Sindrome Coronarica Acuta Antiaggreganti: quale molecola ...
Transcript of Sindrome Coronarica Acuta Antiaggreganti: quale molecola ...
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Sindrome Coronarica Acuta
Antiaggreganti: quale molecola, quale paziente, quale durata?
Alessandra Chinaglia
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Antiaggreganti piastrinici
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Quale molecola ?
ASPIRINA
+
P2Y12 receptor inhibitor
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Quale molecola ?Caratteristiche degli antagonisti del recettore piastinico P2Y12 orali
SerebruanySerebruany, JACC 2005, JACC 2005
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Quale molecola ?Caratteristiche degli antagonisti del recettore piastinico P2Y12 orali
SerebruanySerebruany, JACC 2005, JACC 2005
Variability in plateletresponsiveness to clopidogrel
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Ticagrelor ha maggiore attività antipiastrinica rispetto a clopidogrel ?
Clopidogrel-nonresponsive patients Clopidogrel-responsive patients
* P < 0.0001, † P < 0.001, ‡ P < 0.05* P < 0.0001, † P < 0.001, ‡ P < 0.05
Gurbel, Circulation. 2010;121:1188-1199
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Quale paziente ?
Età avanzataAlto rischio emorragico
Insufficienza renaleDiabete mellito
SCA
NSTEMI STEMI
PCI PPCI FibrinolisiChirurgia Terapia medica
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SCA
STEMI nSTEMI
PCI Non PCI
N Engl J Med 2001;345: 494-502
SCA
STEMI nSTEMI
PCI Non PCI
N Engl J Med 2007;357:2001-15
SCA
STEMI nSTEMI
PCI Non PCI
SCA
STEMI nSTEMI
PCI Non PCIX
N Engl J Med 2012;367:1297-309N Engl J Med 2009;361:1045-57
CLOPIDOGREL PRASUGREL TICAGRELOR
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Triton TIMI 38PRASUGREL vs CLOPIDOGREL
Primary study endpoint: cardiovascular death, myocardial infarction, stroke
Wiviott, NEJM 2007; 357; 20: 2001
Unstable angina or NSTEMI : 74%
PCI: 99% STENT 94%
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CV DeathNonfatal MI
Nonfatal Stroke All Cause Death UTVR Stent Thrombosis
Wiviott SD et al. New Engl J Med 2007;357:2001-2015
TRITONTRITON--TIMI 38: TIMI 38: Major Efficacy End Points at 15 Months (All ACS)Major Efficacy End Points at 15 Months (All ACS)
HR 0.76 P<0.001
HR 0.89 P=0.31
HR 1.02 P=0.93
HR 0.95 P=0.64
(n=6,795)
(n=6,813)
End
Poin
t (%
)
HR 0.66 P<0.001
HR 0.48 P<0.001
2.12.4
7.3
9.5
1.01.0
3.03.2
2.5
3.7
1.1
2.4
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TRITON-TIMI 38: Non-CABG TIMI Major Bleeds at 15 Months (All ACS)
Non-CABGTIMI Major
TIMI Major Spontaneous
TIMI Major Related to Instrumentation
TIMI Major Trauma
(n=6,716)
(n=6,741)
Subsets of Non-CABG TIMI Major
1.8%n=111
P=0.032.4%n=146
0.6%n=38
0.7%n=45
0.2%n=12
0.2%n=9
1.1%n=61
1.6%n=92
P=0.45
P=0.01
P=0.51
Wiviott SD et al. New Engl J Med 2007;357:2001-2015
Endp
oint
(%)
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PLATOTicagrelor vs clopidogrel
Morte cardiovascolare,infarto miocardico, stroke
9.8%11.7%
N Engl J Med 2009;361:1045-57
Unstable angina or NSTEMI : 62%
PCI: 61%
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PLATOACS (37% STEMI – NSTEMI)
Ticagrelor vs clopidogrel
Wallentin L, et al. N Engl J Med. 2009;361:1045-1057.
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Total major bleeding
NS
NS
NS
NS
NS
0
K-M
est
imat
ed ra
te (%
per
yea
r)
PLATO major bleeding
1
2
3
4
5
6
7
8
9
10
12
11
13
TIMI major bleeding
Red cell transfusion *
PLATO life-threatening/
fatal bleeding
Fatal bleeding
TicagrelorClopidogrel
Major bleeding and major or minor bleeding according to TIMI criteria refer to nonadjudicated events analyzed with the use of a statistically programmed analysis in accordance with definition described in (Wiviott SD et al. NEJM. 357:2001-2015); *Proportion of patients (%); NS = not significant
11.611.2
7.9 7.7
8.9 8.9
5.8 5.8
0.3 0.3
Wallentin L et al. N Engl J Med. 2009 Sep 10;361(11):1045-57
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Non-CABG and CABG-related major bleeding
p=0.0264
p=0.0246
NS
NS
9K
-M e
stim
ated
rate
(%
per
yea
r)
Non-CABGPLATO major
bleeding
8
7
6
5
4
3
2
1
0Non-CABGTIMI major bleeding
CABGPLATO major
bleeding
CABG TIMI major bleeding
TicagrelorClopidogrel
4.5
3.8
2.8
2.2
7.4
7.9
5.3
5.8
Wallentin L et al. N Engl J Med. 2009 Sep 10;361(11):1045-57
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NSTEMI sottoposto a PCI ?
Cannon, Lancet 2010
Cardiovascular death, myocardial infarction, or stroke
p=0·0025
PCI: 77 %
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NSTEMI sottoposto a PCI ?
Cannon, Lancet 2010
All cause death p=0·0025
PCI: 77 %
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Cannon, Lancet 2010
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Quale paziente ?
Età avanzataAlto rischio emorragico
Insufficienza renaleDiabete mellito
SCA
NSTEMI STEMI
PCITICAGRELORPRASUGREL
PPCI FibrinolisiChirurgia0 Terapia medica
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N Engl J Med 2012;367:1297-309
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Hazard ratio 0.75, 0.61 to 0.93; P=0.01
James, BMJ 2011;342
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Quale paziente ?
Età avanzataAlto rischio emorragico
Insufficienza renaleDiabete mellito
SCA
NSTEMITICAGRELOR STEMI
PCITICAGRELORPRASUGREL
PPCI FibrinolisiChirurgia0
Terapia medicaTICAGRELOR
CLOPIDOGREL
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NSTEMI ad alto rischio (anziani) ?
Husted, Circ Cardiovasc Qual Outcomes, 2012 Sep 1;5(5):680-8
Cardiovascular death/MI/stroke All cause mortality
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Husted, Circ Cardiovasc Qual Outcomes, 2012 Sep 1;5(5):680-8
Major bleeding Non-CABG-related bleeding
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26
RRR 38%
RRR 19%
James, Circulation published online May 9, 2012
NSTEMI con pregresso TIA/stroke ?
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27James, Circulation published online May 9, 2012
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Quale paziente ?
Età avanzata: TICAGRELOR, CLOPIDOGRELAlto rischio emorragico: TICAGRELOR, CLOPIDOGRELInsufficienza renaleDiabete mellito
SCA
NSTEMI STEMI
PCITICAGRELORPRASUGREL
PPCI FibrinolisiChirurgia0
Terapia medicaTICAGRELOR
CLOPIDOGREL
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Circulation. 2010;122:1056-1067
HR 0.77; 95% CI 0.65 to 0.90
17%
22%
7,9%
8,9%
HR, 0.72; 95% CI,0.58 to 0.89
10%
14%
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Circulation. 2010;122:1056-1067
15.1%
14.3%;
HR, 1.07; 95% CI, 0.88 to 1.30
8.5%
7.3%
HR, 1.28; 95% CI, 0.97 to 1.68
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Quale paziente ?
Età avanzata: TICAGRELOR, CLOPIDOGRELAlto rischio emorragico: CLOPIDOGREL, TICAGRELORInsufficienza renale: TICAGRELORDiabete mellito:
SCA
NSTEMI STEMI
PCITICAGRELORPRASUGREL
PPCI FibrinolisiChirurgia0
Terapia medicaTICAGRELOR
CLOPIDOGREL
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Wiviott, Circulation. 2008;118:1626-1636
NNT : 13 DM on insulin, 26 DM not on insulin, 71 no DM
Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
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Wiviott, Circulation. 2008;118:1626-1636
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James, EurHJ, August 29, 2010
NSTEMI ad alto rischio (diabete) ?
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James, EurHJ, August 29, 2010
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Quale paziente ?
Età avanzata: TICAGRELOR, CLOPIDOGRELAlto rischio emorragico: CLOPIDOGREL, TICAGRELORInsufficienza renale: TICAGRELORDiabete mellito: PRASUGREL
SCA
NSTEMI STEMI
PCITICAGRELORPRASUGREL
PPCI FibrinolisiChirurgia0
Terapia medicaTICAGRELOR
CLOPIDOGREL
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SCA
STEMI nSTEMI
PCI Non PCI
N Engl J Med 2001;345: 494-502
SCA
STEMI nSTEMI
PCI Non PCI
N Engl J Med 2007;357:2001-15
SCA
STEMI nSTEMI
PCI Non PCI
SCA
STEMI nSTEMI
PCI Non PCIX
N Engl J Med 2012;367:1297-309N Engl J Med 2009;361:1045-57
CLOPIDOGREL PRASUGREL TICAGRELOR
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Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke cardiovascular death, non-fatal myocardial infarction, urgent target vessel revascularisation
Stent thrombosis TIMI major bleeding unrelated to CABG surgery
Lancet 2009; 373: 723–31
3534 pazientiPCI 97%
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7544 pazientiPCI 82%
HR, 1.63; 95% CI, 1.07 to 2.48; P<0.02
HR, 0.87; 95% CI, 0.75 to 1.01; P<0.07
HR, 0.83; 95% CI, 0.67 to 1.02; P0.07
HR, 0.80; 95% CI, 0.65 to 0.98; P0.03
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Quale paziente ?
Età avanzata: TICAGRELOR, CLOPIDOGRELAlto rischio emorragico: CLOPIDOGREL, TICAGRELORInsufficienza renale: TICAGRELORDiabete mellito: PRASUGREL
SCA
NSTEMI STEMI
PCITICAGRELORPRASUGREL
PPCIPRASUGRELTICAGRELOR
FibrinolisiChirurgia0
Terapia medicaTICAGRELOR
CLOPIDOGREL
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Quanto è rapida l’inibizione piastrinica dopo il carico ?
Am Heart J 2007;153:66.e9266.e16 Circulation. 2009;120:2577-2585
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Parodi, JACC 2013;61:1601–6
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Alexopoulos Circ Cardiovasc Interv. 2012;5:797-804
Pre-hospital vs In-hospital Initiation of Ticagrelor Therapy in STEMI PatientsPlanned for Percutaneous Coronary Intervention (ATLANTIC) study
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Bhatt, N Engl J Med, March 10 2013
Death from any cause,myocardial infarction, ischemia-driven revascularization, stent thrombosisat 48 hours after randomization
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Quale durata ?CLOPIDOGREL
PRASUGREL
TICAGRELOR
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30 day and 31–365 day mortality after first time hospitalisation for myocardial infarction between 1984 and 2008
in a Danish nationwide cohort study
Schmidt et al. BMJ 2012
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Mortalità complessiva al fup a 6 mesiInH su tutti i pz, a 30 gg e a 6 mesi su quelli con dato disponibile
8,2% 7,5%
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Quale molecola ?Caratteristiche degli antagonisti del recettore piastinico P2Y12 orali
reversibileNOTicagrelor
2-4 ore75-85%irreversibileSIPrasugrel
2 ore40-60%irreversibileSIClopidogrel
Tempo dal caricoIPA massimaLEGAMEProfarmaco
Variability in platelet responsiveness to clopidogrel
SerebruanySerebruany, JACC 2005, JACC 2005
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Coronarografia: 43.7 %CABG 16.5 %PCI 21.2 %
CUREDeath from Cardiovascular Causes, Nonfatal Myocardial Infarction, Stroke
N Engl J Med 2001;345: 494-502
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COMMIT Lancet 2005;366:1607-21
COMMIT: CLOPIDOGREL 75 mg (non carico)45852 pazienti trattati con aspirina e fibrinolisi (54%) o non riperfusi
Morte, Re-IMA o Stroke
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CLARITY: clopidogrel 300 vs placebo3491 pazienti < 75 anni trattati con fibrinolisi + aspirina
End Point: Death from Cardiovascular causes, Recurrent Myocardial Infarctionor Recurrent Ischemia Leading to the Need for Urgent Revascularization.
Sabatine, NEJM, 352;12; 2005: 1179
14.1%
11.6%
P=0.03
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58
EventTicagrelor,%
(n=2601)Clopidogrel, %
(n=2615) p valueCV death, MI or stroke 12.0 14.3 0.045
MI 7.2 7.8 0.555
CV death 5.5 7.2 0.019
All-cause death 6.1 8.2 0.010
Non-CV death 0.6 1.0 0.252
Stroke 2.1 1.7 0.162
CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; NSTEMI, non-ST-segment elevated myocardial infarction; UA, unstable angina.James S, et al. BMJ 2011;342:d3527.
[James 2011:K]
Clopidogrel betterTicagrelor better
1.0 2.00.2
HR (95% CI)
NSTEMI sottoposto a PCI ?PLATO intent for non-invasive management
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NSTEMI
STRATEGIA CONSERVATIVA
PRASUGREL
PCI
TICAGRELORCLOPIDOGREL
DiabeteGiovane
Alto rischioInsufficienza renale
Età avanzataPeso<60 kg
TICAGRELOR
Alto rischioemorragico
TAOPeso<60 kg
CLOPIDOGREL
TICAGRELORCLOPIDOGREL