A magdy when 2 pci after mi
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Transcript of A magdy when 2 pci after mi
Ahmed Magdy, MD, FACC, FSCAINational Heart Institute, Cairo
Optimizing Optimizing ReperfusionReperfusion for for STEMISTEMI Rapid deliveryRapid delivery of reperfusion therapy is of reperfusion therapy is
essential whether PPCI or thrombolyticsessential whether PPCI or thrombolytics Each of these reperfusion methods has Each of these reperfusion methods has
its its merits and shortcomings.merits and shortcomings. The The idealideal reperfusion strategy would reperfusion strategy would
deliver deliver rapid, complete and rapid, complete and sustained reperfusion with sustained reperfusion with normalization of micro-normalization of micro-vascular flow.vascular flow.
Assessing Reperfusion Options for Assessing Reperfusion Options for Patients with STEMIPatients with STEMI11
STEP 1:STEP 1: Assess Assess time time from symptom onset, from symptom onset, risk of STEMIrisk of STEMI, , risk of risk of thrombolysisthrombolysis, , time for transporttime for transport to PCI lab to PCI lab
STEP 2:STEP 2: Determine whether fibrinolysis or invasive Determine whether fibrinolysis or invasive strategy is preferred*strategy is preferred*
Fibrinolysis preferred if:Fibrinolysis preferred if: Invasive strategy preferred if:Invasive strategy preferred if: Early presentation (<3 hours)Early presentation (<3 hours) Invasive strategy not an optionInvasive strategy not an option Delay to invasive strategyDelay to invasive strategy
Skilled PCI lab with surgical backup Skilled PCI lab with surgical backup availableavailable
High risk (i.e. cardiogenic shock)High risk (i.e. cardiogenic shock) Contraindications to fibrinolysisContraindications to fibrinolysis Late presentation (>3 hours)Late presentation (>3 hours) Diagnosis of STEMI is in doubtDiagnosis of STEMI is in doubt
*If presentation is <3 hours from onset and no delay to an invasive strategy, there is no preference for either strategy
JACC 44: 671, 2004
Patients Transported by EMS After Calling 9-1-1
Onset of STEMI
Symptoms
Call 9
11Cal
l Fas
t
9-1-1 EMS
Dispatch
EMS on-scene•Encourage 12-lead ECG
•Consider prehospital fibrinolytic if capable and EMS-to-needle <
30 min
EM
S T
riag
e P
lan
Not PCICapableHospital
PCICapableHospital
Interhospital
TransferHospital Fibrinolysis:Door-to-needle within<30 min
EMS transport:EMS to Balloon within 90 min
Patient self-transport: Hospital Door-to-Balloon within 90 min
EMS transportEMS on
scene Within 8 min
Dispatch
1 min
Patient
5 min afterSymptom onset
Goals
Total ischemic time: Within 120 min*
* Golden hour = First 60 min Adapted from Panel A Figure 1
Antman et al. JACC 2004;44:676.
Gersh, B. J. et al. JAMA 2005;293:979-986.
1)Time is myocardium 2)Infarct size is outcome
Relationship Between Duration of Symptoms of MI Before Reperfusion Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial SalvageTherapy, Mortality Reduction, and Extent of Myocardial Salvage
1)Time is myocardium 2)Infarct size is outcome
Relationship Between Duration of Symptoms of MI Before Reperfusion Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial SalvageTherapy, Mortality Reduction, and Extent of Myocardial Salvage
Modified by collaterals,ischemic preconditioning,myocardial oxygen uptake, other vessels
Gersh, B. J. et al. JAMA 2005;293:979-986.
1)Time is myocardium 2)Infarct size is outcome
Relationship Between Duration of Symptoms of MI Before Reperfusion Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial SalvageTherapy, Mortality Reduction, and Extent of Myocardial Salvage
1)Time is myocardium 2)Infarct size is outcome
Relationship Between Duration of Symptoms of MI Before Reperfusion Relationship Between Duration of Symptoms of MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial SalvageTherapy, Mortality Reduction, and Extent of Myocardial Salvage
Modified by collaterals,ischemic preconditioning,myocardial oxygen uptake, other vessels
Symptom onset to hospArrival 2 hr
Thrombolysis given, 2 ½ hr
Symptom onset to balloon3 ½ hrThrombolysis induced reperfusion 3 ½ hr
Importance of Rapid Time toImportance of Rapid Time to Treatment With Treatment With FibrinolysisFibrinolysis in in STEMISTEMI
Time from onset of symptoms to treatment (hours)Time from onset of symptoms to treatment (hours)
Abs
olut
e %
diff
eren
ce
Abs
olut
e %
diff
eren
ce
in m
orta
lity
at 3
5 da
ysin
mor
talit
y at
35
days 3.5% 3.5%
2.5% 2.5%
1.8%1.8% 1.6% 1.6%
0.5% 0.5% 0.00.0
1.01.0
3.03.0
2.02.0
4.04.0
0 – 10 – 1 2 – 32 – 3 4 – 64 – 6 7 – 127 – 12 12 – 2412 – 24
The Fibrinolytics Therapy Trialists’ collaborative group. The Fibrinolytics Therapy Trialists’ collaborative group. LancetLancet. 1994; 343:311. . 1994; 343:311.
PCIPCI In-hospital Mortality In-hospital Mortality vs Door to Balloon Timevs Door to Balloon Time
4.96.1
8
12.2
0
2
4
6
8
10
12
14
Door to Balloon Time (hours)
In-hospDeathRate
0-1.4 1.5-1.9 2.0-2.9 >3.0
N= 2,322
Brodie BR, JACC 47, 2006
N=384 N=493 N=750 N=673
Recent Influences of Recent Influences of PracticePracticeSalvage is Time Salvage is Time Dependant Dependant
Superiority of PPCI over fibrinolysis Superiority of PPCI over fibrinolysis if if Door-to-Balloon Door-to-Balloon completed in a completed in a timely fashiontimely fashion
Acknowledgement that Time Matters in PPCIAcknowledgement that Time Matters in PPCI– Recommendations for time to reperfusion Recommendations for time to reperfusion
updatedupdated
Mortality rates with primary PCI as a function of PCI-related time
delay
P = 0.006
0 20 40 60 80 100
PCI-Related Time Delay (door-to-balloon - door to needle)
Ab
solu
te R
isk D
iffere
nce in
A
bsolu
te R
isk D
iffere
nce in
D
eath
D
eath
(%
)(%
)
-50
510
15
Circle sizes = sample size of the individual study.
Solid line= weighted meta-regression.
Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-6
62 min62 min BenefitFavors PCIBenefitFavors PCI
HarmFavors LysisHarmFavors Lysis
For Every 10 min delay to PCI: 1% reduction in mortality difference towards lytics
Causes of Time WasteCauses of Time Waste Many patients are not educated, may Many patients are not educated, may
wait clinic hourswait clinic hours Bias of Initial diagnosisBias of Initial diagnosis Long rush hours, difficult transportLong rush hours, difficult transport Availability of beds in CCUAvailability of beds in CCU Availability of cath labs, ready staff and Availability of cath labs, ready staff and
experienced doctorsexperienced doctors Cost of interventionCost of intervention
Thrombolytics are Frequently Used During Off Hours
PCI post thrombolysis in PCI post thrombolysis in STEMISTEMI
Prehospital TLPrehospital TL+ immediate transfer+ immediate transfer
Rescue PCIRescue PCI for failed TL for failed TL
Immediate post-Immediate post-lysislysis
« facilitated PCI « facilitated PCI »»
<24h post <24h post lysis lysis ESC PCI ESC PCI GL 05GL 05
Delayed PCIDelayed PCI before discharge before discharge
PCI post thrombolysis in PCI post thrombolysis in STEMI:STEMI:
Prehospital TLPrehospital TL+ immediate transfer+ immediate transfer
Rescue PCIRescue PCI for failed TL for failed TL
Immediate post-Immediate post-lysislysis
« facilitated PCI « facilitated PCI »»
<24h post <24h post lysis lysis ESC PCI GL ESC PCI GL 0505
Delayed PCIDelayed PCI before discharge before discharge
CAPTIM
RESCUE, REACT
PACT PRAGUE GRACIA 2 ASSENT-4 FINESSE
SIAM IIIGRACIA 1CAPITAL AMIWESTCARESS
« Open artery hypothesis »OAT SWISSI II
Following Following successfulsuccessful thrombolytic thrombolytic therapy, patients should undergo therapy, patients should undergo early early angiography and PCI of their IRAangiography and PCI of their IRA
PCI post thrombolysis in PCI post thrombolysis in STEMI:STEMI:
Defined: more than 50% reduction in Defined: more than 50% reduction in ST elevation in 60 to 90 min post TL ST elevation in 60 to 90 min post TL RxRx
Defined: less than 24hours post TL Defined: less than 24hours post TL RxRx
PCI postPCI post thrombolysis thrombolysis in STEMI: RATIONALE in STEMI: RATIONALE
1.1. Risk of Risk of reocclusionreocclusion high high
2. Early angiographic 2. Early angiographic risk risk stratificationstratification
3.3. High likelihood of High likelihood of residual complex residual complex stenosisstenosis despite successful TL Rx despite successful TL Rx
Rescue PCI
Impact of TIMI Flow Pre-PCI on Infarct Size
Facilitated Angioplasty
Primary, secondary and bleeding end Primary, secondary and bleeding end points in FINESSEpoints in FINESSE
End pointsEnd points Primary Primary PCI (%) PCI (%)
AbciximaAbciximabb
+PCI%) +PCI%)
(abcixima/(abcixima/
reteplase)reteplase)
-facilitated -facilitated PCI (%) PCI (%)
p, p, combined+ combined+ PCI vs PCI vs primary PCI primary PCI
p, combin p, combin +PCIvs +PCIvs abciximab-abciximab-facilitate facilitate
Primary end Primary end point* point*
10.710.7 10.510.5 9.89.8 NSNS NSNS
All-cause All-cause mortality mortality
4.54.5 5.55.5 5.25.2 NSNS NSNS
ComplicationComplications of MI s of MI
8.98.9 7.57.5 7.47.4 NSNS NSNS
Death Death 4.54.5 5.55.5 5.25.2 NSNS NSNS
TIMI major TIMI major bleeding bleeding
2.62.6 4.14.1 4.84.8 0.0250.025 NSNS
TIMI minor TIMI minor bleeding bleeding
4.34.3 6.06.0 9.79.7 <0.001<0.001 0.006 0.006
(Earlier ) Delayed PCI
OAT Occluded Artery TrialOAT Occluded Artery Trial
OAT Occluded Artery OAT Occluded Artery TrialTrial
Disadvantages of OAT
Comments on CARESSComments on CARESS
Again use of Again use of potent antiplateletpotent antiplatelet agent (abciximab), platelets agent (abciximab), platelets inactivated at time of PCI, (In ASSENT inactivated at time of PCI, (In ASSENT IV < 10% use!!)IV < 10% use!!)
Bleeding reassuring as pts > 75yo Bleeding reassuring as pts > 75yo excludedexcluded
Median time from TL Rx to PCI Median time from TL Rx to PCI 212 212 minmin
Post-Lysis PCI studiesPost-Lysis PCI studies
25.6
50.6
9
21
11.6
24.4
4.1
11.1
0
10
20
30
40
50
60
refractIs/D/MI/TLR
D/MI/Revasc D/MI/UA/stoke refract Is/D/MI
PCI
"Conservative"
GRACIA-1GRACIA-1SIAM IIISIAM III CAPITAL MICAPITAL MI CARESSCARESS
P=0.001 P=0.0008 P=0.04 P=0.001
N=1436N=1436
TTrial of rial of RRoutine outine ANANgioplasty and gioplasty and SStenting after tenting after FFibrinolysis to ibrinolysis to EEnhance nhance RReperfusion in eperfusion in AAcute cute
MMyocardial yocardial IInfarctionnfarction
The TRANSFER-AMI trialThe TRANSFER-AMI trial
Warren J. Cantor, David Fitchett, Bjug Warren J. Cantor, David Fitchett, Bjug Borgundvaag, Michael Heffernan, Eric A. Borgundvaag, Michael Heffernan, Eric A.
Cohen, Laurie J. Morrison, John Ducas, Anatoly Cohen, Laurie J. Morrison, John Ducas, Anatoly Langer, Shamir Mehta, Charles Lazzam, Brian Langer, Shamir Mehta, Charles Lazzam, Brian Schwartz, Vladimir Dzavik, Amparo Casanova, Schwartz, Vladimir Dzavik, Amparo Casanova, Paramjit Singh, Shaun G. Goodman on behalf Paramjit Singh, Shaun G. Goodman on behalf
of the TRANSFER-AMI Investigatorsof the TRANSFER-AMI Investigators
BackgroundBackground Treatment delays can reduce or eliminate Treatment delays can reduce or eliminate
benefits of primary PCIbenefits of primary PCI STEMI pts presenting to non-PCI centres often STEMI pts presenting to non-PCI centres often
cannot undergo primary PCI in timely manner, cannot undergo primary PCI in timely manner, and therefore receive thrombolysisand therefore receive thrombolysis
The role and optimal timing of routine early The role and optimal timing of routine early PCI after fibrinolysis remains controversialPCI after fibrinolysis remains controversial
ObjectiveObjective
To compare: To compare:
Pharmacoinvasive strategy (transfer to PCI Pharmacoinvasive strategy (transfer to PCI centre for routine early PCI within 6 hrs) centre for routine early PCI within 6 hrs) with with
Standard treatment (early transfer only for Standard treatment (early transfer only for failed reperfusion, otherwise cath > 24 failed reperfusion, otherwise cath > 24 hrs) hrs)
for for high-riskhigh-risk STEMI patients receiving STEMI patients receiving thromboysis at thromboysis at non-PCI centresnon-PCI centres..
PCI CentrePCI CentreCath LabCath Lab
CommunityCommunityHospitalHospitalEmergencyEmergencyDepartmentDepartment
Cath / PCI within 6 Cath / PCI within 6 hrs regardless of hrs regardless of
reperfusion statusreperfusion status
Cath and Cath and Rescue PCI Rescue PCI
GP IIb/IIIa GP IIb/IIIa InhibitorInhibitor
TNK + ASA + Heparin / Enoxaparin + TNK + ASA + Heparin / Enoxaparin + ClopidogrelClopidogrel
““PharmacoinvasivePharmacoinvasiveStrategy”Strategy”
UrgentUrgent Transfer to PCI Transfer to PCI CentreCentre Assess chest pain, STAssess chest pain, ST
resolutionresolution at 60-90 minutes after at 60-90 minutes after
randomizationrandomization
‘‘High Risk’ ST Elevation MI within 12 hours of symptom onsetHigh Risk’ ST Elevation MI within 12 hours of symptom onset
Failed Reperfusion*Failed Reperfusion*Successful ReperfusionSuccessful Reperfusion
Elective Cath Elective Cath PCIPCI
> 24 hrs later> 24 hrs later
““Standard Standard Treatment”Treatment”
* ST segment resolution < 50% & persistent chest pain, or hemodynamic instability* ST segment resolution < 50% & persistent chest pain, or hemodynamic instability
Repatriation of stable patients within 24 hrs of PCI
Randomization stratified by age (≤75 vs. > 75) and by enrolling siteRandomization stratified by age (≤75 vs. > 75) and by enrolling site
ProceduresProcedures
Cardiac Cath performed (%)Cardiac Cath performed (%)
Time- TNK to Cath (hrs)Time- TNK to Cath (hrs)
PCI performed (%)PCI performed (%)
Stent used (% of PCI cases)Stent used (% of PCI cases)
Time- TNK to PCI (hrs)Time- TNK to PCI (hrs)
PCI within 6 hrs of TNK (%)PCI within 6 hrs of TNK (%)
PCI within 12 hrs of TNK (%)PCI within 12 hrs of TNK (%)
GP IIb/IIIa inhibitor use (%)GP IIb/IIIa inhibitor use (%)
Time- TNK to GP IIb/IIIa inhib. (hrs) Time- TNK to GP IIb/IIIa inhib. (hrs)
IABP use (%)IABP use (%)
CABG performed (%)CABG performed (%)
Standard Standard
TreatmentTreatment
(n=508)(n=508)8282
27 (4, 69)27 (4, 69)
6262
9898
18 (4, 73)18 (4, 73)
3838
4747
5353
11 (4, 63)11 (4, 63)
66
88
PharmacoinvasivePharmacoinvasive
StrategyStrategy
(n=522)(n=522)9797
3 (2, 4)3 (2, 4)
8484
9898
4 (3, 5)4 (3, 5)
8989
9797
7373
4 (3, 5)4 (3, 5)
77
66
Selected Medications Selected Medications UsedUsed
ASA 1ASA 1stst 6 hrs 6 hrs
Clopidogrel 1Clopidogrel 1stst 6 hrs * 6 hrs *
HeparinHeparin
EnoxaparinEnoxaparin
Beta Blocker 1Beta Blocker 1stst 6 hrs 6 hrs
ASA at dischargeASA at discharge
Clopidogrel at dischargeClopidogrel at discharge
Beta Blocker at dischargeBeta Blocker at discharge
ACE Inhibitor at dischargeACE Inhibitor at discharge
Lipid Lowering at dischargeLipid Lowering at discharge
Standard Standard
TreatmentTreatment
(n=508)(n=508)
9797
6969
5757
5555
6161
8585
7373
7979
7474
8080
PharmacoinvasivePharmacoinvasive
StrategyStrategy
(n=522)(n=522)
9898
8787
5757
5151
5555
8585
7979
8181
7373
8181
* p< 0.05* p< 0.05
00
22
44
66
88
1010
1212
1414
1616
1818
00 55 1010 1515 2020 2525 3030
10.610.6
16.616.6
Days from RandomizationDays from Randomization
% of Patients% of Patients
Standard PCI > 24 hrs (n=496)Standard PCI > 24 hrs (n=496)Invasive < 6 hrs (n=508)Invasive < 6 hrs (n=508)
n=496n=496n=508n=508
422422468468
415415466466
415415463463
414414461461
414414460460
412412457457
Primary Endpoint: 30-Day Death, re-MI, Primary Endpoint: 30-Day Death, re-MI, CHF, Severe Recurrent Ischemia, CHF, Severe Recurrent Ischemia,
Shock Shock
OR=0.537 (0.368, 0.783); p=0.0013
Components of Primary Components of Primary EndpointEndpoint
DeathDeath
ReinfarctionReinfarction
Recurrent IschemiaRecurrent Ischemia
Death/MI/IschemiaDeath/MI/Ischemia
New / worsening CHFNew / worsening CHF
Cardiogenic ShockCardiogenic Shock
Standard Standard
TreatmentTreatment
(n=498)(n=498)
3.63.6
6.06.0
2.22.2
11.711.7
5.25.2
2.62.6
PharmacoinvasivePharmacoinvasive
StrategyStrategy
(n=512)(n=512)
3.73.7
3.33.3
0.20.2
6.56.5
2.92.9
4.54.5
P-ValueP-Value
0.940.94
0.0440.044
0.0190.019
0.0040.004
0.0690.069
0.110.11
Safety Endpoints - Safety Endpoints - BleedingBleeding
Intracranial hemorrhageIntracranial hemorrhage
TIMI scaleTIMI scale
MajorMajor
Major (non-CABG-Major (non-CABG-related)related)
GUSTO scaleGUSTO scale
ModerateModerate
SevereSevere
Severe (non-CABG-Severe (non-CABG-related)related)
TransfusionsTransfusions
Standard Standard
TreatmentTreatment
(n=498)(n=498)1.21.2
4.64.6
3.23.2
2.22.2
1.41.4
1.21.2
5.55.5
PharmacoinvasivePharmacoinvasive
StrategyStrategy
(n=512)(n=512)0.20.2
4.34.3
2.22.2
3.53.5
0.60.6
0.60.6
7.17.1
P-ValueP-Value
0.0660.066
0.880.88
0.330.33
0.260.26
0.220.22
0.340.34
0.310.31
SummarySummary Compared with ‘Standard
Treatment’, a ‘Pharmacoinvasive Strategy’ of routine early PCI within 6 hrs after thrombolysis is associated with a 6% absolute (46% relative) reduction in the composite of death, reinfarction, recurrent ischemia, heart failure and shock
Summary Summary
The pharmacoinvasive strategy is not The pharmacoinvasive strategy is not associated with any increase in associated with any increase in transfusions, severe bleeding or transfusions, severe bleeding or intracranial hemorrhage despite high use intracranial hemorrhage despite high use of GP IIb/IIIa inhibitors during PCIof GP IIb/IIIa inhibitors during PCI
In contrast to older trials, routine early PCI after In contrast to older trials, routine early PCI after thrombolysis using stents and contemporary thrombolysis using stents and contemporary pharmacotherapy is safe and effectivepharmacotherapy is safe and effective– Benefit seen despite high cath/PCI rates Benefit seen despite high cath/PCI rates
in Standard Treatment group (including in Standard Treatment group (including ~40% rescue PCI)~40% rescue PCI)
ConclusionsConclusions For high-risk STEMI patients receiving For high-risk STEMI patients receiving
thrombolysis at non-PCI centres, urgent thrombolysis at non-PCI centres, urgent transfer and PCI within 6 hours is transfer and PCI within 6 hours is associated with significantly less ischemic associated with significantly less ischemic complications and no excess in bleedingcomplications and no excess in bleeding
Transfers to PCI centres should be initiated Transfers to PCI centres should be initiated immediately after thrombolysis without immediately after thrombolysis without waiting to see whether reperfusion is waiting to see whether reperfusion is successfulsuccessful
Regional systems should be developed to Regional systems should be developed to ensure timely transfers of STEMI patients to ensure timely transfers of STEMI patients to PCI centres PCI centres
Results• Early PCI within 6 hrs after thrombolysis was associated with a 6% absolute reduction in the primary study composite endpoint . Standard 16.6% vs Pharmacoinvasive 10.6% (OR = 0.0013 = 0.537 [.368, 0.783]: p = 0.0013 (Figure)
Conclusions• Challenges findings of older studies regarding timing of fibrinolysis and PCI• Pharmacoinvasive strategy was safe and effective•Findings provide important information for shaping future guidelines
16.6
10.6
0
2
4
6
8
10
12
14
16
18
20
16.6
10.6
0
2
4
6
8
10
12
14
16
18
20
TRANSFER-MITrial Design: TRANSFER-MI was a randomized study comparing
pharmacoinvasive strategy (transfer to PCI center for routine early PCI within 6 hrs) with standard treatment (early transfer only for failed reperfusion) for high-risk STEMI patients receiving thrombolysis at non-PCI centers (N=1,060). The primary endpoint was 30-day composite of death, reinfarction, recurrent Ischemia, CHF, shock.
Standard Pharmacoinvasive
30 Day Composite (death, reinfarction, recurrent ischemia,
CHF, shock) OR = 0.537p =0.0013
Kastrani, K et al. Presented at ACC, 2008 @2008, American Heart Association. All rights reserved.
% of pts
InterpretationInterpretation
PCI is the default strategyPCI is the default strategy for STEMI patients for STEMI patients admitted to centers without PCI facilities who admitted to centers without PCI facilities who were initially treated with reteplase, heparin and were initially treated with reteplase, heparin and abciximab, abciximab, transfer for PCItransfer for PCI was associated with was associated with a reduction in the primary endpoint of death, MI a reduction in the primary endpoint of death, MI or refractory ischemia at 30 days compared with or refractory ischemia at 30 days compared with continued medical management with continued medical management with revascularization only performed for rescue PCI. revascularization only performed for rescue PCI.
The message from the two studiesThe message from the two studies that that primary PCI does not need facilitation (FINESSE) primary PCI does not need facilitation (FINESSE) but if already received facilitation by lysis or IIb-but if already received facilitation by lysis or IIb-IIIa antagonists, immediate PCI rather than IIIa antagonists, immediate PCI rather than rescue PCI is better.rescue PCI is better.
PCI for AMI Strategies
In summary: European In summary: European GLGL
Egypt COMBATMI 2010 March 24-26, Cairo Sheraton Hotel
2010
4th. Acute Cardiac Care Course
EGYPT COMBAT MI 2010
Cairo Sheraton, March 24-26, 2010