1558_koreastemi11
TRANSCRIPT
-
8/6/2019 1558_KoreaSTEMI11
1/32
Treatment of STEMI in 2011:Treatment of STEMI in 2011:
Management of PatientsManagement of PatientsPresenting to NonPresenting to Non- -PCI CentersPCI Centers
Stephen G. Ellis, M.D.Professor of Medic ine
Direc tor Invasive Servic esCo-Direc tor Card iac Gene Bank
-
8/6/2019 1558_KoreaSTEMI11
2/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
3/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
How do you tell?How do you tell?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
4/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
Which one?Which one?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
5/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
How highHow highrisk?risk?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
6/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
Who shouldWho shouldget lytics?get lytics?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
7/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI--Less emphasis on difference between DTNLess emphasis on difference between DTNand DTB per seand DTB per se
-- m u ance y cs or presen a on m nm u ance y cs or presen a on m n--Otherwise PCI except for high risk, early presentingOtherwise PCI except for high risk, early presenting
pts with long DTB delay and low risk of bleedingpts with long DTB delay and low risk of bleeding--Kee decision tree sim le thinkinKee decision tree sim le thinkin - ->dela s>dela s
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
8/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
Which one?Which one?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
9/32
-
8/6/2019 1558_KoreaSTEMI11
10/32
SSENT IV SSENT IV - - Trial Desi n Trial Desi n ASSENT IV Study Design ASSENT IV Study Design
STEMI patients < 6 hrs, PCI within 1-3 hrsN=4000
Randomization 1:1, Open Label
Clopidogrel only after angiogram when decision for stent implantation is made
Primary PCI
IIb/IIIa investigator discretionPre-treatment with Full Dose TNK followed
by Primary PCI
Primary Endpoint * : Composite of Death or Cardiogenic Shock or Congestive Heart
(clopidogrel if stent)IIb/IIIa bail out only* (clopidogrel if stent)
Failure within 90 Days
* * Used in only 9.6% Used in only 9.6%
-
8/6/2019 1558_KoreaSTEMI11
11/32
Sto ed on Basis of Mortalit at 30 Da sSto ed on Basis of Mortalit at 30 Da s ASSENT IV Preliminary Data ASSENT IV Preliminary Data
1010
Mortality (%)Mortality (%)
TNK + PCITNK + PCI
88
P = 0.04P = 0.04
44 3.8
22
50/82850/828 32/83532/83500
6.7 vs 5.0% (p=.14) at 90 days6.7 vs 5.0% (p=.14) at 90 days
Van de Werf ESC 2005 18.8 vs 13.7% (p=.006) MACE at 90 days18.8 vs 13.7% (p=.006) MACE at 90 days
-
8/6/2019 1558_KoreaSTEMI11
12/32
cute MIcute MIPlatelet Activation by FibrinolyticsPlatelet Activation by Fibrinolytics
Normalized Maximal Aggregation RateNormalized Maximal Aggregation Rate
1.51.5 SK
1.01.0
0.50.5
Time (min)Time (min)00 5050 100100 150150 200200 250250
Rudd and Loscalzo, CircRes 90Rudd and Loscalzo, CircRes 90Rabbit model, .05mM ADP as agonistRabbit model, .05mM ADP as agonistSGE; 0802-3, 22
-
8/6/2019 1558_KoreaSTEMI11
13/32
FINESSE: Stud Desi nFINESSE: Stud Desi n Acute ST Elevation MI (or New LBBB*) within 6h pain onset Acute ST Elevation MI (or New LBBB*) within 6h pain onset
Presenting at Hub or Spoke with estimated time to PCI between 1 and 4 hoursPresenting at Hub or Spoke with estimated time to PCI between 1 and 4 hours
Randomize 1:1:1N=3000 *Only 5U if 75
*LocalizedIMI excluded
PlaceboPlacebo
Reteplase (5U+5U)*Abciximab
PlaceboAbciximab
Transfer To Cath LabASA, unfractionated heparin 40U/kg (max 3000u)
Abciximab Placebo Placebo
. .
Primary PCI with Abciximab Infusion (12 h)
Primary endpoint at 90 days: All-cause mortality, resuscitated VFoccurring > 48H, cardiogenic shock, or readmission/ED visit for CHF
-
8/6/2019 1558_KoreaSTEMI11
14/32
All Cause Mortalit Throu h 1 Year All Cause Mortalit Throu h 1 Year
7.4%
6.3%.
-
8/6/2019 1558_KoreaSTEMI11
15/32
FINESSE: 1 Year Mortality byFINESSE: 1 Year Mortality by
All Cause Mortality Through 1 Year
20%
25%
10.0%
15%
c e n t a g e
p=.093
4.6% 4.9%6.1% 6.5%
5%
10% P e
0%
Nonanterior (n=1279) Anterior (n=1173)
Primary PCI with In Lab AbciximabAbciximab Facililated PCI
Abciximab/Reteplase Facilitated PCI
-
8/6/2019 1558_KoreaSTEMI11
16/32
HORIZONS: ThreeHORIZONS: Three- -Year All Year All- -Cause MortalityCause Mortality
1010Bivalirudin alone (n=1800)Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)Heparin + GPIIb/IIIa (n=1802)
7.7%7.7%
l i t y ( %
l i t y ( %
77
88
33--yr HR [95%CI]=yr HR [95%CI]=
..
e M o r t
e M o r t
44
55
664.8%
P=0.03P=0.030.75 [0.58, 0.97]0.75 [0.58, 0.97]
l l l l - - C a u C a u 22
33
11--yr HR [95%CI]=yr HR [95%CI]=3.4%
00
00 1212 1515 1818 2121 2424 2727 3030 3333 363633 66 99
. . , .. . , .P=0.04P=0.04
1611161115681568
166016601689168916701670
18001800Bivalirudin aloneBivalirudin alone 1098109818021802 16431643
MonthsMonthsNumber at riskNumber at risk
Heparin+GPIIb/IIIaHeparin+GPIIb/IIIa1633163315931593
1574157415251525 10431043
-
8/6/2019 1558_KoreaSTEMI11
17/32
Impact of PreImpact of Pre- -randomization Heparin inrandomization Heparin in
--
1010
8.5
Bivalirudin
Heparin + GP IIb/IIa
1010
66
8 7.5
66
8
5.6
7.2
444.8
.
444.6
.
2222
Pre-treatment=
Pre-treatment=
NoPre-treatment
=
NoPre-treatment
=Pre-treatment
=Pre-treatment
=
NoPre-treatment
=
NoPre-treatment
=
Astroulakis Z, Hill JM, Eur Heart J Suppl 2009;11:C13Astroulakis Z, Hill JM, Eur Heart J Suppl 2009;11:C13- -C18C18SGE; 0310-3, 71
-
8/6/2019 1558_KoreaSTEMI11
18/32
Impact of PreImpact of Pre- -randomization Heparin inrandomization Heparin in
--
1010
8.5
Bivalirudin
Heparin + GP IIb/IIa
1010
66
8 7.5
66
8
5.6
7.2
444.8
.
444.6
.
2222
Pre-treatment=
Pre-treatment=
NoPre-treatment
=
NoPre-treatment
=Pre-treatment
=Pre-treatment
=
NoPre-treatment
=
NoPre-treatment
=
Astroulakis Z, Hill JM, Eur Heart J Suppl 2009;11:C13Astroulakis Z, Hill JM, Eur Heart J Suppl 2009;11:C13- -C18C18SGE; 0310-3, 71
-
8/6/2019 1558_KoreaSTEMI11
19/32
STEMISTEMIImportance of Early Heparin Administrative/HorizonsImportance of Early Heparin Administrative/Horizons
3.03.0
P = 0.006P = 0.006
Pre Randomization HeparinPre Randomization Heparin
2.02.0
2.52.5. es
No
1.51.5%% P = 0.02P = 0.02AcuteAcuteStentStent
ThrombosisThrombosis
0.50.5
.. . 0.8
BivalirudinBivalirudin Randomized+
RandomizedHe arin + GP I
0.00.0.
Dangas, ACC 2009Dangas, ACC 2009SGE; 0310-3, 72
-
8/6/2019 1558_KoreaSTEMI11
20/32
Triton TIMI 38 STEMI Triton TIMI 38 STEMI
All ACS/PCIAll ACS/PCIpatientspatients
N=13,608N=13,608 2 patients were missing data2 patients were missing datafor primary or secondaryfor primary or secondaryUA/NSTEMIUA/NSTEMI
STEMI patientsSTEMI patients
pa en spa en sN=10,074N=10,074
Within 14Within 14days for days for
= ,= ,
STEMISTEMI
-
8/6/2019 1558_KoreaSTEMI11
21/32
STEMI CohortSTEMI Cohort== TRITON TIMI TRITON TIMI- -3838
15
12.4%Clopidogrel
10
n t ( % ) 9.5% 10.0%
HR 0.79-
P e r c e 6.5%
HR 0.68-
. .
P=0.02rasugre
NNT = 42
. .P=0.002 TIMI Major
NonCABG Bleeds Prasugrel 2.4
0
Clopidogrel.
Days From RandomizationMontalescot et al Lancet 2008.Adapted with permission from Antman EM.SGE; 0410-8, 31
-
8/6/2019 1558_KoreaSTEMI11
22/32
Triton TIMI 38: Stent Thrombosis: Triton TIMI 38: Stent Thrombosis:
3.03.0Stent Thrombosis (%)Stent Thrombosis (%)
2.8%
2.4%
2.02.0
p=0.02RRR=42%p=0.008
RRR=51%
1.0
1.6%1.2%
Clopidogrel
Prasugrel
HR=0.58 (0.360.93)NNT=83
Time (Days)
0.0
Time (Days)
0.00 450300 350 40025020015050 1000 450300 350 40025020015050 100
Montalescot G et al. Lancet 2009;373:723Montalescot G et al. Lancet 2009;373:723 3131SGE; 0411-1, 10
-
8/6/2019 1558_KoreaSTEMI11
23/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
ASA, Prasugrel*,ASA, Prasugrel*,heparin, BB, statinsheparin, BB, statins
*May give with PCI*May give with PCI(clopidogrel needs(clopidogrel needsloadinloadin
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
24/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
How highHow highrisk?risk?
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
25/32
CARESSCARESS--ININ--AMI: Desi n AMI: Desi n
pts for whom primary PCI not readilypts for whom primary PCI not readilyavailableavailable
Comparison, after half doseComparison, after half doserete lase+abciximab between routinerete lase+abciximab between routine
immediate referral for cath/PCI and selectiveimmediate referral for cath/PCI and selectiverescue PCI approach in pts who do notrescue PCI approach in pts who do notqualify for primary angioplastyqualify for primary angioplasty
High risk patients only (Killip class > 2, EFHigh risk patients only (Killip class > 2, EF 15 mm)
Di Mario et al. Lancet 2008;371.559
SGE; 0410-8, 61
-
8/6/2019 1558_KoreaSTEMI11
26/32
CARESSCARESS--ININ--AMI: Primary Outcome AMI: Primary Outcomeprimary 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
10.7%
4.4%
HR=0.40 (0.21-0.76)
Di Mario et al. Lancet 2008;371:559.SGE; 0410-8, 64
-
8/6/2019 1558_KoreaSTEMI11
27/32
Transfer AMI Transfer AMI
Cath/PCI After Lysis: Routine or Rescue?Cath/PCI After Lysis: Routine or Rescue?
1,059 pts STEMI 100, Killip 2- -3 or 3 or RVMl rxd with TenecteplaseRVMl rxd with TenecteplaseRR routine or routine or
0.10
0.150.80.8
-10 -
-
8/6/2019 1558_KoreaSTEMI11
28/32
Intervention After Fibrinol sisIntervention After Fibrinol sisProbability of death, non-fatal reinfarction, or ischemia-driven revascularization
30
500 Patients
-
20Conservative
intervention.
ST elevation in 2 leads
Number at riskTime since randomization (months)
0 2 4 6 8 10 120
dependency
Randomized to either routine
Intervention 248 230 228 226 223 222 221Conservative 251 225 217 211 208 202 195
Probability of death, non-fatal reinfarction
30
Ischemia only driven cath(20% crossover)
10
20
Conservative
1 end pt: death, MI or ischemia reg revasc at 12months
Number at riskTime since randomization (months)
0 2 4 6 8 10 120
intervention
SGE; 0411-11, 1
Fernandez-Aviles Lancet 04Intervention 248 236 235 232 229 228 227Conservative 251 235 230 226 225 221 217
-
8/6/2019 1558_KoreaSTEMI11
29/32
Clinical Outcome at 30 DaysClinical Outcome at 30 Days
2525
conservative21%21% RR 0.49 (0.27RR 0.49 (0.27- -0.89)0.89)
1515
invasiveP=0.03P=0.03
--
1010 10%10% 9.8%9.8%
P=0.14P=0.14(%)(%)
55 4.5%4.5%2.3%2.3% 2.2%2.2%
Death, reDeath, re- -MI,MI,stroke, newstroke, new
ischemiaischemia
Death, reDeath, re- -MI,MI,strokestroke
DeathDeath
SGE; 0410-1, 13Bohmer E. JACC 55:102, 2010 n=266 patients > 90 min from FMCBohmer E. JACC 55:102, 2010 n=266 patients > 90 min from FMC- ->PCI, rxd with>PCI, rxd withtenecteplase (not selected for high risk) Invasivetenecteplase (not selected for high risk) Invasive- - PCI (89%) 163 min, Cons (71%)PCI (89%) 163 min, Cons (71%)3 da s after TNK3 da s after TNK
-
8/6/2019 1558_KoreaSTEMI11
30/32
2009 ACC Guidelines: Triage and Transfer for PCI2009 ACC Guidelines: Triage and Transfer for PCI
All but veryAll but veryLow riskLow risk
SGE; 0410-1, 48FJ Kushner et al., 2009 STEMI Guideline UpdatesFJ Kushner et al., 2009 STEMI Guideline Updates
-
8/6/2019 1558_KoreaSTEMI11
31/32
STEMI: Summar + ConclusionsSTEMI: Summar + Conclusions
PCI trumps primary lytics exceptPCI trumps primary lytics exceptsx < 90 min if lytics given quickly (ambulance)sx < 90 min if lytics given quickly (ambulance)
very long transfer times (time depends onvery long transfer times (time depends onpa en r s pro epa en r s pro e No role for routine facilitated PCINo role for routine facilitated PCI
,,should be transferred for cath/PCI immediately =>should be transferred for cath/PCI immediately =>pharmacopharmaco- -invasive strategy with adequate antiinvasive strategy with adequate anti- -p a e e erapyp a e e erapy
DAP with prasugrel (except when contraindicated),DAP with prasugrel (except when contraindicated),--
SGE; 1109-9, 32
-
8/6/2019 1558_KoreaSTEMI11
32/32
STEMI Triage for Non Cath Lab HospitalsSTEMI Triage for Non Cath Lab Hospitals
Final WordFinal Word Have protocol for patient transfer in good weather Have protocol for patient transfer in good weather
and bad (eg helicopter, ground transport) worked outand bad (eg helicopter, ground transport) worked outwith receiving hospital(s)with receiving hospital(s)
os r age pro oco n eos r age pro oco n e-- should be relatively simpleshould be relatively simple-- ,,
that can be given iv push)that can be given iv push)
Post contraindications to lytics alsoPost contraindications to lytics also
SGE; 1109-9, 32