primary pci state of the art - jcr · –pharmacoinvasive approach •to aspirate or not to...
TRANSCRIPT
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Primary PCI State of the Art
A/Prof Michael Nguyen Fremantle Hospital/Fiona Stanley Hospital
Perth Australia JCR Meeting Busan 2014
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Content
• Evidence of Primary PCI vs Thrombolysis – When, Why, How
– Transfer PCI
– Facilitated PCI
– Pharmacoinvasive approach
• To Aspirate or not to Aspirate
• Adjunctive anticoagulation
• Culprit only vs Preventative PCI
• My Overview
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Case: Mr Complex
• 78 yo man presents with severe central chest pain to regional hospital (60 minutes from PCI capable hospital).
• Pain started 60 minute ago
• ECG – 4 mm of inferior ST elevation
• PHX – NIDDM
– Smoker
– Due to have prostatic surgery for prostate cancer
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What next?
• Transfer PPCI?
• Thrombolysis and wait?
• Thrombolysis and transfer for rescue PCI if needed?
• Thrombolysis and invasive strategy irrespective of ST segment resolution?
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Class I Recommendation
All STEMI patients should undergo rapid evaluation
for reperfusion therapy and have a reperfusion
strategy implemented promptly after contact with the
medical system. (Level of Evidence: A)
Reperfusion Therapy
Antman EM, et al. Available at: http://www.acc.org/clinical/guidelines/stemi/index.pdf.
Accessed November 1, 2005.
Medical system goal is to facilitate rapid recognition and
treatment of patients with STEMI such that door-to-needle (or
medical contact–to-needle) time for initiation of fibrinolytic
therapy can be achieved within 30 minutes or that door-to-
balloon (or medical contact–to-balloon) time for PCI can be
kept within 90 minutes.
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Goal of Fibrinolytic Therapy Alone: Open Arteries and Reduce Mortality
4.6
87.9
15.7
0
2
4
6
8
10
12
14
16
TIMI 3 TIMI 0,1,2
Pati
en
t M
ort
ali
ty (
%) 30 Days
2 Years
Ross AM, et al. Circulation. 1998;97:1549-1556.
90 min TIMI Flow Post-fibrinolytic
GUSTO-I (STK vs t-PA) Angiographic Investigators: Post-lytic TIMI Flow Predicts Mortality
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Pharmacologic Reperfusion Available Resources
Class I Recommendations
STEMI patients presenting to a facility without
the capability for expert, prompt intervention
with primary PCI within 90 minutes of first
medical contact should undergo fibrinolysis
unless contraindicated (Level of Evidence: A)
Antman EM, et al. J Am Coll Cardiol. Available at: http://www.acc.org/clinical/guidelines/stemi/index.pdf. Accessed November 1, 2005.
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ACC/AHA STEMI Guidelines: Primary Percutaneous Coronary Intervention
Class I Recommendations
• Level of Evidence: B
– Primary PCI should be performed as quickly as possible (goal of medical contact-to-balloon or door-to-balloon time < 90 minutes).
– If the symptom duration is within 3 hours and the expected door-to-balloon time minus the expected door-to-needle time is:
• < 60 mins - primary PCI preferred
• > 60 mins - fibrinolytic therapy preferred
– If symptom duration is greater than 3 hours, primary PCI is generally preferred.
Antman EM, et al. J Am Coll Cardiol. Available at:
http://www.acc.org/clinical/guidelines/stemi/index.pdf
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Time Dependency?
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PCI-Related Time Delay (door-to-balloon, door to-needle)
Circle sizes = sample size of the individual study.
Solid line = weighted meta-regression.
For every 10 min delay to PCI: 1% reduction in mortality difference vs lytics
Nallamothu BK, Bates ER. Am J Cardiol. 2003:92:824
Favors PCI
Favors Lysis
P = 0.006
62 min
Ab
so
lute
Ris
k D
iffe
ren
ce i
n D
eath
(%
)
15
10
5
0
-5 0 20 40 60 80 100
Mortality With 1° PCI Vs Time
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PCI vs Faciliated PCI: Meta-analysis
• 17 STEMI trials
• Received either
– Primary PCI (N=2267)
– Facilitated PCI (N=2237)
• Short term outcomes (< 42 days)
– Death, CVA, non-fatal re-MI
– Urgent TVR, re-bleed
Keely EC, Boura JA, Grines CL. Lancet, 2006
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Facilitated PCI Meta-analysis
f-PCI (%) PCI (%) OR (95% CI)
Initial TIMI 3 37 15 3.18 (2.22, 4.45)
Final TIMI 3 89 88 1.19 (0.88, 1.64)
Death 5 3 1.38 (1.01, 1.87)
Urgent TVR 4 1 2.39 (1.23, 4.66)
ICH 0.7 0.1 P=0.0014
Keely EC, Boura JA, Grines CL. Lancet, 2006
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Facilitated PCI Meta-analysis
• Conclusions
“Facilitated PCI offers no benefit over primary PCI and should not be used outside of the context of randomized clinical trials”
Furthermore, facilitated interventions with thrombolytic based regimens should be avoided.
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no lytic
STREAM design – Pharmaco-invasive approach
RANDOMIZATION 1:1 by IVRS, OPEN LABEL
Am
bu
lan
ce
/ER
Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30
ECG at 90 min: ST resolution ≥ 50%
Standard primary PCI
Aspirin
Clopidogrel:
LD 300 mg + 75 mg QD
Enoxaparin:
30 mg IV + 1 mg/kg SC
Q12h
Antiplatelet and
antithrombin treatment
according to local standards
angio >6 to 24 hrs
PCI/CABG if indicated immediate angio +
rescue PCI if indicated
YES NO
Strategy A: pharmaco-invasive Strategy B: primary PCI
Aspirin
Clopidogrel:
75 mg QD
Enoxaparin:
0.75 mg/kg SC Q12h
PC
I H
os
pit
al
STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2
leads
≥75y: ½ dose TNK <75y:full dose After 20% of the planned
recruitment, the TNK
dose was reduced by
50% among patients ≥75
years of age.
Armstrong et al NEJM 2013;368(15):1379-87
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All-cause mortality
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Cardiac mortality
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All-cause mortality before & after amendment
Patients randomized before Am. (n=382) Patients randomized after Am. (n=1,510)
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Mr Complex
• Thrombolysis given at Regional hospital and patient transferred to your hospital.
• On arrival patient still has 2/10 pain and 2mm Inferior ST elevation
• What next?
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Radial vs Femoral
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RIFLE STEACS - flow chart
Design
• DESIGN:
Prospective, randomized (1:1),
parallel group, multi-center trial.
• INCLUSION CRITERIA:
all ST Elevation Myocardial
infarction (STEMI) eligible for
primary percutaneous coronary
intervention.
• ESCLUSION CRITERIA:
contraindication to any of both
percutaneous arterial access.
international normalized ratio
(INR) > 2.0.
1001 patients enrolled between January
2009 and July 2011 in 4 clinical sites in Italy
Clinical follow-up at
1 month in 100%
Femoral arm
(N=501)
Radial arm
(N=500)
Femoral arm
(N=534)
Radial arm
(N=467)
Clinical follow-up at
1 month in 100%
Intention-to-treat analysis
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NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%
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NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target lesion revascularization, stroke
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%
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Cardiac death Myocardial
Infarction
Target Lesion
Revascularization
Cerebrovascular
Accident
femoral arm radial armp = 0.020
30-day MACCE rate
RIFLE STEACS – results
p = 1.000 p = 0.604 p = 0.725
9.2%
5.2%
1.4% 1.2% 1.8% 1.2% 0.6% 0.8%
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OR CI 95% p value
Female gender 1.5 (1.1-2.3) 0.037
CKD 2.1 (1.4-3.1) 0.001
Radial access 0.6 (0.4-0.9) 0.012
Killip class 1.8 (1.5-2.2) 0.001
LAD culprit 1.7 (1.2-2.6) 0.006
TIMI 0 basal 1.4 (1.0-2.1) 0.073
LVEF <50% 1.6 (1.1-2.5) 0.025
TIMI 0-1 final 2.4 (1.1-5.1) 0.024
30-day NACE predictors
RIFLE STEACS – results
p= 0.002
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STEMI-RADIAL
A Prospective Randomized Trial of Radial vs. Femoral Access in Patients with ST-Segment Elevation Myocardial Infarction
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STEMI-RADIAL - objectives
To compare radial vs femoral approach in
primary PCI for patients with STEMI < 12
hours in very high volume radial centers
(> 80% primary PCI)
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1.1% 0.3%
2.8%
5.3%
0.8% 0.8% 0.3% 0.3%
0.9% 0.6% 0.0% 0.3%
Gastro- intestinal
Hb drop ≥4g/dL w/o overt
Hb drop ≥3g/dL with overt
Hematoma ≥15cm
Transfusion Vascular complication
femoral radial
STEMI RADIAL - results
30-day bleeding and access site compl.
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MACE Death MI Stroke
femoral arm radial arm
p = 0.7
30-day MACE
STEMI RADIAL - results
p = 0.64
p = 0.72
p = 1.0
4.2%
3.5% 3.1%
2.3%
0.8% 1.2%
0.3% 0.3%
MACE = composite of death, myocardial infarction and stroke
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Anticoagulation?
• Heparin alone?
• Heparin and Glycoprotein 2b3a?
• Bivalirudin?
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Harmonizing Outcomes with Revascularization and Stents in AMI
3602 pts with STEMI with symptom onset ≤12 hours
Emergent angiography, followed by triage to…
Primary PCI CABG – Medical Rx –
UFH + GP IIb/IIIa inhibitor
(abciximab or eptifibatide)
Bivalirudin monotherapy
(± provisional GP IIb/IIIa)
Aspirin, thienopyridine R
1:1
3006 pts eligible for stent randomization R
3:1
Bare metal EXPRESS stent Paclitaxel-eluting TAXUS stent
Clinical FU at 30 days, 6 months, 1 year, and then
yearly through 3 years; angio FU at 13 months
Stone, GW N Engl J Med 2008;358:2218-30.
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3-Year Major Bleeding
(non-CABG)*
* Intracranial, intraocular, retroperitoneal, access site bleed requiring intervention/surgery, hematoma ≥5 cm, hgb ↓
≥3g/dL with or ≥4g/dL w/o overt source; reoperation for bleeding; or blood product transfusion
12
0
4
6
8
10
0.64 (0.51, 0.80)
2
0
12 15 18 21 24 27 30 33 36
P=0.0001
3-yr HR (95%CI)
6.9%
10.5%
Majo
r B
leedin
g (
%)
Months
3 6 9
Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)
9.4%
6.0%
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
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3-Year Cardiac Mortality '
5.1%
Time in Months Time in Months
Bivalirudin alone (n=1800) Heparin + GPIIb/IIIa (n=1802)
Ca
rdia
c M
ort
alit
y (
%)
P=0.001
3-yr HR (95%CI)
0.56 (0.40, 0.80)
2.9%
0 12 15 18 21 24 27 30 33 36
Months
3 6 9
0
1
6
5
4
3
2
3.8%
2.1%
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
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3-Year Cardiac Mortality
Landmark analysis
5
4
3
2
1
0
0 3 6 9 12 15 18 21 24 27 30 33 36
Heparin + GP IIb/IIIa (n=1802)
Bivalirudin (n=1800)
3 year HR (95% CI)
0.49 0.28 –0.86
p=0.01
30 day HR (95% CI)
0.62 (0.40 – 0.96)
p=0.03
2.2%
1.1%
Card
iac m
ort
alit
y (
%)
1.8%
2.9%
Months
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
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3-Year Reinfarction
Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)
6.2%
8.2%
Re
infa
rctio
n (
%)
0
1
2
3
4
5
6
7
8
9
10
P=0.04
3-yr HR (95%CI)
0.76 (0.59, 0.99)
0 12 15 18 21 24 27 30 33 36
Months
3 6 9
4.4%
3.6%
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
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3-Year Reinfarction
Landmark analysis
10
8
6
4
2
0 0 3 6 9 12 15 18 21 24 27 30 33 36
3-year HR (95% CI)
0.66 (0.49 – 0.90)
p=0.007
30-day HR (95% CI)
1.07 (0.66 – 1.73)
p=0.79 6.5%
4.4%
Rein
farc
tion
(%
)
1.8% 1.9%
9
7
5
3
1
Months
Heparin + GPIIb/IIIa (n=1802)
Bivalirudin (n=1800)
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
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3-Year Stent Thrombosis
(ARC Definite/Probable)
6
0
2
3
4
5
0.89 (0.65, 1.23)
1
0
12 15 18 21 24 27 30 33 36
p=0.49
HR (95%CI)
4.5% 5.1%
Ste
nt T
hro
mbosis
(%
)
Months
3 6 9
Bivalirudin alone (n=1611)
Heparin + GPIIb/IIIa (n=1591)
3.5%
3.0%
Stone, GW Lancet 2011 Published online June 13. DOI:10.1016/S0140-6736(11)60764-2
ARC= Academic Research Consortium
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Dr Adeel Shahzad
Dr Rod Stables (PI)
Liverpool Heart and Chest Hospital
Liverpool, UK
How Effective are
Antithrombotic Therapies in PPCI
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• Single centre RCT
• Trial recruitment: Feb 2012 - Nov 2013 22 months
• Bivalirudin v Unfractionated Heparin
• STEMI patients
– Randomised at presentation
– Acute phase management with Primary PCI
• Philosophy for clinical teams:
• Assess ‘Every Patient - Every Time’
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1917 patients scheduled for emergency angiography
29 (1.5%) already randomised in the trial
59 (3.0%) met one or more other exclusion criteria
1829 eligible for recruitment
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1917 patients scheduled for emergency angiography
29 (1.5%) already randomised in the trial
59 (3.0%) met one or more other exclusion criteria
1829 eligible for recruitment
1829 Randomised
Representative ‘Real-World’ Population
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Characteristic Bivalirudin (%) Heparin (%)
P2Y12 use - Any 99.6 99.5
- Clopidogrel 11.8 10.0
- Prasugrel 27.3 27.6
- Ticagrelor 61.2 62.7
GPI use 13.5 15.5
Radial arterial access 80.3 82.0
PCI performed 83.0 81.6
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• Dual oral anti-platelet therapy pre-procedure
• Heparin: 70 units/kg body weight pre-procedure
• Bivalirudin: Bolus 0.75 mg/kg
Infusion 1.75 mg/kg/hr - procedure duration
• GPI - Abciximab
• Selective (‘bailout’) use in both groups
• ESC guideline indications
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Bivalirudin Heparin n % % n
MACE 79 8.7 % v 5.7 % 52
Absolute risk increase = 3.0% (95% CI 0.6, 5.4)
Relative risk = 1.52 (95% CI 1.1 – 2.1) P=0.01
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Event curve shows first event experienced
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Bivalirudin Heparin n % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0.7% 6
Any MACE 79 8.7 % v 5.7 % 52
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Bivalirudin Heparin n % % n
Death 46 5.1 % v 4.3 % 39
CVA 15 1.6% v 1.2% 11
Reinfarction 24 2.7% v 0.9% 8
TLR 24 2.7% v 0.7% 6
Any MACE 79 8.7 % v 5.7 % 52
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Bivalirudin Heparin n % % n
All Events 24 3.4 % v 0.9 % 6
Relative risk = 3.91 (95% CI 1.6 - 9.5) P=0.001
ARC definite or probable stent thrombosis events
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Bivalirudin Heparin n % % n
Major Bleed 32 3.5 % v 3.1 % 28
Relative risk = 1.15 (95% CI 0.7 - 1.9) P=0.59
Major Bleed BARC grade 3-5
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Mr Complex
• Heparin alone with plan for GPIIb/IIIa bailout
• Thrombectomy?
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Bivalirudin versus Heparin and Heparin plus Tirofiban in Patients
with AMI Undergoing PCI
Yaling Han, MD, FACC
On behalf of the BRIGHT investigators
Thirty-Day and One-Year Outcomes of the
BRIGHT Trial
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Trial Design
2194 patients with AMI eligible for emergent PCI
Bivalirudin aloneN=735
Biv 0.75mg/kg bolus + 1.75mg /kg/h infusion (0.3mg/kg bolus if ACT< 225s). Bailout GPI permitted.Biv infusion (0.2mg/kg/h) continued for at least 30 min post PCI.
Heparin aloneN=729
Heparin 100U/kg bolus + additional dose if ACT <200 s.Bailout GPI permittedACT goal = 250-300.
Heparin plus tirofibanN=730
Heparin 60U/kg bolus .Tirofiban 10μg/kg bolus + 0.15 μg/kg/min infusion for 18-36 h.ACT goal = 200-250.
Clinical follow-up at 30 days and one year
R
(clinicaltrials.gov number: NCT01696110)
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Primary and Principal Secondary Endpoint Events at 30 Days
P<0.001
P<0.001P=0.74
- Biv vs. UFH, p=0.009Relative risk 0.67 (0.50-0.90), NNT=23.1
- Biv vs. H+T, p < 0.001Relative risk 0.52 (0.39-0.69), NNT=12.3
- UFH vs. H+T, p=0.04Relative risk 0.78 (0.61-0.99), NNT=26.2
(%)
Biv=bivalirudin; UFH=Heparin; H+T=heparin + tirofiban
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Safety Endpoints at 30 days
P=0.77 (3-way)
(%)P=0.07 (3-way)P=0.04 (Biv vs. pooled H)P=0.12 (Biv vs. UFH)P=0.02 (Biv vs. H+T)
Biv=bivalirudin; UFH=Heparin; H+T=heparin + tirofiban
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59
Thrombus Aspiration During PCI for
STEMI
NEW
Recommendation
Aspiration thrombectomy is
reasonable for patients
undergoing primary PCI
I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III I I I IIa IIa IIa IIb IIb IIb III III III IIa IIa IIa IIb IIb IIb III III III
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FZ 2008-1
Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial
infarction Study (TAPAS)
Mortality and reinfarction at 1 year
F. Zijlstra, MD PhD
Thoraxcenter
University Medical Center Groningen,
The Netherlands
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FZ 2008-5
1071 STEMI patients randomized
535 were assigned to thrombus aspiration
33 did not undergo PCI 502 underwent primary PCI
295 underwent TA followed by direct stenting 153 underwent TA with additional
balloon dilation 54 had crossover to conventional PCI
536 were assigned to conventional PCI
33 did not undergo PCI 503 underwent primary PCI
485 underwent balloon dilation followed by stenting 12 underwent conventional PCI
with additional TA 6 had crossover to TA
530 complete follow-up at 1 year 530 complete follow-up at 1 year
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Mortality at 1 year
Time (days)
0 100 200 300 400
Mort
alit
y (
%)
0
2
4
6
8
10
12Conventional PCI
Thrombus-Aspiration
Log-Rank p = 0.040
*Unpublished results
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Mortality or non-fatal ReMI at 1 year
Time (days)
0 100 200 300 400
De
ath
or
Rein
farc
tio
n (
%)
0
2
4
6
8
10
12 Conventional PCI
Thrombus-Aspiration
Log-Rank p = 0.016
*Unpublished results
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Ole Fröbert, MD, PhD - on behalf of the TASTE investigatorsDepartement of Cardiology
Örebro University Hospital
Sweden
UCRUppsala Clinical
Research Center
“Aspiration of the blood clot or ‘thrombus’ that
causes a heart attack, before balloon dilatation
and stenting, improves survival”
trial hypothesis
Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE trial)
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29 Swedish, 1 Danish and 1 Icelandic hospital
Multicenter, prospective, randomized, controlled open-label
trial enrolling 7244 patients who had a diagnosis of ST-
elevation myocardial infarction (STEMI)
Novel Registry-Based Randomized Clinical Trial concept:
national heart registries served as platforms for
randomization, case reports and follow-up
no patients lost to follow-up
powerful tool to capture outcome data with a high degree of fidelity
inexpensive
Half of the patients were assigned to balloon treatment only
(known as percutaneous coronary intervention, or PCI) and
the other half had their blood clot aspirated before PCI
Methods
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TASTE and previous studies on thrombus
aspiration
0 1000 2000 3000 4000 5000 6000 7000 8000
Liistro
DEAR-MI
EXPIRA
PIHRATE
X AMINE ST
MUSTELA
Kaltoft
Chevalier
PREPARE
VAMPIRE
INFUSE-AMI
AIMI
JETSTENT
TAPAS
TASTE
Number of patients
TASTE
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All-cause mortality at 30 days
HR 0.94 (0.72 - 1.22), P=0.63
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Thrombectomy?
• Case by case
• Large thrombus burden
• Complete occlusion of vessel – acts as significant adjunct to PPCI procedure.
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Mr Complex
• What next?
• PCI to non-culprit lesion during same procedure
• PCI to non-culprit before discharge?
• PCI to non-culprit in 2 weeks?
• PCI only if refractory angina?
• PCI only if objective evidence of ischemia with functional tesing?
• Refer for CABG? (NIDDM, Multi-vessel disease)
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Primary PCI in STEMI (ACC 2013 STEMI
guidelines)
Primary PCI is reasonable in patients with STEMI if there is clinical
and/or ECG evidence of ongoing ischemia between 12 and 24
hours after symptom onset.
I IIa IIb III
PCI should not be performed in a noninfarct artery at the time of
primary PCI in patients with STEMI who are hemodynamically
stable
I IIa IIb III
Harm
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Randomised multicentre single-blind trial conducted
in five UK cardiac centres
Preventive Angioplasty in Myocardial Infarction Trial
PRAMI Trial
N Engl J Med September 1st 2013;369. DOI: 10.1056/NEJMoa1305520
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Risk Reduction 65%
Cardiac Death, Nonfatal MI or Refractory Angina
in patients having infarct-artery PCI
Hazard Ratio 0.35
(95% CI 0.21 to 0.58),
p<0.001
n=234 n=231
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11
27
Preventive PCI No Preventive PCI
Risk Reduction 64%
Hazard Ratio 0.36
(95% CI 0.18 to 0.73),
p=0.004
n=234 n=231
Cardiac Death, Nonfatal MI or Refractory Angina
in patients having infarct-artery PCI
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Prami
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CVLPRIT trial
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Content – My Overview
• Evidence of Primary PCI vs Thrombolysis – When, Why, How
– Primary PCI in PCI capable hospital. DTB < 90min
– Transfer PCI – DTB <120 min from FMC
– Pharmaco-invasive approach is preferred option if patient presents < 3hrs and Primary or Transfer PCI unable to be achieved.
• To Aspirate or not to Aspirate – Jury is out. Individual cases selection. Reasonable for high thrombotic burden to aid with PCI procedure.
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CONTENT – My Overview
• Adjunctive anticoagulation - Heparin with GP Iib/IIIa bailout is reasonable especially with radial access. Data conflicting
• Culprit only vs Preventative PCI – Preventative PCI reasonable option however timing is open – at time of procedure, before discharge, few weeks after discharge, following objective evidence of ischemia all reasonable.