Transcript No Slide Title

Occluded Artery Trial: 1° Hypothesis and Design
1° Hypothesis: Late PCI to open occluded IRA will ↓
death/reinfarction/class IV CHF by 25% compared to MED alone
• 2166 Acute MI pts (2000-2005)
• TIMI 0 or 1 flow
• 3-28 days post MI
+
High Risk
• EF<50%
• Proximal occlusion affecting
≥25% LV
TOSCA 2
PCI with Stent
of IRA
• 87% successful PCI
• 83% open IRA at 1 yr (TOSCA)
Exclude:
• 3V/LM disease
• Clinically unstable
due to ischemia,
hemodynamics
Medical RX
• 8% crossover to PCI (total)
• 25% open IRA at 1 yr (TOSCA)
Hochman JS et al. NEJM 12/06
Occluded
Artery
Trial
OAT: 1° Composite Endpoint
2255
Death, Nonfatal MI, Class IV CHF
H a z a rd R a tio : P C I v s . M E D = 1.16 , 95 % C I (0 .92 ,1.4 5 ), p = 0 .2 0
Death, MI, CHF Class IV (%)
2200
17.2 %
1155
PCI
E D%
M
15.6
MED
1100
HR: PCI vs MED=1.16
95% Cl (0.92, 1.45)
p=0.20
55
00
00
11
2
4
3
5
Y e a rs a fte r E n ro llm e n t
Number at Risk
N
Noo.. aatt R
R is
iskk
PCI:
1082
P C I 1084
10 8
MED:
M
ME
ED
D
10
1088
895
8 95
909
90
9099
719
7 19
714
7 14
482
482
474
474
265
265
268
268
85
85
78
78
Hochman JS et al. NEJM 12/06
Occluded Artery Trial (OAT):
Economics and Quality of Life (EQOL) Outcomes
Occluded
Artery
Trial
Three Major Analyses Planned Prospectively
• QOL by ITT
• Cost for US pts by ITT
• Cost-effectiveness analysis
QOL and cost prespecified secondary
endpoints in OAT
Occluded
Artery
Trial
Duke Activity Status Index (0-58)
OAT QOL Substudy:
Duke Activity Status Index (DASI)
50
P= .50
∆ = -1.0
40
36.3
37.3
P= .007
P= .36
P= .029
∆ = 3.5
∆ = 1.0
∆ = 1.7
37.0
36.8
33.3
36.0
37.1
35.4
30
20
10
0
Baseline
PCI
4 Mos
MED
12 Mos
Score 0-58
higher = better
24 Mos
Clinically significant
 > 4 points
Occluded
Artery
Trial
OAT QOL Substudy:
Rose Effort Angina
40
% of Patients
P = .83
30
26
27
P = .01
20
17
P = .36
P = .03
13
10
10
12
10
7
0
Baseline
PCI
4 Mos
MED
12 Mos
24 Mos
OAT Economic Substudy:
Medical (Hosp + MD) Costs in US by Rx Strategy
$30,000
PCI (n=236)
∆ = $10,176
Costs in 2005 US$
MED (n=233)
$25,000
$22,859
2-yr net cost for PCI
$7050
$20,000
$15,000
$12,683
∆ = -$1877
$10,000
$5,290
∆ = -$1249
$3,413
$5,000
$1,560
$2,809
$0
0-30 Days
31 Days-12 Mos
12 Mos-24 Mos
Occluded
Artery
Trial
OAT Economic Substudy:
Cost-Effectiveness Analysis
• Pre-specified 2-year cost-effectiveness
analysis, using
2-yr empirical survival
2-yr utility (preference) weights
2-yr costs in US cohort
• In 1000 repetitions (bootstrap analysis)
92% had either lower costs/higher QALYs
for MED (65%) or CE ratio > $100,000 per
QALY for PCI vs MED (27%)
Occluded
Artery
Trial
OAT Economic and Quality of Life:
Conclusions
Occluded
Artery
Trial
• PCI associated with clinically significant benefit in physical
functioning at 4 mos, not sustained at 1 yr or beyond and no
significant effects on psychological well being (prespecified 1
QOL endpoints)
• Secondary QOL endpoints showed modest symptom benefits
for PCI that attenuated over time
• Economic analysis in US pts showed that strategy of routine
PCI was substantially more expensive than optimal medical
therapy alone out to 2 yrs and the small symptom benefits
provided were insufficient to make PCI an economically
attractive strategy in OAT eligible pts