eli i. lev , md director, inteventional cardiology unit , hasharon hospital
DESCRIPTION
STEMI – Interventional Techniques and Antithrombotic Therapy in the Cathetterization Laboratory. Eli I. Lev , MD Director, Inteventional Cardiology Unit , Hasharon Hospital Rabin Medical Center , Tel Aviv University, Israel. Outline. Primary PCI - PowerPoint PPT PresentationTRANSCRIPT
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STEMI – Interventional Techniques and Antithrombotic Therapy in the
Cathetterization Laboratory
Eli I. Lev, MD
Director, Inteventional Cardiology Unit,
Hasharon Hospital Rabin Medical Center,
Tel Aviv University, Israel
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Outline
• Primary PCI
• Aspiration, manual thrombectomy and distal protection devices
• Choice of stent
• Pharmacothaerpy, including IC GP IIb/IIIa inhibitors
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Decline in Deaths from Cardiovascular Disease in Relation to Scientific Advances
Nabel EG and Braunwald E. 2012;366:54-63Nabel EG and Braunwald E. 2012;366:54-63
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Geoffrey Hartzler, M.DGeoffrey Hartzler, M.D..First Primary Angioplasty in AMI, 1979First Primary Angioplasty in AMI, 1979
1946 - 2012
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Primary PCI versus Thrombolytics Swedish Heart Intensive Care Registry (RIKS-HIA)
11.4%
15.9%
9.6%
4.9%
7.6%
4.8%
0%
4%
8%
12%
16%
20%
Death (30 DAYS) Death (1 YEAR) Reinfarction
Eve
nt r
ate
Lysis PCI
P<0.001 P<0.001 p<0.001
Stenestrand, U. et al. JAMA 2006;296:1749-1756.
16,043 7,084
23,174 patients
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3.0
4.2
5.7
7.4
0
2
4
6
8
10
<90 90-120 121-150 >150
Mor
talit
y (%
)
N=29,222P < 0.0001
Years 1999-02
Door-to-Balloon Time (minutes)
McNamara McNamara J Am Coll Cardiol 2006;47:2180-2186
NRMI-3-4: Primary PCI Door-to-Balloon Time vs. Mortality
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Do whatever it takes to reduce time from symptom onset to ER arrival and time from ER arrival to PCI!
Public awareness of MI Sx
Chest pain centers of excellence with lower DBTs
and excellent outcomes
Regional coordination
Ambulance ECG telemetry
Ambulance/ER CCL activation
ICs sleep in hospital
Continual QI
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96738 patients with STEMI undergoing PCI 2005-9 participating in the Cath-PCI registry
Menees et al, NEJM 2013
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ESC STEMI guidelines 2012
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Primary PCI should be performed in patients within 12 hours of onset of STEMI.
Primary PCI should be performed in patients with STEMI presenting to a hospital with PCI capability within 90 minutes of first medical contact as a systems goal.
Primary PCI should be performed in patients with STEMI who develop severe CHF or cardiogenic shock and are suitable candidates for revascularization as soon as possible, irrespective of time delay
AHA/ACC GL - Primary PCI of the Infarct Artery
I IIaIIbIII
I IIaIIbIII
I IIaIIbIII
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Survival Benefits in Patients Undergoing Late PCI of the Infarct-Related Artery
8.4%
6.3%
0%
4%
8%
12%
Death at 3 yrs
Eve
nt
rate
Conservative therapy
Invasive therapyP=0.03
3560 pts
Abbate et al. J Am Coll Cardiol, 2008; 51:956-964
Meta-analysis of randomized trials
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9.17.0
4.4
17.218.4
9.4
5.3 4.5
15.6
22.0
0
5
10
15
20
25
Death ReMI Class IV HF Primary EP SubsequentRevasc
PCI (n=1082)
Med Rx (N=1084)
OAT: The Occluded Artery TrialAdverse events at 4 Years
Hochman JS et al. NEJM Hochman JS et al. NEJM 2006;355:2395-4072006;355:2395-407
P = 0.20
P = 0.03
P=0.83 P=0.13 P=0.92
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ACC/AHA GL - Primary PCI for STEMILate Presentations
a. Severe CHFa. Severe CHF
b. Hemodynamic or electrical instabilityb. Hemodynamic or electrical instability
c. Persistent ischemic symptomsc. Persistent ischemic symptoms
It is reasonable to perform primary PCI for It is reasonable to perform primary PCI for patients with onset of symptoms within thepatients with onset of symptoms within theprior prior 12-2412-24 hours and hours and 1 of the following1 of the following
III IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIII
Mortality and complications are higher in patients presenting latePCI is more challenging - Higher rate of no reflow, Organized thrombus
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The Goal of Primary PCI in STEMI
•Restore flow in the culprit artery and optimize myocardial perfusion (by angio and EKG criteria)
•Preserve LV function.
•Reduce MI complications
•Reduce mortality.
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Markers of myocardial perfusion - ST Resolution and Myocardial Blush in STEMI
Sorajja P. et al Eur Heart J 2005
Sub-Analysis of the CADILLAC Trial (N=456)
6.35.1
1.2
10.1
0
2
4
6
8
10
12
One year Mortality
Mor
talit
y-18
0 d
ays(
%) <70%ST-Blush 0/1
>70%ST-Blush 0/1<70%ST-Blush 2/3>70%ST-Blush 2/3
P=0.01
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Impact of Macroscopic Distal Emboli
DE occurred in 27 of 178 (15%) pts after primary PTCA
↓ ST res
↑ Infarct size
↑ Mortality
Henriques JPS et al. Henriques JPS et al. EHJEHJ 2002;23:1112-7 2002;23:1112-7
PLCX filling PLCX filling defect at primary defect at primary PCI sitePCI site
Distal Distal thromboembolithromboemboli
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Mechanical Approaches to ThrombusMechanical Approaches to Thrombus
ThrombectomyThrombectomy(AngioJet, X-Sizer)(AngioJet, X-Sizer)
GuardWire, GuardWire, FilterWire, AngioGuard, EmboShield, etc.FilterWire, AngioGuard, EmboShield, etc.
Distal protectionDistal protection (GuardWire, FilterWire, AngioGuard, etc.)(GuardWire, FilterWire, AngioGuard, etc.)
Thrombus aspirationThrombus aspiration(Rinspirator, Pronto, Export, (Rinspirator, Pronto, Export,
Rescue, Eliminate, etc.)Rescue, Eliminate, etc.)
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Manual thrombectomy and distal embolic protection devices : Myocardial Blush
De Luca G. et al Am Heart J 2007Meta-analysis of 15 STEMI studies
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Manual thrombectomy and distal embolic protection devices : 30 day mortality
De Luca G. et al Am Heart J 2007Meta-analysis of 18 STEMI studies
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THROMBUS ASPIRATION
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22
Patients presenting with Patients presenting with Acute Myocardial Infarction within Acute Myocardial Infarction within 12 hours after onset of symptoms12 hours after onset of symptoms
Patients presenting with Patients presenting with Acute Myocardial Infarction within Acute Myocardial Infarction within 12 hours after onset of symptoms12 hours after onset of symptoms
1:1 randomizationN = 1071 patients
1 siteNetherlands
Primary Aspiration with Primary Aspiration with Export CatheterExport Catheter
n = 535n = 535
Primary Aspiration with Primary Aspiration with Export CatheterExport Catheter
n = 535n = 535
Primary Endpoint: Primary Endpoint: • Myocardial Blush Grade of 0 or 1Myocardial Blush Grade of 0 or 1
Secondary Endpoints: Secondary Endpoints: • TIMI 3 flowTIMI 3 flow• Complete resolution of ST-segment elevationComplete resolution of ST-segment elevation• Absence of persistent ST-segment deviation,Absence of persistent ST-segment deviation,•Reinfarction, death, and MACE at 30 days. Reinfarction, death, and MACE at 30 days.
Primary Endpoint: Primary Endpoint: • Myocardial Blush Grade of 0 or 1Myocardial Blush Grade of 0 or 1
Secondary Endpoints: Secondary Endpoints: • TIMI 3 flowTIMI 3 flow• Complete resolution of ST-segment elevationComplete resolution of ST-segment elevation• Absence of persistent ST-segment deviation,Absence of persistent ST-segment deviation,•Reinfarction, death, and MACE at 30 days. Reinfarction, death, and MACE at 30 days.
Conventional StentingConventional Stentingn = 536n = 536
Conventional StentingConventional Stentingn = 536n = 536
ProcedureProcedure 1yr1yr30d30d
Randomized, Open Label, Single Center Trial
TAPAS Study overview
Svilaas T et al. N Engl J Med 2008
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TAPAS study
Svilaas T et al. N Engl J Med 2008
18
38
44
13
31
57
0
10
20
30
40
50
60
<30% 30%-70% >70%
Control
Aspiration
26
41
32
17
37
46
0
5
10
15
20
25
30
35
40
45
50
Blush 0-1 Blush 2 Blush 3
Control
Aspiration
Blush score ST Resolution @60 min
P=0.001 P=0.001
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24
Sig. reduction of cardiac death or non-fatal MI in Aspiration Group at 1 year
-43%
. Vlaar et al (TAPAS): a 1-year follow-up study, Lancet 2008; 371: 2008; 1915-20
TAPAS Study: Clinical Events
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TAPAS Study: Clinical Events
Log-Rank P=0.04
Svilaas T et al. N Engl J Med 2008Vlaar PG et al. Lancet 2008
Mortality
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Primary endpoint: Infarct size at 30 days (cMRI)Primary endpoint: Infarct size at 30 days (cMRI)2º endpoints: TIMI flow, blush, ST-resolution, MACE (30d, 1 yr)2º endpoints: TIMI flow, blush, ST-resolution, MACE (30d, 1 yr)
INFUSE-AMI TrialINFUSE-AMI Trial452 pts with anterior STEMI452 pts with anterior STEMI
Anticipated Sx to PCI <5 hrs, TIMI 0-2 flow in prox or mid LADAnticipated Sx to PCI <5 hrs, TIMI 0-2 flow in prox or mid LADPrimary PCI with bivalirudin anticoagulationPrimary PCI with bivalirudin anticoagulation
Manual aspirationManual aspiration No aspirationNo aspiration
R R 1:11:1
IC AbcxIC Abcx No AbcxNo Abcx IC AbcxIC Abcx No AbcxNo Abcx
R R 1:11:1
R R 1:11:1
Stratified by symptoms to angio <3 vs ≥3 hrs, Stratified by symptoms to angio <3 vs ≥3 hrs, and prox vs mid LAD occlusionand prox vs mid LAD occlusion
Pre-loaded with aspirin andPre-loaded with aspirin andclopidogrel 600 mg or prasugrel 60 mgclopidogrel 600 mg or prasugrel 60 mg
Infuse-AMI, Stone G et al, JAMA 2012
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INFUSE-AMI: Reperfusion post-PCI*
*Core laboratory assessed*Core laboratory assessed
Manual aspirationN=229
No aspirationN=223
90.1%
7.6%
2.2%
0 50 100
P=0.36P=0.36
Corrected TIMICorrected TIMIframe counts:frame counts: 20 [16, 26]20 [16, 26] vs.vs. 20 [16, 26]20 [16, 26] P=0.40P=0.40
83.4%
16.6%
0 50 100
MBG2/3
MBG0/1
79.3%
20.7%
0 50 100
P=0.26P=0.26
Infuse-AMI, Stone G et al, JAMA 2012
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INFUSE-AMI: STR 60 minutes post-PCI*
*Core laboratory assessed*Core laboratory assessed
ST
-seg
men
t re
solu
tion
(%)
ST
-seg
men
t re
solu
tion
(%)
[45.2, 87.2]
[55.8, 87.4]
P=0.23P=0.23
P=0.37P=0.37
Infuse-AMI, Stone G et al, JAMA 2012
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INFUSE-AMI: Infarct size at 30 days*- Major secondary endpoint -
0
10
20
30
40
50
AspirationAspirationN=229N=229
No aspirationNo aspirationN=223N=223
Infa
rct
size
, %
LVIn
farc
t si
ze,
%LV
Median [IQR]Median [IQR]
17.0%17.0%[9.0, 22.8][9.0, 22.8]
Median [IQR]Median [IQR]
17.3%17.3%[7.1, 25.5][7.1, 25.5]
P=0.51
*Core laboratory assessed. No interaction was present between the 2 randomization groups *Core laboratory assessed. No interaction was present between the 2 randomization groups for the primary 30-day infarct size endpoint (p=0.46) for the primary 30-day infarct size endpoint (p=0.46)
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INFUSE-AMI: Infarct size at 30 daysEffect of IC abciximab via Clearway RX
0
10
20
30
40
50
IC abciximabIC abciximabN=229N=229
No abciximabNo abciximabN=223N=223
Infa
rct
size
, %L
VIn
farc
t si
ze, %
LV
Median [IQR]Median [IQR]
15.1%15.1%[6.8, 22.7][6.8, 22.7]
Median [IQR]Median [IQR]
17.9%17.9%[10.3, 25.4][10.3, 25.4]
P=0.03
*Core laboratory assessed*Core laboratory assessed Stone GW et al. JAMA 2012;307:0n-lineStone GW et al. JAMA 2012;307:0n-line
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Updated aspiration meta-analysis
• Aspiration thrombectomy vs. conventional PPCI (18 trials, n=3,936):
• ST-segment resolution at 60 minutes (RR=1.31; 95% CI 1.16-1.48; p<0.0001) and TIMI blush grade 3 post-PCI (RR=1.37; 95% CI 1.19-1.59; p<0.0001) were both improved by aspiration
• MACE: RR = 0.76; 95% CI 0.63-0.92; p=0.006 with aspiration• All-cause mortality (RR=0.71, 95% CI 0.51-0.99; p=0.049) -
significantly reduced with aspiration • Final infarct size (p=0.64) and ejection fraction (p=0.32) at 1
month were similar.
Kumbbani DJ et al JACC 2013
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TASTE Trial
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TASTE Trial
• 7244 pts with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration + PCI or PCI only (as part of the SCAAR registry)
• No differences in 30 day mortality (primary endpoint), trends for less rehospitalization for Re-MI (p=0.09) and for less stent thrombosis (p=0.06) with aspiration
NEJM 2013
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2012 STEMI ESC Guidelines
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NEW Recommendation Aspiration thrombectomy
is reasonable for patientsundergoing primary PCI III IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIII
Kushner et al. Circulation. 2009;120:2271–2306
2011 STEMI UpdateThrombus Aspiration During PCI for STEMI
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CHOICE OF STENT
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Long-term (3-5 year) FU after DES vs. BMS in AMITVR (N=6,026 pts)
TVR DES BMS OR [95%CI] P
DEDICATION 8.9% 19.8% 0.40 [0.25, 0.64] <0.01
PASEO 6.1% 21.1% 0.24 [0.11, 0.54] <0.01
STRATEGY 10.3% 26.1% 0.33 [0.14, 0.75] 0.01
SESAMI 8.3% 16.0% 0.46 [0.23, 0.92] 0.03
MISSION 8.9% 15.8% 0.54 [0.27, 1.09 0.09
TYPHOON 11.9% 21.5% 0.49 [0.30, 0.80] <0.01
PASSION 7.7% 10.5% 0.73 [0.42, 1.26] 0.26
HORIZONS-AMI 12.5% 17.7% 0.67 [0.53-0.84] 0.001
META-ANALYSIS 0.50 [0.40-0.64] <0.001
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
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Long-term (3-5 year) FU after DES vs. BMS in AMIStent thrombosis (N=6,026 pts)
Stent thrombosis DES BMS OR [95%CI] P
DEDICATION 2.9% 3.2% 0.90 [0.36, 2.24] 0.82
PASEO 1.1% 2.2% 0.49 [0.07, 3.57] 0.48
STRATEGY 6.9% 7.9% 0.86 [0.28, 2.66] 0.79
SESAMI 5.1% 5.1% 1.00 [0.37, 2.73] 1.00
MISSION 3.1% 2.0% 1.69 [0.40, 7.20] 0.48
TYPHOON 5.3% 5.5% 0.90 [0.42, 2.00] 0.83
PASSION 4.2% 3.4% 1.19 [0.52, 2.69] 0.68
HORIZONS-AMI 5.1% 4.4% 1.15 [0.77-1.72] 0.50
META-ANALYSIS 1.06 [0.81-1.39] 0.67
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
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Long-term (3-5 year) FU after DES vs. BMS in AMIMortality (N=6,026 pts)
DEATH DES BMS OR [95%CI] P
DEDICATION 10.5% 6.4% 1.73 [0.97, 3.08] 0.06
PASEO 8.3% 12.2% 0.65 [0.29, 1.49] 0.31
STRATEGY 18.4% 15.9% 1.19 [0.54, 2.62] 0.66
SESAMI 3.2% 5.0% 0.61 [0.20, 1.92] 0.40
MISSION 4.4% 6.6% 0.69 [0.25, 1.85] 0.46
TYPHOON 4.0% 6.6% 0.61 [0.27, 1.36] 0.23
PASSION 8.9% 11.5% 0.75 [0.45, 1.27] 0.29
HORIZONS-AMI 5.6% 6.6% 0.84 [0.60-1.17] 0.33
META-ANALYSIS 0.88 [0.68-1.11] 0.27
Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41Adapted from Ziada KM et al. JACC CI Int 2011;4;39-41
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EXAMINATION TrialEXAMINATION Trial
0 1 2 3
Xience V
Vision
Acute Subacute Late
p = 0.01p = 0.01
1504 pts with STEMI undergoing PCI within 481504 pts with STEMI undergoing PCI within 48 (85% primary PCI within (85% primary PCI within 1212) were randomized to Xience V EES vs. Vision BMS) were randomized to Xience V EES vs. Vision BMS
Stent thrombosis (Def/prob) within 1 yearStent thrombosis (Def/prob) within 1 year
2.6%2.6%
0.9%0.9%
Definite ST was reduced with Xience V from 1.9% to 0.5%, p=0.01Definite ST was reduced with Xience V from 1.9% to 0.5%, p=0.01
Sabate M. et al, Lancet 2012Sabate M. et al, Lancet 2012
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Guidelines
ESC - STEMI 2012
It is reasonable to use a drug-eluting stent as an alternative to a
bare-metal stent for primary PCI in STEMI
III IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIII IIaIIaIIaIIbIIbIIbIIIIIIIIIIIaIIaIIaIIbIIbIIbIIIIIIIII
AHA/ACC - STEMI 2012
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The MGuard Coronary Stent System
• A stent wrapped with ultra-thin (20μm) polymer mesh sleeve.
• The mesh is designed for plaque sealing during stent expansion in order to prevent embolization of athero-thrombotic debris.
• The sleeve expands seamlessly when the stent is deployed, without affecting the structural integrity of the stent.
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MASTER TRIAL DESIGN
Primary Endpoint: complete ST-segment resolution at 60-90 minSecondary endpoints: TIMI flow, Myocardial Blush Grade, MACE (30d, 6m, 12m)
Substudies: Cardiac MRI at 3-5 days (2x30 patients)Angiographic follow-up at 13 months (50 patients)
Primary Endpoint: complete ST-segment resolution at 60-90 minSecondary endpoints: TIMI flow, Myocardial Blush Grade, MACE (30d, 6m, 12m)
Substudies: Cardiac MRI at 3-5 days (2x30 patients)Angiographic follow-up at 13 months (50 patients)
432 patients with STEMIpain <12 hrs, de novo lesions432 patients with STEMIpain <12 hrs, de novo lesions
Pre-dilatation and/or AspirationTIMI 2 or 3
Pre-dilatation and/or AspirationTIMI 2 or 3
R1:1R
1:1
BMS or DESBMS or DESMGuardMGuard
Stone G et al, JACC 2012
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TIMI FLOW
P=0.006
P=0.01
Stone et. al, J Am Coll Cardiol. 2012;60:1975-1984.
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ST SEGMENT RESOLUTION
P=0.005
P=0.008
Stone et. al, J Am Coll Cardiol. 2012;60:1975-1984.
PRIMARY ENDPOINTPRIMARY
ENDPOINT
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30 DAYS CLINICAL RESULTS*
MGUARD
(N=217)
CONTROL BMS / DES
(N=216)P
MACE 4 (1.8%) 5 (2.3%) 0.75
All cause mortality 0 (0.0%) 4 (1.9%) 0.06
Cardiac death 0 (0.0%) 4 (1.9%) 0.06
Reinfarction 3 (1.4%) 2 (0.9%) 1.00
TLR, ischemia-driven 4 (1.8%) 1 (0.5%) 0.37
TVR, ischemia-driven 5 (2.3%) 1 (0.5%) 0.10
Stent Thrombosis
Definite or Probable 3 (1.4%) 2 (0.9%) 0.67
Definite 3 (1.4%) 1 (0.5%) 0.62
Stroke 1 (0.5%) 0 (0.0%) 1.00
TIMI Bleeding
Major or Minor 4 (1.9%) 4 (1.9%) 0.75
Major 3 (1.4%) 2 (0.9%) 1.00* Secondary endpointsStone et. al, J Am Coll Cardiol. 2012;60:1975-1984.
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Anti-thrombotic Therapy
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TRITON-TIMI 38: STEMI Subgroup TRITON-TIMI 38: STEMI Subgroup Analysis (n=3,534)Analysis (n=3,534)
0
1
2
3
4
5
6
7
All causeDeath
CV death RE-MI Stentthrombosis
Non CABGbleeding
Prasugrel
Clopidogrel
P=0.05P=0.05P=0.045P=0.045
P=0.01P=0.01
P=0.01P=0.01 P=0.4P=0.4
Montalescot et al, Lancet 2009Montalescot et al, Lancet 2009
No informationon markersof perfusion
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TRITON-TIMI 38: TRITON-TIMI 38: STEMI SubgroupSTEMI Subgroup Analysis (n=3,534)Analysis (n=3,534)
Montalescot et al, Lancet 2009Montalescot et al, Lancet 2009
DeathMI
Stroke
DeathMI
Stroke
DeathMI
UTVR
DeathMI
UTVR
StentThrombosis
StentThrombosis
Non-CABGRelatedTIMI Major
Bleeding
Non-CABGRelatedTIMI Major
Bleeding
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PLATO STEMI – 8,430 patients Primary endpoint: CV death, MI or stroke
0 1 2 3 4 5 6 7 8 9 10 11 12
12
11
10
9
8
7
6
5
4
3
2
1
0
Months
HR: 0.85 (95% CI = 0.74–0.97), p=0.07
No. at risk
Clopidogrel
Ticagrelor
4,229
4,201
3,892
3,887
3,823
3,834
3,730 3,022
3,011
2,333
2,297
1,868
1,8913,732
11.0
9.3
Clopidogrel
Ticagrelor
K-M
est
ima
ted
rat
e (%
per
ye
ar)
Steg G et al, Circulation 2010
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PLATO STEMI - All cause mortality
0 1 2 3 4 5 6 7 8 9 10 11 12
7
6
5
4
3
2
1
0
K-M
est
imat
ed r
ate
(% p
er y
ear)
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
MonthsNo. at riskTicagrelorClopidogrel
Clopidogrel
Ticagrelor
4.9
6.0
HR 0.82 (95% CI = 0.68–0.99), p=0.04
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K-M
est
imat
ed r
ate
(% p
er y
ear)
0 1 2 3 4 5 6 7 8 9 10 11 12
10
8
6
4
2
0
Months No. at riskTicagrelorClopidogrel
4,165 3,431 3,254 3,137 2,440 1,786 1,6404,181 3,430 3,297 3,159 2,441 1,804 1,635
Clopidogrel
Ticagrelor 9.0
9.3
PLATO STEMI - Primary safety event: major bleeding
HR 0.96 (95% CI = 0.83–1.12), p=0.63
Steg G et al, Circulation 2010
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ESC STEMI Guidelines 2012
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Is there still a role for GP IIb/IIIa inhibitors in the era of the new platelet
ADP receptor inhibitors ?
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Abciximab in Primary PCI Meta-analysisAbciximab in Primary PCI Meta-analysis8 RCTs – 3,949 pts with AMI w/i 128 RCTs – 3,949 pts with AMI w/i 12 undergoing primary (7) or undergoing primary (7) or
rescue (1) PCI rand to abciximab vs. placebo or controlrescue (1) PCI rand to abciximab vs. placebo or control
p=0.06p=0.06RR 0.71 RR 0.71
[0.49,1.02][0.49,1.02]
p=0.01p=0.01RR 0.72 RR 0.72
[0.55,0.94][0.55,0.94]
6–12 months6–12 months
De Luca G et al. De Luca G et al. JAMAJAMA 2005;293:1759–1765 2005;293:1759–1765
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Updated meta-analysis of effect of GPIs on 30 day mortality in pts with STEMI
De Luca et al, EHJ 2009
Favors GPIs Favors Control
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Updated meta-analysis of effect of GP IIb/IIIa inhibitors on 30 day re-MI
De Luca et al, EHJ 2009
Favors GPIsFavors control
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Updated meta-analysis of effect of GP IIb/IIIa inhibitors on major bleeding
De Luca rt al, EHJ 2009
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HORIZONS AMI - 1-Year Major Adverse CV Events3602 patients with STEMI
Number at riskNumber at riskBivalirudin aloneBivalirudin aloneHeparin+GPIIb/IIIaHeparin+GPIIb/IIIa
Bivalirudin alone (n=1800))
Heparin + GPIIb/IIIa (n=1802)
1800 1627 1579 1544 13941802 1619 1573 1540 1380
MA
CE
(%
)
0123456789
101112131415
Time in Months
0 1 2 3 4 5 6 7 8 9 10 11 12
11.9%11.9%11.9%11.9%
Diff [95%CI] = 0.0% [-2.1, 2.2]
HR [95%CI] = 1.00 [0.83, 1.21]
P=0.98
**MACE = All cause death, reinfarction, ischemic TVR or stroke
Stone G et al, NEJM 2008, Lancet 2009
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Number at riskNumber at riskBivalirudin aloneBivalirudin aloneHeparin+GPIIb/IIIaHeparin+GPIIb/IIIa
1800 1621 1601 1586 14481802 1544 1532 1515 1368
Ma
jor
Ble
ed
ing
(%
)
0
1
2
3
4
5
6
7
8
9
10
11
12
Time in Months
00 11 2 3 4 5 6 7 8 9 10 11 12
9.2%9.2%
5.8%5.8%Diff [95%CI] = -3.4% [-5.2, -1.7]Diff [95%CI] = -3.4% [-5.2, -1.7] 22
HR [95%CI] =HR [95%CI] =
0.61 [0.48, 0.78] 0.61 [0.48, 0.78]
P<0.0001P<0.0001
HORIZONS - 1-Year Major Bleeding (non-CABG)
Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)
Stone G et al, NEJM 2008, Lancet 2009
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HORIZONS AMI 1-Year Mortality
Number at riskNumber at riskBivalirudin aloneHeparin+GPIIb/IIIa
Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)
1800 1705 1684 1669 15201802 1678 1663 1646 1486
CardiacCardiac
Non CardiacNon Cardiac
Mo
rtal
ity
(%)
0
1
2
3
4
5
Time in Months
0 1 2 3 4 5 6 7 8 9 10 11 12
3.8%
2.1%
1.3%1.1%
HR [95%CI] =0.57 [0.38, 0.84]
P=0.005
2.9%
1.8%
Δ = 1.1%P=0.03
Δ = 1.7%
Stone G et al, NEJM 2008, Lancet 2009
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GPIIb/IIIa’s and prasugrel in the TRITON
O’Donoghue, et al, JACC 2009
Similar findings for ticagrelor in the PLATO
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RAPID Study
Parodi et al, JACC 2013
50 paients with STEMI undergoing primary PCI
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FABULOUS-PRO Study
Valgimigli et al, JACC Card Interv 2012
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IC Abciximab During STEMI
CICERO trialIC vs. IV Abciximab in STEMI
Death, re-infarction, CHF, TVR
IC vs. IV Abciximab in 154 patients with STEMI
Thiele et al, Circulation 2008
0
10
20
30
40
50
60
70
80
MBG 2-3 Comp. STResolution
Infarct size- CK*100
IVAbciximab
ICAbcixinab
534 STEMI patients,all underwent thrombus aspiration
Gu et al, Circulation 2010
P=0.02
P=0.01
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AIDA STEMI: 2065 pts with STEMI <12 rand to PPCI with IC vs IV bolus abcx (+12 IV abcx in all)
Primary EP @ 90 daysIC Abcx
(n=935)
IV Abcx
(n=932)OR (95% CI)
P value
Death, ReMI, or new CHF 65 (7.0%) 71 (7.6%) 0.91 (0.91-1.28) 0.58
- Death 42 (4.5%) 34 (3.6%) 1.24 (0.78-1.97) 0.36
- Cardiac 35 33
- Non-cardiac 7 1
- Reinfarction 17 (1.8%) 17 (1.8%) 1.0 (0.51-1.96) 0.99
- New CHF 22 (2.4%) 38 (4.1%) 0.57 (0.33-0.97) 0.04
Thiele H et al. Lancet 2012:Thiele H et al. Lancet 2012:
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Meta-analysis of IV vs IC Bolus Abciximab Meta-analysis of IV vs IC Bolus Abciximab (+ 12 (+ 12 Infusion) During Primary PCI in Infusion) During Primary PCI in
STEMISTEMI6 RCTs, 1246 total pts randomized6 RCTs, 1246 total pts randomized30-Day Mortality30-Day Mortality
Study or SubgroupStudy or Subgroup EventsEvents
Intracoronary Intracoronary abciximababciximab
NN
CICERO 2010CICERO 2010
Crystal AMI 2010Crystal AMI 2010
Dominguez-Rodriguez 2009Dominguez-Rodriguez 2009
EASY-MI 2010EASY-MI 2010
Iversen 2011Iversen 2011
Thiele 2008Thiele 2008
Total (95% CI) Total (95% CI)
Total eventsTotal events
Heterogeneity: Heterogeneity: ChiChi22=1.88, df=3 (P=0.60); 1=1.88, df=3 (P=0.60); 122=0%=0%
Test for overall effect: Test for overall effect: Z=2.11 (P=0.03)Z=2.11 (P=0.03)
55
00
00
00
22
22
99
271271
2525
2525
5353
185185
7777
636636
1.4%1.4%
77
11
00
00
99
33
2020
263263
2323
2525
5252
170170
7777
610610
3.3%3.3%
33.7%33.7%
7.4%7.4%
44.8%44.8%
14.1%14.1%
100.0%100.0%
Odds RatioOdds RatioM-H, FixedM-H, Fixed
95% CI95% CIEventsEvents
Intravenous Intravenous abciximababciximab
NN WeightWeight
Favors ICFavors IC
0.69 (0.22, 2.19)0.69 (0.22, 2.19)
0.29 (0.01, 7.59)0.29 (0.01, 7.59)
Not estimableNot estimable
Not estimableNot estimable
0.20 (0.04, 0.92)0.20 (0.04, 0.92)
0.66 (0.11, 4.05)0.66 (0.11, 4.05)
0.43 (0.20, 0.94)0.43 (0.20, 0.94)
Odds RatioOdds RatioM-H, FixedM-H, Fixed
95% CI95% CI
Favors IVFavors IV0.010.01 0.10.1 11 1010 100100
Navarese EP et al. Platelets 2011:Navarese EP et al. Platelets 2011:
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INFUSE-AMI: Infarct size at 30 daysEffect of IC abciximab via Clearway RX
0
10
20
30
40
50
IC abciximabIC abciximabN=229N=229
No abciximabNo abciximabN=223N=223
Infa
rct
size
, %L
VIn
farc
t si
ze, %
LV
Median [IQR]Median [IQR]
15.1%15.1%[6.8, 22.7][6.8, 22.7]
Median [IQR]Median [IQR]
17.9%17.9%[10.3, 25.4][10.3, 25.4]
P=0.03
*Core laboratory assessed*Core laboratory assessed Stone GW et al. JAMA 2012;307:0n-lineStone GW et al. JAMA 2012;307:0n-line
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Summary• Optimizing myocardial perfusion during STEMI is challenging.
• Manual thrombus aspiration appeared promising especially from initial studies (TAPAS), but recent studies (INFUSE-MI, TASTE) and registries failed to duplicate the favorable effect
• Embolic protection devices are of doubtful benefit for STEMI PCI
• DES preferred stents; MGuard stent may be beneficial in STEMI PCI but needs to be tested in further clinically powered trials.
• Pharmacotherapy: the new anti-platelet agents clearly have an advantage over clopidogrel in the setting of STEMI primary PCI, all should be given ASAP
• GP IIb/IIIa inhibitors should mainly be given in “bailout” situations, but early administrartion as “bridge” should be studied
• IC GP IIb/IIIa administration appears to have an advantage over IV
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Thank you !
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Brosh D. et al Am J Cardiol 2007
12.5
4.3
0
2
4
6
8
10
12
14
Mortality
Mor
talit
y-18
0 d
ays(
%) NoReflow+ (N=40)
Normal flow (N=559)
Effect of ‘No Reflow’ on STEMI Outcome
‘No Reflow’ was associated with ↑ severe LV dysfunction
Odds Ratio=3.4 (P=0.02)