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Pharmaco-Invasive Approach for STEMI
Michael C. Kontos, MD
Medical Director, Coronary Intensive Care Unit
Director, Chest Pain Evaluation Center
Associate Professor
Departments of Internal Medicine (Cardiology), Radiology and
Emergency Medicine
Virginia Commonwealth University Medical Center
Richmond, Virginia
Disclosures
• Consultant:
• Roche
Primary PCI vs Thrombolysis in STEMI: Quantitative Analysis (23 RCTs, N=7739)
Keeley EC, et al. Lancet. 2003;361:13-20
Treatment Strategies for Patients with Who Require Transfer for Primary PCI
• Primary PCI (no matter how long it takes)
• Full dose fibrinolytics with elective transfer or for rescue PCI
• Full dose fibrinolytics with routine transfer and rescue PCI as needed
• Half dose fibrinolytics with transfer and rescue PCI as needed
30 Day Mortality for Transfer for Primary PCI vs
Immediate Thrombolysis
Giuseppe De Luca et al Ann of Emer Med 2008;52;665–676
23% decrease (p=0.02)
58% decrease in re-MI
Advantage of PCI Compared With Fibrinolysis
Decreases as PCI-Related Delay Increases
Pinto DS, et al. Circulation. 2006;114:2019-2025.
Od
ds o
f D
eath
Wit
h F
ibri
no
lysis
PCI-Related Delay (door-to-balloon–door-to-needle time), min
PC
I B
ett
er
Fib
rin
oly
sis
Bett
er
2.0
1.5
1.25
1.0
0.8
0.5
60 75 90 105 114 135 150 165 180
STEMI Door-to-Balloon Times For Transfer Patients Remain Prolonged
Transfer in DTB Times Non-Transfer in DTB Times
Tim
e (
min
)
ACTION Registry-GWTG DATA: January 01, 2014 - December 31, 2014
25th %tile median
Facilitated PCI
• A strategy to enhance primary PCI by improved early infarct vessel patency
• Options: • full dose thrombolytics
• half dose thrombolytics with GP IIb/IIIa inhibitors
• GP IIb/IIIa inhibitors alone
• No benefit and/or worse outcomes • ASSENT-IV trial--TNK
• FINESSE trial—TNK +/- abciximab
• Limitations: minimal delay to PCI, no routine ADP antagonist used
Pharmaco-Invasive PCI
• A strategy to improve fibrinolysis outcomes for patients where transfer for primary PCI cannot be achieved in recommended times
• Fibrinolytics administered per current guidelines
• Immediate transfer to PCI centers
• PCI of the infarct related artery subsequently performed
45% decrease re-MI
35% decrease D/MI
April 11, 2013
no lytic
Study Protocol 1892 patients randomized
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
YE
S
N
O
Strategy A: pharmaco-invasive Strategy B: primary PCI
Aspirin
Clopidogrel:
75 mg QD
Enoxaparin:
0.75 mg/kg SC Q12h
PC
I H
osp
ital
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.
62
Sx onset
1st Medical
contact
61
1 Hour 2 Hours n=1892
29
Randomize
IVRS
9
Rx TNK
31 86
Sx onset
Rx
PPCI
100
min
178
min
Median Times to Treatment (min)
1st Medical
contact
78 min
difference Randomize
IVRS
117 min D2B Time
62
Sx onset
61
1 Hour 2 Hours
29 9
Rx TNK
31 86
Sx onset
Rx
PPCI
100 min
178 min
Median Times to Treatment (min)
36% Rescue PCI at 2.2h
n=1892
64% non-urgent cath at 17h
1st Medical
contact Randomize
IVRS
1st Medical
contact Randomize
IVRS
117 min D2B Time
PRIMARY ENDPOINT
TNK 12.4%
PPCI 14.3%
TNK vs PPCI
Relative Risk 0.86, 95%CI (0.68-1.09)
p=0.24
Dth
/Sh
ock
/CH
F/R
eMI
(%)
a
30 Day End-Points
Pharmaco-invasive
(N=944)
PPCI
(N=948)
P-value
All cause death
Cardiac death
(43/939) 4.6%
(31/939) 3.3%
(42/946) 4.4%
(32/946) 3.4%
0.88
0.92
Congestive heart
failure
(57/939) 6.1% (72/943) 7.6% 0.18
Cardiogenic shock (41/939) 4.4% (56/944) 5.9% 0.13
Reinfarction (23/938) 2.5% (21/944) 2.2% 0.74
Association of PCI-Related Delay and Treatment
STREAM Sub-Study
Gershlick AH et al. Heart 2015;101:692
30-day death/CHF/MI/shock
Mortality with Pharmaco-Invasive vs Primary PCI Observational Studies
4,3
2,5
4,4
3
5,4
4,4 4,1
7
0
1
2
3
4
5
6
7
8
Ottawa Minneapolis Korea Mayo
Pharmaco-Invasive Primary PCI Primary PCI
Unanswered Questions
• What does of fibrinolytics should be used?
• Full dose? 1/2 dose?
• Is there a benefit of using newer P2Y12 antagonists?
• ticagrelor, prasugrel
• When is the ideal time to perform angiography?
• Immediately? Delayed?
No Harm For Early PCI After Fibrinolytics Patient Level Data From 7 Pharmaco-Invasive Trials
Maden M, et al JACC Interv 2015;8;166
No Harm For Early PCI After Fibrinolytics Patient level Data 7 Trials
Maden M, et al JACC Interv 2015;8;166
Conclusions
• Primary PCI remains the optimal reperfusion therapy when
performed within guideline recommended times
• A pharmaco-invasive strategy in patients in whom primary
PCI is delayed is effective with similar (if not better)
outcomes compared to primary PCI
• Angiography with intent to carry out revascularization after
fibrinolytic treatment should be routinely performed
• Reduced dose fibrinolytics may be considered in older
patients
Gracias!
Virginia Commonwealth University Medical Center (Medical College of Virginia)
Founded 1838
Richmond, Virginia
Original Hospital
From: Early routine percutaneous coronary intervention after fibrinolysis vs. standard therapy in ST-segment
elevation myocardial infarction: a meta-analysis Eur Heart J. 2010;31(17):2156-2169. doi:10.1093/eurheartj/ehq204
Eur Heart J | Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010. For permissions
please email: [email protected]
Non-PCI Hospitals
Guideline for STEMI
ESC Recommendations
Arch Intern Med. 2011;171(21):1879-1886.
Median door-in to door-out (DIDO) times, 2009
CMS Data, 1034 hospitals, 13,776 patients
Median time 68 (52-91) minutes
9.7% < 30 minutes
31% > 90 minutes
Longer DIDO time assoc with increased
Mortality!
Reperfusion Therapy for Patients with STEMI