PPCI in STEMI Dr Hassan Mhish Dr Hassan Mhish Interventional Cardiology Consultant Cardiology Fellowship Program Director Prince Salman Heart Center King Fahd Medical City Riyadh, KSA ESC at the 22nd Annual Conference of the Saudi Heart Association February 21th, 2011
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PPCI in STEMI
Dr Hassan MhishDr Hassan MhishInterventional Cardiology Consultant
Cardiology Fellowship Program Directorgy p gPrince Salman Heart Center
King Fahd Medical CityRiyadh, KSA
ESC at the 22nd Annual Conference of the Saudi Heart Association
February 21th, 2011
Primary PCI vs Thrombolysis in STEMI: Q tit ti A l i (23 RCT * N 7739)Quantitative Analysis (23 RCTs*, N=7739)
25 Short-term outcomes
P<.0001 PCITh b l ti
15
20
y, %
outcomes(4–6 wk)
Thrombolytictherapy
P<.0001
10
15
Freq
uenc
y
P=.0002 P<.0001P=.032
5
F
P<.0001
0 Death NonfatalMI
RecurrentIschemia
Hemor-rhagicStroke
MajorBleed
Death, Nonfatal
Reinfarction,or Stroke
Keeley EC, et al. Lancet. 2003;361:13-20.
S*The criterion for time to treatment was 6 h or less in 9 of the trials, 12 h in 13 trials, and up to 36 h in the SHOCK trial.
Background:
2007 focused update of the ACC/AHA STEMI guidelines
Pathway: Triage and Transfer for PCI (in STEMI)STEMI patient who is aSTEMI patient who is acandidate for reperfusion
Initially seen at a PCIcapable facility
Initially seen at a non-PCIcapable facilitycapable facility
considered (Class IIb, LOE:C), especially if ischemic symptoms
early diagnostic angio & possible PCI or CABG (Class IIa, LOE:B),
facility, evaluate for timing of diagnostic angioDiagnostic angio
Medicaltherapy only
PCI CABG
y ppersist and failure to reperfuse is suspected
High-risk patients as defined by 2007 STEMI Focused Update should
g
2009 STEMI Focused Update. Appendix 5
py y Update should undergo cath (Class 1: LOE B)
Clinical ImplicationsI t l ti d l t f i h th t t•Incremental time delays to reperfusion have the greatest
impact on myocardial salvage and survival in the first 2-3 hours and have much less impact after 3 hours.p
•Short DBT impact mortality most in pts presenting early whocan be reperfused within the 3 hour window of optimumcan be reperfused within the 3 hour window of optimumbenefit
Mortality Reduction %
100
60
80 Mortality Reduction %y %
0
20
40
60Myocardial Salvage %
Myocardial Salvage %0 3 6 9 12 24Hours
Gersh JAMA 2007
Mortality With Primary PCI vs Lysis b R l ti Ti iby Relative Timing
ath
(%)
15
P= 006nce
in D
e
10
Favors PCI
P=.006
62 min
sk D
iffer
en 5
0 Favors Lysis
solu
te R
is 0
-54040 8080 100100
PCI-Related Time Delay(Door-to-Balloon Minus Door-to-Needle), min
Abs 00 2020 4040 6060 8080 100100
Circle sizes=sample size of individual study; solid line=weighted meta-regression.For every 10-minute delay to PCI: 0.94% reduction in mortality difference vs lytics.Nallamothu et al. Am J Cardiol. 2003;92:824-826 (B).
Time vs. InTime vs. In--Hospital Mortality Hospital Mortality 3/43/4DoorDoor––toto––Balloon Time: NRMIBalloon Time: NRMI––3/43/4
6
8
ity %
5.75.7
7.47.4N = 29,222N = 29,222PP < 0.001< 0.001
4
6
al M
orta
li
3 03 0
4.24.2
2
-hos
pita 3.03.0
0<= 90 90 - 120 120 - 150 > 150
In
Door-to-Balloon (minutes)McNamara RL, et al. JACC. 2006;47:2180.
Interhospital Delay in Transfer Patients
15
p yDoor-to-Door Times
12.1
15
(%)
(%)
6.26.4
10
orta
lity
(or
talit
y (
3.25
MM
0< 30" 30 – 59" 60 – 89" > 90"
De Luca G, et al. Am J Cardiol. 2005;95:1361.
D2B Time And Mortality2300 Patients2300 Patients
High risk = Killip class 3 or 4 age >70 anterior MI
Brodie BR, JACC 2006;47:289
High risk = Killip class 3 or 4, age >70, anterior MI
Terkelsen et al, JAMA 2010
Background: Various delays Symptom
onset
Transportation
EMScall
Arrival atPCI centre
D2B
PPCI
Patient delay Transportationdelay
D2Bdelay
Health Care System delay
Field-triagedto a PCI centre
Treatment delay
T i
Arrival atPCI centre
PPCIArrival atlocal hospital
Departure fromlocal hospital
Patient delayTransportation
delayLocal hospital
delay
Health Care System delay
D2Bdelay
InterhospitaldelayTransferred
from local hospitals
Treatment delay
System delay and mortality
Kaplan-Meier failure estimatesKaplan-Meier Cumulative Mortality System delay
0.25
0.30
25 3
0
121-180 min.
181-360 min.
.15
0.20
0
0-60 min.
ality,
%15
20
61-120 min.
050.
100
Mor
ta5
10
1
0.00
0.
1 2 3 4 5 6F ll ( )
0
1 2 3 4 5 6Follow-up (years)Follow-up (years)
Terkelsen et al, JAMA 2010
MANAGEMENT OF STEMIMANAGEMENT OF STEMI“It is not enough that we do ourIt is not enough that we do our best; sometimes we have to do what is required”
Sir Winston Churchill
Th b l iThrombolysis • Golden time: the first 2 hours
TimeTime--independent Periodindependent PeriodGoal: Open InfarctGoal: Open Infarct Related ArteryRelated ArteryGoal: Myocardial SalvageGoal: Myocardial Salvage Goal: Open InfarctGoal: Open Infarct--Related ArteryRelated Artery
Gersh BJ, et al. Gersh BJ, et al. JAMAJAMA 2005;293:979.2005;293:979.
Cadillac Plus Horizons-AMI
CADILLACN= 2082
HORIZONS-AMIN = 3602
PCI PerformedN 2082
PCI PerformedN 3345
Door-to-Balloon Time Door-to-Balloon Time
N=2082 N = 3345
Data AvailableN = 1909
Data AvailableN = 2639
Total Study PopulationPCI Performed
and DBT Data AvailableN = 4548
Impact of Door-to-Balloon Time (90 min) O Y M t liton One Year Mortality
All Patients
DBT 90 i4.3%
DBT > 90 min3.1%
DBT < 90 min
Unadjusted HR 0.72 (0.52–0.99)j ( )p = 0.045
Impact of Door-to-Balloon Time on One Year Mortalityon One Year Mortality
Early (< 1.5 hrs) vs Late Presenters
Time to Presentation > 1.5 hoursTiTime to Presentation < 1.5 hours Time to Presentation > 1.5 hours
DBT > 90 min4.6%
3 8%
HR 0.49 (0.26-0.93)p = 0.029
DBT > 904.6%
HR 0.86 (0.58-1.28)p = 0.47
DBT < 90 min
DBT > 90 minDBT > 90
DBT < 90
3.8%
1.9%
DBT > 90
DBT < 90 4.0%
DBT < 90
Impact of Door-to-Balloon Time in Early Presenters:Comparison of High and Low Risk GroupsComparison of High and Low Risk Groups
(TIMI Risk < 2 vs > 2)
High Risk Low Risk
Time to Presentation < 1.5 hrs
DBT > 907.0%
g Low Risk
HR 0 52 (0 14-1 89)
DBT < 90 3.7%
HR 0 52 (0 24 1 08) DBT > 90 1.5%
HR 0.52 (0.14 1.89)p = 0.32
HR 0.52 (0.24-1.08)p = 0.08
DBT 90
DBT < 90 0.8%
TRANSFER-AMI
Study of pharmacoinvasive strategyStudy of pharmacoinvasive strategy 1059 patients with STEMI
non-PCI-capable hospitals within 12 hrs of symptom onsetwithin 12 hrs of symptom onset
with ≥ 1 high-risk feature
Cantor et al. N Eng J Med 2009;360:26.
Recommendations for Triage and Transfer for PCI: *High Risk Definition
Defined in TRANSFER AMI as >2 mm ST• Defined in TRANSFER-AMI as >2 mm ST-segment elevation in 2 anterior leads or ST elevation at least 1 mm in inferior leads
ith t l t f th f ll iwith at least one of the following: – systolic blood pressure <100 mm Hg – heart rate >100 beats per minute p– Killip Class II-III – >2 mm of ST-segment depression in the
anterior leadsanterior leads – >1mm of ST elevation in right-sided lead V4
indicative of right ventricular involvement
Cantor et al. N Eng J Med 2009;360:26.
TRANSFER-AMI--Designg• All patients received standard-dose tenecteplase
(TNK), ASA, and either UFH or enoxaparin.( ), , p– a pharmaco-invasive strategy (immediate
transfer for PCI within 6 hours of fibrinolytic therapy) or totherapy) or to
– standard treatment after fibrinolytic therapy (included rescue PCI as required for ongoing chest pain and less than 50% resolution of STchest pain and less than 50% resolution of ST-elevation at 60-90 minutes or hemodynamic instability).St d d t t t ti t h did t i– Standard treatment patients who did not require rescue PCI remained at the initial hospital for at least 24 hours and coronary angiography within
fthe first 2 weeks encouraged
Cantor et al. N Eng J Med 2009;360:26.
TRANSFER-AMI--Design (cont.)g ( )
• Clopidogrel loading (300 mg for patients < 75• Clopidogrel loading (300 mg for patients < 75 years of age, and 75 mg >75 years of age) strongly encouraged in all study patients
• GP IIb/IIIa receptor antagonists administered at the PCI-capable hospitals according to institutions’ standard practiceinstitutions standard practice
Cantor et al. N Eng J Med 2009;360:26.
TRANSFER-AMI: ResultsProceduresProcedures
Pharmaco-invasive vs. Standard Treatment
Median time to TNK administration from symptom onset
Approximately 2 hrs in both groups
symptom onset
Median time from TNK to
2.8 hrs vs. 32.5 hrsTNK to catheterizationCoronary 98.5% vs. 88.7%yangiography
PCI performed 84.9% vs. 67.4%
Cantor et al. N Engl J Med 2009;360:26.
TRANSFER-AMI: Efficacy Kaplan Meier Curves for Primary Endpoint
primary end point: composite of death, reinfarction, recurrent ischemia, newor worsening CHF, or shock within 30 days pharmaco-invasive group=11 0% vs standard treatment group=17 2%
17.2%
pharmaco-invasive group=11.0% vs. standard treatment group=17.2%
11.0%
Cum
ulative Incidence
p=0.004
Days
RR= 0.64, 95 CI% (0.47-0.87)Cantor et al. N Engl J Med 2009;360:26
TRANSFER-AMI--Safety Resultsy
• Incidence of TIMI major and minor bleeding andIncidence of TIMI major and minor bleeding and GUSTO moderate and severe bleeding was not different between groups
• There was higher incidence of GUSTO mild bleeding in the pharmaco-invasive group (13.0% compared to 9.0% in the standard treatmentcompared to 9.0% in the standard treatment group, p=0.036).
Cantor et al. N Eng J M 2009;360:26.
TRANSFER-AMISt d C l iStudy Conclusion
• Following treatment with fibrinolyticFollowing treatment with fibrinolytic therapy in high risk STEMI pts presenting to hospitals without PCI-presenting to hospitals without PCI-capability, transfer to a PCI center to undergo coronary angiography and PCIundergo coronary angiography and PCI should be initiated immediately without waiting to determine whetherwaiting to determine whether reperfusion has occurred.
Cantor et al. N Eng J M 2009;360:26.
CARESS-IN-AMI:CARESS IN AMI:inclusion Criteria
• STEMI patients presenting within 12 hours from symptom onset with one or y pmore of the following high-risk criteria:
• summation of ST-segment elevationsummation of ST segment elevation ≥15 mm in all 12 ECG leads,
• new left bundle branch block previous• new left bundle branch block, previous MI, Killip class II or III, and left ventricular ejection fraction <35%ventricular ejection fraction <35%
CARESS-IN-AMI: Primary Outcomeprimary outcome (composite of all cause mortality reinfarction & refractory MI within 30 days)primary outcome (composite of all cause mortality, reinfarction, & refractory MI within 30 days) occurred significantly less often in the immediate PCI group vs. standard care/rescue PCI group
MetaMeta--analysis of Clopidogrel analysis of Clopidogrel Pretreatment in PCIPretreatment in PCI
MetaMeta--analysis of Clopidogrel analysis of Clopidogrel Pretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCIPretreatment in PCI
No. (%)No. (%)SourceSource ClopidogrelClopidogrel PlaceboPlacebo OR (95% CI)OR (95% CI)MI Before PCIMI Before PCI
TREATMENT PCI t t t ith l id l (600TREATMENT: pre-PCI treatment with clopidogrel (600 mg), followed by abciximab vs. placebo
INCLUSION: suspected acute MI (ST change or LBBB) INCLUSION: suspected acute MI (ST change or LBBB) within 24 h of symptom onset
EXCLUSION: high risk for bleeding, prior stroke,shock,trauma, thrombolytics, hypertension,relevant hematologic deviations
1° OUTCOMES i f t i d th t k t1° OUTCOMES: infarct size, death, stroke, urgentrevascularization of affected artery
Mehilli et al. Circ. 2009;119:1933-1940
Effects of Abciximab
P= 0 47
P= 0.40
P 0.47
No significant difference in infarct size or major bleeding
Mehilli et al. Circ. 2009;119:1933-1940
Use of Glycoprotein IIb/IIIa Receptor Antagonists in STEMIAntagonists in STEMI
Modified
It is reasonable to start treatment with glycoprotein
Recommendation
g y pIIb/IIIa receptor antagonists at the time of primary PCI (with or without stenting) in selected patients with STEMI:III IIIIII IIbIIbIIb IIIIIIIIIIII IIIIII IIbIIbIIb IIIIIIIIIIII IIIIII IIbIIbIIb IIIIIIIIIIIIIII IIbIIbIIb IIIIIIIII with STEMI:
CONCLUSIONS:CONCLUSIONS:• STEMI patients who present to hospitals with requisite
f iliti d ti PPCI i th f d t tfacilities and expertise, PPCI is the preferred strategy. • Fibrinolysis without delay may provide maximal
advantage in younger patients at low risk of hemorrhage g y g p gand mortality presenting earlier (only if the delay to PPCI is beyond the acceptable time frame for that patient),
• High risk STEMI patients except very early STEMI• High-risk STEMI patients, except very early STEMI patients without Q waves on the admission ECG, might benefit from PPCI, even when longer delays are
id blunavoidable. • Routine but non-emergent invasive strategy after
fibrinolytic therapy is not only safe and effective but also y py ythe preferred approach.
AMI: special Groups
• Cardiogenic Shock • Large thrombotic burdenLarge thrombotic burden• Late presentation 12-24 hours
Randomized Studies in Cardiogenic Shock
Trial n/N n/NRelative Risk95% CI
Relative Risk95% CIFollow-up
Revascularization (PCI/CABG)SHOCKSMASH
76/15222/32
103/184
83/14918/23
11 /1 2
0.80 (0.66;0.98)0.87 (0.66;1.29)0 82 (0 70 0 98)
1-year30 days
Total 103/184 117/172 0.82 (0.70;0.98)
Early revascularization better
Medical treatmentbetter
Norepinephrine0.75 (0.55;0.93)64/145 50/13528 days
TAPAS: 1-Year ResultsT i l d i P ti t ith ST l ti di l i f ti d i d tTrial design: Patients with ST-elevation myocardial infarction were randomized to thrombus aspiration prior to PCI (n = 535) or standard PCI without aspiration (n = 536) and followed for 1 year.
• All-cause mortality: 4.7% vs. 7.6% (p = 0.042), respectively
• Cardiac death: 3 6% vs 6 7% (p = 0 02)
Results
(p = 0.042) (p = 0.05)
8
• Cardiac death: 3.6% vs. 6.7% (p = 0.02), respectively
• Reinfarction: 2.2% vs. 4.3% (p = 0.05), respectively
% 2.2 4.3
4.7 7.6
0
4
Conclusions• In earlier presentation of TAPAS, thrombus
aspiration during acute MI improvedR i f tiAll-cause mortality Re-infarction aspiration during acute MI improved reperfusion
• Extended follow-up to 1 year demonstrates that this strategy reduces death and MIThrombus
aspirationStandard PCI
All-cause mortality Reinfarction
Vlaar PJ, et al. Lancet 2008;371:1915-20
aspiration
FINESSE: Study designFINESSE: Study design
Pre-PCI treatment with ½ -dose lytic plus Treatment
y pabciximab, pre-PCI abciximab alone, and abciximab at time of PCI
Inclusion Suspected acute MI (ST change or LBBB) within 6 h of symptom onset
Exclusion Low risk (<60 yo, localized inferior infarct) high risk for bleeding
1° OUTCOMES Death, VF after 48 hours, shock, CHF within 90 days
51
Ellis et al. N Eng J Med. 2008;358:2205-2217.
Primary, secondary, and bleeding end Primary, secondary, and bleeding end points in FINESSEEnd point Primary
PCI (%)Abciximab-facilitated
Combination (abciximab/
p, combination-facilitated vs
p, combination-
End point Primary PCI (%)
Abciximab-facilitated
Combination (abciximab/
p, combination-facilitated vs
p, combination-PCI (%) facilitated
(%)(abciximab/reteplase)-facilitated (%)
facilitated vsprimary PCI
combination-facilitated vsabciximab-facilitated
PCI (%) facilitated (%)
(abciximab/reteplase)-facilitated (%)
facilitated vsprimary PCI
combination-facilitated vsabciximab-facilitated
Primary end point* at 90 days
10.7 10.5 9.8 NS NS
>70% ST segment resolution within
31.0 33.1 43.9 0.003 0.01
Primary end point* at 90 days
10.7 10.5 9.8 NS NS
>70% ST segment resolution within
31.0 33.1 43.9 0.003 0.01
60–90 minTIMI major or minor bleeding through discharge
6.9 10.1 14.5 <0.001 0.00860–90 minTIMI major or minor bleeding through discharge
6.9 10.1 14.5 <0.001 0.008
through discharge or day 7through discharge or day 7*All-cause mortality; rehospitalization or emergency department treatment for CHF; resuscitated ventricular fibrillation occurring >48 hours after randomization; cardiogenic shock
52
Ellis et al. N Eng J Med. 2008;358:2205-2217
OnTIME 2: Study design
Acute myocardial infarctionAcute myocardial infarctiondiagnosed in ambulance or referral centerdiagnosed in ambulance or referral center