seleccion tratamiento antitrombotico #asturgalaico15
TRANSCRIPT
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Selección del tratamiento antitrombótico
@rafavidalperez
Rafael Vidal PérezHospital Universitario Lucus Augusti (Lugo)
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Conflicto de intereses• Boehringer Ingelheim • Almirall /Bayer Healthcare• Pfizer / Bristol-Myers Squibb
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Recomendaciones para dar una charla
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Creo que voy a hablar de ciencia ficción hasta 2020
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Guías de práctica clínica y situación económica actual
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2013
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Diagrama en espina de pescado
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19%RivDab Api
2013
Ventas
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Índice• Que sabíamos y dosis de recuerdo• Discutiendo la evidencia y mundo real• Grado de control de anticoagulación con AVK
y su predicción• Algoritmos de selección tratamiento-Guías• ¿Qué queda por saber?
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Que sabíamos y dosis de recuerdo
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Fibrilación auricular: datos epidemiológicosRegistro OFRECE
• La prevalencia de fibrilación auricular (FA) en la población general española mayor de 40 años es elevada, del 4,4%
• La prevalencia global es similar en varones que en mujeres, pero se observan diferencias en función de las décadas de edad analizada, y se incrementa escalonadamente a partir de los 60 años
• Hay más de un millón de pacientes con FA en la población española, de los que más de 90.000 están sin diagnosticar
Gómez-Doblas JJ, et al, en representación de los colaboradores del estudio OFRECE. Prevalence of Atrial Fibrillation in Spain. OFRECE Study Results. Rev Esp Cardiol. 2013 Nov 25. pii: S0300-8932(13)00405-3. doi: 10.1016/j.recesp.2013.07.015
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Estudios regionales: Datos del área del Barbanza
2Barrios V, Calderón A, Escobar C, de la Figuera M. Pacientes con fibrilación auricular asistidos en consultas de atención primaria. Val-FAAP Rev Esp Cardiol. 2012;65:47–53.3Grupo Barbanza para el Estudio de las Enfermedades Cardiovasculares. Características de los pacientes con cardiopatías en un área sanitaria de la provincia de A Coruña. Estudio Barbanza 2000. Rev Clin Esp. 2003;203:570–6
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¿Son necesarios los Registros Locales?
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DISOCIACIÓN GUÍASREALIDAD DIARIA
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FA
Necesidad de anticoagulación
Control del ritmo y la frecuencia cardíaca
Tratamiento de la enfermedad subyacenteTratamiento causal
Síntomas de tipo FA
• Control de la frecuencia•±Control del ritmo• Medicamentos antiarrítmicos• Ablación
Considerar una derivación
• IECA/ARA II• Estatinas/AGP• Otros
Evaluar el riesgo de TE • Anticoagulante oral
• Aspirina• Ninguno
Registrar ECG de 12 derivaciones
• Presentación• Puntuación EHRA• Enfermedad asociada• Valoración inicial
Tomar el pulso a > 65 años
¿Cómo tratar al paciente con fibrilación auricular?
2012 focused update of the ESC Guidelines for the management
of atrial fibrilation
Gráfica elaborada de Camm AJ, Kirchhof P, Lip GYH, et al. Guidelines for the management of atrial fibrillation. The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31;2369-429.
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Prevención de ictus en la fibrilación auricularNuevos anticoagulantes orales
N Engl J Med. 2013;369:2093-104
2009 2011
2011 2013
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< que Warfarina> que Warfina
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¿Hacían falta los NACOs?
Antagonistas de la vitamina K Nuevos anticoagulantes orales
Monitorización de laboratorio con ajuste de dosis frecuente (estrecha ventana terapéutica) Respuesta menos predecible Interacciones frecuentes con otros fármacos Interacciones con alimentos Comienzo y desaparición de acción lentos
Necesidad de terapia puente (heparina)
No necesita monitorización ni ajuste de dosis frecuentes Efecto anticoagulante lineal y predecible Mínimas interacciones farmacológicas Ausencia de interacciones con los alimentos Inicio y final de acción rápidos
Tabla elaborada de Ansell J, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008; 133(6 Suppl):160S-198S.
Anti doto Si Anti doto NoP r o n t o S I
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Eur Heart J 2014 35: 3155-3179
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Eur Heart J 2014 35: 3155-3179
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Discutiendo la evidencia y mundo real
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NUEVAS EVIDENCIAS SOBRE AAS
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Risk of myocardial infarction/coronary death
Risk of thromboembolism
Risk of bleeding Risk of all-cause death
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Friberg L et col. J Am Coll Cardiol. 2015;65(3):225-232.
Conclusions The risk of ischemic stroke in patients with AF and a CHA2DS2-VASc score of 1 seems to be lower than previously reported.
Retrospective study of 140,420 patients with AF in Swedish nationwide health registries on the basis of varying definitions of “stroke events.”
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Tze-Fan C et col. J Am Coll Cardiol. 2015;65(7):635-642
National Health Insurance Research Database in Taiwan. De 186,570 pacientes con FA 12935 hombres7900 mujeres
Conclusions Not all risk factors in CHA2DS2-VASc score carry an equal risk, with age 65 to 74 years associated with the highest stroke rate. Oral anticoagulation should be considered for AF patients with 1 additional stroke risk factor given their high risk of ischemic stroke.
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Lip GYH et col. J Am Coll Cardiol. 2015;65(14):1385-1394
Danish Registries 39,400 patients with incident nonvalvular AF with CHA2DS2-VASc risk factor 0 or 1 +23,572 were not treated+5,353 were initiated on aspirin, +10,475 were initiated on warfarin.
Conclusions Low-risk patients (CHA2DS2-VASc = 0 [male], 1 [female]) have a truly low risk for stroke and bleeding. With 1 additional stroke risk factor (CHA2DS2-VASc = 1 [male], = 2 [female]), there was a significant increase in event rates
(particularly mortality) if nonanticoagulated.
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DenmarkPatients discharged with non-valvular AFN=121 280
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N=1.028
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http://www.medscape.com/viewarticle/818013
That means we can tell an AF patient similar to the 60 000+ enrolled in the three randomized clinical trials that he or she has a 99.4% chance of not having an ICH on a NOAC drug and a 98.8% chance of not having one on warfarin.
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All-cause stroke or systemic embolism
MajorBleeding
Compared with standard adjusted dose VKA, new oral anticoagulants were associated with modest reductions in the absolute risk of stroke and major bleeding. People on antiplatelet drugs experienced more strokes compared with anticoagulant drugs without any reduction in bleeding risk
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Thrombosis and Haemostasis 111.5/2014
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Thrombosis and Haemostasis 111.5/2014
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DATOS SEGUIMIENTO FDADABIGATRAN
http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm
As a result of our latest findings, we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use
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New-user cohorts of propensity score–matched elderly patients enrolled in Medicare who initiated dabigatran or warfarin for treatment of nonvalvular atrial fibrillation between October 2010 and December 2012. N:134 414 patients with 37 587 person-years of follow-up
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Using a cohort of non-valvular AF patients initiating anticoagulation from October 2010 to December 2012 drawn from a large US database of commercial and Medicare supplement claims N: 64 935; 32.5% used dabigatran
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Clin Cardiol. 2015 Feb;38(2):63-8
US Department of Defense EMRs, which served as the sole data source for this study. Theobservational period for this report was January 1, 2013, to March 31, 2014, and only patients with confirmed NVAF were included N=27467
In this large observational study, the MB rate was generally consistent with the registration trial results, and fatal bleeds were rare.
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Europace (2015) 17, 514–523
Once-daily dosing may increase absolute adherence, but twice daily dosing regimens may be more forgiving in patients with suboptimal adherence.Prospective clinical evaluation is needed, also to relate outcome factors of drug regimen to the type of patient: one regimen may not suit all.
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Bonde AN et col. JACC 2014;64(23):2471-82
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Circulation. 2015;131:972-979
Dabigatran and Rivaroxaban use in the atrial fibrillation–end-stage renal disease population has steadily risen where 5.9% of anticoagulated dialysis patients are started on dabigatrian or rivaroxaban
Dabigatran (RR, 1.48; 95% CI, 1.21–1.81; P=0.0001) and Rivaroxaban (RR, 1.38; 95% CI, 1.03–1.83; P=0.04) associated with a higher risk of major bleeding when compared with warfarin.
The risk of hemorrhagic death was even larger with dabigatran (RR, 1.78; 95% CI, 1.18–2.68; P=0.006) and rivaroxaban (RR, 1.71; 95% CI,0.93–3.12; P=0.07) referent to warfarin.
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Grado de control de anticoagulación con AVK y su predicción
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Situaciones de uso de NACOs
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DATOS ESTUDIO ANFAGAL
Cortesía Sergio Cinza Sanjurjo
► Objetivos• Conocer el TRT en los pacientes que realizan su control de INR en nuestro
los centros de salud de la Comunidad Autónoma de Galicia• Analizar las variables que condicionan aumento tanto de trombosis como
de hemorragia en el paciente anticoagulado• Analizar las comorbilidades que puedan condicionar el uso de
anticoagulantes
• Estudio Transversal• Criterios Inclusión:
• Pacientes mayores de 65 años• Diagnóstico de FA no valvular• A tratamiento con antivitamínicos K
Rev Esp Cardiol 2014 In press
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DATOS ESTUDIO ANFAGAL
Cortesía Sergio Cinza Sanjurjo
► Tiempo Medio: 10,6±0,4 meses
► Determinaciones: 13,7±0,2
► AVK:• Acenocumarol (98,2%) • Warfarina (1,8%)
► Validación:• Hematólogo: 46,4% • Equipo de AP: 35,4% • Mixto: 18,2%
► Escalas:• CHADs2 = 2,3±0,1• CHADs-Vasc = 3,8±0,1 • Has-Bled = 3,1±0,1
47.0%
53.0% Varón
Mujer
Rev Esp Cardiol 2014 In press
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DATOS ESTUDIO ANFAGAL
Cortesía Sergio Cinza SanjurjoRev Esp Cardiol 2014 In press
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DATOS ESTUDIO ANFAGAL
Cortesía Sergio Cinza SanjurjoRev Esp Cardiol 2014 In press
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DATOS ESTUDIO ANFAGAL
Cortesía Sergio Cinza Sanjurjo
Predictores Mal control
Rev Esp Cardiol 2014 In press
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Población del Estudio (n=734)
Edad, media ± D.S. (años) 77.4 ± 8.8
Género
Femenino, n (%) 331 (45.1)
IMC, media ± D.S 29.9 ± 5.2
Hábitos
Ejercicio físico regular, n (%) 262 (35.7)
No fumador, n (%) 488 (66.5)
Historia médica previa/comorbilidades
HTA, n (%) 583 (79.4)
Dislipemia, n (%) 406 (55.3)
Diabetes Mellitus, n (%) 230 (31.3)
Ictus/AIT, n (%) 104 (14.2)
INR lábil conocido, n (%) 93 (12.7)
Datos de INR en tratamiento con AVK
Cortesía Sergio Cinza Sanjurjo Vivencio Barrios
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Rev Esp Cardiol 2015 In press
Calidad de la Anticoagulación y comorbilidades asociadas en pacientes con Fibrilación Auricular no valvular en consultas de Cardiología
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www.calculadoratrt.comTIEMPO DE RANGO TERAPÉUTICO
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Some physicians may be reluctant to use an additional scoring system for the only purpose of identifying the risk of a low TTR with VKA, such a tool may avoid simplistic strategies with ‘VKA strategy for everybody’ (a ‘trial of warfarin’ strategy advocated and sometimes imposed by payers) or ‘NOAC for everybody unless contraindicated’ (rather defended by evidence-based medicine but maybe too expensive)
Europace (2015) 17 (5): 671-673
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Europace. 2015 May;17(5):711-7N=911
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Algoritmos de selección tratamiento-Guías
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¿Qué queda por saber?
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J Am Coll Cardiol 2015;65:1340–60 JAMA. 2015;313(19):1950-1962.
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