ABSTRACT
Introducción y objetivos: Los anticoagulantes orales directos (ACOD) se han mostrado eficaces y seguros en pacientes con fibrilación auricular; sin embargo, los pacientes con FA y bioprótesis están infrarrepresentados en los ensayos clínicos, por lo que la evidencia en este grupo es menor. Nuestro objetivo fue analizar la seguridad y eficacia de los ACODs en esta población revisando la información existente en la literatura. Métodos: Se realizó una búsqueda y revisión sistemática con los ensayos clínicos aleatorizados y estudios observacionales comparativos desde 2017 a enero de 2022, que comparasen ACODs y antagonistas de vitamina K (AVK) en pacientes con FA y bioprótesis. Se utilizó la hazard ratio al 95% del intervalo de confianza para comparar ambos grupos en términos de mortalidad total y cardiovascular, ictus/embolia sistémica y hemorragia mayor. Se realizó un metanálisis combinando los resultados de los estudios incluidos. Resultados: Se incluyeron 12 estudios (un total de 30.283 pacientes). Los ACODs se asociaron a una reducción significativa del 9% de la mortalidad total (HR=0,91; IC95%, 0,85-0,97; p=0,0068; I2=8%), sin diferencias significativas en el riesgo de ictus/embolismo sistémico (HR=0,87; IC95%, 0,67-1,14; p=0,29; I2=45%) o hemorragia mayor (HR=0,82; IC95%, 0,67-1,00; p=0,054; I2=48.7%). Conclusiones: En pacientes con FA portadores de bioprótesis, los ACODs podrían asociarse a una reducción de la mortalidad total sin reducción de eficacia en la prevención de ictus/embolia sistémica o aumento del riesgo de hemorragia mayor.(AU)
Introduction and objectives: Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature. Methods: A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed. Results: We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I2=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I2=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I2=48.7%). Conclusions: DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.(AU)
Subject(s)
Humans , Male , Female , Atrial Fibrillation , Bioprosthesis , Anticoagulants , CardiologyABSTRACT
INTRODUCTION AND OBJECTIVES: Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature. METHODS: A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed. RESULTS: We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I2=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I2=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I2=48.7%). CONCLUSIONS: DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.
Subject(s)
Atrial Fibrillation , Embolism , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Anticoagulants , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Hemorrhage/complications , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control , Embolism/epidemiology , Embolism/etiology , Embolism/prevention & control , Administration, Oral , Vitamin KABSTRACT
Antecedentes y objetivo: La fibrilación auricular y la anticoagulación merman la calidad de vida de los pacientes. El objetivo del estudio es valorar la calidad de vida y el grado de satisfacción tras el cambio de anticoagulante de AVK a edoxabán.Material y métodosEstudio prospectivo, multicéntrico, que incluye a 105 pacientes en tratamiento con dicumarínicos que se sustituye por edoxabán. Se valoró la calidad de vida antes y después a través del cuestionario EQ-5D y el grado de satisfacción con la escala CRES-4.ResultadosEdad media 75 años, CHA2DS2VASC 3,5puntos, HASBLED 2,1puntos; eventos tromboembólicos y hemorragias clínicamente relevantes durante el seguimiento <1%. El EQ5D mostró una mejoría global significativa en los parámetros de movilidad y ansiedad (p=0,023, IC95%: 0,0175-0,23; p=0,019, IC95%: 0,028-0,31). El CRES-4 recoge una satisfacción con el terapeuta del 95%, una repercusión positiva en la vida del 73% y negativa del 3,8%. La situacional emocional atribuida al cambio de tratamiento mejoró (41% vs 69,5%, p=0,0001). Se correlacionó débilmente la puntuación final del CRES-4 con la situacional emocional del EQ-5D.ConclusionesEl cambio de anticoagulante por edoxabán mejora la calidad de vida y el grado de satisfacción del paciente, pudiendo emplearse conjuntamente los cuestionarios de calidad de vida EQ-5D y el CRES-4. (AU)
Background and objective: Atrial fibrillation and anticoagulation decrease the quality of life of patients. The aim of this study is to assess the quality of life and the degree of satisfaction after changing from VKA to edoxaban anticoagulants.Material and methodsProspective, multicentre study, including 105 patients in dicumarinic anticoagulant treatment replaced by edoxaban. Their quality of life was evaluated before and after using the EQ-5D questionnaire, and the degree of satisfaction with CRES-4 scale.ResultsAverage 75 years, CHA2DS2VASC3,5 and HASBLED2,1; thromboembolic events and clinically relevant bleeding during follow-up <1%. EQ-5D showed a significant overall improvement in the mobility and anxiety parameters (P=.023, 95%CI: .0175-.23; P=.019, 95%CI:=.028-.31). The CRES-4 questionnaire showed satisfaction with the therapist of 95%, a positive impact on life of 73% and a negative impact of 3.8%. The emotional state attributed to the change in treatment improved (41% vs 69.5%, P=.0001). The final score of the CRES-4 weakly correlated with the emotional situation of the EQ-5D questionnaire.ConclusionsThe change of anticoagulant for edoxaban improves the quality of life and the degree of patient satisfaction, and the EQ-5D and CRES-4 quality of life questionnaires can be used complementarily. (AU)
Subject(s)
Humans , Patient Satisfaction , Personal Satisfaction , Pyridines , Quality of Life , Thiazoles , Prospective Studies , Surveys and QuestionnairesABSTRACT
BACKGROUND AND OBJECTIVE: Atrial fibrillation and anticoagulation decrease the quality of life of patients. The aim of this study is to assess the quality of life and the degree of satisfaction after changing from VKA to edoxaban anticoagulants. MATERIAL AND METHODS: Prospective, multicentre study, including 105 patients in dicumarinic anticoagulant treatment replaced by edoxaban. Their quality of life was evaluated before and after using the EQ-5D questionnaire, and the degree of satisfaction with CRES-4 scale. RESULTS: Average 75 years, CHA2DS2VASC3,5 and HASBLED2,1; thromboembolic events and clinically relevant bleeding during follow-up <1%. EQ-5D showed a significant overall improvement in the mobility and anxiety parameters (P=.023, 95%CI: .0175-.23; P=.019, 95%CI:=.028-.31). The CRES-4 questionnaire showed satisfaction with the therapist of 95%, a positive impact on life of 73% and a negative impact of 3.8%. The emotional state attributed to the change in treatment improved (41% vs 69.5%, P=.0001). The final score of the CRES-4 weakly correlated with the emotional situation of the EQ-5D questionnaire. CONCLUSIONS: The change of anticoagulant for edoxaban improves the quality of life and the degree of patient satisfaction, and the EQ-5D and CRES-4 quality of life questionnaires can be used complementarily.
