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SAFE-STEMI for Seniors NIH Application
Sunil V. Rao MD
SAFE-STEMI for Seniors
n Why radial vs. femoral?
n Why seniors?
Bleeding in Stable angina, NSTEMI, & STEMI
NSTEMI STEMI
Rao SV, et. al., JACC 2010
Stable Angina
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
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
R I V A L
STEMI Subgroup
STEMI NSTEMI
Mehta S, JACC 2012
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
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
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
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
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
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%
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
Preliminary trial design
n Potential Primary endpoints
l 30-day all-cause mortality
l 1-year mortality
l 1-year NACE
n NCRI infrastructure
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
Radial trends: CathPCI
Feldman D, et. al. Circulation 2013