strive teleconf presentation aug10 2005
TRANSCRIPT
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CVD Critical Pathways Group 2005 Teleconferences
This activity is supported by an educational grant from
the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
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August 10, 2005
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Faculty
Gregg C. Fonarow, MDEliot Corday Professor of Medicine
and Cardiovascular ScienceDirector, Ahmanson-UCLA Cardiomyopathy Center
UCLA Division of CardiologyUCLA Medical Center
Los Angeles, California
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The Network for Continuing Medical Education
requires that CME faculty disclose, during the planning
of an activity, the existence of any personal financial or
other relationships they or their spouses/partners have
with the commercial supporter of the activity or with the
manufacturer of any commercial product or service
discussed in the activity.
Disclosure Statement
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Gregg C. Fonarow, MD, has served as a consultant
to and has received research support from
GlaxoSmithKline, Pfizer Inc., and Scios Inc. He has
also received honoraria from Merck & Co., Inc.
The team from Aurora Sinai Medical Center reports
no such relationships.
Faculty Disclosure Statement
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Polling Question #1
What is your institution’s status in terms of establishing critical pathways for ACS?
1) ACS pathways are not in place
2) ACS pathways are in place, but not updated per current ACC/AHA UA/NSTEMI and STEMI Guidelines
3) ACS pathways are up-to-date, but not regularly implemented
4) ACS pathways are up-to-date and regularly followed
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Cost-effectiveness of CVD Therapies: Which Therapies Provide Good Value?
Gregg C. Fonarow, MD
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Cost-effectiveness
The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance
The use of incremental cost-effectiveness estimates provides a rationale for health economic allocation discussions and funding decisions
The cost per quality life-year gained is a commonly reported measurement in outcomes research
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Cost-effectiveness There is no absolute standard for at what level a
therapy is considered “cost-effective” and at what level a therapy is not “cost-effective”
Many consider therapies at or below $50,000 per quality adjusted life-year gained to be “cost-effective” relative to other accepted therapies such a hemodialysis. Above $100,000 per QALY gained, many consider as indicating the therapy is less attractive
A therapy that reduces total medical costs while adding QALY is described as cost dominant (less than $0)
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13 million individuals in the US with prevalent coronary disease 6 million individuals with prevalent cerebral vascular disease 5 million individuals with prevalent peripheral vascular disease
40 million office visits annually 5 million hospitalizations annually 226 billion dollars in direct costs in 2004 368 billion dollars in total costs in 2004
Average direct costs over a 5-year period
$ 51,211 MI $ 34,581 Unstable angina
$ 9,780 Sudden death$ 62,524 CABG$ 58,453 PTCA
Heart and Stroke Facts: 2004 Statistical Supplement, American Heart Association.
Cost of Atherosclerosis
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Reported C/E Ratios: Cardiovascular Interventions
$16,491/LYGEptifibatide for ACS7
$2080/LYGLisinopril post-AMI2
$32,678/LYGt-PA vs SK10
$5400-$32,000/LYGStatin8,9
$6318/LYGClopidogrel – CURE5
$5910/LYGClopidogrel – PCI-CURE4
$3685/LYGClopidogrel – CREDO3
$220/LYGSmoking cessation post-AMI1
C/E RatioIntervention
1. Krumholz HM, et al. J Am Coll Cardiol. 1993;22:1697-1702.2. Franzosi MG, et al. Pharmacoeconomics. 1998;13:337-346.3. Beinart S, et al. AHA Scientific Sessions; 2003.4. Mahoney EM, et. al. AHA Scientific Sessions; 2003.5. Weintraub WS, et al. AHA Scientific Sessions; 2003.
6. Mahoney EM, et al. JAMA. 2002;288:1851-1858. 7. Hillegass WB, et al. Pharmacoeconomics. 2001;19:41-55. 8. Tsevat J, et al. Am Heart J. 2001;141:727-734. 9. Johannesson M, et al. N Engl J Med. 1997;336:332-336.10. Mark DB, et al. N Engl J Med. 1995;332:1418-1424.
LYG = life-year gained.
Early invasive strategy6 $12,739/LYG
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Cause of DeathCause of DeathSimvastatinSimvastatin
(10,269) (10,269)Placebo Placebo (10,267)(10,267)
VascularCoronary 587 707Other vascular 194 230
ANY VASCULAR 781 (7.6%) 937 (9.1%)
NonvascularNeoplastic 359 345Respiratory 90 114Other medical 82 90Nonmedical 16 21
NONVASCULAR 547 (5.3%) 570 (5.6%)
ALL CAUSES 1328 (12.9%) 1507 (14.7%)
HPS Simvastatin: Cause-Specific MortalityRisk ratio and 95% CI
STATINBetter
PLACEBOBetter
17% SE 4reduction(2P<0.0001)
5% SE 6reduction (NS) 13% SE 4
reduction(2P<0.001)
0.6 0.8 1.0 1.2 1.40.4
Heart Protection Study Collaborative Group. Lancet. 2002;360:7-22.Reprinted with permission from Elsevier Science.
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Cost-effectiveness of Simvastatin in Patients at Different Levels of Vascular Disease Risk:
British Heart Protection Study Purpose: Determine the range of cost-effectiveness
of statin therapy in persons ranging from intermediate to high vascular event risk
Methods: – 20,536 adults (aged 40-80 years) with vascular
disease or diabetes– Randomly assigned to 40 mg simvastatin daily
or placebo for an average of 5 years Results: Simvastatin use was associated with a
highly significant 22% (95% CI 16-27; P<.001) proportional reduction in hospitalization costs for all vascular events
Mihaylova B, et al. Lancet. 2005;365:1779-1785.
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Reductions in 5-Year Vascular Event Costs (and 95% CI) With Simvastatin Allocation
by Baseline Risk Subgroups
Reproduced with permission from Mihaylova B, et al. Lancet. 2005;365:1779-1785.
• Estimated absolute reductions in vascular event costs per person allocated simvastatin ranged from UK £847 (US $1524) in the highest-risk quintile to £264 ($475) in the lowest-risk quintile
• Mean excess cost of statin therapy among participants allocated simvastatin was £1497 ($2694)
US dollar figures computed at a conversion rate of $1.80 per British pound.MVE = major vascular event.
1500
1125
750
375
01(12%) 2(18%) 3(22%) 4(28%) 5(42%)
Risk subgroup (5-year MVE risk)
Co
st r
edu
ctio
ns
(£)
% o
f statin co
st (2001 p
rices)
100
75
50
25
0
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Discounted Incremental Costs, Effects, and Cost-effectiveness During 5-Year Mean
Follow-up by Risk Group and Overall
Adapted with permission from Mihaylova B, et al. Lancet. 2005;365:1779-1785.
US dollar figures computed at a conversion rate of $1.80 per British pound.
MVE Vascular deaths Cost perRisk Group Incremental avoided per Cost per avoided per vascular death
(5-year MVE risk) cost 1000 persons MVE avoided 1000 persons avoided
1 (12%) £1164/$2095 37 £31,100/$55,980 4 £296,300/$533,340
2 (18%) £1062/$1912 58 £18,300/$32,940 7 £147,800/$266,040
3 (22%) £987/$1777 80 £12,300/$22,140 13 £78,900/$142,020
4 (28%) £893/$1607 93 £9600/$17,280 18 £46,600/$89,280
5 (42%) £630/$1134 141 £4500/$8100 29 £21,400/$38,520
Overall £947/$1705 82 £11,600/$20,880 14 £66,600/$119,880
*Discounted at 3.5% per annum. MVE = major vascular event.
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Months of Follow-up
*In addition to other standard therapies.Adapted with permission from Yusuf S, et al. N Engl J Med. 2001;345:494-502.
CURE Primary End Point: MI/Stroke/CV Death
Clopidogrel + Aspirin*(n=6259)
Placebo + Aspirin*(n=6303)
P<.001N=12,562
3 6 90 12
20%Relative RiskReduction
0.12
0.14
0.10
0.06
0.08
0.00
0.04
0.02
Cu
mu
lati
ve H
aza
rd R
ate
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Long-term Cost-effectiveness of Clopidogrel in Patients With NSTEMI
Adapted with permission from Weintraub WS, et al. J Am Coll Cardiol. 2005;45:838-845.
*Based on Medicare costs and Framingham and Saskatchewan life expectancy estimates; N=12,562.
ICER = incremental cost-effectiveness ratio; LYG = life-year gained.
Cost-effectiveness of Clopidogrel*
∆ Cost ∆ Life-Years ICER % <50,000/LYG
No direct costs beyond trial period
Framingham Medicare
$442 0.0699 $6318 93.9%
Saskatchewan Medicare
$442 0.0682 $6475 97.7%
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27%Relative RiskReduction
Months30 6 9 12
0
5
15
10
De
ath
, MI,
or
Str
ok
e (
%)
P=.02
8.5%
11.5%
Clopidogreln=1053
Placebon=1063
Adapted with permission from Steinhubl SR, et al. JAMA. 2002;288:2411-2420.
CREDO Study: 1-Year Primary Outcome
NNT=33
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-
12 -
-
8 -
-
4 -
-
0 -
4.6
CREDO Study: Benefit of Clopidogrel in PCI Patients at Various Time Intervals
Rand. to 1 Year Rand. to Day 28 Day 29 to 1 Year
Co
mb
ined
En
dp
oin
t O
ccu
rren
ce (
%)
MI, Stroke, or Death – ITT Population
Clopidogrel*
Placebo*
37.4% RRRP=.04
19.7% RRRP=.21
26.9% RRRP=.02
*Plus aspirin and other standard therapies.†Steinhubl S, et al. JAMA. 2002;288:2411-2420. ‡Steinhubl S. 75th Scientific Sessions of the AHA; November 18, 2002; Chicago, Ill.
8.5†
11.5†
5.5‡
6.9‡
2.9‡
4.6‡
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Cost-effectiveness of Prolonged Clopidogrel Therapy After PCI
Adapted with permission from Cowper PA, et al. J Am Coll Cardiol. 2005;45:369-376.
Modeled Outcomes and Cost-effectiveness
N=3976.
Total Sample
Variable Clopidogrel No Clopidogrel
Total Cost* $3,715 $2,819Outcomes MI (1 month to 1 yr) 3.24% 5.80%Cost-effectiveness $/MI avoided $34,336 $/yr of life saved $15,696
*Between 1 and 12 months following PCI.
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Cost-effectiveness of Prolonged Clopidogrel Therapy After PCI
Adapted with permission from Cowper PA, et al. J Am Coll Cardiol. 2005;45:369-376.
N=3976.
Modeled Outcomes and Cost-effectiveness
High-Risk Subset Low-Risk Subset
No NoVariable Clopidogrel Clopidogrel Clopidogrel Clopidogrel
Total Cost* $4,082 $3,307 $3,311 $2,328Outcomes MI (1 month to 1 yr) 4.46% 8.0% 2.06% 3.70%Cost-effectiveness $/MI avoided $21,893 $59,939 $/yr of life saved $10,333 $26,568
*Between 1 and 12 months following PCI
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2159 low- to intermediate-risk patients undergoing elective PCI with stent placement
Abciximab +70 U/kg heparin
(n=1079)
Placebo + 140 U/kg heparin
(n=1080)
End Points:• Primary 30-day death/MI/urgent target-vessel revascularization
• Secondary30-day bleeding complications
ISAR-REACT: Trial Design
Clopidogrel*(600-mg loading dose)
Randomized
*In addition to aspirin.
Kastrati A, et al. N Engl J Med. 2004;350:232-238.
Clopidogrel 150 mg/d until discharge, then
75 mg/d for 4 wk*
Clopidogrel 150 mg/d until discharge, then
75 mg/d for 4 wk*
325-500 mg Aspirin
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ISAR-REACT Primary End Point: 30-Day Death/MI/UTVR
4.0% 4.0%
0%
2%
4%
6%
P = NS
Death/MI/UTVR
0.9%0.7%
0%
1%
2%
3%
4%
P = NS
UTVR
0.3% 0.3%
0%
1%
2%
3%
4%
P = NS
Death
Abciximab +Clopidogrel
Placebo + Clopidogrel Abciximab +
ClopidogrelPlacebo +
ClopidogrelAbciximab +Clopidogrel
Placebo +Clopidogrel
UTVR = urgent target-vessel revascularization.Adapted with permission from Kastrati A, et al. N Engl J Med. 2004;350:232-238.
% o
f P
atie
nts
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High Cost of Post-MI Heart Failure
Impact of Heart Failure on Cost of Managing Post-MI Patients
$31,426
$44,997
05,000
10,00015,00020,00025,00030,00035,00040,00045,000
Post-MI Patients Post-MI Patients WithHeart Failure
Mean Annual Cost of Management
50,000
$13,571 per year
for patients who
develop heart failure
Akhras KS, et al. Abstract presented at: Heart Failure Society of America 2003 Scientific Meeting; September 21-24, 2003; Las Vegas, Nev.
Do
llar
s
(n=5298)
(n=2345)
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Impact of Eplerenone on Relative Risk of Total Mortality Post-MI With LVD
Months Since Randomization
Cu
mu
lati
ve
Inci
den
ce (
%)
22
0
2
20
16
18
14
12
10
8
6
4
RR=.85 (95% CI, .75-.96) P=.008
Placebo (n=3,313)
Eplerenone (n=3,319)
3633302724211815129630
Pitt B, et al. N Engl J Med. 2003;348:1309-1321.
CI = confidence interval; RR = relative risk.
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Early Benefits of Eplerenone When Added to Standard Post-MI Patient Care
Pitt B, et al. N Engl J Med. 2003;348:1309-1321.
All CauseMortality
CardiovascularMortality
Sudden CardiacDeath
Heart FailureHospitalization
30 Days
-31 -32-37
-18
-50-45-40-35-30-25-20
-15-10-505
10
Re
lati
ve
Ris
k (
%)
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Cost-effectiveness of Eplerenone vs Placebo in MI Patients With LV Dysfunction and HF
Adapted with permission from Weintraub WS, et al. Circulation. 2005;111:1106-1113.
Cost-effectiveness of Eplerenone
N=6632.
∆ Cost, $ ∆ Effectiveness ICER, $ <50,000/LYG, %
No added costs resultingfrom life-years saved
Life-years Framingham 1391 0.1014 13,718 96.7 Saskatchewan 1391 0.0636 21,876 93.8 Worcester 1391 0.1337 10,402 98.8
LYG indicates life-years gained.
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Critical Pathways for UA/NSTEMIUnstable Angina/
Non–ST-elevation MI*
ASA, Clopidogrel, -blockers, ACEI, statinHeparin or LMWH
Conservative Strategy Invasive Strategy
DC Home or ETT Hour 8-12
Cath/PCI Hour (0-6)
D/C Home Hour 8-16 D/C Day Hour 18-24
+
Rest pain
Adapted from UCLA Clinical Pathway for ACS. Available at: www.med.ucla.edu/champ.
ECG + and/or Troponin +Troponin -
6-hr Troponin - / ECG -
ASA, clopidogrel, -blockers, ACEI, statin, omega 3, and exercise
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CHAMP Study: UCLA
Designed to determine whether physician/patient compliance with preventive therapies can be improved through a hospital-initiated program
Tracked initiation of aspirin, β-blocker, ACE inhibitor, statins
Used preprinted orders, guidelines, lectures, discharge forms
Population: patients with symptomatic atherosclerosis treated at university-associated teaching hospital
Methods: no specific algorithms used before CHAMP (1992-1993)
National guidelines (ACC/AHA, NCEP ATP I and ATP II) used in CHAMP (1994-1995)
Evaluation: treatment rates and clinical outcomes pre-CHAMP and CHAMP in patients hospitalized for AMI
Fonarow GC, Gawlinski A. Am J Cardiol. 2000;85(3A):10A-17A.
Cardiac Hospitalization Atherosclerosis Management Program
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0
5
10
15
CHAMP Study: Clinical Events for the First Year After Discharge for Acute MI
Fonarow GC, et al. Am J Cardiol. 2001;87:819-822.
Eve
nt R
a te
, %
RecurrentMI
HeartFailure
Hospitalization TotalMortality
Pre-CHAMP
Post-CHAMP
7.8
4.7
14.8
7.0
3.3* 2.6
7.6*
3.3*
* P<0.05
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256 AMI pts discharged in 92/93 pre-CHAMP compared to 302 pts in 94/95 post-CHAMPUCLA Med Center Accounting Model, total costs averaged over each pt dc; meds at AWP
Fonarow GC, et al. Am J Cardiol. 2001;87:819-822.
CHAMP: Economic Analysis
$4,176
$3,182
Pre-CHAMP Post-CHAMP$1,000
$10,000
Total Medical Cost Per Patient Discharged (1 year)
P<0.001
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86,735 AMI patients in NRMI IV treated between 7/00 and 3/01. ACC/AHA Class I therapy.Hospitals divided into quartiles to composites of quality.
Peterson ED. Circulation. 2002;106:II-722. Abstract.
Median Performance Lagging Hospitals Leading Hospitalson Care Processes (n=271) (n=271)
Aspirin <24 h 73% 93%β-blocker <24 h 50% 86%Reperfusion 50% 71%DC ACEI 40% 70%DC Lipid Therapy 58% 80%Smoking Advice 7% 65%
Mortality 17.6% 11.9%
Variation in Acute MI Care Quality in 1085 Hospitals and Its Association
With Mortality Rates
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Performance Matters!
Reprinted with permission from Peterson ED. Presented at: Annual Scientific Sessions of the AHA; November 17-20, 2002; Chicago, Ill.
Relationship Between Process and Outcome in CRUSADE
5.9
5.04.6
3.6
0
1
2
3
4
5
6
7
<65% 65%-75% 75%-80% >80%
Hospital Composite Adherence Quartiles
In-h
os
pit
al M
ort
alit
y (
%)
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Featured Institution
Aurora Sinai Medical Center
Milwaukee, Wisconsin
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Polling Question #2
1) We are currently on the same item
2) We have since moved to the next checkbox on the checklist
3) We have progressed by more than one item on the checklist
4) ACS pathways are up-to-date and regularly followed
If you participated in a previous teleconference, how much progress have you made since then?
(Please refer to the checklists on the next 3 slides.)
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Progress Checklist:Immediate Goals
Assemble team and set up meeting of working group
Develop draft pathways
Circulate pathways to all cardiology, ED, and CV nursing staff for comments
Circulate discharge plan and other tools to all cardiology, ED, and CV nursing staff for comments
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Progress Checklist:Short-term Goals/Activities
Finalize critical pathways
Launch critical pathways
Circulate memo
Grand rounds/conference: Cardiology/IM
Grand rounds/conference: Emergency Dept.
Grand rounds/conference: Nursing
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Progress Checklist:Long-term Goals/Activities
Monitor data: which registry?
NRMI
AHA Get With The Guidelines
ACC National Cardiovascular Data Registry
CRUSADE
GRACE
REACH
Other
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Question-and-Answer Session
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Concluding Remarks
Gregg C. Fonarow, MD
Next program: Wednesday, September 14, 2005at 12:00 Noon Eastern Time (9:00 AM Pacific)
Topic: The CRUSADE National Quality Improvement Initiative: 2005 Update
Faculty: Christopher P. Cannon, MD