from stemis to stents: updates in pci practice · coronary syndromes (acs) acute coronary...
TRANSCRIPT
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From STEMIs to Stents:
Updates in PCI practice
Arnold Seto, MD, MPA
Assistant Clinical Professor,
UC-Irvine and Long Beach VA
Director of Interventional Cardiology Research
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3
Hospitalizations in the U.S. Due to Acute
Coronary Syndromes (ACS)
Acute Coronary
Syndromes*
1.57 Million Hospital Admissions - ACS
UA/NSTEMI† STEMI
1.24 million Admissions per year
.33 million Admissions per year
Heart Disease and Stroke Statistics – 2007 Update. Circulation 2007; 115:69-171.
*Primary and secondary diagnoses. †About 0.57 million NSTEMI and 0.67 million UA.
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Main goal in STEMI:
Prompt Reperfusion
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Percutaneous Coronary Intervention
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Case Presentation
A 54 y.o. male with HTN, tobacco, presents
with chest pain that started an hour ago. The
nearest PCI center is 30 miles away, and it will
take slightly more than an hour to transfer the
patient. His BP is 150/90, O2 saturation 95%
on RA, and P 90. He has no other medical
problems.
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EKG
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Case Presentation
After giving him aspirin, nitroglycerin, morphine,
oxygen (MONA), and heparin, you should:
A) Transfer to the nearest PCI center for emergent PCI
B) Administer thrombolytics (TNKase)
C) Admit to medicine, let the 2nd year medicine resident /
hospitalist decide what to do after his/her assessment
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Reperfusion
The 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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Case Presentation
After giving him aspirin, nitroglycerin, morphine,
oxygen (MONA), and heparin, you should:
A) Transfer to the nearest PCI center for emergent PCI
B) Administer thrombolytics (TNKase)
C) Admit to medicine, let the 2nd year medicine resident /
hospitalist decide what to do after his/her assessment
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Door to Balloon Time and Mortality
A DTB time of 90 minutes or less is
recommended (Class I)
DTB time is tracked by registries esp ACC-
NCDR and the focus of QI initiatives
DTB time <90 min are now publicly reported as
a quality metric, and tied to reimbursement from
CMS.
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Door to Balloon Time and Mortality
Menees DS et al. N Engl J Med 2013;369:901-909.
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Radial or femoral access in
STEMI?
Radial access is associated with a lower risk of
vascular complications and access site bleeding.
Bleeding is associated with increased mortality
Transfusion risks
Withholding of antiplatelet agents
RIVAL study of radial vs. femoral showed a
difference in mortality in STEMI subgroup.
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Radial or femoral access in STEMI?
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Thrombus Aspiration
Routine thrombus aspiration was shown to have
benefit (ST segment resolution, 1 yr mortality) in
the TAPAS trial.
The TASTE trial was recently published registry-
randomized trial of 7000 pts.
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TASTE Trial:
Kaplan–Meier Curves for Death from Any
Cause and Hospitalization Due to
Reinfarction.
Fröbert O et al. N Engl J Med
2013;369:1587-1597.
P = 0.09
P = 0.63
No difference in mortality
? Trend toward reduced
rehospitalization
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STEMI: Heparin/GP2b3a or Angiomax?
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Direct Thrombin Inhibitor: Bivalirudin
Predictable anticoagulant
response
Inhibits soluble and fibrin-
bound thrombin
Inhibits thrombin-induced
platelet aggregation
No HIT
Needs continuous infusion
No antidote
Cost
Disadvantages Advantages
Xiao Z, Theroux P: Circulation 1998;97:251-256
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20
HORIZONS-AMI: Time-to-Event Curves through 30
days: Net Adverse Clinical Events
Treatment with bivalirudin alone compared with UFH + GP IIb/IIIa
Inhibitors resulted in reduced 30-day rates of net adverse
clinical events
[HR=0.75, (0.62-0.92); p=0.006]
Stone et al. N Eng J Med. 2008;358:2218-30.
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21
HORIZONS-AMI: Time-to-Event Curves through 30
days: Major Bleeding
HR=0.59 (0.45-0.76); p<0.0001
* 40% less bleeding in Bivalirudin group at 30 days
Stone et al. N Eng J Med. 2008;358:2218-30.
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HORIZONS-AMI Trial
Demonstrated reduction in bleeding without
major ischemic risks (except. Acute stent
thrombosis). Also with ? Mortality benefit
Criticized for:
Mandated use of GPIIb/IIIa
Some bivalirudn pts had heparin IV bolus
Change in practice to radial
Change in practice to new Plavix-like drugs
Bivalirudin might be best continued 2-4 hrs after PCI
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2218 patients with STEMI with symptom onset >20 min and ≤12h
Randomized in ambulance or non-PCI hospital
Intent for primary PCI
UFH/LMWH ± GPI Per standard practice
Bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion)
+ prolonged optional infusion (PCI dose or 0.25 mg/kg/h)
(provisional GPI only)
Aspirin + P2Y12 inhibitor
(any) as soon as possible R
1:1
Primary endpoint: 30-day death or non-CABG related major bleeding
Key Secondary endpoint: Death, Re-infarction or non-CABG major bleeding at 30 days
Clinical FU at 30 days and 1 year
EUROMAX Trial Design
clinicaltrials.gov NCT01087723
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Days from Randomization Date
Eve
nt
Rate
Bivalirudin 1089 1038 1024 1020 1007 988 791
Heparins with optional GPI
1109 1024 1003 998 984 958 765
Bivalirudin
Heparins with optional GPI 8.4%
Log-rank p = 0.002
Patients at risk:
Primary Endpoint: Death or Major Bleed, 30 day
5.1%
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Bivalirudin (N=1089) n/N (%)
Heparins with optional GPI
(N=1109) n/N (%)
Relative Risk (95% CI)
Interaction P-value
ALL 55/1089 (5.1) 94/1109 (8.5) 0.60 [0.43, 0.82)
Age
>65 years 39/394 (9.9) 61/434 (14.1) 0.70 [0.48, 1.03] 0.31
≤65 years 16/695 (2.3) 33/675 (4.9) 0.47 [0.26, 0.85]
Sex
Male 32/814 (3.9) 64/861 (7.4) 0.53 [0.35, 0.80] 0.47
Female 23/275 (8.4) 30/248 (12.1) 0.69 [0.41, 1.16]
Diabetes
Yes 12/127 (9.4) 18/169 (10.7) 0.89 [0.44, 1.77] 0.26
No 40/946 (4.2) 71/926 (7.7) 0.55 [0.38, 0.80]
Arterial access site
Radial 20/510 (3.9) 33/502 (6.6) 0.60 [0.35, 1.03] 0.97
Femoral 31/558 (5.6) 53/582 (9.1) 0.61 [0.40, 0.94]
Vessels with stenosis >50%
1 vessel with stenosis >50% 19/591 (3.2) 33/556 (5.9) 0.54 [0.31, 0.94] 0.66
≥2 vessels with stenosis >50% 28/407 (6.9) 49/462 (10.6) 0.65 [0.42, 1.01]
Stent type
At least one drug-eluting stent 22/538 (4.1) 39/529 (7.4) 0.55 [0.33, 0.92] 0.84
All bare metal stents 16/330 (4.8) 27/336 (8.0) 0.60 [0.33, 1.10]
Subgroup Analysis: Death/Major Bleed at 30 Days (ITT)
0.1 1.0 10.0
Bivalirudin better Heparins with optional GPI better
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Outcomes, 30 days, con’t Bivalirudin (N=1089)
Heparins with optional GPI
(N=1109)
Relative risk [95% CI]
P Value
Reinfarction 19 (1.7) 10 (0.9) 1.93 (0.90–4.14) 0.08
Q-wave 3 (0.3) 2 (0.2) 1.53 (0.26–9.12) 0.68
Non-Q-wave 16 (1.5) 8 (0.7) 2.04 (0.88–4.74) 0.09
Stent thrombosis (ARC definition) 17 (1.6) 6 (0.5) 2.89 (1.14–7.29) 0.02
Definite 17 (1.6) 6 (0.5) 2.89 (1.14–7.29) 0.02
Probable 0 (0) 0 (0) – n/a
Acute (≤24 hours) 12 (1.1) 2 (0.2) 6.11 (1.37–27.24) 0.007
Subacute (>24 hours to 30 days) 5 (0.5) 4 (0.4) 1.27 (0.34–4.73) 0.75
Ischemia-driven revascularization 24 (2.2) 17 (1.5) 1.44 (0.78–2.66) 0.25
Reinfarction, ischemia-driven revascularization or stent thrombosis
29 (2.7) 21 (1.9) 1.41 (0.81–2.45) 0.23
Any stroke 6 (0.6) 11 (1.0) 0.56 (0.21–1.50) 0.24
Ischemic 6 (0.6) 9 (0.8) 0.68 (0.24–1.9) 0.46
Hemorrhagic 0 2 (0.2) Not applicable 0.50
Acquired thrombocytopenia 7 (0.7) 14 (1.4) 0.50 (0.20–1.24) 0.13
n/a: not applicable.
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NCDR 2009-2011
970,865 PCIs performed for ACS. GPI used in 33.6%
Safley, ACC2013 Abstract 2115M-218
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RAPID Study
Parodi. JACC 2013.
Morphine use had a 5.29 OR for high platelet
reactivity.
High residual platelet reactivity (HRPR; PRU ≥240) was found in
44% and 60% patients (p=0.258) at 2 hours. The mean time to achieve a PRU <240 was
3±2 and 5±4 hours in the prasugrel and ticagrelor group,
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Drug Eluting Stents
Control Paclitaxel
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Stents
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Millions face risk from drug-coated stents
“Millions of Americans could be walking around with tiny time bombs in their hearts” “Potentially lethal heart devices a frightening problem for patients, doctors” “The FDA panel might recommend they not be used at all” By Robert Bazell Chief science correspondent NBC News Nov 2006 – March 2007
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December 2006 FDA Findings
DES are associated with a clinically important
numerical excess of late stent thromboses (after 1 year
post-implantation) compared to BMS; however, the
magnitude of this excess is uncertain and additional
data are needed.
The panel reached consensus that the DES safety
concerns do not outweigh their benefits compared to
BMS when used within the limits of the approved
labeling.
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BMS and DES equivalents
Vision (CoCr)
Liberte/Veriflex
Driver (CoCr)
Integrity (CoCr)
Element (CoCr)
Omega (PtCr)
BxVelocity
Xience/Promus (Everolimus)
Taxus Liberte (Paclitaxel)
Endeavor (Zotarolimus)
Resolute Integrity (ZES)
Promus Element (EES)
Taxus Element aka ION (PES)
Cypher (Sirolimus, discontinued)
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Stents
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EES has less stent thrombosis
than BMS?
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Stents: Summary
DES have been shown to have reduced
restenosis rates compared with BMS.
2nd generation stents (Xience, Endeavor/
Resolute) carry a lower risk of stent thrombosis
than 1st generation stents (Taxus, Cypher)
12 months of dual antiplatelet therapy may be
unnecessary for DES.
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Optimize Trial: DAPT Usage P
ati
en
ts o
n D
AP
T (
%)
Time After Initial Procedure
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Primary Endpoint: NACCE at 1 Year (All-Cause Death, MI, Stroke, Major Bleeding)
Month 0 1 3 6 12
No. at risk 1563 1520 1504 1468 1384
No. events 18 25 11 18 21
No. at risk 1556 1514 1497 1466 1381
No. events 16 25 11 16 22
Log-Rank P = 0.84
HR 1.03 (0.77 – 1.38)
Cu
mu
lati
ve
In
cid
en
ce
of
NA
CC
E (
%)
Time After Initial Procedure (Months)
0 12
0
10
15
5
3 6 9
6.0 5.8
12M DAPT
3M DAPT
Non-inferiority
P-value = 0.002
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Conclusions
In patients from daily clinical practice
with stable coronary artery disease or
low risk ACS undergoing PCI with E-
ZES, short-term DAPT (3 months) is non-
inferior to long-term DAPT (12 months)
in terms of the occurrence of death, MI,
stroke, or major bleeding.
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Bioabsorbable vascular scaffold
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Schömig A. N Engl J Med 2009;361:1108-1111.
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42
0
5
10
15
0 30 60 90 180 270 360 450
HR 0.81
(0.73-0.90)
P=0.0004
Prasugrel
Clopidogrel
Days
En
dp
oin
t (%
)
12.1
9.9
HR 1.32
(1.03-1.68)
P=0.03
Prasugrel
Clopidogrel 1.8
2.4
138
events
35
events
Balance of
Efficacy and Safety
CV Death / MI / Stroke
TIMI Major
NonCABG Bleeds
NNT = 46
NNH = 167
Adapted with permission from Wiviott SD et al
NEJM 357:2007
TRITON: Results
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Prasugrel
Ticagrelor
Bivalirudin
Fondaparinux