, Cancer, Follow-Up Studies, Heparin, Low-Molecular-Weight, Intention to Treat Analysis, Middle Aged, Thiazoles, Venous Thromboembolism, General Medicine, medicine.disease, Thrombosis, chemistry, 030220 oncology & carcinogenesis, Anesthesia, Venous Thromboembolism, cancer, thrombosis, business, medicine.drug
Abstract

BACKGROUND Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. METHODS In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group). Treatment was given for at least 6 months and up to 12 months. The primary outcome was a composite of recurrent venous thromboembolism or major bleeding during the 12 months after randomization, regardless of treatment duration. RESULTS Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, -3.4 percentage points; 95% CI, -7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6). CONCLUSIONS Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin. (Funded by Daiichi Sankyo; Hokusai VTE Cancer ClinicalTrials. gov number, NCT02073682.)

Published
2018

40. Characteristics, treatment patterns and outcomes of patients presenting with venous thromboembolic events after knee arthroscopy in the RIETE Registry

Author

Weinberg I., Giri J., Kolluri R., Arcelus J. I., Falga C., Soler S., Braester A., Bascunana J., Gutierrez-Guisado J., Monreal M., Adarraga M. D., Agudo P., Aibar M. A., Aibar J., Amado C., Akasbi M., Aranda C., Arenas A., Ballaz A., Barba R., Barron M., Barron-Andres B., Blanco-Molina A., Camon A. M., Carrasco C., Castro J., Cruz A. J., de Ancos C., del Toro J., Demelo P., Diaz-Pedroche M. C., Diaz-Peromingo J. A., Farfan A. I., Fernandez-Capitan C., Fidalgo M. A., Font C., Font L., Garcia M. A., Garcia-Bragado F., Garcia-Morillo M., Garcia-Raso A., Gavin O., Gayol M. C., Gil-Diaz A., Gomez V., Gonzalez-Martinez J., Grau E., Gutierrez J., Hernandez-Blasco L., 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., Loscos S., Lumbierres M., Marchena P. J., Martin-Fernandez M., Martin-Guerra J. M., Martin-Romero M., Mellado M., Modesto M., Morales M. V., Nieto J. A., Nunez A., Nunez M. J., Olivares M. C., Otalora S., Otero R., Pedrajas J. M., Pellejero G., Perez-Jacoiste A., Perez-Rus G., Peris M. L., Pesce M. L., Porras J. A., Rivas A., Rodriguez-Davila M. A., Rodriguez-Fernandez L., Rodriguez-Hernandez A., Rosa V., Rosillo-Hernandez E. M., Rubio C. M., Ruiz-Alcaraz S., Ruiz-Artacho P., Ruiz-Ruiz J., Ruiz-Sada P., Sahuquillo J. C., Samperiz A., Sanchez-Munoz-Torrero J. F., Sancho T., Sanoja I. D., Soto M. J., Surinach J. M., Tapia E., Torres M. I., Trujillo-Santos J., Uresandi F., Usandizaga E., Valle R., Vela J. R., Vilar C., Gutierrez P., Vazquez F. J., Vilaseca A., Vanassche T., Vandenbriele C., Verhamme P., Yoo H. H. B., Hirmerova J., Maly R., Salgado E., Benzidia I., Bertoletti L., Bura-Riviere A., Debourdeau P., Falvo N., Farge-Bancel D., Hij A., Mahe I., Moustafa F., Brenner B., Ellis M., Tzoran I., Barillari G., Bilora F., Bortoluzzi C., Brandolin B., Bucherini E., Camerota A., Ciammaichella M., Dentali F., Di Micco P., Grandone E., Imbalzano E., Lessiani G., Maida R., Mastroiacovo D., Ngoc V., Pace F., Parisi R., Pesavento R., Pinelli M., Prandoni P., Quintavalla R., Rocci A., Siniscalchi C., Sotgiu P., Tufano A., Visona A., Gibietis V., Skride A., Strautmane S., Bosevski M., Zdraveska M., Bounameaux H., Mazzolai L., Caprini J., Bui H. M., Weinberg, I., Giri, J., Kolluri, R., Arcelus, J. I., Falga, C., Soler, S., Braester, A., Bascunana, J., Gutierrez-Guisado, J., Monreal, M., Adarraga, M. D., Agudo, P., Aibar, M. A., Aibar, J., Amado, C., Akasbi, M., Aranda, C., Arenas, A., Ballaz, A., Barba, R., Barron, M., Barron-Andres, B., Blanco-Molina, A., Camon, A. M., Carrasco, C., Castro, J., Cruz, A. J., de Ancos, C., del Toro, J., Demelo, P., Diaz-Pedroche, M. C., Diaz-Peromingo, J. A., Farfan, A. I., Fernandez-Capitan, C., Fidalgo, M. A., Font, C., Font, L., Garcia, M. A., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Gavin, O., Gayol, M. C., Gil-Diaz, A., Gomez, V., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L., 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., Loscos, S., Lumbierres, M., Marchena, P. J., Martin-Fernandez, M., Martin-Guerra, J. M., Martin-Romero, M., Mellado, M., Modesto, M., Morales, M. V., Nieto, J. A., Nunez, A., Nunez, M. J., Olivares, M. C., Otalora, S., Otero, R., Pedrajas, J. M., Pellejero, G., Perez-Jacoiste, A., Perez-Rus, G., Peris, M. L., Pesce, M. L., Porras, J. A., Rivas, A., Rodriguez-Davila, M. A., Rodriguez-Fernandez, L., Rodriguez-Hernandez, A., Rosa, V., Rosillo-Hernandez, E. M., Rubio, C. M., Ruiz-Alcaraz, S., Ruiz-Artacho, P., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Sanoja, I. D., Soto, M. J., Surinach, J. M., Tapia, E., Torres, M. I., Trujillo-Santos, J., Uresandi, F., Usandizaga, E., Valle, R., Vela, J. R., Vilar, C., Gutierrez, P., Vazquez, F. J., Vilaseca, A., Vanassche, T., Vandenbriele, C., Verhamme, P., Yoo, H. H. B., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Debourdeau, P., Falvo, N., Farge-Bancel, D., Hij, A., Mahe, I., Moustafa, F., Brenner, B., Ellis, M., Tzoran, I., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Camerota, A., Ciammaichella, M., Dentali, F., Di Micco, P., Grandone, E., Imbalzano, E., Lessiani, G., Maida, R., Mastroiacovo, D., Ngoc, V., Pace, F., Parisi, R., Pesavento, R., Pinelli, M., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Sotgiu, P., Tufano, A., Visona, A., Gibietis, V., Skride, A., Strautmane, S., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Caprini, J., Bui, H. M., Vanassche, Thomas, Vandenbriele, Christophe, and Verhamme, Peter

Subjects
Male, medicine.medical_specialty, Knee Joint, Treatment duration, 030204 cardiovascular system & hematology, 03 medical and health sciences, Anticoagulation, Arthroscopy, 0302 clinical medicine, Deep vein thrombosi, Recurrence, Internal medicine, Deep vein thrombosis, medicine, Humans, cardiovascular diseases, Registries, Knee arthroscopy, Aged, Venous Thrombosis, 030222 orthopedics, Hematology, medicine.diagnostic_test, business.industry, Incidence (epidemiology), Incidence, Pulmonary embolism, Venous thromboembolism, Anticoagulants, Female, Middle Aged, Treatment Outcome, Venous Thromboembolism, Small sample, medicine.disease, Orthopedic surgery, Cardiology and Cardiovascular Medicine, business
Abstract

Knee arthroscopy is the most common orthopedic procedure worldwide. While incidence of post-arthroscopy venous thromboembolic events (VTE) is low, treatment patterns and patient outcomes have not been described. Patients from the "Registro Informatizado Enfermedad TromboEmbolica" who had confirmed post-arthroscopy VTE were compared to patients with provoked, post bone-fracture, and to patients with unprovoked VTE. Baseline characteristics, presenting signs and symptoms, treatment and outcomes including recurrent VTE, bleeds or death were compared. A total of 101 patients with post-arthroscopy VTE and 19,218 patients with unprovoked VTE were identified. Post-arthroscopy patients were younger (49.5 vs. 66 years, P

Published
2018

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

Author

Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Koshlia, V., Fraiz, J., Krakhmalova, O., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.

Subjects
Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract

Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.

Published
2017

44. Prediction of early mortality in patients with cancer-associated thrombosis in the RIETE Database

Author

Fuentes, HE, Tafur, AJ, Caprini, JA, Alatri, A, Trujillo-santos, J, Farge-bancel, D, Rosa, V, Font, L, Vilaseca, A, Monreal, M, Adarraga, MD, Aibar, MA, Aibar, J, Amado, C, Aranda, C, Arcelus, JI, Ballaz, A, Barba, R, Barillari, G, Barron, M, Barron-Andres, B, Bascunana, J, Benzidia, I, Bertoletti, L, Blanco-Molina, A, Bilora, F, Bortoluzzi, C, Bosevski, M, Bounameaux, H, Braester, A, Brandolin, B, Brenner, B, Bucherini, E, Bui, HM, Bura-Riviere, A, Camon, AM, Carrasco, C, Castro, J, Cesta, A, Ciammaichella, M, Cruz, JA, de Ancos, C, del Toro, J, Demelo, P, Dentali, F, Diaz-pedroche, MD, Diaz-Peromingo, JA, Di Micco, P, Di Pangrazio, M, Ellis, M, Encabo, M, Falga, C, Falvo, N, Farfan, AI, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Fresa, M, Furest, I, Garcia, MA, Garcia-Braoado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grandone, E, Grau, E, Guijarro, R, Gutierrez, J, Gutierrez, P, Hernandez-Blasco, L, Hu, A, Hirmerova, J, Imbalzano, E, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jou, I, Joya, MD, Krstevski, G, Lessiani, G, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Mahe, I, Maida, R, Maly, R, Manrique-Abos, I, Marchena, PJ, Martin-Fernandez, M, Martin-Guerra, JM, Martin-Romero, M, Mastroiacovo, D, Mazzolai, L, Mellado, M, Merah, A, Morales, MD, Moustafa, F, Ney, B, Nieto, JA, Nunez, MJ, Olivares, MD, Otalora, S, Otero, R, Pace, F, Parisi, R, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Jacoiste, A, Perez-Rus, G, Peris, ML, Pesavento, R, Pesce, ML, Porras, JA, Prandoni, P, Quinta-Valla, R, Riesco, D, Rivas, A, Rocci, A, Rodriguez-Davila, MA, Rodriguez-Hernandez, A, Rubio, CM, Ruiz-Alcaraz, S, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Ruiz-Torregrosa, P, Sahuquillo, JC, Sala-Sainz, C, Salgado, E, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Sanoja, ID, Siniscalchi, C, Skride, A, Soler, S, Sotgiu, P, Soto, MJ, Surinach, JM, Tiraferri, E, Tonello, D, Torres, MI, Tufano, A, Tzoran, I, Uresandi, F, Usandizaga, E, Valle, R, Vanassche, T, Vandenbriele, C, Vazquez, FJ, Verhamme, P, Villalobos, A, Visona, A, Hong, NV, Yoo, HH, and Zdraveska, M

Subjects
Neoplasms, Thrombosis, Mortality, premature
Abstract

Background: Proper risk stratification of patients for early mortality after cancer-associated thrombosis may lead to personalized anticoagulation protocols. Therefore, we aimed to derive and validate a scoring system to predict early mortality in this population. To this end, we selected patients with active cancer and thrombosis from the Computerized Registry of Patients with Venous Thromboembolism database. Methods: The main outcome was all cause mortality within the month following a thrombotic event. We used a simple random selection to split arc data in a derivation and a validation cohort. In the derivation cohort, we used recursive partitioning and binary logistic regression to identify groups at risk and to determine the likelihood of the primary outcome. The risk score was developed based on odds ratios from the final multivariate model, and then tested in the validation cohort. Results: In 10,025 eligible patients, we identified 6 predictors of 30-day mortality: leukocytosis >= 11.5x109/L; platelet count = 7). The AUC for the overall score was 0.74, and using a cutoff >= 7 points, the model had a negative predictive value of 94.4%, a positive predictive value of 23.1%, a sensitivity of 73.3%, and a specificity of 64.6% in the validation cohort. Conclusions: Our validated risk model may assist physicians in the selection of patients for outpatient management, and perhaps anticoagulant, considering expanding anticoagulation options.

Published
2019

45. Frequency and prognostic impact of acute kidney injury in patients with acute pulmonary embolism. Data from the RIETE registry

Author

Murgier, M, Darmon, M, Zeni, F, Valle, R, Del Toro, J, Llamas, P, Mazzolai, L, Villalobos, A, Monreal, M, Brenner, B, Farge-Bancel, D, Barba, R, Di Micco, P, Bertoletti, L, Tzoran, I, Reis, A, Bounameaux, H, Maly, R, Verhamme, P, Bosevski, M, Caprini, JA, Adarraga, MD, Aibar, MA, Aibar, J, Alfonso, M, Amado, C, Aranda, C, Arcelus, JI, Ballaz, A, Barron, M, Barron-Andres, B, Bascunana, J, Blanco-Molina, A, Camon, AM, Carrasco, C, Cruz, AJ, del Pozo, R, del Toro, J, Diaz-Pedroche, MC, Diaz-Peromingo, JA, Encabo, M, Falga, C, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gomez, V, Gonzalez-Martinez, J, Grau, E, Guijarro, R, Gutierrez, J, Isern, V, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jimenez, J, Jou, I, Joya, MD, Lalueza, A, Lima, J, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Lorenzo, A, Loring, M, Lumbierres, M, Madridano, O, Marchena, PJ, Martin-Martos, F, Martin-Romero, M, Morales, MV, Nieto, JA, Nunez, A, Nunez, MJ, Olivares, MC, Otalora, S, Otero, R, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Peris, ML, Pesce, ML, Porras, JA, Riesco, D, Rivas, A, Rodriguez-Davila, MA, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Sahuquillo, JC, Sala-Sainz, MC, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Soto, MJ, Surinach, JM, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Usandizaga, E, Vela, J, Vidal, G, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Hirmerova, J, Salgado, E, Benzidia, I, Bura-Riviere, A, Hij, A, Merah, A, Mahe, I, Moustafa, F, Braester, A, EllisM, Bilora, F, Bortoluzzi, C, Brandolin, B, Bucherini, E, Cattabiani, C, Ciammaichella, M, Dentali, F, DiMicco, P, Giorgi-Pierfranceschi, M, Grandone, E, Imbalzano, E, Maida, R, Mastroiacovo, D, Ngoc, V, Pace, F, Pallotti, G, Parisi, R, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Romualdi, R, Siniscalchi, C, Sotgiu, P, Tiraferri, E, Tonello, D, Tufano, A, Visona, A, Skride, A, Krstevski, G, Zdraveska, M, and Caprini, J

Subjects
Risk, Pulmonary embolism, Bleeding, Mortality, Biomarkers, Acute kidney injury
Abstract

Rationale: Acute kidney injury (AKI) is associated with a poor outcome. Although pulmonary embolism(PE) may promote AKI through renal congestion and/or hemodynamic instability, its frequency and influence on outcome in patients with acute PE have been poorly studied. Methods: The frequency of AKI (defined according to the "Kidney Disease: Improving Global Outcomes" definition) at baseline and its influence on the 30-day mortality was evaluated in patients with acute PE from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. We used multivariate analysis to assess whether the presence of AKI influenced the risk for 30-day death. Results: The study included 21,131 patients, of whom 6222 (29.5%) had AKI at baseline: 4385 patients (21%) in stage 1, 1385 (6.5%) in stage 2 and 452 (2%) in stage 3. The proportion of patients with high-risk PE in those with no AKI, AKI stage 1, AKI stage 2 or AKI stage 3 was: 2.8%, 5.3%, 8.8% and 12%, respectively (p < 0.001). After 30 days, 1236 patients (5.9%) died. Overall mortality was 4% in patients with no AKI, 8.4% in AKI stage 1, 14% in AKI stage 2 and 17% in AKI stage 3 (all p < 0.001). AKI was independently associated with an increased risk of all-cause death at 30 days (odds ratio = 1.25; 95% CI: 1.02-1.54). Conclusions: One in every 3-4 patients with acute PE had AKI at baseline. The presence of AKI independently predicted 30-day mortality. This study suggests that AKI may deserve to be evaluated as a prognostic factor in patients with acute PE. (C) 2019 Elsevier B.V. All rights reserved.

Published
2019

46. Venous thromboembolism in young adults: Findings from the RIETE registry

Author

Lacruz, B, Tiberio, G, Latorre, A, Villalba, JC, Bikdeli, B, Hirmerova, J, Lorenzo, A, Mellado, M, Canas, I, Monreal, M, Adarraga, MD, Agud, M, Agudo, P, Aibar, MA, Aibar, J, Amado, C, Arcelus, JI, Ballaz, A, Barba, R, Barron, M, Barron-Andres, B, Bascunana, J, Bolado, C, Blanco-Molina, A, Camon, AM, Carrasco, C, Castro, J, de Ancos, C, del Toro, J, Demelo, P, Diaz-Simon, R, Diaz-Peromingo, JA, Encabo, M, Falga, C, Farfan, AI, Fernandez-Capitan, C, Fernandez-Criado, MC, Fernandez-Ovalle, H, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Raso, A, Gavin, O, Gaya-Manso, I, Gayol, MC, Gil-Diaz, A, Gomez, V, Gomez-Cuervo, C, Gonzalez-Martinez, J, Grau, E, Gutierrez, J, Hernandez-Blasco, LM, Iglesias, M, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jou, I, Joya, MD, Lalueza, A, Lima, J, Llamas, P, Lobo, JL, Lopez-Jimenez, L, Lopez-Miguel, P, Lopez-Nunez, JJ, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Loring, M, Madridano, O, Maestre, A, Marchena, PJ, Martin, M, Martin-Fortea, MP, Martin-Guerra, JM, Martinez-Gonzalez, L, Melia, C, Montesa, C, Morales, MV, Nieto, MA, Nieto, JA, Nunez, MJ, Olivares, MC, Otalora, S, Otero, R, Ovejero, A, Pedrajas, JM, Pellejero, G, Perez-Ductor, C, Perez-Pinar, M, Perez-Rus, G, Penis, ML, Porras, JA, Redrado, J, Rivas, A, Rodriguez-Galan, I, Rodriguez-Hernandez, A, Rubio, CM, Ruiz-Artacho, P, Ruiz-Ruiz, J, Ruiz-Sada, P, Sahuquillo, JC, Sala-Sainz, MC, Salazar, V, Salgueiro, G, Samperiz, A, Sanchez-Camara, S, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Surinach, JM, Tolosa, C, Torres, MI, Trujillo-Santos, J, Uresandi, F, Valle, R, Vidal, G, Villares, P, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanassche, T, Vandenbriele, C, Verhamme, P, Yoo, HHB, Maly, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Debourdeau, P, Farge-Bancel, D, Hij, A, Mahe, I, Merah, A, Moustafa, F, Schellong, S, Braester, A, Brenner, B, Ellis, M, Tzoran, I, Sharif-Kashani, B, Barillari, G, Bilora, F, Bortoluzzi, C, Brandolin, B, Ciammaichella, M, Dentali, F, Di Micco, P, Grandone, E, Maida, R, Mastroiacovo, D, Pace, F, Parisi, R, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Sotgiu, P, Tufano, A, Visona, A, Hong, NV, Gibietis, V, Kigitovica, D, Skride, A, Bosevski, M, Bounameaux, H, Mazzolai, L, Caprini, J, Bui, HM, and Pham, KQ

Subjects
Young, Anticoagulants, Outcomes, Venous thromboembolism
Abstract

Background: Little is known on the clinical characteristics, risk factors and outcomes during anticoagulation in young patients with acute venous thromboembolism (VTE). Methods: We used data from the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to assess the clinical characteristics, risk factors and outcomes during anticoagulation in VTE patients aged 10-24 years. Data were separately analyzed according to initial presentation and gender. Results: Of 76,719 patients with VTE, 1571 (2.0%) were aged 10-24 years. Of these, 989 (63%) were women and 669 (43%) presented with pulmonary embolism (PE). Most women were using estrogens (680, 69%) or were pregnant (101, 10%), while 59% of men had unprovoked VTE. Women were more likely to present with PE (48% vs. 34%). The majority (87%) of PE patients had Sat O-2 levels >= 90% at baseline. The vast majority (97%) of PE patients were at low risk according to the PESI score, many (90%) at very low risk. During the course of anticoagulation (median, 192 days), 40 patients had VTE recurrences, 17 had major bleeding and 10 died (3 died of PE). Women had as many VTE recurrences as major bleeds (15 vs. 14 events), while men had many more VTE recurrences than major bleeding (25 vs. 3 events). Conclusions: VTE is associated with low risk of short-term mortality in young adults. Noticeable gender differences exist in the risk factor profile and the risk of VTE recurrences and major bleeding in the course of anticoagulation.

Published
2019

47. Comparison of seven prognostic tools to identify low-risk pulmonary embolism in patients aged <50 years

Author

Jara-Palomares L, Alfonso M, Maestre A, Jimenez D, Garcia-Bragado F, Font C, Reyes R, Blasco L, Vidal G, Otero R, Monreal M, Adarraga M, Aibar M, Aibar J, Amado C, Arcelus J, Ballaz A, Barba R, Barron M, Barron-Andres B, Bascunana J, Blanco-Molina A, Camon A, Canas I, Carrasco C, Castro J, de Ancos C, Del Toro J, Demelo P, Diaz-Peromingo J, Diaz-Simon R, Falga C, Farfan A, Fernandez-Capitan C, Fernandez-Criado M, Fernandez-Nunez S, Fidalgo A, Font L, Garcia M, Garcia-Morillo M, Garcia-Raso A, Gavin-Sebastian O, Gayol M, Gil-Diaz A, Gomez V, Gomez-Cuervo C, Gonzalez-Martinez J, Grau E, Gutierrez J, Gutierrez-Gonzalez S, Iglesias M, Jaras M, Jou I, Joya M, Lalueza A, Lima J, Llamas P, Lobo J, Lopez-Jimenez L, Lopez-Miguel P, Lopez-Nunez J, Lopez-Saez J, Lorente M, Lorenzo A, Loring M, Madridano O, Marchena P, Martin J, Mellado M, Morales M, Nieto M, Nieto J, Nunez M, Olivares M, Pedrajas J, Pellejero G, Prez-Rus G, Peris M, Porras J, Rivas A, Rodriguez-Davila M, Rodriguez-Hernandez A, Rubio C, Ruiz-Artacho P, Ruiz-Ruiz J, Ruiz-Sada P, Sahuquillo J, Salazar V, Samperiz A, Munoz-Torrero J, Sancho T, Soler S, Surinach J, Tapia E, Tolosa C, Torres M, Trujillo-Santos J, Uresandi F, Valle R, Villares P, Gutierrez P, Vazquez F, Vilaseca A, Vanassche T, Vandenbriele C, Verhamme P, Hirmerova J, Maly R, Celis G, del Pozo G, Salgado E, Benzidia I, Bertoletti L, Bura-Riviere A, Debourdeau P, Farge-Bancel D, Hij A, Mahe I, Moustafa F, Schellong S, Braester A, Brenner B, Tzoran I, Sharif-Kashani B, Barillari G, Bilora F, Bortoluzzi C, Brandolin B, Bucherini E, Ciammaichella M, Dentali F, Di Micco P, Maida R, Mastroiacovo D, Mumoli N, Pace F, Parisi R, Pesavento R, Prandoni P, Quintavalla R, Rocci A, Romualdi R, Sinicalchi C, Tufano A, Visona A, Hong N, Zalunardo B, Gibietis V, Kigitovica D, Skride A, Bosevski M, Bounameaux H, Mazzolai L, Caprini J, Bui H, Pham K, Reis A, and RIETE Investigators

Abstract

In young patients with acute pulmonary embolism (PE), the predictive value of currently available prognostic tools has not been evaluated. Our objective was to compare prognostic value of 7 available tools (GPS, PESI, sPESI, Prognostic Algorithm, PREP, shock index and RIETE) in patients aged

Published
2019

48. Mortality after pulmonary embolism in patients with diabetes. Findings from the RIETE registry

Author

de Miguel-Diez, J, Lopez-de-Andres, A, Jimenez-Trujillo, I, Hernandez-Barrera, V, Jimenez-Garcia, R, Lorenzo, A, Pedrajas, JM, Visona, A, Lopez-Miguel, P, Monreal, M, Adarraga, MD, Aibar, MA, Aibar, J, Alfonso, M, Amado, C, Aranda, C, Arcelus, JI, Ballaz, A, Barba, R, Barron, M, Barron-Andres, B, Bascunana, J, Blanco-Molina, A, Camon, AM, Carrasco, C, Cruz, AJ, del Toro, J, Diaz-Pedroche, MC, Diaz-Peromingo, JA, Falga, C, Fernandez-Capitan, C, Fidalgo, MA, Font, C, Font, L, Furest, I, Garcia, MA, Garcia-Bragado, F, Garcia-Morillo, M, Garcia-Ortega, A, Gavin, O, Gomez, V, Gonzalez-Martinez, J, Grau, E, Guijarro, R, Guirado, L, Gutierrez, J, Hernandez-Blasco, L, Isern, V, Jara-Palomares, L, Jaras, MJ, Jimenez, D, Jimenez, J, Jou, I, Joya, MD, Lalueza, A, Lima, J, Lobo, JL, Lopez-Jimenez, L, Lopez-Reyes, R, Lopez-Saez, JB, Lorente, MA, Loring, M, Lumbierres, M, Madridano, O, Marchena, PJ, Martin-Martos, Morales, MV, Nieto, JA, Nunez, A, Nunez, MJ, Olivares, MC, Otalora, S, Otero, R, Pellejero, G, Perez-Ductor, C, Perez-Jacoiste, A, Penis, ML, Pesce, ML, Porras, JA, Riesco, D, Rivas, A, Rodriguez-Davila, MA, Rosa, V, Rubio, CM, Ruiz-Artacho, P, Sahuquillo, JC, Sala-Sainz, MC, Samperiz, A, Sanchez-Munoz-Torrero, JF, Sancho, T, Soler, S, Soto, MJ, Surinach, JM, Tolosa, C, Torrents, A, Torres, MI, Trujillo-Santos, J, Uresandi, F, Usandizaga, E, Valle, R, Vela, J, Vidal, G, Villalobos, A, Gutierrez, P, Vazquez, FJ, Vilaseca, A, Vanasschc, T, Vandenbriele, C, Verhamme, P, Hirmerova, J, Maly, R, Salgado, E, Benzidia, I, Bertoletti, L, Bura-Riviere, A, Farge-Bancel, D, Hij, A, Merah, A, Mahe, I, Moustafa, F, Braester, A, Brenner, B, Ellis, M, Tzoran, I, Bilora, F, Bortoluzzi, C, Brandolin, B, Bucherini, E, Cattabiani, C, Ciammaichella, M, Dentali, F, Di Micco, P, Giorgi-Pierfranceschi, M, Grandone, E, Imbalzano, E, Maida, R, Mastroiacovo, D, Ngoc, V, Pace, F, Parisi, R, Pesavento, R, Prandoni, P, Quintavalla, R, Rocci, A, Siniscalchi, C, Sotgiu, P, Tiraferri, E, Tufano, A, Zalunardo, B, Kalejs, R, Skride, A, Vitola, B, Bosevski, M, Zdraveska, M, Ii, B, Fresa, M, Mazzolai, L, Caprini, J, and Bui, HM

Subjects
Cardiovascular events, Type 2 diabetes mellitus, Pulmonary embolism, Comorbidity, Mortality
Abstract

Background: Among patients presenting with pulmonary embolism (PE), those with diabetes are at increased risk to die than those without diabetes. The reasons have not been identified. We used the RIETE (Registro Informatizado Enfermedad Trombo Embolica) database to compare the mortality rate and the causes of death during anticoagulation in patients with PE according to the presence or absence of diabetes. Methods: A matched retrospective cohort study from consecutively enrolled patients in RIETE, from 179 hospitals in 24 countries. For each patient with diabetes we selected two patients with no diabetes matched by age, sex and year of diagnosis of the PE. Results: As of September 2017, there were 2010 PE patients with diabetes and two age-and-gender matched controls. Mean age was 74 +/- 11 years, 46% were men. Patients with diabetes were more likely to have comorbidities, to be using antiplatelets and to have more severe PE. During anticoagulation (median, 219 days), patients with diabetes had a higher mortality (hazard ratio [HR]: 1.45; 95% confidence intervals [CI]: 1.25-1.67) and a higher rate of arterial ischemic events (HR: 2.89; 95%CI: 1.71-4.94) than those without diabetes. On multivariable analysis, diabetes was not associated with an increased risk for death (HR: 1.26; 95%CI: 0.97-1.63). We also failed to find differences according to the use of antiplatelet drugs concomitantly. Conclusions: In our cohort of patients with PE, diabetes was not an independent predictor for death. The influence of arterial events or antiplatelet drugs (if any) was low.

Published
2019

49. Impact of sex, age, and risk factors for venous thromboembolism on the initial presentation of first isolated symptomatic acute deep vein thrombosis

Author

Barco, S., Klok, F.A., Mahe, I., Marchena, P.J., Ballaz, A., Rubio, C.M., Adarraga, M.D., Mastroiacovo, D., Konstantinides, S.V., Monreal, M., Aibar, M.A., Aibar, J., Akasbi, M., Amado, C., Arcelus, J.I., Barba, R., Barron, M., Barron-Andres, B., Bascunana, J., Blanco-Molina, A., Camon, A.M., Carrasco, C., Castro, J., Ancos, C. de, Toro, J. del, Demelo, P., Diaz-Pedroche, M.C., Diaz-Peromingo, J.A., Encabo, M., Falga, C., Farfan, A.I., Fernandez-Aracil, C., Fernandez-Capitan, C., Fernandez-Criado, M.C., Criado, M.C., Fidalgo, M.A., Font, C., Font, L., Garcia, M., Garcia-Bragado, F., Garcia-Morillo, M., Garcia-Raso, A., Garcia-Rodenas, M.M., Gavin, O., Gil-Diaz, A., Gil-Gil, F., Guirado, L., Gomez, V., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gutierrez, J., Hernandez-Blasco, L.M., Iglesias, M., Iglesias-Perez, C., Jara-Palomares, L., Jaras, M.J., Jimenez, D., Jou, I., Joya, M.D., 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., Martin-Asenjo, M., Martin-Fernandez, M., Martin-Guerra, J.M., Mellado, M., Morales, M.V., Nieto, J.A., Nunez, M.J., Olivares, M.C., Otalora, S., Otero, R., Pedrajas, J.M., Pellejero, G., Perez-Jacoiste, A., Perez-Rus, G., Peris, M.L., Pesce, M.L., Porras, J.A., Rivas, A., Rodriguez-Davila, M.A., Rodriguez-Hernandez, A., 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., Verhamme, P., Hirmerova, J., Maly, R., Salgado, E., Benzidia, I., Bertoletti, L., Bura-Riviere, A., Debourdeau, P., Farge-Bancel, D., Hij, A., Moustafa, F., Braester, A., Brenner, B., Ellis, M., Tzoran, I., Barillari, G., Bilora, F., Bortoluzzi, C., Brandolin, B., Bucherini, E., Ciammaichella, M., Dentali, F., Micco, P. di, Grandone, E., Imbalzano, E., Lessiani, G., Maggi, F., Maida, R., Mumoli, N., Hong, N.V., Pace, F., Parisi, R., Pesavento, R., Prandoni, P., Quintavalla, R., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Kigitovica, D., Skride, A., Sablinskis, K., Bosevski, M., Zdraveska, M., Bounameaux, H., Mazzolai, L., Caprini, J., Bui, H.M., RIETE Investigators, Barco, S., Klok, F. A., Mahe, I., Marchena, P. J., Ballaz, A., Rubio, C. M., Adarraga, M. D., Mastroiacovo, D., Konstantinides, S. V., Monreal, M., and Tufano, A.

Subjects
medicine.medical_specialty, Epidemiology, Deep vein, 030204 cardiovascular system & hematology, Distal DVT, 03 medical and health sciences, 0302 clinical medicine, Deep vein thrombosi, Deep vein thrombosis, Internal medicine, medicine, cardiovascular diseases, First episode, Pregnancy, Provoking risk factors, business.industry, Cancer, Hematology, medicine.disease, Thrombosis, Pathophysiology, Pulmonary embolism, medicine.anatomical_structure, Provoking risk factor, 030220 oncology & carcinogenesis, Sex, business, Venous thromboembolism
Abstract

Background and aims Sex-specific differences exist for the initial presentation of acute venous thromboembolism (VTE): men are more likely to present with proximal deep vein thrombosis (DVT) in the lower limbs (versus pulmonary embolism [PE] or isolated distal DVT [IDDVT]) than women. We studied in detail the influence of sex, age, and VTE risk factors on the initial presentation of IDDVT versus proximal DVT. Methods A total of 24,911 patients with a first episode of objectively diagnosed acute symptomatic lower-limb DVT (without symptomatic PE) were enrolled in RIETE (years 2000–2017) and included in the present analysis. Results A total of 4266 (17.1%) patients had IDDVT. No trend for more IDDVT diagnoses was observed over time. Women aged 40–69 had a higher proportion of IDDVT, especially between 40 and 49 years (+6.7%; 95CI +3.7%; +9.9%), whereas men had more often proximal DVT. The presenting location of first acute DVT depended on sex, age, and the prevalence and type of VTE risk factors. Recent surgery was independently associated with a diagnosis of IDDVT in both women and men, whereas active cancer and pregnancy were associated with proximal DVT. Conclusions The interaction between age and VTE risk factors influences the presenting location (distal versus proximal) of the first acute lower-limb DVT observed in women and men. Our observations extend to IDDVT the concept that different clinical manifestations of acute VTE may not fully share the same pathophysiological mechanisms: this contributes to explain sex-specific prognostic differences.

Published
2019

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