Download - Jose f diaz sca casa corazon
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La antiagregación adecuada para los
360º del SCA
José F. Díaz, MD, FESCComplejo Hospitalario Universitario de Huelva
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Clopidogrel + ASA*
3 6 9
Placebo + ASA*
Months of Follow-Up
11.4%
9.3%
20% RRRP < 0.001
N = 12,562
0 12
* In combination with standard therapy
The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.
CURE:Primary End Point – MI/Stroke/CV Death
2001
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2007
2009
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Primary EndpointCV Death,MI,Stroke
Wiviot SD, Braunwald E, McCabe CH et al NEJM 2007
0
5
10
15
0 30 60 90 180 270 360 450
HR 0.81(0.73-0.90)P=0.0004
Prasugrel
Clopidogrel
Days
Endp
oint
(%)
12.1
9.9
HR 1.32(1.03-1.68)P=0.03
Prasugrel
Clopidogrel1.82.4
CV Death / MI / Stroke
TIMI Major NonCABG Bleeds
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TRITON TIMI 38 Net clinical benefit: Bleeding risk subgroups
OVERALL
≥60 kg
<60 kg
<75
≥75
No
Yes
0.5 1 2
Prior stroke/TIA
Age
Weight
Risk (%)+54
–16
–1
–16
+3
–14
–13
Prasugrel better Clopidogrel betterHR
Pint = 0.006
Pint = 0.18
Pint = 0.36
Wiviot SD, Braunwald E, McCabe CH et al NEJM 2007
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Cum
ulat
ive
Inci
denc
e (%
)PLATO Study
N: 18.624
Days after randomization
Wallentin L et al. N Engl J Med 2009;361:1045-57.
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James SK et al. BMJ 2011; 342:d3527
Mortality reduction in Invasive and non-invasive treatment strategies
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SCASEST
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Admisión Manejo Inicial Angiografía IPC
Curso Hospitalario
PLATO TRITON
Momento de la inclusión de los pacientes SCASEST en PLATO y TRITON
PLATO: - Manejo Invasivo y Conservador antes de A.C.
TRITON: - Sólo ICP después de A.C.
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TRILOGY: PRASUGREL NSTEMI MANEJO MÉDICO
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ACCOASTEstudio de pretratamiento o tratamiento antes versus después de conocer la anatomía coronaria
en NSTEMINSTEMI + troponin >1.5x ULN local laboratory value
clopidogrel-naïve or clopidogrel 75 mg maintenance dose
PRIMARY ENDPOINTSEFFICACY: CV death, MI, stroke, urgent revascularisation. GPIIb/IIIa inhibitor bailout at 7 days
SAFETY: TIMI major and minor bleeding
Placebo(non-pretreatment)
Randomisation 1:1, double blind n=4100 (event-driven)
Prasugrel 30 mg(pretreatment, restricted to
48 hrs prior to angiography/PCI)
Coronary angiography
Prasugrel 30 mg
PCI
Prasugrel 60 mg
PCI
Coronary angiography
Prasugrel 10 mg or 5 mg maintenance therapy (based on
weight and age) daily for 30 days (started 18–24 hrs post-PCI)
Montalescot G, et al. N Engl J Med 2013. DOI: 10.1056/NEJMoa1308075.
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Población con PCI (68,7%) Población general del estudio
ACCOAST: Resultados
Montalescot G, et al. N Engl J Med 2013. DOI: 10.1056/NEJMoa1308075.
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Tiempo administración SCASESTAntes de conocer anatomía coronaria
y antes de ICP
Time, hours Ticagrelor(n=9333)
Clopidogrel(n=9291)
Patients with STEMI
Median 0.25 0.25
IQR 0.05–0.75 0.05–0.72
Patients with NSTEMI
Median 3.93 3.65
IQR 0.48–46.9 0.45–50.8
Wallentin L, et al. N Engl J Med. 2009;361:1045–1057
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Resultados PLATO SCASEST
Lindholm et al. European Heart Journal 2014. doi:10.1093/eurheartj/ehu160
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PLATO SCASEST: Beneficio independientemente si se ralizó o no revascularización
Lindholm et al. European Heart Journal 2014. doi:10.1093/eurheartj/ehu160
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Timing of Benefit (Landmark Analysis – 30 days)
Antman EM. NYHA 2007; http://circ.ahajournals.org/cgi/content/meeting_abstract/118/18_MeetingAbstracts/S_818-c
NNT=70
NNT=227
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Wallentin L et al. N Engl J Med 2009;361:1045-57.
Primary efficacy endpoint over time (composite of CV death, MI or stroke)
8,688
8,763
0 10 20 30
8
6
4
2
0
Cum
ulat
ive
inci
denc
e (%
)
Clopidogrel
Ticagrelor4.775.43
HR 0.88 (95% CI 0.77–1.00), p=0.045
No. at risk
Clopidogrel
Ticagrelor
9,291
9,333
8,875
8,942
8,763
8,827
Days after randomisation
31 90 150 210 270 330
8
6
4
2
0
Clopidogrel
Ticagrelor
5.28
6.60
8,688
8,673
8,286
8,397
6,379
6,480
Days after randomisation*
HR 0.80 (95% CI 0.70–0.91), p<0.001
8,437
8,543
6,945
7,028
4,751
4,822
Cum
ulat
ive
inci
denc
e (%
)
*Excludes patients with any primary event during the first 30 days
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2015 ESC NSTE-ACS Guidelines
AS SOON AS POSSIBLE
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2015 ESC NSTE-ACS Guidelines
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2015 ESC NSTE-ACS Guidelines
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Eventos IsquémicosIschemic endpoint
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Sangradosbleeding
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PCI-CURE
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Ticagrelor LD despúes del diagnóstico de NSTE-ACS
Prasugrel en el momento de la ICP
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SCACEST
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PLATO Vs TRITON TIMI 38SCACEST
PLATO
SCACEST TRITON TIMI 38
Montalescot G et al. Lancet 2009;373:723–731;Steg PG, et al. Circulation 2010;122:2131–2141
El número de pacientes STEMI (40,5%) no fue limitado por el diseño del estudio
El número de pacientes STEMI fue limitado al 26% por el diseño del estudio
All Intended for pPCI
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STEMI Cohort N: 3534
Montalescot et al. Lancet 2009; 373: 723–31
0
5
10
15
0 30 60 90 180 270 360 450
Prasugrel
Clopidogrel
Days
Endp
oint
(%)
12.1
9.9
Prasugrel
Clopidogrel1.82.4
CV Death / MI / Stroke
TIMI Major NonCABG Bleeds
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Montalescot et al. Lancet 2009; 373: 723-31
TRITON STEMI-PCI
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Montalescot et al. Lancet 2009; 373: 723-31
TRITON STEMI-PCI
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TRITON-TIMI 38: Mortality in STEMI
Days from Randomization
0 30 90 180 270 360 450
All
Cau
se D
eath
(%)
0.00.51.01.52.02.53.03.54.04.55.0
Hazard Ratio, 0.76(95% CI, 0.54-1.07)p = 0.11
Prasugrel 3.3%
Clopidogrel 4.3%
Prasugrel - 1769 1694 1666 1644 1619 1605 1324
Clopidogrel - 1765 1683 1653 1636 1615 1598 1299
Number at Risk:
Data on File, Daiichi Sankyo, Inc. and Eli Lilly and Company
CI=Confidence Interval; STEMI=ST-Elevation Myocardial Infarction; TRITON-TIMI=TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel Thromobolysis In Myocardial Infarction
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Población STEMI PLATO
ACS, acute coronary syndromes; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; STE, ST-segment elevation.
10.8%
9.4%
STE-ACSTicagrelor (n=3752)Clopidogrel (n=3792)HR (95% CI) = 0.87(0.75–1.01)p=0.07
Months after randomisation
CV
dea
th, M
I or s
troke
(%)
Steg PG, et al. Circulation 2010;122:2131–2141.
ICP 1ª Sin contar Infartos al alta
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Población STEMI PLATOICP 1ª Contabilizando Infartos al Alta
Steg AHA 2009 Oral Presentation; Steg PG, et al. Circulation 2010;122:2131–2141
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PLATO STEMI: All Cause MortalityK
-M E
stim
ated
Rat
e (%
Per
Yea
r)
Months
Clopidogrel
Ticagrelor
5.0
6.1
HR 0.82 (95% CI = 0.67-1.00), p = 0.05
4,201 4,005 3,962 3,876 3,150 2,413 1,9934,229 4,029 3,989 3,912 3,195 2,471 1,980
No. at riskTicagrelor
ClopidogrelCI=Confidence Interval; HR=Hazard Ratio; K-M=Kaplan-Meier; PLATO=PLATelet Inhibitiion and Patient Outcomes; STEMI=ST-Elevation Myocardial Infarction
0
1
2
3
4
5
6
7
0 1 2 3 4 5 6 7 8 9 10 11 12
Steg PG, et al. Circulation 2010;122:2131–2141.
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Int J Cardiol. 2013 Oct 9;168(4):4566-7
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Protocol BPrasugrel LD: 60mg/Clopidogrel 600mgContrainidcation for Prasugrel use:- >75 años- <60kg- History Ictus- Fibrinolysis- Recent surgery- High Bleeding Risk
Protocol ATicagrelor LD: 180mg /Clopidogrel 600mgContrainidcation for Ticagrelor use:- Fibrinolysis- Recent surgery- High Bleeding Risk- Dialysis
Int J Cardiol. 2013 Oct 9;168(4):4566-7
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GUÍAS SCACEST ESC 2012
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Ticagrelor 180 mg Dosis de carga
PlaceboDosis de cargaPrehospitalario
PlaceboDosis de carga
Ticagrelor 180 mg Dosis de cargaIntrahospitalario
Aleatorización, doble ciego
Ticagrelor 90 mg/bid 30 días
Objetivo primario
o
SCACEST planeado para ICPN=1862*
Consentimiento informado por escrito en la unidad móvilSíntomas de IAM durante más de 30 min pero menos de 6 h
Nueva y persistente elevación del segmento ST ≥1 mm en doso más derivaciones contiguas del ECG
≥70% Resolución de la elevación ST previo a ICP
*Consentimiento y aleatorizado
Montalescot G et al. Am Heart J 2013;165:515-522. Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024].
Flujo TIMI grado 3 del vaso responsable del IM en la angiografía inicial
ATLANTIC: población de estudio y diseño
Pre-hospital ticagrelor administration a short time before PCI in patients with ongoing STEMI is safe but does not improve pre-PCI coronary reperfusion. It may, however, reduce the risk of post-PCI stent thrombosis.
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CONCLUSIONES Los nuevos antiagregantes son más eficaces que clopidogrel
en el SCA. Prasugrel contraindicado en ictus previo, neutro en bajo peso
y ancianos. Mayor efectividad en diabéticos y STEMI Ticagrelor: consistente en todos los grupos. Reduce la
mortalidad Ambos (sobre todo ticagrelor) mantienen e incluso
incrementan la eficacia en el seguimiento En NSTEMI, el pretratamiento con prasugrel no es eficaz.
Ticagrelor sí (PLATO) En STEMI, ticagrelor en pretratamiento reduce la trombosis del
stent sin incrementar el sangrado Manejo más sencillo con Ticagrelor
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HUELVA