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1. Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: Patient-Level Network Meta-Analyses of Randomized Clinical Trials With Interaction Testing by Age and Sex

Author: Carnicelli, Anthony P, Hong, Hwanhee, Connolly, Stuart J, Eikelboom, John, Giugliano, Robert P, Morrow, David A, Patel, Manesh R, Wallentin, Lars, Alexander, John H, Bahit, M Cecilia, Benz, Alexander P, Bohula, Erin A, Chao, Tze-Fan, Dyal, Leanne, Ezekowitz, Michael, Fox, Keith Aa, Gencer, Baris, Halperin, Jonathan L, Hijazi, Ziad, Hohnloser, Stefan H, Hua, Kaiyuan, Hylek, Elaine, Kato, Eri Toda, Kuder, Julia, Lopes, Renato D, Mahaffey, Kenneth W, Oldgren, Jonas, Piccini, Jonathan P, Ruff, Christian T, Steffel, Jan, Wojdyla, Daniel, and Granger, Christopher B
Subjects: Male, Network Meta-Analysis, Age Factors, Administration, Oral, Anticoagulants, Sex Factors, Risk Factors, Physiology (medical), Humans, Female, Warfarin, 610 Medicine & health, Cardiology and Cardiovascular Medicine, 360 Social problems & social services, Aged, Randomized Controlled Trials as Topic
Abstract: Background: Direct oral anticoagulants (DOACs) are preferred over warfarin for stroke prevention in atrial fibrillation. Meta-analyses using individual patient data offer substantial advantages over study-level data. Methods: We used individual patient data from the COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation) database, which includes all patients randomized in the 4 pivotal trials of DOACs versus warfarin in atrial fibrillation (RE-LY [Randomized Evaluation of Long-Term Anticoagulation Therapy], ROCKET AF [Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation], ARISTOTLE [Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation], and ENGAGE AF-TIMI 48 [Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48]), to perform network meta-analyses using a stratified Cox model with random effects comparing standard-dose DOAC, lower-dose DOAC, and warfarin. Hazard ratios (HRs [95% CIs]) were calculated for efficacy and safety outcomes. Covariate-by-treatment interaction was estimated for categorical covariates and for age as a continuous covariate, stratified by sex. Results: A total of 71 683 patients were included (29 362 on standard-dose DOAC, 13 049 on lower-dose DOAC, and 29 272 on warfarin). Compared with warfarin, standard-dose DOACs were associated with a significantly lower hazard of stroke or systemic embolism (883/29 312 [3.01%] versus 1080/29 229 [3.69%]; HR, 0.81 [95% CI, 0.74–0.89]), death (2276/29 312 [7.76%] versus 2460/29 229 [8.42%]; HR, 0.92 [95% CI, 0.87–0.97]), and intracranial bleeding (184/29 270 [0.63%] versus 409/29 187 [1.40%]; HR, 0.45 [95% CI, 0.37–0.56]), but no statistically different hazard of major bleeding (1479/29 270 [5.05%] versus 1733/29 187 [5.94%]; HR, 0.86 [95% CI, 0.74–1.01]), whereas lower-dose DOACs were associated with no statistically different hazard of stroke or systemic embolism (531/13 049 [3.96%] versus 1080/29 229 [3.69%]; HR, 1.06 [95% CI, 0.95–1.19]) but a lower hazard of intracranial bleeding (55/12 985 [0.42%] versus 409/29 187 [1.40%]; HR, 0.28 [95% CI, 0.21–0.37]), death (1082/13 049 [8.29%] versus 2460/29 229 [8.42%]; HR, 0.90 [95% CI, 0.83–0.97]), and major bleeding (564/12 985 [4.34%] versus 1733/29 187 [5.94%]; HR, 0.63 [95% CI, 0.45–0.88]). Treatment effects for standard- and lower-dose DOACs versus warfarin were consistent across age and sex for stroke or systemic embolism and death, whereas standard-dose DOACs were favored in patients with no history of vitamin K antagonist use ( P =0.01) and lower creatinine clearance ( P =0.09). For major bleeding, standard-dose DOACs were favored in patients with lower body weight ( P =0.02). In the continuous covariate analysis, younger patients derived greater benefits from standard-dose (interaction P =0.02) and lower-dose DOACs (interaction P =0.01) versus warfarin. Conclusions: Compared with warfarin, DOACs have more favorable efficacy and safety profiles among patients with atrial fibrillation.
Published: 2023

2. Contribuciones de la estadística en tiempos de pandemia

Author: Saino, Martín [Comp], Stimolo, María Inés [Comp.], Guardiola, Mariana [Comp.], Aguirre, Alberto Frank Lázaro, Beijo, Luiz Alberto, Alves Nogueira, Denismar, Alabar, Fabio, Solis, Juan Manuel, Hurtado, Rafael, Ruiz, Sebastián León, Alegría Jiménez, Alfredo, Emery, Xavier, Lantuéjoul, Christian, Álvarez-Vaz, Ramón, Massa, Fernando, Vernazza, Elena, Lezcano, Mikaela, Urruticoechea, Alar, del Callejo Canal, Diana, Canal Martínez, Margarita, Ruggia, Ornela, Tolosa, Leticia Eva, Rojo, María Paula, Nicolas, María Claudia, Barbaroy, Tomás, Villarreal, Fernanda, Pisani, María Virginia, Quintana, Alicia, Elorza, María Eugenia, Peretti, Gianluca, Buzzi, Sergio Martín, Settecase, Eugenia, Paccapelo, María Valeria, Cuesta, Cristina, Maglione, Dora, Paredes, Paula, Luna, Silvia, Klimisch, Bárbara, Saenz, José Luis, Rosas, Juan E, Pérez de Vida, Fernando, Marella, Muzio, Berberian, Natalia, Freitas Galletti, Agda Jessica de, Ponce, Daniela, Silveira, Liciana Vaz de A., Bellassai, Juan Carlos, Pappaterra, María Lucía, Ojeda, Silvia María, Ascua, Melina Belén, Roldán, Dana Agustina, Rodi, Ayrton Luis, Ventre, Giuliana, González, Agustina, Palacio, Gabriela, Bigolin, Sabina, Ferrero, Susana, Del Medico, Ana Paula, Tenaglia, Gerardo, Lavalle, Andrea, Vitelleschi, María Susana, Pratta, Guillermo, Demaio, Alejo, Paz, Hernández, Di Palma, Fabricio, Calizaya, Pablo, Avalis, Francisca, Caro, Norma Patricia, Fernícola, Marcela, Dundray, Fabián, Calviño, Amalia, Nuñez, Myriam, Farfán Machaca, Yheni, Coaquira, Frida, Ferreri, Noemí M., Pascaner, Melina, Bossolasco, María Luisa, Martinez, Facundo, Faviere, Gabriela, Angelini, Julia, Bortolotto, Eugenia B., Cervigni, Gerardo, Chiapella, Luciana C., Grendas, Leandro, Daray, Federico, Leal, Danilo, Nicolis, Orietta, Bonadies, María Eugenia, Ponteville, Christiane, Catalano, Mara, Re, Juan Pablo, Dillon, Justina, Carnevali, Graciela H., Justo, Claudio Eduardo, Iglesias, Maximiliano, Gómez, Pablo Sebastián, Real, Ariel Hernán, Vargas, Silvia Lorena, López Calcagno, Yanil, Batto, Mabel, Sampaolesi, Edgardo, Tealdi, Juan Manuel, García Bazán, Gaspar, Monroy Caicedo, Xiomara Alejandra, Bermúdez Rubio, Dagoberto, Ricci, Lila, Kelmansky, Diana Mabel, Rapelli, Cecilia, García, María del Carmen, Bussi, Javier, Marí, Gonzalo, Méndez, Fernanda, García Mata, Luis Ángel, Ramírez González, Marco Antonio, Rossi, Laura., Vicente, Gonzalo, Scavino, Marco, Estragó, Virginia, Muñoz, Matías, Castrillejo, Andrés, Da Rocha, Naila Camila, Macola Pacheco Barbosa, Abner, Corrente, José Eduardo, Spataro, Javier Ignacio, Salvatierra, Luca Mauricio, Nahas, Estefanía, Márquez, Viviana, Boggio, Gabriela, Arnesi, Nora, Harvey, Guillermina, Wojdyla, Daniel, Blasco, Manuel, Stanecka, Nancy, Caro, Valentina, Sigal, Facundo, Blacona, María Teresa, Rodriguez, Norberto Vicente, Loiacono, Karina Valeria, García, Gregorio, Ciardullo, Emanuel, Mitas, Gerardo, Funkner, Sofía, Dieser, María Paula, Martín, María Cristina, Peitton, Lucas, Borgognone, María Gabriela, Terreno, Dante D., Castro González, Enrique L., Roldán, Janina Micaela, González, Gisela Paula, Geri, Milva, De Santis, Mariana, Marfia, Martín, Kudraszow, Nadia L., Closas, Humberto, Amarilla, Mariela, Jovanovich, Carina, de Castro, Idalia, Cruz, Rosa, Dusicka, Alicia, Quaglino, Marta, Kalauz, Roberto José Andrés, Gogni, Valeria, Rubio, Luisina, Prunello, Marcos, Cugno, José Agustín, Feo Cediel, Yennyfer, Bianco, María José, Joekes, Silvia, Porta, Rodrigo, Righetti, Andrea, Valentini, Gabriel, Truccone, Marianella Soledad, Arriola, Edgardo, Azzolina, Yesica, Barcarolo, Pedro Henrique, Bederian, Virginia, Bonfili, Oscar Jorge, Borda-Casallas, Ximena A., Braz, Gabriela, Casini, Rossana, Castro, María José, Crespi, Germán, Curia, Lisandro, D´Amelio, Adriana Graciela, D´Andrea, Rodolfo, De Los Ríos, Claudia, Del Duca, Silvina, Delfante, María Alejandra, Grajales, Luis F., González, Mariana Verónica, Gomez, Mariana, García, Fernando, Largo, Rommel, Lastiri, José María, Lescano, Maira Celeste, Maciel Vilhena, Vera Debora, Marquez, Pamela, Martínez, Javier, Minatta, Nicolás, Moneta Pizarro, Adrián M, Nardechia, Lucía, Ortiz, Pablo [Comp.], Ozan, Nelida Susana, Votto, Thays, Vietri, Silvia, Viana Nunes, José Messildo, Ulloa Arellano, Víctor Manuel, Trucchi, Carlos, Tari, Johana Gisel, Specterman, Sergio, Soto, Julio, Seguín, M., Sattler, Silvana A., Sandoval, Marisa, Robles Colonia, Saditt Rocío, Quijada Monroy, Verónica del Carmen, Porciuncula, Mauren, Petrini, Juliana, and Parada, Brisa
Subjects: Riesgo financiero, SARS-CoV-2, COVID-19, Estadísticas, Índice de sincronía, Crisis financieras, Pandemias
Abstract: Esta publicación es una compilación de las actividades realizadas en el marco del XLVIII Coloquio Argentino de Estadística y la VI Jornada de Educación Estadística Martha Aliaga organizada por la Sociedad Argentina de Estadística y la Facultad de Ciencias Económicas. Se presenta un resumen para cada uno de los talleres, cursos realizados, ponencias y poster presentados. Para los dos últimos se dispone de un hipervínculo que direcciona a la presentación del trabajo. Ellos obedecen a distintas temáticas de la estadística con una sesión especial destinada a la aplicación de modelos y análisis de datos sobre COVID-19. Fil: Saino, Martín. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Stimolo, María Inés. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Ortiz, Pablo. Universidad Nacional de córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Guardiola, Mariana. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Aguirre, Alberto Frank Lázaro. Universidade Federal de Alfenas. Departamento de Estatística. Instituto de Ciências Exatas; Brasil. Fil: Alves Nogueira, Denismar. Universidade Federal de Alfenas. Departamento de Estatística. Instituto de Ciências Exatas; Brasil. Fil: Beijo, Luiz Alberto. Universidade Federal de Alfenas. Departamento de Estatística. Instituto de Ciências Exatas; Brasil. Fil: Solis, Juan Manuel. Universidad Nacional de Jujuy. Centro de Estudios en Bioestadística, Bioinformática y Agromática; Argentina. Fil: Alabar, Fabio. Universidad Nacional de Jujuy. Centro de Estudios en Bioestadística, Bioinformática y Agromática; Argentina. Fil: Ruiz, Sebastián León. Universidad Nacional de Jujuy. Centro de Estudios en Bioestadística, Bioinformática y Agromática; Argentina. Fil: Hurtado, Rafael. Universidad Nacional de Jujuy; Argentina. Fil: Alegría Jiménez, Alfredo. Universidad Técnica Federico Santa María. Departamento de Matemática; Chile. Fil: Emery, Xavier. Universidad de Chile. Departamento de Ingeniería en Minas; Chile. Fil: Emery, Xavier. Universidad de Chile. Advanced Mining Technology Center; Chile. Fil: Álvarez-Vaz, Ramón. Universidad de la República. Instituto de Estadística. Departamento de Métodos Cuantitativos; Uruguay. Fil: Massa, Fernando. Universidad de la República. Instituto de Estadística. Departamento de Métodos Cuantitativos; Uruguay. Fil: Vernazza, Elena. Universidad de la República. Facultad de Ciencias Económicas y de Administración. Instituto de Estadística; Uruguay. Fil: Lezcano, Mikaela. Universidad de la República. Facultad de Ciencias Económicas y de Administración. Instituto de Estadística; Uruguay. Fil: Urruticoechea, Alar. Universidad Católica del Uruguay. Facultad de Ciencias de la Salud. Departamento de Neurocognición; Uruguay. Fil: del Callejo Canal, Diana. Universidad Veracruzana. Instituto de Investigación de Estudios Superiores, Económicos y Sociales; México. Fil: Canal Martínez, Margarita. Universidad Veracruzana. Instituto de Investigación de Estudios Superiores, Económicos y Sociales; México. Fil: Ruggia, Ornela. CONICET; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Agropecuarias. Departamento de desarrollo rural; Argentina. Fil: Tolosa, Leticia Eva. Universidad Nacional de Córdoba; Argentina. Universidad Católica de Córdoba; Argentina. Fil: Rojo, María Paula. Universidad Nacional de Córdoba; Argentina. Fil: Nicolas, María Claudia. Universidad Nacional de Córdoba; Argentina. Universidad Católica de Córdoba; Argentina. Fil: Barbaroy, Tomás. Universidad Nacional de Córdoba; Argentina. Fil: Villarreal, Fernanda. CONICET, Universidad Nacional del Sur. Instituto de Matemática de Bahía Blanca (INMABB); Argentina. Fil: Pisani, María Virginia. Universidad Nacional del Sur. Departamento de Matemática; Argentina. Fil: Quintana, Alicia. Universidad Nacional del Sur. Departamento de Matemática; Argentina. Fil: Elorza, María Eugenia. CONICET. Universidad Nacional del Sur. Instituto de Investigaciones Económicas y Sociales del Sur; Argentina. Fil: Peretti, Gianluca. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Buzzi, Sergio Martín. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Estadística y Matemática; Argentina. Fil: Settecase, Eugenia. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadísticas. Instituto de Investigaciones Teóricas y Aplicadas en Estadística; Argentina. Fil: Settecase, Eugenia. Department of Agriculture and Fisheries. Leslie Research Facility; Australia. Fil: Paccapelo, María Valeria. Department of Agriculture and Fisheries. Leslie Research Facility; Australia. Fil: Cuesta, Cristina. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadísticas. Instituto de Investigaciones Teóricas y Aplicadas en Estadística; Argentina. Fil: Saenz, José Luis. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Luna, Silvia. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Paredes, Paula. Universidad Nacional de la Patagonia Austral; Argentina. Instituto Nacional de Tecnología Agropecuaria. Estación Experimental Agropecuaria Santa Cruz; Argentina. Fil: Maglione, Dora. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Rosas, Juan E. Instituto Nacional de Investigación Agropecuaria (INIA); Uruguay. Fil: Pérez de Vida, Fernando. Instituto Nacional de Investigación Agropecuaria (INIA); Uruguay. Fil: Marella, Muzio. Sociedad Anónima Molinos Arroceros Nacionales (SAMAN); Uruguay. Fil: Berberian, Natalia. Universidad de la República. Facultad de Agronomía; Uruguay. Fil: Ponce, Daniela. Universidad Estadual Paulista. Facultad de Medicina; Brasil. Fil: Silveira, Liciana Vaz de A. Universidad Estadual Paulista; Brasil. Fil: Freitas Galletti, Agda Jessica de. Universidad Estadual Paulista; Brasil. Fil: Bellassai, Juan Carlos. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Centro de Investigación y Estudios de Matemáticas (CIEM-Conicet); Argentina. Fil: Pappaterra, María Lucía. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Centro de Investigación y Estudios de Matemáticas (CIEM-Conicet); Argentina. Fil: Ojeda, Silvia María. Universidad Nacional de Córdoba. Facultad de Matemática, Astronomía, Física y Computación; Argentina. Fil: Ascua, Melina Belén. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Roldán, Dana Agustina. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Rodi, Ayrton Luis. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Ventre, Giuliana. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: González, Agustina. Universidad Nacional de Rio Cuarto. Facultad de Ciencias Exactas, Físico-Químicas y Naturales. Departamento de Matemática; Argentina. Fil: Palacio, Gabriela. Universidad Nacional de Rio Cuarto. Facultad de Ciencias Exactas, Físico-Químicas y Naturales. Departamento de Matemática; Argentina. Fil: Bigolin, Sabina. Universidad Nacional de Rio Cuarto. Facultad de Ciencias Exactas, Físico-Químicas y Naturales. Departamento de Matemática; Argentina. Fil: Ferrero, Susana. Universidad Nacional de Rio Cuarto. Facultad de Ciencias Exactas, Físico-Químicas y Naturales. Departamento de Matemática; Argentina. Fil: Del Medico, Ana Paula. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ciencias Agrarias de Rosario (IICAR); Argentina. Fil: Pratta, Guillermo. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ciencias Agrarias de Rosario (IICAR); Argentina. Fil: Tenaglia, Gerardo. Instituto Nacional de Tecnología Agropecuaria. Instituto de Investigación y Desarrollo Tecnológico para la Agricultura Familiar; Argentina. Fil: Lavalle, Andrea. Universidad Nacional del Comahue. Departamento de Estadística; Argentina. Fil: Demaio, Alejo. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Hernández, Paz. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Di Palma, Fabricio. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Calizaya, Pablo. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Avalis, Francisca. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Caro, Norma Patricia. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Caro, Norma Patricia. Universidad Nacional de Córdoba. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Fernícola, Marcela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Fil: Nuñez, Myriam. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Fil: Dundray, , Fabián. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Fil: Calviño, Amalia. Universidad de Buenos Aires. Instituto de Química y Metabolismo del Fármaco. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Farfán Machaca, Yheni. Universidad Nacional de San Antonio Abad del Cusco. Departamento Académico de Matemáticas y Estadística; Argentina. Fil: Paucar, Guillermo. Universidad Nacional de San Antonio Abad del Cusco. Departamento Académico de Matemáticas y Estadística; Argentina. Fil: Coaquira, Frida. Universidad Nacional de San Antonio Abad del Cusco. Escuela de posgrado UNSAAC; Argentina. Fil: Ferreri, Noemí M. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Pascaner, Melina. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Martinez, Facundo. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Bossolasco, María Luisa. Universidad Nacional de Tucumán. Facultad de Ciencias Naturales e Instituto Miguel Lillo; Argentina. Fil: Bortolotto, Eugenia B. Universidad Nacional de Rosario. Centro de Estudios Fotosintéticos y Bioquímicos (CEFOBI); Argentina. Fil: Bortolotto, Eugenia B. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Faviere, Gabriela S. Universidad Nacional de Rosario. Centro de Estudios Fotosintéticos y Bioquímicos (CEFOBI); Argentina. Fil: Faviere, Gabriela S. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Angelini, Julia. Universidad Nacional de Rosario. Centro de Estudios Fotosintéticos y Bioquímicos (CEFOBI); Argentina. Fil: Angelini, Julia. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Cervigni, Gerardo. Universidad Nacional de Rosario. Centro de Estudios Fotosintéticos y Bioquímicos (CEFOBI); Argentina. Fil: Cervigni, Gerardo. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Valentini, Gabriel. Instituto Nacional de Tecnología Agropecuaria. Estación Experimental Agropecuaria INTA San Pedro; Argentina. Fil: Chiapella, Luciana C.. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas; Argentina. Fil: Chiapella, Luciana C. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET); Argentina. Fil: Grendas, Leandro. Universidad Buenos Aires. Facultad de Medicina. Instituto de Farmacología; Argentina. Fil: Daray, Federico. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET); Argentina. Fil: Daray, Federico. Universidad Buenos Aires. Facultad de Medicina. Instituto de Farmacología; Argentina. Fil: Leal, Danilo. Universidad Andrés Bello. Facultad de Ingeniería; Chile. Fil: Nicolis, Orietta. Universidad Andrés Bello. Facultad de Ingeniería; Chile. Fil: Bonadies, María Eugenia. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Fil: Ponteville, Christiane. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Fil: Catalano, Mara. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Catalano, Mara. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Dillon, Justina. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Carnevali, Graciela H. Universidad Nacional de Rosario. Facultad de Ciencias Exactas, Ingeniería y Agrimensura; Argentina. Fil: Justo, Claudio Eduardo. Universidad Nacional de la Plata. Facultad de Ingeniería. Departamento de Agrimensura. Grupo de Aplicaciones Matemáticas y Estadísticas (UIDET); Argentina. Fil: Iglesias, Maximiliano. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Gómez, Pablo Sebastián. Universidad Nacional de Córdoba. Facultad de Ciencias Sociales. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Fil: Real, Ariel Hernán. Universidad Nacional de Luján. Departamento de Ciencias Básicas; Argentina. Fil: Vargas, Silvia Lorena. Universidad Nacional de Luján. Departamento de Ciencias Básicas; Argentina. Fil: López Calcagno, Yanil. Universidad Nacional de Luján. Departamento de Ciencias Básicas; Argentina. Fil: Batto, Mabel. Universidad Nacional de Luján. Departamento de Ciencias Básicas; Argentina. Fil: Sampaolesi, Edgardo. Universidad Nacional de Luján. Departamento de Ciencias Básicas; Argentina. Fil: Tealdi, Juan Manuel. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Buzzi, Sergio Martín. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Estadística y Matemática; Argentina. Fil: García Bazán, Gaspar. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Monroy Caicedo, Xiomara Alejandra. Universidad Nacional de Rosario; Argentina. Fil: Bermúdez Rubio, Dagoberto. Universidad Santo Tomás. Facultad de Estadística; Colombia. Fil: Ricci, Lila. Universidad Nacional de Mar del Plata. Facultad de Ciencias Exactas y Naturales. Centro Marplatense de Investigaciones Matemáticas; Argentina. Fil: Kelmansky, Diana Mabel. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Instituto de Cálculo; Argentina. Fil: Rapelli, Cecilia. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Escuela de Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: García, María del Carmen. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Escuela de Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Bussi, Javier. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Méndez, Fernanda. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística (IITAE); Argentina. Fil: García Mata, Luis Ángel. Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Acatlán; México. Fil: Ramírez González, Marco Antonio. Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Acatlán; México. Fil: Rossi, Laura. Universidad Nacional de Cuyo. Facultad de Ciencias Económicas; Argentina. Fil: Vicente, Gonzalo. Universidad Nacional de Cuyo. Facultad de Ciencias Económicas; Argentina. Universidad Pública de Navarra. Departamento de Estadística, Informática y Matemáticas; España. Fil: Scavino, Marco. Universidad de la República. Facultad de Ciencias Económicas y de Administración. Instituto de Estadística; Uruguay. Fil: Estragó, Virginia. Presidencia de la República. Comisión Honoraria para la Salud Cardiovascular; Uruguay. Fil: Muñoz, Matías. Presidencia de la República. Comisión Honoraria para la Salud Cardiovascular; Uruguay. Fil: Castrillejo, Andrés. Universidad de la República. Facultad de Ciencias Económicas y de Administración. Instituto de Estadística; Uruguay. Fil: Da Rocha, Naila Camila. Universidade Estadual Paulista Júlio de Mesquita Filho- UNESP. Departamento de Bioestadística; Brasil Fil: Macola Pacheco Barbosa, Abner. Universidade Estadual Paulista Júlio de Mesquita Filho- UNESP; Brasil. Fil: Corrente, José Eduardo. Universidade Estadual Paulista Júlio de Mesquita Filho – UNESP. Instituto de Biociencias. Departamento de Bioestadística; Brasil. Fil: Spataro, Javier. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Economía; Argentina. Fil: Salvatierra, Luca Mauricio. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Nahas, Estefanía. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Márquez, Viviana. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Boggio, Gabriela. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Arnesi, Nora. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Harvey, Guillermina. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Settecase, Eugenia. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Instituto de Investigaciones Teóricas y Aplicadas de la Escuela de Estadística; Argentina. Fil: Wojdyla, Daniel. Duke University. Duke Clinical Research Institute; Estados Unidos. Fil: Blasco, Manuel. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Economía y Finanzas; Argentina. Fil: Stanecka, Nancy. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Caro, Valentina. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Sigal, Facundo. Universidad Austral. Facultad de Ciencias Empresariales. Departamento de Economía; Argentina. Fil: Blacona, María Teresa. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Escuela de Estadística; Argentina. Fil: Rodriguez, Norberto Vicente. Universidad Nacional de Tres de Febrero; Argentina. Fil: Loiacono, Karina Valeria. Universidad Nacional de Tres de Febrero; Argentina. Fil: García, Gregorio. Instituto Nacional de Estadística y Censos. Dirección Nacional de Metodología Estadística; Argentina. Fil: Ciardullo, Emanuel. Instituto Nacional de Estadística y Censos. Dirección Nacional de Metodología Estadística; Argentina. Fil: Ciardullo, Emanuel. Instituto Nacional de Estadística y Censos. Dirección Nacional de Metodología Estadística; Argentina. Fil: Funkner, Sofía. Universidad Nacional de La Pampa. Facultad de Ciencias Exactas y Naturales; Argentina. Fil: Dieser, María Paula. Universidad Nacional de La Pampa. Facultad de Ciencias Exactas y Naturales; Argentina. Fil: Martín, María Cristina. Universidad Nacional de La Pampa. Facultad de Ciencias Exactas y Naturales; Argentina. Fil: Martín, María Cristina. Universidad Nacional del Sur. Departamento de Matemática; Argentina. Fil: Peitton, Lucas. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística; Argentina. Queensland Department of Agriculture and Fisheries; Australia. Fil: Borgognone, María Gabriela. Queensland Department of Agriculture and Fisheries; Australia. Fil: Terreno, Dante D. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Contabilidad; Argentina. Fil: Castro González, Enrique L. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Contabilidad; Argentina. Fil: Roldán, Janina Micaela. Universidad Nacional de La Pampa. Facultad de Ciencias Exactas y Naturales; Argentina. Fil: González, Gisela Paula. CONICET. Instituto de Investigaciones Económicas y Sociales del Sur; Argentina. Universidad Nacional del Sur; Argentina. Fil: De Santis, Mariana. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Geri, Milva. CONICET. Instituto de Investigaciones Económicas y Sociales del Sur; Argentina. Fil: Geri, Milva. Universidad Nacional del Sur. Departamento de Economía; Argentina. Universidad Nacional del Sur. Departamento de Matemática; Argentina. Fil: Marfia, Martín. Universidad Nacional de la Plata. Facultad de Ingeniería. Departamento de Ciencias Básicas; Argentina. Fil: Kudraszow, Nadia L. Universidad Nacional de la Plata. Facultad de Ciencias Exactas. Centro de Matemática de La Plata; Argentina. Fil: Closas, Humberto. Universidad Tecnológica Nacional; Argentina. Fil: Amarilla, Mariela. Universidad Tecnológica Nacional; Argentina. Fil: Jovanovich, Carina. Universidad Tecnológica Nacional; Argentina. Fil: de Castro, Idalia. Universidad Nacional del Nordeste; Argentina. Fil: Franchini, Noelia. Universidad Nacional del Nordeste; Argentina. Fil: Cruz, Rosa. Universidad Nacional del Nordeste; Argentina. Fil: Dusicka, Alicia. Universidad Nacional del Nordeste; Argentina. Fil: Quaglino, Marta. Universidad Nacional de Rosario; Argentina. Fil: Kalauz, Roberto José Andrés. Investigador Independiente; Argentina. Fil: González, Mariana Verónica. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Estadística y Matemáticas; Argentina. Fil: Lescano, Maira Celeste. Universidad Nacional de Tucumán. Escuela de enfermería; Argentina. Fil: Gogni, Valeria. Universidad de Buenos Aires. Facultad de Ciencias Económicas; Argentina. Fil: Bianco, María José. Universidad de Buenos Aires. Facultad de Ciencias Económicas; Argentina. Fil: Rubio, Luisina. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Escuela de Estadística; Argentina. Fil: Prunello, Marcos. Universidad Nacional de Rosario. Facultad de Ciencias Económicas y Estadística. Escuela de Estadística; Argentina. Fil: Cugno, José Agustín. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Feo Cediel, Yennyfer. Universidad de Buenos Aires. Facultad de Ciencias Económicas. Centro de Investigación en Métodos Cuantitativos Aplicados a la Economía y la Gestión (CMA); Argentina. Fil: Loiacono, Karina Valeria. Ministerio de Salud. Dirección de Estadísticas e Información en Salud; Argentina. Fil: Loiacono, Karina Valeria. Universidad Nacional Tres de Febrero; Argentina. Instituto Universitario Hospital Italiano; Argentina. Fil: Joekes, Silvia. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Porta, Rodrigo. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Righetti, Andrea. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Angelini, Julia. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro de Estudios Fotosintéticos y Bioquímicos; Argentina. Fil: Faviere, Gabriela. Universidad Nacional de Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro de Estudios Fotosintéticos y Bioquímicos; Argentina. Fil: Valentini, Gabriel. Instituto Nacional de Tecnología Agropecuaria. Estación Experimental Agropecuaria San Pedro; Argentina. Fil: Truccone, Marianella Soledad. Universidad Nacional de Villa María. Instituto Académico Pedagógico de Ciencias Sociales; Argentina. Fil: Arriola, Edgardo. Universidad Tecnológica Nacional; Argentina. Fil: Azzolina, Yesica. Oficina Meteorológica Río Gallegos. Servicio Meteorológico Nacional. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Bonfili, Oscar Jorge. Oficina Meteorológica Río Gallegos. Servicio Meteorológico Nacional. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Marquez, Pamela Vanesa. Oficina Meteorológica Río Gallegos. Servicio Meteorológico Nacional. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Parada, Brisa Agustina. Oficina Meteorológica Río Gallegos. Servicio Meteorológico Nacional. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Sandoval, Marisa Susana. Oficina Meteorológica Río Gallegos. Servicio Meteorológico Nacional. Universidad Nacional de la Patagonia Austral; Argentina. Fil: Casini, Rossana. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Matemática; Argentina. Fil: Braz, Gabriela. Universidade Federal do Rio Grande. Programa de Pós-Graduação em Educação em Ciências (PPGEC); Brasil. Fil: Porciuncula, Mauren. Universidade Federal do Rio Grande. Instituto de Matemática, Estatistica e Física; Brasil. Fil: Votto, Thays. Universidade Federal do Rio Grande. Programa de Pós-Graduação em Educação em Ciências (PPGEC); Brasil. Fil: Barcarolo, Pedro Henrique. Universidade Federal do Rio Grande. Instituto de Matemática, Estatistica e Física; Brasil. Fil: Bederian, Virginia. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Instituto de Estadística y Demografía; Argentina. Fil: Borda-Casallas, Ximena A. Universidad Nacional de Colombia. Facultad de Ciencias; Colombia. Fil: Grajales, Luis F. Universidad Nacional de Colombia. Facultad de Ciencias, Departamento de Estadística; Colombia. Fil: Curia, Lisandro. Universidad Nacional del Comahue. Departamento de Matemática; Argentina. Fil: D´Andrea, Rodolfo. Pontificia Universidad Católica; Argentina. Universidad Nacional del Centro de la provincia de Buenos Aires; Argentina. Fil: Largo, Rommel. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Delfante, María Alejandra. Hospital Italiano de Buenos Aires; Argentina. Fil: Lastiri, José María. Hospital Italiano de Buenos Aires; Argentina. Fil: Specterman, Sergio. Hospital Italiano de Buenos Aires; Argentina. Fil: Del Duca, Silvina. Universidad Nacional de Buenos Aires. Facultad de Ciencias Económicas; Argentina. Fil: Vietri, Silvia. Universidad Nacional de Buenos Aires. Facultad de Ciencias Económicas. Departamento de Matemática; Argentina. Fil: De Los Ríos, Claudia. Universidad Nacional de San Juan. Facultad de Ciencias Exactas, Físicas y Naturales. Departamento Biología; Argentina. Fil: Seguín, Marcelo. Universidad Nacional de San Juan. Facultad de Ingeniería. Departamento Matemática; Argentina. Fil: Ozán, Nélida Susana. Universidad Nacional de San Juan. Facultad de Ingeniería. Departamento Matemática; Argentina. Fil: Lescano, Maira Celeste. Universidad Nacional de Tucumán. Escuela de enfermería; Argentina. Fil: Nardechia, Lucía. Universidad Nacional de Cuyo; Argentina. Fil: D´Amelio, Adriana Graciela. Universidad Nacional de Cuyo; Argentina. Fil: Tari, Johana Gisel. Dirección General de Escuelas; Argentina. Fil: Soto, Julio. Universidad Nacional de la Patagonia Austral. Instituto de Trabajo, Economía y Territorio; Argentina. Fil: Maciel Vilhena, Vera Debora. Universidade Federal do Pará. Instituição de Educação Matemática Cientifica; Brasil. Fil: Viana Nunes, José Messildo. Universidade Federal do Pará. Instituição de Educação Matemática Cientifica; Brasil. Fil: Petrini, Juliana. Universidade Federal de Alfenas. Instituto de Ciências Exatas. Departamento de Estatística; Brasil. Fil: Robles Colonia, Saditt Rocío. Universidade Federal de Alfenas. Instituto de Ciências Exatas. Departamento de Estatística; Brasil. Fil: Ulloa Arellano, Víctor Manual. Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Acatlán; México. Fil: Quijada Monroy, Verónica del Carmen. Universidad Nacional Autónoma de México. Facultad de Estudios Superiores Acatlán. Centro Tecnológico para la Educación a Distancia; México. Fil: García, Fernando. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Trucchi, Carlos. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Matemática; Argentina. Fil: Crespi, Germán. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Contabilidad; Argentina. Fil: Martinez, Javier. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Contabilidad; Argentina. Fil: Sattler, Silvana A. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Contabilidad; Argentina. Fil: González, Mariana Verónica. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas. Departamento de Estadística y Matemáticas; Argentina. Fil: Gómez, Mariana. Universidad Nacional de San Juan. Facultad de Ingeniería. Departamento Matemática; Argentina. Fil: Minatta, Nicolás. Hospital Italiano de Buenos Aires; Argentina. Fil: Castro, María José. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Fisicomatemática; Argentina. Fil: Moneta Pizarro, Adrián Maximiliano. Universidad Nacional de Córdoba. Facultad de Ciencias Económicas; Argentina. Fil: Elorza, María Eugenia. Universidad Nacional del Sur. Departamento de Economía; Argentina.
Published: 2021

3. Stent Thrombosis in Patients with Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial

Author: Lopes, Renato D, Leonardi, Sergio, Wojdyla, Daniel M, Vora, Amit N, Thomas, Laine, Storey, Robert F, Vinereanu, Dragos, Granger, Christopher B, Goodman, Shaun G, Aronson, Ronald, Windecker, Stephan, Thiele, Holger, Valgimigli, Marco, Mehran, Roxana, Alexander, John H, University of Zurich, and Lopes, Renato D
Subjects: 2737 Physiology (medical), 610 Medicine & health, cardiovascular diseases, 11171 Cardiocentro Ticino, 2705 Cardiology and Cardiovascular Medicine
Abstract: We describe the incidence, timing, and characteristics of stent thrombosis and its consequences in patients with atrial fibrillation (AF) in the AUGUSTUS trial1 who received a coronary stent during their qualifying admission (acute coronary syndrome [ACS] or elective percutaneous coronary intervention [PCI]) and the randomized treatment effects of low-dose aspirin (compared with placebo) and apixaban (compared with vitamin K antagonist [VKA]) on the risk of stent thrombosis. We included patients who received a stent during their qualifying admission. We excluded patients with medically-managed ACS (n=1097) or an unknown qualifying index event (n=19). The protocol was approved by appropriate ethics committees; patients provided written informed consent prior to participation.
Published: 2020
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4. Efecto de los antimaláricos sobre los diferentes dominios del índice de daño SLICC en pacientes de la cohorte GLADEL

Author: Pons-Estel, Guillermo J., Quintana, Rosana, Wojdyla, Daniel, Alarcón, Graciela S., Serrano, Rosa María, Ugarte-Gil, Manuel, Pimentel-Quiroz, Víctor, Soriano, Enrique R., Catoggio, Luis J., Scolnik, Marina, Sacnun, Mónica, Saurit, Verónica, Caeiro, Francisco, Alvarellos, Alejandro, Sarano, Judith, García, Mercedes, Onetti, Laura, Drenkard, Cristina, Berbotto, Guillermo, Scherbarth, Hugo R., Sato, Emilia, Bonfa, Eloisa, Ferreira Borba, Eduardo, Costallat, Lilian, Xavier, Ricardo, Tavares Brenol, Joao C., Da Silva, Nilzio A., Cavalcanti, Fernando, Massardo, Loreto, Jacobelli, Sergio, Neira, Oscar, Molina, José F, Vásquez, Gloria, Gómez-Puerta, José A., Alonso Gonzalez, Luis, Iglesias Gamarra, Antonio, Guibert-Toledano, Marlene, Reyes, Gil A., Cardiel, Mario H., Pascual-Ramos, Virginia, García de la Torre, Ignacio, Barile, Leonor, Silveira, Luis H., Amigo, Mary-Carmen, Sauza del Pozo, María Josefina, Acevedo-Vásquez, Eduardo M., Alfaro-Lozano, José, Segami, María Inés, Chacón-Díaz, Rosa, Abadi, Isaac, Esteva Spinetti, María H, and Pons-Estel, Bernardo A.
Subjects: antimalarials, daño acumulado, Latin America, systemic lupus erythematosus, lupus eritematoso sistémico, antimaláricos, Latinoamérica, damage accrual
Abstract: Objetivos: Estimar el efecto de los antimaláricos (AM) sobre los diferentes dominios del índice de daño SLICC (SDI). Métodos: Se estudiaron pacientes con diagnóstico clínico reciente (≤2 años) de lupus eritematoso sistémico (LES) de la cohorte GLADEL. Variable de estudio: aumento en los dominios del SDI desde el ingreso a la cohorte. Variables independientes: características sociodemográficas, clínicas, laboratorio y tratamientos. El efecto de los AM, como variable dependiente del tiempo, sobre los dominios más frecuentes del SDI (ajustado por factores de confusión) fue examinado con un modelo de regresión de Cox multivariado. Resultados: De 1466 pacientes estudiados, 1049 (72%) recibieron AM con un tiempo medio de exposición de 30 meses (Q1-Q3: 11-57) y 665 pacientes (45%) presentaron daño durante un seguimiento medio de 24 meses (Q1-Q3: 8-55); 301 eventos fueron cutáneos, 208 renales, 149 neuropsiquiátricos, 98 musculoesqueléticos, 88 cardiovasculares y 230 otros. Después de ajustar por factores de confusión, el uso de AM se asoció a un menor riesgo de daño renal (HR 0,652; IC 95%: 0,472-0,901) y en el límite de la significancia estadística (HR 0,701, IC 95%: 0,481-1,024) para el dominio neuropsiquiátrico. Conclusión: En GLADEL, el uso de AM se asoció independientemente a un menor riesgo de daño acumulado renal. Objective: To assess the effects of antimalarials (AM) over the items of the SLICC Damage Index (SDI). Methods: Patients with recent (≤2 years) diagnosis of systemic lupus erythematosus (SLE) from the GLADEL cohort were studied. End-point: increase in items SDI since cohort entry. Independent variables (socio-demographic, clinical, laboratory and treatment) were included. The effect of AM as a time dependent variable on most frequent SDI items (adjusting for potential confounders) was examined with a multivariable Cox regression model. Results: Of the 1466 patients included in this analysis, 1049 (72%) received AM with a median exposure time of 30 months (Q1-Q3: 11-57). Damage occurred in 665 (45%) patients during a median follow-up time of 24 months (Q1-Q3: 8-55). There were 301 integument, 208 renal, 149 neuropsychiatric, 98 musculoskeletal, 88 cardiovascular and 230 others less frequently represented damages. After adjusting for potential confounders at any time during follow-up, a lower risk of renal damage (HR 0.652; 95% CI: 0.472-0.901) and borderline for neuropsychiatric damage (HR 0.701, 95% CI: 0.481-1.024) was found. Conclusion: In the GLADEL cohort, after adjustment for possible confounding factors, AM were independently associated with a reduced risk of renal damage accrual.
Published: 2018

5. The Association between LDL-C and Incident Atherosclerotic Cardiovascular Disease in Older Adults: Results from the National Institutes of Health Pooled Cohorts

Author: Nanna, Michael G., Navar, Ann Marie, Wojdyla, Daniel, and Peterson, Eric D.
Subjects: Male, Stroke, National Institutes of Health (U.S.), Risk Factors, Hypertension, Humans, Female, Cholesterol, LDL, Prospective Studies, Atherosclerosis, Article, United States, Aged
Abstract: Elevated low-density lipoprotein cholesterol (LDL-C) in early adulthood is associated with increased risk of atherosclerotic cardiovascular disease (ASCVD). The strength of the association between LDL-C and ASCVD among older adults, however, is less understood.We examined individual-level cohort data from the National Institutes of Health Pooled Cohorts (Framingham Study, Framingham Offspring Study, Multi-Ethnic Study of Atherosclerosis, and Cardiovascular Health Study), which prospectively measured CVD risk factors and incident disease.Prospective cohort study.Adults, aged 75 years or older, free of ASCVD.We evaluated the associations between LDL-C and incident ASCVD (stroke, myocardial infarction, and cardiovascular death) in unadjusted analysis and in multivariable-adjusted Cox proportional hazards models. We assessed 5-year Kaplan-Meier ASCVD event rates in patients with and without hyperlipidemia (LDL-C ≥130 mg/dL or on lipid-lowering medications), stratified by the number of other risk factors, including smoking, diabetes, and hypertension.We included 2667 adults, aged 75 years or older (59% female), free of ASCVD; median age was 78 years, with median LDL-C of 117 mg/dL. In both unadjusted and adjusted analyses, there was no association between LDL-C and ASCVD (adjusted hazard ratio = 1.022; 95% confidence interval = 0.998-1.046; P = .07). Among adults without other risk factors (free of smoking, diabetes, and hypertension), event rates were similar between those with and without hyperlipidemia (Kaplan-Meier rates = 5.8% and 7.0%, respectively). Among adults with one or two or more other risk factors, the presence of hyperlipidemia was also not associated with 5-year CVD event rates (Kaplan-Meier rates = 12.8% vs 15.0% [P = .44] for one other risk factor and 21.9% vs 24.0% [P = .59] for two or more other risk factors).Among a well-characterized cohort, LDL-C was not associated with CVD risk among adults aged 75 years or older, even in the presence of other risk factors. J Am Geriatr Soc 67:2560-2567, 2019.
Published: 2019

6. Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial

Author: Vora, Amit N, Alexander, John H, Wojdyla, Daniel M, Aronson, Ronald, Granger, Christopher B, Darius, Harald, Windecker, Stephan, Mehran, Roxana, Averkov, Oleg, Budaj, Andrzej, Kong, David F, Kobalava, Zhanna, Mehta, Rajendra H, Mirza, Zulfiqar, Guimaraes, Patricia Oliveira, Parkhomenko, Alexander, Quadros, Alexandre, Thiele, Holger, Goodman, Shaun G, and Lopes, Renato D
Subjects: 610 Medicine & health
Published: 2019
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7. Digoxin and Mortality in Patients With Atrial Fibrillation

Author: Lopes, Renato D, Rordorf, Roberto, De Ferrari, Gaetano M, Leonardi, Sergio, Thomas, Laine, Wojdyla, Daniel M, Ridefelt, Peter, Lawrence, John H, De Caterina, Raffaele, Vinereanu, Dragos, Hanna, Michael, Flaker, Greg, Al-Khatib, Sana M, Hohnloser, Stefan H, Alexander, John H, Granger, Christopher B, Wallentin, Lars, and ARISTOTLE Committees and Investigators
Subjects: Male, medicine.medical_specialty, Digoxin, heart failure, 030204 cardiovascular system & hematology, Risk Assessment, Sudden death, Death, Sudden, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Cause of Death, atrial fibrillation, digoxin, mortality, Cardiology and Cardiovascular Medicine, Internal medicine, Outcome Assessment, Health Care, polycyclic compounds, medicine, Humans, In patient, cardiovascular diseases, 030212 general & internal medicine, Correlation of Data, Aged, Cause of death, business.industry, digestive, oral, and skin physiology, Hazard ratio, Atrial fibrillation, Middle Aged, medicine.disease, Confidence interval, carbohydrates (lipids), Heart failure, Cardiology, Female, business, Anti-Arrhythmia Agents, medicine.drug
Abstract: Background Digoxin is widely used in patients with atrial fibrillation (AF). Objectives The goal of this paper was to explore whether digoxin use was independently associated with increased mortality in patients with AF and if the association was modified by heart failure and/or serum digoxin concentration. Methods The association between digoxin use and mortality was assessed in 17,897 patients by using a propensity score–adjusted analysis and in new digoxin users during the trial versus propensity score–matched control participants. The authors investigated the independent association between serum digoxin concentration and mortality after multivariable adjustment. Results At baseline, 5,824 (32.5%) patients were receiving digoxin. Baseline digoxin use was not associated with an increased risk of death (adjusted hazard ratio [HR]: 1.09; 95% confidence interval [CI]: 0.96 to 1.23; p = 0.19). However, patients with a serum digoxin concentration ≥1.2 ng/ml had a 56% increased hazard of mortality (adjusted HR: 1.56; 95% CI: 1.20 to 2.04) compared with those not on digoxin. When analyzed as a continuous variable, serum digoxin concentration was associated with a 19% higher adjusted hazard of death for each 0.5-ng/ml increase (p = 0.0010); these results were similar for patients with and without heart failure. Compared with propensity score–matched control participants, the risk of death (adjusted HR: 1.78; 95% CI: 1.37 to 2.31) and sudden death (adjusted HR: 2.14; 95% CI: 1.11 to 4.12) was significantly higher in new digoxin users. Conclusions In patients with AF taking digoxin, the risk of death was independently related to serum digoxin concentration and was highest in patients with concentrations ≥1.2 ng/ml. Initiating digoxin was independently associated with higher mortality in patients with AF, regardless of heart failure.
Published: 2018

8. Predictive Factors According to Type of Infection in Systemic Lupus Erythematosus Patients : Data from a Multi-Ethnic, Multi-National, Latin-American Cohort

Author: Ugarte Gil, Manuel, Pons Estel, Guillermo J., Wojdyla, Daniel, Cardiel, Mario, Pascual Ramos, Virginia, Garcia De La Torre, Ignacio, Barile, Leonor, Amigo, Mary Carmen, Silveira, Luis H., Sauza del Pozo, Mara Josefina, Guibert Toledano, Marlene, Reyes, Gil A., Iglesias Gamarra, Antonio, Vasquez, Gloria, Molina, José Fernando, Gómez Puerta, José Alfredo, Gónzalez, Luis Alonso, Chacón Díaz, Rosa, Esteva Spinetti, Maria H, Abadi, Isaac, Acevedo Vásquez, Eduardo M., Alfaro Lozano, Jose, Segami, Ines, Massardo, Loreto, Neira, Oscar, Sato, Emilia, Bonfa, Eloisa, Borba, Eduardo, Alarcón, Graciela S., and Pons Estel, Bernardo
Subjects: Biological Factors, Lupus Eritematoso Sistémico, Lupus Erythematosus, Cutaneous, Predicción, Factores Biológicos, Forecasting
Abstract: COL0010959
Published: 2018

9. Additional file 3: of Distribution of postpartum blood loss: modeling, estimation and application to clinical trials

Author: Carvalho, José, Piaggio, Gilda, Wojdyla, Daniel, Widmer, Mariana, and A. Gülmezoglu
Abstract: Table A3. Quantiles for the fitted three-parameter lognormal and empirical distributions, with 95% CI, by treatment (a: Misoprostol trial; b: Active Management trial; d: Althabe et al. trial), or aggregated treatments (c: CHAMPION trial). (PDF 145 kb)
Published: 2018
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10. Additional file 1: of Distribution of postpartum blood loss: modeling, estimation and application to clinical trials

Author: Carvalho, José, Piaggio, Gilda, Wojdyla, Daniel, Widmer, Mariana, and A. Gülmezoglu
Subjects: fungi
Abstract: Table A1. Characteristics of studies analysed for blood loss: four randomised clinical trials (RCTs), one observational study. (PDF 92 kb)
Published: 2018
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11. Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial

Author: Norgren, Lars, Patel, Manesh R, Hiatt, William R, Wojdyla, Daniel M, Fowkes, F Gerry R, Baumgartner, Iris, Mahaffey, Kenneth W, Berger, Jeffrey S, Jones, W Schuyler, Katona, Brian G, Held, Peter, Blomster, Juuso I, Rockhold, Frank W, and Björck, Martin
Subjects: body regions, 610 Medicine & health
Abstract: OBJECTIVES Critical limb ischaemia (CLI) implies an increased risk of cardiovascular morbidity and mortality, and the optimal antithrombotic treatment is not established. DESIGN, MATERIALS, METHODS The EUCLID trial investigated the effect of monotherapy with ticagrelor versus clopidogrel in 13,885 patients with peripheral artery disease (PAD); the primary endpoint was cardiovascular death, myocardial infarction, or ischaemic stroke. Patients planned for revascularisation or amputation within 3 months, were excluded. This analysis focuses on the subgroup with CLI, defined by rest pain (58.8%), major (9.0%) or minor (32.2%) tissue loss. RESULTS In EUCLID, 643 patients (4.6%) had CLI at baseline. Diabetes mellitus was more common in the CLI group, while coronary disease, carotid disease, and hypertension were more common in the non-CLI group. A majority of CLI patients (62.1%) had only lower extremity PAD. In patients enrolled on the ankle brachial index (ABI) criteria, ABI was 0.55 ± 0.21 (mean ± SD) for those with CLI versus 0.63 ± 0.15 for those without CLI. The primary efficacy endpoint significantly increased among patients with CLI compared with those without CLI with a rate of 8.85 versus 4.28/100 patient years (adjusted for baseline characteristics hazard ratio [HR] 1.43 [95% CI 1.16-1.76]; p = 0.0009). When acute limb ischaemia requiring hospitalisation was added to the model, significant differences remained (adjusted HR 1.38, [95% CI 1.13-1.69]; p = 0.0016). The 1 year mortality was 8.9%. A trend towards increased lower limb revascularisation among those with CLI was observed. Bleeding (TIMI major, fatal, intracranial) did not differ between those with and without CLI. CONCLUSIONS Nearly 5% of patients enrolled in EUCLID had CLI at baseline. Milder forms of CLI dominated, a result of the trial design. Patients with CLI had a significantly higher rate of cardiovascular mortality and morbidity versus those without CLI. Further efforts are required to reduce the risk of cardiovascular events in PAD, especially in patients with CLI. CLINICALTRIALS.GOV: NCT01732822.
Published: 2018
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12. Additional file 2: of Distribution of postpartum blood loss: modeling, estimation and application to clinical trials

Author: Carvalho, José, Piaggio, Gilda, Wojdyla, Daniel, Widmer, Mariana, and A. Gülmezoglu
Abstract: Table A2. Goodness of fit statistics for the three-parameter lognormal and other distributions, by treatment (a: Misoprostol trial; b: Active Management trial; d: Althabe et al. trial), or aggregated treatments (c: CHAMPION trial). (PDF 134 kb)
Published: 2018
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13. A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls

Author: Bahamondes, Luis, Brache, Vivian, Meirik, Olav, Ali, Moazzam, Habib, Ndema, Landoulsi, Sihem, Bahamondes, M. Valeria, Massai, Rebeca, Montero, Juan Carlos, Villarroel, Claudio, Kovacs, Laszlo, Pal, Attila, Koloszar, Sandor, Tooth, Marta, Orawan, Kiriwat, Akin, Ayse, Erbaydar, Nüket Paksoy, Erdost, Türküler, Aybaş, Güldali, Beksac, Sinan, Dilbaz, Berna, Haberal, Ali, Kurttekin, Cuma, Giray, Emine, Aktün, Hale, Mollamahmutoglu, Leyla, Tümay, Erdoğan, Evran, Ayşe, Kasule, Jonathan, Chipato, Tsungai, Schmidt, Johannes, Farley, Tim, Culwell, Kelly, Jackson, Emily, Piaggio, Gilda, Hazelden, Catherine, Habib, Ndema Abu, Fersurella, Antonio-Lucio, Steiner, Markus, Hubacher, David, Acevedo, Ninky, Coker, Joy, Kijkuarn, Orawan, Wojdyla, Daniel, Campodonico, Liana, Burgueno, Fernando, Pinol, Alain, Bahamondes, L., Brache, V., Meirik, O., Ali, M., Habib, N. Abu, and Landoulsi, S.
Abstract: STUDY QUESTION Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN, SIZE, DURATION This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. PARTICIPANTS, SETTING, METHODS The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was
Published: 2017

14. Cutaneous Manifestations in Patients with Systemic Lupus Erythematosus: Data from a Multiethnic Latin American Cohort (GLADEL)

Author: Salinas Maria J Haye, Saurit Veronica, Alvarellos Alejandro, Caeiro Francisco, Wojdyla Daniel, Drenkard Cristina, Pons-Estel Guillermo J, Catoggio Luis J, Sarano Judith, Borba Eduardo Ferreira, Sato Emilia, Jacobelli Sergio, Ramírez Luis A, Guibert -Toledano Marlene, Pascual-Ramos Virginia, Cardiel Mario H, Segami Maria I, Abadi Isaac, Alarcon Graciela S, Pons-Estel Bernardo A, and Lupus (GLADEL) Latin American Study Group on
Subjects: medicine.medical_specialty, Latin Americans, business.industry, Cohort, Medicine, In patient, business, Dermatology
Published: 2016

15. Response to Letters Regarding Article, 'Saphenous Vein Graft Failure After Coronary Artery Bypass Surgery: Insights From PREVENT IV'

Author: Hess, Connie N., Lopes, Renato D., Gibson, C. Michael, Hager, Rebecca, Wojdyla, Daniel M., Englum, Brian R., Mack, Michael J., Califf, Robert M., Kouchoukos, Nicholas T., Peterson, Eric D., and Alexander, John H.
Subjects: Male, medicine.medical_specialty, business.industry, Confounding, Observational analysis, Saphenous vein graft, Graft Occlusion, Vascular, Vein graft, Coronary Artery Disease, Article, Surgery, Coronary artery bypass surgery, Vein harvesting, Postoperative Complications, Physiology (medical), Humans, Medicine, Female, Saphenous Vein, Observational study, Coronary Artery Bypass, Cardiology and Cardiovascular Medicine, business
Abstract: We thank Drs Bisleri and Hernandez-Vaquero and their colleagues for their interest in our study.1 We agree with Drs Bisleri and Muneretto that our study was not designed to determine the effect of endoscopic vein harvesting (EVH) on vein graft failure (VGF). As with any observational analysis of an assignable intervention, these results should be interpreted with care because of potential residual confounding. We first reported a possible association between EVH and adverse VGF and clinical outcomes in 2009.2 Since then, other, equally confounded, observational studies have provided conflicting results.3,4 A recent publication from the PRoject of …
Published: 2015

16. Comparison of Clinical Trial Outcome Patterns in Patients Following Acute Coronary Syndromes and in Patients With Chronic Stable Atherosclerosis

Author: Mahaffey, Kenneth W., Wojdyla, Daniel M., Pieper, Karen S., Tricoci, Pierluigi, Alexander, John H., Lincoff, A. Michael, Brennan, Danielle M., Bhatt, Deepak L., Wallentin, Lars, and Harrington, Robert A.
Subjects: Hospitalization, Clinical Trials as Topic, Treatment Outcome, Fibrinolytic Agents, Ischemia, Risk Factors, Clinical Investigations, Humans, Hemorrhage, Acute Coronary Syndrome, Atherosclerosis, Follow-Up Studies
Abstract: BACKGROUND: The transition of patients with atherosclerotic vascular disease from the acute phase of the disease to the chronic stable atherosclerosis (CSA) phase has not been well characterized. We sought to compare ischemic and bleeding outcomes in hospitalized patients enrolled in clinical trials of non–ST‐elevation acute coronary syndrome (ACS) with patients enrolled in outpatient trials of CSA. HYPOTHESIS: The risk for recurrent events will differ between the 2 populations. METHODS: Patient‐level outcome data were evaluated from 3 consecutive trials of patients with ACS with long‐term follow‐up and 2 trials of patients with CSA. Kaplan‐Meier curves were generated for ischemic and bleeding outcomes. RESULTS: In total, 37 370 patients were included in these analyses. Of these, 28 489 (76.2%) were from ACS trials and 8881 (23.8%) from chronic trials. During the first year of follow‐up, 1353 deaths, 1081 cardiovascular (CV) deaths, 2113 myocardial infarctions (MIs), and 397 strokes occurred across the trials. Six‐month Kaplan‐Meier event rates for CV death, MI, or stroke were higher in the ACS trials compared with the CSA trials (8.6% vs 2.7%), as were the 1‐year CV death rate (3.6% vs 1.7%) and 1‐year rates for GUSTO moderate or severe bleeding (6.0% vs 1.3%). Qualitatively, the Kaplan‐Meier curves appear to show an early increased risk as well as a continued increased risk over time. CONCLUSIONS: Patients with ACS enrolled while in the hospital appear to have different risk profiles for ischemic and bleeding outcomes compared with outpatients enrolled with CSA, including those patients with ACS after the acute phase.
Published: 2014

17. Relationship of -Blocker Dose with Outcomes in Ambulatory Heart Failure Patients with Systolic Dysfunction: Results from the HF-ACTION Trial

Author: Fiuzat, Mona, Wojdyla, Daniel, Kitzman, Dalane, Fleg, Jerome, Keteyian, Steven J., Kraus, William E., Piña, Ileana L., Whellan, David, and O’Connor, Christopher M.
Subjects: Hospitalization, Male, Stroke, Adrenergic beta-Antagonists, Bradycardia, Myocardial Infarction, Humans, Female, Middle Aged, Exercise, Article, United States, Heart Failure, Systolic
Abstract: This study sought to examine the association between baseline beta-blocker (BB) dose and outcomes in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.Beta-blockers reduce morbidity and mortality in chronic heart failure (HF) patients with reduced ejection fraction, but it is unclear whether titrating to higher BB doses improves outcomes in this setting.The HF-ACTION trial was a randomized, multicenter trial enrolling 2,331 ambulatory HF patients with systolic dysfunction (New York Heart Association functional class II to IV, left ventricular ejection fraction0.35) randomized to exercise training versus usual care, with median follow-up of 2.5 years. The BB dose at baseline was standardized with carvedilol equivalents and analyzed as a continuous variable and by discrete dose groups. The relationship between BB dose and the primary endpoint of all-cause mortality or all-cause hospitalization and other cardiovascular secondary endpoints was determined before and after adjustment for variables significantly associated with outcomes in the HF-ACTION cohort.Ninety-five percent of patients were receiving a BB. There was a significant inverse relationship between BB dose and all-cause death or hospitalization but not other cardiovascular endpoints after adjustment for other predictors of outcome, with a linear benefit up to the 50-mg daily dose. There was a significant association between BB dose and change in peak VO(2) at 3 months. There was no increase in bradycardia with higher doses of BB.There was a significant inverse relationship between BB dose and the endpoint of all-cause death or all-cause hospitalization in this well-treated HF cohort with systolic dysfunction, supporting recommendations that titrating doses up to 50 mg/day might confer a benefit in such patients. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437).
Published: 2012

18. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared to clopidogrel: Data from the PLATO trials

Author: Patel, Manesh R., Becker, Richard C., Wojdyla, Daniel M., Emanuelsson, Håkan, Hiatt, William, Horrow, Jay, Husted, Steen, Steg, P.G., Storey, R.F.., Wallentin, L., and James, S.K.
Abstract: 14299: Cardiovascular Events in Acute Coronary Syndrome Patients With Peripheral Arterial Disease Treated With Ticagrelor Compared to Clopidogrel: Data From the PLATO Trial Manesh R Patel1; Richard C Becker1; Daniel M Wojdyla2; Håkan Emanuelsson3; William Hiatt4; Jay Horrow5; Steen Husted6; Kenneth W Mahaffey1; Phillippe G Steg7; Robert F Storey8; Lars Wallentin9; Stefan K James10 1 Cardiology, Duke Univ, Durham, NC, 2 Cardiology, Duke Clinical Rsch Institute - Duke Univ, Durham, NC, 3 Rsch and Development, AstraZeneca, 43183 Mölndal, Sweden 4 Cardiology, Univ of Colorado, Denver, CO, 5 Cardiology, AstraZeneca, Wilmington, DE, 6 Cardiology, Aarhus Univ Hosp, DK-8000 Aarhus C, Denmark 7 Cardiology, Hopital Bichat-Claude BernadService de Cardiologie, Paris, France 8 Dept of Cardiovascular Science, Univ of Sheffield, South Yorks, United Kingdom 9 Cardiology, Uppsala Clinical Rsch Cntr, 75185 Uppsala, Sweden 10 Cardiology, Uppsala Clinical Rsch center, 75185 Uppsala, Sweden Background: Patients with peripheral artery disease (PAD) and acute coronary syndrome (ACS) are at high risk for clinical events and are often difficult to manage. We evaluated cardiovascular outcomes of ACS patients with PAD treated with ticagrelor compared with clopidogrel in the PLATO Trial. Methods: The PLATO trial was a multicenter, double-blind, randomized trial, comparing ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-to-600-mg loading dose, 75 mg daily thereafter) for the prevention of cardiovascular events in 18,624 patients admitted with ACS. A post hoc analysis of patients with PAD (n=1144) at baseline compared to those without PAD (n=17,469) was performed for clinical characteristics and outcomes with ticagrelor and clopidogrel at 12 months. Results: PAD patients were older (66 vs. 62 years, p Conclusion: Patients with ACS and PAD have a high rate of death from vascular causes, MI, or stroke. Consistent with the overall trial, ticagrelor use compared to clopidogrel in the PAD patients resulted in similar reductions in clinical events without an increase in major bleeding
Published: 2011

19. Antimalarial Treatment May Have a Time-Dependent Effect on Lupus Survival

Author: Shinjo, Samuel Katsuyuki [UNIFESP], Bonfa, Eloisa, Wojdyla, Daniel, Borba, Eduardo F., Ramirez, Luis A., Scherbarth, Hugo R., Tavares Brenol, Joao C., Chacon-Diaz, Rosa, Neira, Oscar J., Berbotto, Guillermo A., Garcia de La Torre, Ignacio, Acevedo-Vazquez, Eduardo M., Massardo, Loreto, Barile-Fabris, Leonor A., Caeiro, Francisco, Silveira, Luis H., Sato, Emilia Inoue [UNIFESP], Buliubasich, Sandra, Alarcon, Graciela S., Pons-Estel, Bernardo A., Grp Latino Amer Estudio Lupus Erit, Hosp Prov Rosario, Universidade de São Paulo (USP), Univ Nacl Rosario, Univ Antioquia, Hosp Univ San Vicente de Paul, Hosp Interzonal Gen Agudos Dr Oscar Alende, Hosp Clin Porto Alegre, Univ Fed Rio Grande do Sul, Hosp Univ Caracas, Hosp Salvador, Univ Chile, Hosp Escuela Eva Peron, Hosp Gen Occidente Secretaria Salud, Hosp Nacl Guillermo Almenara Irigoyen, Pontificia Univ Catolica Chile, Hosp Especialidades Ctr Med Nacl Siglo XXI, Hosp Privado, Inst Nacl Cardiol Ignacio Chavez, Universidade Federal de São Paulo (UNIFESP), Hosp Nacl Clin, and Univ Alabama
Abstract: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Federico Wilhelm Agricola Foundation Objective. To evaluate the beneficial effect of antimalarial treatment on lupus survival in a large, multiethnic, international longitudinal inception cohort.Methods. Socioeconomic and demographic characteristics, clinical manifestations, classification criteria, laboratory findings, and treatment variables were examined in patients with systemic lupus erythematosus (SLE) from the Grupo Latino Americano de Estudio del Lupus Eritematoso (GLADEL) cohort. the diagnosis of SLE, according to the American College of Rheumatology criteria, was assessed within 2 years of cohort entry. Cause of death was classified as active disease, infection, cardiovascular complications, thrombosis, malignancy, or other cause. Patients were subdivided by antimalarial use, grouped according to those who had received antimalarial drugs for at least 6 consecutive months (user) and those who had received antimalarial drugs for 2 years. Mortality rates among users by duration of antimalarial treatment (per 1,000 person-months of followup) were 3.85 (95% confidence interval [95% CI] 1.41-8.37), 2.7 (95% CI 1.41-4.76), and 0.54 (95% CI 0.37-0.77), respectively, while for nonusers, the mortality rate was 3.07 (95% CI 2.18-4.20) (P for trend < 0.001). After adjustment for potential confounders in a Cox regression model, antimalarial use was associated with a 38% reduction in the mortality rate (hazard ratio 0.62, 95% CI 0.39-0.99).Conclusion. Antimalarial drugs were shown to have a protective effect, possibly in a time-dependent manner, on SLE survival. These results suggest that the use of antimalarial treatment should be recommended for patients with lupus. Hosp Prov Rosario, Rheumatol Serv, RA-2000 Rosario, Santa Fe, Argentina Univ São Paulo, Fac Med, Hosp Clin, São Paulo, Brazil Univ Nacl Rosario, RA-2000 Rosario, Santa Fe, Argentina Univ Antioquia, Medellin, Colombia Hosp Univ San Vicente de Paul, Medellin, Colombia Hosp Interzonal Gen Agudos Dr Oscar Alende, Mar Del Plata, Buenos Aires, Argentina Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil Univ Fed Rio Grande do Sul, Porto Alegre, RS, Brazil Hosp Univ Caracas, Caracas, Venezuela Hosp Salvador, Santiago, Chile Univ Chile, Santiago, Chile Hosp Escuela Eva Peron, Rosario, Santa Fe, Argentina Hosp Gen Occidente Secretaria Salud, Guadalajara, Jalisco, Mexico Hosp Nacl Guillermo Almenara Irigoyen, Lima, Peru Pontificia Univ Catolica Chile, Santiago, Chile Hosp Especialidades Ctr Med Nacl Siglo XXI, Inst Mexicano Seguro Social, Mexico City, DF, Mexico Hosp Privado, Ctr Med Cordoba, Cordoba, Argentina Inst Nacl Cardiol Ignacio Chavez, Mexico City, DF, Mexico Universidade Federal de São Paulo, São Paulo, Brazil Hosp Nacl Clin, Cordoba, Argentina Univ Alabama, Birmingham, W Midlands, England Universidade Federal de São Paulo, EPM, São Paulo, Brazil CNPq: 305468/2006-5 CNPq: 3031165/2008-1 Web of Science
Published: 2010

20. Relationship of Beta-Blocker Dose With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction Results From the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) Trial

Author: Fiuzat, Mona, Wojdyla, Daniel, Kitzman, Dalane, Fleg, Jerome, Keteyian, Steven J., Kraus, William E., Piña, Ileana L., Whellan, David, and O'Connor, Christopher M.
Subjects: beta-blockers, exercise, dose, heart failure, mortality
Abstract: ObjectivesThis study sought to examine the association between baseline beta-blocker (BB) dose and outcomes in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.BackgroundBeta-blockers reduce morbidity and mortality in chronic heart failure (HF) patients with reduced ejection fraction, but it is unclear whether titrating to higher BB doses improves outcomes in this setting.MethodsThe HF-ACTION trial was a randomized, multicenter trial enrolling 2,331 ambulatory HF patients with systolic dysfunction (New York Heart Association functional class II to IV, left ventricular ejection fraction
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21. Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction Results From the HF-ACTION Trial

Author: Fiuzat, Mona, Wojdyla, Daniel, Pina, Ileana, Adams, Kirkwood, Whellan, David, and O’Connor, Christopher M.
Subjects: beta-blockers, exercise, dose, heart rate, heart failure, mortality
Abstract: ObjectivesThis study aimed to compare whether reduced heart rate (HR) or higher beta-blocker (BB) dose affected outcomes to a greater extent in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial population.BackgroundRecent data have shown that HR is an important modifiable factor in reducing mortality in heart failure (HF) patients. It has also been shown that titration of doses of BBs improves outcomes of morbidity and mortality in chronic HF patients with reduced ejection fraction. We aimed to compare whether reduced HR or higher BB dose affected outcomes to a greater extent in the HF-ACTION trial population.MethodsHF-ACTION was a randomized, multicenter trial enrolling 2,331 ambulatory HF patients with systolic dysfunction (New York Heart Association functional class II to IV, left ventricular ejection fraction
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22. Amiodarone, Anticoagulation, and Clinical Events in Patients With Atrial Fibrillation Insights From the ARISTOTLE Trial

Author: Flaker, Greg, Lopes, Renato D., Hylek, Elaine, Wojdyla, Daniel M., Thomas, Laine, Al-Khatib, Sana M., Sullivan, Renee M., Hohnloser, Stefan H., Garcia, David, Hanna, Michael, Amerena, John, Harjola, Veli-Pekka, Dorian, Paul, Avezum, Alvaro, Keltai, Matyas, Wallentin, Lars, and Granger, Christopher B.
Subjects: warfarin, anticoagulants, antiarrhythmia agents, factor Xa, thromboembolism, antithrombotic agents, stroke
Abstract: BackgroundAmiodarone is an effective medication in preventing atrial fibrillation (AF), but it interferes with the metabolism of warfarin.ObjectivesThis study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial.MethodsBaseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone. The interaction between randomized treatment and amiodarone was tested using a Cox model, with main effects for randomized treatment and amiodarone and their interaction. Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization.ResultsIn ARISTOTLE, 2,051 (11.4%) patients received amiodarone at randomization. Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone (56.5% vs. 63.0%; p
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23. Major Bleeding in Patients With Atrial Fibrillation Receiving Apixaban or Warfarin The ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): Predictors, Characteristics, and Clinical Outcomes

Author: Hylek, Elaine M., Held, Claes, Alexander, John H., Lopes, Renato D., De Caterina, Raffaele, Wojdyla, Daniel M., Huber, Kurt, Jansky, Petr, Steg, Philippe Gabriel, Hanna, Michael, Thomas, Laine, Wallentin, Lars, and Granger, Christopher B.
Subjects: factor Xa inhibitor, atrial fibrillation, bleeding
Abstract: ObjectivesThis study sought to characterize major bleeding on the basis of the components of the major bleeding definition, to explore major bleeding by location, to define 30-day mortality after a major bleeding event, and to identify factors associated with major bleeding.BackgroundApixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial.MethodsAll patients who received at least 1 dose of a study drug were included. Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis. Factors associated with major hemorrhage were identified using a multivariable Cox model.ResultsThe on-treatment safety population included 18,140 patients. The rate of major hemorrhage among patients in the apixaban group was 2.13% per year compared with 3.09% per year in the warfarin group (hazard ratio [HR] 0.69, 95% confidence interval [CI]: 0.60 to 0.80; p < 0.001). Compared with warfarin, major extracranial hemorrhage associated with apixaban led to reduced hospitalization, medical or surgical intervention, transfusion, or change in antithrombotic therapy. Major hemorrhage followed by mortality within 30 days occurred half as often in apixaban-treated patients than in those receiving warfarin (HR 0.50, 95% CI: 0.33 to 0.74; p < 0.001). Older age, prior hemorrhage, prior stroke or transient ischemic attack, diabetes, lower creatinine clearance, decreased hematocrit, aspirin therapy, and nonsteroidal anti-inflammatory drugs were independently associated with an increased risk.ConclusionsApixaban, compared with warfarin, was associated with fewer intracranial hemorrhages, less adverse consequences following extracranial hemorrhage, and a 50% reduction in fatal consequences at 30 days in cases of major hemorrhage.
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24. Factors Associated With Major Bleeding Events Insights From the ROCKET AF Trial (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation)

Author: Goodman, Shaun G., Wojdyla, Daniel M., Piccini, Jonathan P., White, Harvey D., Paolini, John F., Nessel, Christopher C., Berkowitz, Scott D., Mahaffey, Kenneth W., Patel, Manesh R., Sherwood, Matthew W., Becker, Richard C., Halperin, Jonathan L., Hacke, Werner, Singer, Daniel E., Hankey, Graeme J., Breithardt, Gunter, Fox, Keith A.A., and Califf, Robert M.
Subjects: anticoagulants, atrial fibrillation, cardiovascular diseases, hemorrhage
Abstract: ObjectivesThis study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).BackgroundThe ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin.MethodsThe risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model.ResultsThe principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (
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24 results on '"Wojdyla, Daniel"'

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24. Factors Associated With Major Bleeding Events Insights From the ROCKET AF Trial (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation)

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