Thromboembolic and bleeding events with rivaroxaban in clinical practice in Spain: impact of inappropriate doses (the EMIR study)
Authors: Fernández Marcelo Sanmartín , Marín Francisco , Rafols Carles , Arribas Fernando , Barrios Vivencio , Cosín-Sales Juan , Sánchez Manuel Anguita , Pérez Cabeza Alejandro , Tercedor Luis , Gamez Lopez Antonio Luis , Ruiz Martín , Cortez Quiroga Gustavo , Arrebola Moreno Antonio Luis , Lopez Sanchez Eduardo Sebastian , Torres Llergo Javier , Motero Carrasco Juan , Sáinz Hidalgo Ignacio , Pérez Muñoz Carlos , Bolea Lafont Adolfo , Barón Esquivas Gonzalo , Francisco Monzón Jose , Renilla González Alfredo , Valverde Andre Irene , Ripoll Vera Tomás , Diez-Aja López Salvador , Melero Pita Antonio , Macias Gallego Alfonso , Duran Bobin Olga , Martin Raimondi Diego , Dominguez Calvo Jesus Ignacio , Perez Rivera Jose Angel , Costa Vazquez Juan R. , Rollán Gómez María Jesús , Freixa Romà , Roca Ivo , Mont Girbau Lluis , Valles Gros Ermengol , Manito Lorite Nicolás , Vilades David , Punti Jordi , Sarrias Axel , Paz Marco , Gomez Zamira , Darnes Sara , Roca Catalán Juan Manuel , Pindado Rodriguez Javier , Andrés Novales Javier , Umaran Juana , Natividad Andres Ruben , Recalde Del Vigo Esther , Beramendi Calero Juan Ramon , Quintas Laura , Porras Ramos Yolanda , Fernandez Mouzo Ricardo , Rodriguez Vilela Alejandro , Díaz Castro Oscar , Gonzalez Juanatey Carlos , Martinez Florez Julio , Rincón Díaz Luis Miguel , Escudier Villa Juan Manuel , Merino Lanza Esther , Antorrena Isabel , Salguero Bodes Rafael , Alegria Eduardo , Llanos Guerrero Cristina , Serra Tomás Viviana , Fuertes Beneitez Javier , Palazuelos Molinero Jorge , Del Castillo Roberto , Alvarez-Vieitez Blanco Antonio , Marin Ortuño Francisco , Ureña Isabel , Olaz Preciado Fernando , Peset Cubero Ana , Quiles Juan , Brouzet Thomas , Chamorro Fernandez Carlos Israel , Cosin Sales Juan , Ridocci Soriano Francisco , Peris Domingo Enrique , Puigdueta Vindel Belen , Parra Jimenez Francisco Javier , Estruch Catalá Gerardo , Martinez Litago Eduardo , Martinez Mateo Virgilio , Royo Gutierrez Manuel , Monzer Khanjikhatib Mohaned , Vazquez Rey Eugenia , Elduayen Gragera Javier , Garcia Aguado Marcos , Cordero Pereda David , Clares Montón Patricia , Manuel Vazquez Jose , Lekuona Iñaki 
Published: March 2021

Aim:
To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years.
Materials & methods:
Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included.
Results:
A total of 1421 patients (74.2 ± 9.7 years, CHA
2
DS
2
-VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75–2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14).
Conclusion:
In clinical practice, rivaroxaban is properly dosed in most patients.