Upstream P2Y 12 RB. Stefano Savonitto Divisione di Cardiologia Arcispedale S. Maria Nuova Reggio Emilia
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1 Upstream P2Y 12 RB Stefano Savonitto Divisione di Cardiologia Arcispedale S. Maria Nuova Reggio Emilia
2 Dio può essere dimostrato Le dimostrazioni dell esistenza di Dio IA
3 Dio non può essere dimostrato La fede è un salto nell incerto IC
4 CREDO Study Design (Early) PCI* 28 Days Load N=1750 Clopidogrel Arm Pretreatment 3-24 h before PCI Clopidogrel 300 mg + ASA (325 mg) Clopidogrel 75 mg QD + ASA 325 mg QD No Load Placebo Arm R Placebo + ASA (325 mg) Clopidogrel 75 mg QD + ASA 325 mg QD * Both groups received clopidogrel 75 mg + ASA 325 mg at time of procedure Plus other standard therapies (50% GPI, 50% statins) Steinhubl S et al. JAMA 2002;288:
5 CREDO: Clopidogrel Loading Dose Timing and Risk of MACE (Posthoc analysis) - 2 Log Odds of Death, MI or UTVR at 28 Days Placebo Clopidogrel p=0.020 for treatment/ timing interaction Hours Prior to PCI (of Study Drug Loading Dose) Steinhubl SR et al. J Am Coll Cardiol 2006;47:
6 Upstream ADPRAs: goals of treatment STABLE Prevention of periprocedural MI Prevention of early stent thrombosis NSTEACS STEMI Prevention of early (re)mi Prevention of periprocedural MI Prevention of early stent thrombosis Opening of culprit enroute Improvement of periprocedural flow Prevention of early stent thrombosis
7 Upstream ADPRAs: goals of treatment STABLE Prevention of periprocedural MI Prevention of early stent thrombosis NSTEACS STEMI Prevention of early (re)mi Prevention of periprocedural MI Prevention of early stent thrombosis Opening of culprit enroute Improvement of periprocedural flow Prevention of early stent thrombosis
8 Clopidogrel Pre-Treatment and Myocardial Damage After Elective Stenting N = 203 No Pre-Treatment Clopidogrel Pre-Treatment (3 days) 60 51, ,3 40 % ,3 3,2 6,3 7,4 17,2 20,4 0 CK-MB > 16 (6-8 h) CK-MB > 16 (16-24 h) Troponin>0.2 (6-8h) Troponin>0.2 (16-24h) van der Heijden et al. JACC 2004; 44:20
9 N=203 Clopidogrel Pre-Treatment and Myocardial Damage After Elective Stenting van der Heijden et al. JACC 2004; 44:20 (3 days)
10 ADVANCE: Troponin I and CK-MB MV PCI, NSTEACS, Diabetics pretreatment with ticlopidine/clopidogrel ng/ml P=.001 P<.01 Troponin I CK-MB Valgimigli M. J Am Coll Cardiol. 2004;44:
11 ARMYDA-5: Study design 30 days 438 Patients with - Stable angina or - NSTE ACS undergoing coronary angiography Randomization Clopidogrel 600 mg given 4-8 hrs before angio N= 218 Clopidogrel 600 mg at the time of PCI N= 220 Medical Rx N= 53 Angiography CABG N= 35 N= 350 PCI 600 mg Preload N= 174 PCI 600 mg in-lab N= 176 Primary end point: Death, MI*, TVR 1 st blood sample before PCI 2 nd and 3 rd blood sample at 8 and 24 hours * MI defined as >3 times UNL post-procedural elevation of CK-MB - CK-MB, troponin-i, myoglobin, CRP Di Sciascio G. JACC 2010;56:550-7
12 ARMYDA-5 PRELOAD P=0.30 % of patients with elevation P= Pre-load In-lab 0 CK-MB Tn-I CONCLUSIONS A strategy of 600-mg in-lab clopidogrel load pre-pci may have similar clinical outcomes as routine 4- to 8-h pre-load. Di Sciascio G. JACC 2010;56:550-7
13 Upstream ADPRAs: goals of treatment STABLE Prevention of periprocedural MI Prevention of early stent thrombosis NSTEACS STEMI Prevention of early (re)mi Prevention of periprocedural MI Prevention of early stent thrombosis Opening of culprit enroute Improvement of periprocedural flow Prevention of early stent thrombosis
14 Cumulative Distribution of Time to (re)mi in ACS: the GUSTO IIb study Cumulative Proportion 1 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 Median (25th, 75th) 7 (4, 27) days: 6 (3, 20) days: p=0.043 Wilcoxon Rank Sum Days ST Elevation NonST Elevation Overall incidence 7% MI defined as CKMB >2xULN Savonitto S, JACC 2002;39:22-9
15 Impact of early intervention in HR pts With NSTEACS: the TIMACS study Risk of Death, MI or stroke 30% of the pts GRS >140) Mehta SR, NEJM 2009;360:
16 Time to angiography among NSTEACS pts In hub and spoke hospitals of the Reggio Emilia province % pts undergoing angiography Hub hosp (N=165) Spoke hosp (N=222) <24h >24-48h >48-72h >72h Savonitto S et al. GIC 2012;13:157-68
17 Clopidogrel Pretreatment: Events in UA/NSTEMI Before Cardiac Catheterization % Patients 20% 15% 10% 5% N=1730 (65%) N=928 (35%) 15.3% 12.1% RR= %CI ( ) p=0.008 RR= % CI ( ) p= % 3.6% Placebo Clopidogrel 0% n = 206 n = 159 n = 68 n = 47 MI or Refractory Ischemia MI Mehta SR. Lancet 2001;358:527-33
18 Pretreament with prasugrel in NSTEMI The ACCOAST RCT Montalescot G. NEJM, September 1, 2013
19 Nord Centro Sud PCI/angiography ratio stratified by age and region < > % corox % PTCA ratio
20 CV Death/MI/Stroke MI Clopidogrel: Double vs Standard Dose Primary Outcome and Components Standard Double HR 95% CI P Intn P PCI (2N=17,232) No PCI (2N=7855) Overall (2N=25,087) PCI (2N=17,232) No PCI (2N=7855) Overall (2N=25,087) CV Death PCI (2N=17,232) No PCI (2N=7855) Overall (2N=25,087) Stroke PCI (2N=17,232) No PCI (2N=7855) Overall (2N=25,087) Yusuf S, NEJM
21 CRUSADE ACTION - NSTEMI Patients Invasive Procedures 100% 80% 75% % Patients 60% 40% 62% 46% 39% 20% 11% 0% Cath Cath < 48 hr PCI PCI < 48 hr CABG ACTION Registry-GWTG DATA: January 1 December 31, 2008
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23 Predictors of reoperation in ACS patients undergoing CABG Odds ratio 95% CI P-value Clopidogrel <5 days Pre-op aspirin Pre-op GPI Prior CABG Berger JS. JACC 2008;52:1693
24 Reoperation for bleeding in ACS pts undergoing CABG Morici N. Int J Cardiol 2013;168:
25 Probability of 30-D death by sum of ST depression on the admission ECG: the GUSTO IIb ECG corelab Probability of 30-day death 0,35 0,3 0,25 0,2 0,15 0, % 3-vessel disease % LM disease 1+2 Q (n=2493) 3 Q (n=1366) 4 Q (n=1333) Incidence of 3VD and LMCA disease by quartiles of Σ ST depression Probability of death 0,05 95% confidence limits sum of ST depression (mm) Savonitto S et al: Eur Heart J 2005;26: 2106
26 How would you treat this patient?
27 Upstream clopidogrel and Risk vs benefit of upstream GPIIb/IIIa blockade Wang TY. Circulation 2011;123:722
28 Upstream ADPRAs: goals of treatment STABLE Prevention of periprocedural MI Prevention of early stent thrombosis NSTEACS STEMI Prevention of early (re)mi Prevention of periprocedural MI Prevention of early stent thrombosis Opening of culprit enroute Improvement of periprocedural flow Prevention of early stent thrombosis
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32 Impaired bioavailability of clopidogrel in STEMI patients Heestermans T, et al Thrombosis Research 2008;122: µmol/l ADP 20 µmol/l ADP Comparison of changes in platelet aggregation induced between STEMI patients (n=9) and healthy controls (n=10) after a 600 mg clopidogrel loading dose.
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34 Stent thrombosis after PPCI in STEMI (ARC Definite/probable) 3 Clopidogrel Prasugrel 2.8 Proportion of patients (%) p=0.008 RRR=51% =1.2 HR=0.58 ( ) NNT= p=0.02 RRR=42% 0 Age-adjusted HR=0.59 ( ) Time (Days) Montalescot G. Lancet 2009;373:723-31
35 Prasugrel vs clopidogrel in PCI for STEMI Montalescot G. Lancet 2009;373: Time from symptom onset to PPCI 3.8 hours (2438 pts) Time from symptom onset to SPCI 47 hours (1094 pts) Use of GPI 64% (no difference PPCI vs SPCI) Prasugrel admin. 27% prior and 72% during PCI
36 Delay from pain to random: 5.3h (3-11) Delay from admission to random 1.2h (0.6-3) 43% Steg PG. Circulation 2010;122:2131
37 Ticagrelor vs clopidogrel in STEMI ECG data and outcome according to time from symptoms ticagrelor clopidogrel Symptoms to random <3 hours (n=1428) -100 mm Symptoms to random >3 hours (n=4378) ΣSTE baseline % pts with resolution >50% ΣSTE baseline % pts with resolution >50% P< y D+MI KM% 1y vasc death KM% 1y D+MI KM% 1y vasc death KM% Armstrong PW; Circulation. 2012;125:514-21
38 Ticagrelor vs clopidogrel in STEMI ECG data and outcome according to time from symptoms ticagrelor clopidogrel Symptoms to random <3 hours (n=1428) -100 mm Symptoms to random >3 hours (n=4378) ΣSTE baseline % pts with resolution >50% ΣSTE baseline % pts with resolution >50% P< y D+MI KM% 1y vasc death KM% 1y D+MI KM% 1y vasc death KM% Armstrong PW; Circulation. 2012;125:514-21
39 Fabolus PRO study Valgimigli M. J Am Coll Cardiol Intv 2012;5:268 77
40 STEMI Patients with high residual PR The RAPID study Parodi G. JACC 2013; accepted 8 jan
41 Clopidogrel pretreatment metanalysis: All-cause mortality Bellemain-Appaix A. JAMA 2012;308:2507
42 Dio non può essere dimostrato La fede è un salto nell incerto IC
43 Dio può essere dimostrato Le dimostrazioni dell esistenza di Dio IA
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