TACTICS-TIMI%2018

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TACTICS-TIMI 18 Economics HRQOL
Treat Angina with Aggrastat and Determine Cost of
Therapy with an Invasive or Conservative Strategy
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Economic QoL Substudy


Economic Data Coordination William Weintraub,
MD, Steven Culler, PhD Emory University Elizab
eth Mahoney, ScD Claudine Jurkovitz, MD, MPH
Edmund Becker, PhD Karen Parker, BS
Haitao Chu, MS John Spertus, MD, MPH TIMI
Study Group Christopher Cannon, MD
Brigham Womens Hospital Carolyn McCabe,
BS Eugene Braunwald, MD Sponsor - Merck
Charles Alexander, MD Laura
Demopoulos, MD John Cook, PhD Peter
DiBattiste, MD Paul DeLucca, PhD Soma Nag,
MS Debbie Robertson, RD MS



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Study Background and Goal

• Unstable angina and non-ST elevation MI 1.3
  million hospital admissions/year in the US alone
• Since society cannot afford to pay for all
  possible medical services, and since both the
  costs and benefits of services vary, decisions
  should consider cost.
• This is the first prospective evaluation of the
  cost of an invasive vs conservative strategy in
  UA/NSTEMI

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TACTICS-TIMI 18 Study Design
PCI/ CABG
N2220 total N1722 US non VA
Early Invasive
Angio
Medical Rx
UA/ NSTEMI
ASA, Hep,Tirofiban
Endpoints
Early Conservative
Medical Rx
Baseline Troponin
ETT
ischemia
Cath/ PCI/ CABG
Chest pain
Randomize
- 24 hrs
Hour 0
6 mos
4 - 48 108
hrs hrs
5
Cardiac Events at 6 Months
P value
INV ()
CONS ()
OR
No. Pts 1o Endpoint Death/MI Death MI Rehosp
ACS
1114 15.9 7.3 3.3 4.8 11.0
1106 19.4 9.5 3.5 6.9 13.7
0.78 0.74 0.93 0.67 0.78
0.025 0.0498 0.74 0.029 0.054
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Economic Study

• Hypothesis
• Costs over a six month period will be similar
  with an invasive or conservative approach to
  UA/NSTEMI

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Economic Methods

• 1o Endpoint Total 6 month costs (hospital,
  professional, meds, ER, ER, outpatient
  procedures, nursing home, rehab, visiting nurse,
  indirect)
• Power Equivalence design with 80
  power the treatments will be judged
  equivalent if the 90 CI for the true cost
  difference lies within the equivalence region
  (-1200, 1200)
• C-E Analysis If one strategy is found to be
  both more costly and more effective than
  another, determine the incremental
  cost-effectiveness
• 2o Endpoints Initial hospitalization costs
  (hospital plus professional)
• 30-day costs
• Quality of Life

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Economic Methods

• Cost
• Hospital Costs UB92 formulation of hospital bill
• (93 complete for initial hospitalization)
• Physician Costs Model based on share of hospital
  bill by DRG
• Outpatient Costs Medicare Fee Schedule
• Medication Costs Average Wholesale Price
• Indirect Costs Lost wages estimated
• Quality of Life
• Angina Seattle Angina Questionnaire
• Utility Health Utilities Index

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Cost of Initial Hospitalization
Difference between groups 1,994 (95 C.I.
688, 3329)
16,000
14,660
14,000
12,667
3,372
12,000
3,047
10,000
Professional
Cost ()
8,000
Costs
6,000
Hospital
11,288
9,619
Costs
4,000
2,000
0
Invasive
Conservative
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6 Month Follow-Up Costs
Difference -1,140 (95 C.I. -2165, -50)
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Primary Endpoint Total Costs 6 Months
? Events -35/1000 patients
? Cost 629 (95 CI -1273, 2465)
(90 CI -912, 2162)
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Effect of Troponin Status on 6 Month Primary
Events Costs
Troponin
Troponin -
?Events 24/1000 pts
?Events -99/1000 pts
?Cost 924 (95 CI -2043, 3654)
?Cost 605 (95 CI -2466, 3466)
24,260
23,655
6,737
8,128
16,506
15,582
Total Cost ()
5,410
6,179
17,523
15,527
11,096
9,403
Invasive
Conservative
Invasive
Conservative
Initial Hosp
Follow-up
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Effect of ST Segment Status on 6 Month Primary
Events Costs
ST Segment
ST Segment -
?Events -99/1000 pts
?Events 3/1000 pts
?Cost 42 (95 CI -4801, 4050)
?Cost 1070 (95 CI -772, 2887)
25,178
25,135
18,938
17,868
7,039
8,533
Total Cost ()
5,704
6,656
18,139
16,602
13,234
11,212
Invasive
Conservative
Invasive
Conservative
Initial Hosp
Follow-up
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Effect of Gender on 6 Month Primary Events
Costs
Male
Female
?Events -41/1000 pts
?Events -26/1000 pts
?Cost 21 (95 CI -2105, 2073)
?Cost 1,748 (95 CI -2163, 4760)
20,708
20,729
20,463
18,715
6,074
6,045
7,620
6,489
Total Cost ()
14,634
14,418
12,226
13,109
Invasive
Conservative
Invasive
Conservative
Initial Hosp
Follow-up
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Effect of Age on 6 Month Primary Events Costs
Age gt 65
Age lt 65
?Events -46/1000 pts
?Events -29/1000 pts
?Cost 772 (95 C.I. -2377, 3668)
?Cost 518 (95 C.I. -1976, 2596)
21,327
20,555
20,033
19,515
4,377
Total Cost ()
5,829
7,444
8,343
16,950
14,726
12,589
11,172
Invasive
Invasive
Conservative
Conservative
Initial Hosp
Follow-up
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Effect of Diabetes on 6 Month Primary Events
Costs
Diabetes
No Diabetes
?Events -76/1000 pts
?Events -22/1000 pts
?Cost 3,232 (95 CI -676, 6573)
?Cost -406 (95 CI -2458, 1746)
24,205
20,973
19,186
19,592
7,514
Total Cost ()
7,492
5,485
7,088
16,691
13,701
13,481
12,504
Invasive
Conservative
Invasive
Conservative
Initial Hosp
Follow-up
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Multivariate Predictors of Total Six Month Costs
Coefficient t value p value
Intercept 14,072 16.25 lt.0001
Troponin ? 0.01 6,978 6.64 lt.0001
ST Shift 5,949 5.09 lt.0001
Diabetes 3,021 2.66 .08
R2 0.070
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Utility, Life Years andQuality-Adjusted Life
Years (QALYs)
p-value 0.20 0.71 0.70 0.56 0.48
Invasive
Conservative
? 0.022 0.006 0.006 -0.002 -0.006
Utility Baseline 30 Day 6 Month Life
Years QALYs
0.664 0.746 0.761 0.486 0.358
0.642 0.740 0.755 0.488 0.364
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Utility and Cost-Utility Analysis

• Fewer Cardiovascular Events With Invasive
  Strategy
• However
• No significant difference in Cost
• No significant difference in Survival
• No significant difference in Utility
• Thus
• Marginal Cost/QALY with Invasive vs
  Conservative
• Strategy Cannot be Reliably Estimated

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Seattle Angina Scores
Invasive
Conservative
?6M
BL
?6M
BL
Physical Functioning Angina Stability Angina
Frequency Treatment Satisfaction Quality of Life
74 44 65 91 56
10.3 32.6 22.3 0.40 21.2
74 45 65 90 56
11.4 32.4 22.1 0.54 21.0
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Summary

• Total 6 month costs are similar in the two
  treatment arms
• Initial hospital costs are higher with an
  invasive strategy
• Follow-up costs are higher with a
  conservative strategy
• ST Troponin subgroups show greater
• benefit at similar six month cost

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Conclusion
In UA/NSTEMI treated with GPIIb/IIIa blockade
The benefit of the invasive strategy is achieved
without an economically relevant increase in cost