safe-stemi for seniors nih applicationcardiac-safety.org/wp-content/uploads/2014/...sunil v. rao md...
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SAFE-STEMI for Seniors NIH Application
Sunil V. Rao MD
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SAFE-STEMI for Seniors
n Why radial vs. femoral?
n Why seniors?
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Bleeding in Stable angina, NSTEMI, & STEMI
NSTEMI STEMI
Rao SV, et. al., JACC 2010
Stable Angina
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Stone, TCT 2010
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 5 years; angio FU at 13 months
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Three-Year All-Cause Mortality
P=0.03
3-yr HR [95%CI]=
0.75 [0.58, 0.97]
5.9%
7.7% A
ll-C
au
se
Mo
rta
lity (
%)
0
1
2
3
4
5
6
9
10
1611 1568
1660 1689 1670
1800 Bivalirudin alone
0 12 15 18 21 24 27 30 33 36
1098 1802 1643
Months
3 6 9
Number at risk
Heparin+GPIIb/IIIa 1633 1593
1574 1525 1043
0.71 [0.51, 0.98]
P=0.04
1-yr HR [95%CI]=
Bivalirudin alone (n=1800)
Heparin + GPIIb/IIIa (n=1802)
7
8
4.8%
3.4%
Stone, TCT 2010
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R I V A L
STEMI Subgroup
STEMI NSTEMI
Mehta S, JACC 2012
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All Rights Reserved, Duke Medicine 2008
Outcomes associated with transradial primary
PCI in the US
Baklanov D, et. al. JACC 2013
Higher with radial Lower with radial
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RIFLE STEACS - flow chart
Design
• DESIGN:
Prospective, randomized (1:1),
parallel group, multi-center trial.
• INCLUSION CRITERIA:
all ST Elevation Acute Coronary
Syndrome (STEACS) 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
access shift
6.1% (61)
Romagnoli E, et. al. JACC 2012
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NACE MACCE Bleeding (BARC ≥2)
overall femoral arm radial arm
p = 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
• Bleeding Academic Research Consortium (BARC) = bleeding definition adopted
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026 17.3
21.0
13.6
9.3
11.4
7.2
10.0
12.2
7.8
Romagnoli E, et. al. JACC 2012
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Cardiac death Myocardial
Infarction
Target Lesion
Revascularization
Cerebrovascular
Accident
overall femoral arm radial arm
p = 0.020
30-day MACCE rate
RIFLE STEACS – results
p = 1.000 p = 0.604 p = 0.725
7.2
9.2
5.2
1.3 1.4 1.2 1.5 1.8 1.2
0.7 0.6 0.8
Romagnoli E, et. al. JACC 2012
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The right patient population
n 30-day and 1-year MACE and mortality rates from STEMI are low
n A high-risk patient population is needed
l Older patients are at high risk for bleeding, mortality, and MACE
n Radial expertise in these groups is needed
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Event rates: CathPCI linked with Medicare
n STEMI mortality, Age > 75 years
l 30-day: 15%
l 1-year: 23.9%
l 2-years: 29.4%
l 3-years: 34.9%
n In-hospital Bleeding rates, age > 65 years
l 3.1% (48.6% access site bleeding)
n ACTION Registry
l In-hospital major bleeding, ACS pts age ≥ 75
years 18%
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Preliminary trial design
n Inclusion criteria l Age ≥ 75 years with STEMI undergoing primary PCI
l Able to give informed consent
n Exclusion criteria l Unable or unwilling to give informed consent
l Participation in another clinical trial
l Previous participation in SAFE Primary PCI
l Absent bilateral radial or femoral pulses
l Active dialysis graft in the arm to be used for radial access in case of assignment to radial approach
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Preliminary trial design
n Potential Primary endpoints
l 30-day all-cause mortality
l 1-year mortality
l 1-year NACE
n NCRI infrastructure
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Power calculation: 1 year NACE
n Assume 1 year event rate 15%
n Assume 4% absolute reduction
l Driven by bleeding reduction (RIFLE STEACS)
n At alpha 0.05, sample size of 1200 patients per arm
gives 80% power
n Total sample size 2500 patients
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Radial trends: CathPCI
Feldman D, et. al. Circulation 2013