David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun...
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Transcript of David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun...
David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun Wang, Kate Robertus, Elizabeth M. Mahoney, Yueping Zhu,
Keith D. Dawkins, A. Pieter Kappetein on behalf of the SYNTAX Investigators
Saint Luke’s Mid America Heart InstituteUniversity of Missouri-Kansas City
Kansas City, Missouri
Health Related Quality of Life and U.S. Economic Outcomes of PCI with
Drug-Eluting Stents vs. Bypass Surgery: 1-Year Results from the SYNTAX Trial
Disclosures
SYNTAX was funded by a research grant from Boston Scientific, Inc.
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 2
Background
Recently 1-year results from the SYNTAX trial have demonstrated that for patients with left main and/or 3-vessel disease, CABG results in lower rates of MACCE than PCI with DES–- driven by a significant reduction in the need for repeat revascularization
Since there were no overall differences in irreversible endpoints, however, quality of life and economic factors should be important considerations in determining the optimal treatment for these highly prevalent conditions
To address these issues, both quality of life and health economic analyses were included in the design of the SYNTAX trial
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 3
Instrument Description/Role
Seattle Angina Questionnaire (SAQ)
CAD-specific QOLDomains: Angina Frequency, Physical Limitations, Disease Perception/QOLScores: 0-100 (higher = better)
SF-36 General physical and mental healthScores: 0-100 (higher = better)
EQ-5D (EuroQOL) Generic instrument for assessment of utilities and QALYsScores: 0-1 (0=death; 1=perfect health)
Methods: Quality of Life
Assessments performed by self-administered questionnaires at baseline, 1, 6, and 12 months
Primary endpoint: SAQ-Angina Frequency Scale
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 4
Cost-Effectiveness Analysis
Analytic PerspectiveUS healthcare system
Patient PopulationAll patients with complete 1 yr follow-up, regardless of country of origin
General approachMultiply counts of resources derived from trial population by price weights derived from a comparable US population
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 5
Cath lab and OR costs based on measured resource utilization (procedure duration, balloons, stents, wires, etc.) and current unit costs
Drug-eluting stent cost =$2000/stent
Ancillary hospital costs based on event-based (rather than resource-based) regression models of SYNTAX-eligible U.S. patients using 2006 MedPAR data
Avoids distortions due to marked differences in LOS across different health care systems
Costs also included for-- other CV and non-CV hospitalizations, MD fees, outpatient CV care/testing, cardiac rehabilitation, and outpatient medications
Costing Methods:Revascularization Procedures/Hospitalizations
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 6
Primary EndpointsTotal 1-year medical care costs
Incremental Cost-Effectiveness Ratio ($/QALY gained)
Secondary EndpointsIndividual components of cost
Disease-specific C/E ratios ($/repeat revascularization avoided, $/death, MI, or stroke avoided)
Prespecified SubgroupsLeft main vs. 3-vessel disease
Diabetes
SYNTAX score tertiles
Economic Analysis Plan
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 7
Baseline QOLBaseline QOL
PCI(n=837)
CABG(n=802)
SAQ Angina Frequency 7026 6927
Daily (0-30) 11.7% 11.6%
Weekly (40-60) 26.2% 27.9%
Monthly (70-90) 39.9% 38.4%
None (100) 22.2% 22.1%
SAQ QOL 4623 4523
SF-36 PCS 4010 4010
SF-36 MCS 4512 4512
EQ-5D Utility 0.750.19 0.740.19
P=NS for all comparisonsSYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 8
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 9
Primary QOL Endpoint: SAQ-Angina Frequency
60
65
70
75
80
85
90
95
100
Baseline 1 month 6 months 12 months
PCI
CABG
= +1.3P=0.17
= -1.7P=0.04
= -1.7P=0.03
60
65
70
75
80
85
90
95
100
Baseline 1 month 6 months 12 months
PCI
CABG
= +1.3P=0.17
= -1.7P=0.04
= -1.7P=0.03
SAQ-AF: Substantial Improvement*
* Defined as improvement ≥ 20 points vs. baselineSYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 10
54.7%56.5% 57.6%
52.4%57.4% 58.3%
0%
20%
40%
60%
80%
1 month 6 months 12 months
PCI CABG P = NS for all timepoints
54.7%56.5% 57.6%
52.4%57.4% 58.3%
0%
20%
40%
60%
80%
1 month 6 months 12 months
PCI CABG P = NS for all timepoints
SAQ-AF: Angina-Free*
* Defined as SAQ-AF score = 100SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 11
71.6%68.5%64.4%
76.3%72.0%
61.6%
0%
20%
40%
60%
80%
100%
1 month 6 months 12 months
PCI CABG
P=NSP=NS
P=0.05
71.6%68.5%64.4%
76.3%72.0%
61.6%
0%
20%
40%
60%
80%
100%
1 month 6 months 12 months
PCI CABG
P=NSP=NS
P=0.05
Generic QOL and Utilities
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 12
0.5
0.6
0.7
0.8
0.9
1
Baseline 1 month 6 months 12 months
30
40
50
Baseline 1 month 6 months 12 months
SF-36 Mental Component Summary
P<0.001 P=0.23 P=0.43
30
35
40
45
50
55
Baseline 1 month 6 months 12 months
P<0.001 P=0.50 P=0.07
P<0.001 P=0.16 P=0.99
SF-36 Physical Component Summary
EQ-5D Utilities (US)
PCI
CABG
0.5
0.6
0.7
0.8
0.9
1
Baseline 1 month 6 months 12 months
30
40
50
Baseline 1 month 6 months 12 months
SF-36 Mental Component Summary
P<0.001 P=0.23 P=0.43
30
35
40
45
50
55
Baseline 1 month 6 months 12 months
P<0.001 P=0.50 P=0.07
P<0.001 P=0.16 P=0.99
SF-36 Physical Component Summary
EQ-5D Utilities (US)
PCI
CABG
PCI
CABG
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 13
$14,318
$8,108
$10,909$20,536
$0
$10,000
$20,000
$30,000
$40,000
$50,000
PCI CABG
PhysicianFees
Room +Ancillary
RepeatProcedures
IndexProcedure
$27,560
=$5693 (p<0.001)
$33,254
$14,318
$8,108
$10,909$20,536
$0
$10,000
$20,000
$30,000
$40,000
$50,000
PCI CABG
PhysicianFees
Room +Ancillary
RepeatProcedures
IndexProcedure
$27,560
=$5693 (p<0.001)
$33,254
Initial Hospitalization Costs
RevascularizedPopulation
Follow-up Costs
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 14
2,253
218
1,499
4,457
1,006
1,051
1,131
2,954
$0
$2,000
$4,000
$6,000
PCI CABG
Hospitalizations MD fees RehabServices
Outpatient Medications
=$1502=$1502
=$368=$368 =($834)=($834)
=$1247=$1247
2,253
218
1,499
4,457
1,006
1,051
1,131
2,954
$0
$2,000
$4,000
$6,000
PCI CABG
Hospitalizations MD fees RehabServices
Outpatient Medications
=$1502=$1502
=$368=$368 =($834)=($834)
=$1247=$1247
Total F/U Costs
PCI $8425
CABG $6144
Total F/U Costs
PCI $8425
CABG $6144
= $2282
p<0.001
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 15
Total 1-Year Costs
$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
PCI CABG
1-Year Follow-up
InitialHospitalization
=$3590 (P<0.001)
$35,991
$39,581
$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
PCI CABG
1-Year Follow-up
InitialHospitalization
=$3590 (P<0.001)
$35,991
$39,581
Cost-Effectiveness of CABG vs. PCI*Overall Population
*$/QALY
-$10,000
-$5,000
$0
$5,000
$10,000
-0.10 -0.05 0.00 0.05 0.10
Quality Adjusted Life-Years (CABG-PCI)
1-
yr c
os
t (C
AB
G-P
CI)
CABG Dominated cost = $3590
effect = - 0.02 QALYs
CABG Dominated cost = $3590
effect = - 0.02 QALYs
$50,000 per QALY$50,000 per QALY
*$/QALY
-$10,000
-$5,000
$0
$5,000
$10,000
-0.10 -0.05 0.00 0.05 0.10
Quality Adjusted Life-Years (CABG-PCI)
1-
yr c
os
t (C
AB
G-P
CI)
CABG Dominated cost = $3590
effect = - 0.02 QALYs
CABG Dominated cost = $3590
effect = - 0.02 QALYs
CABG Dominated cost = $3590
effect = - 0.02 QALYs
CABG Dominated cost = $3590
effect = - 0.02 QALYs
$50,000 per QALY$50,000 per QALY$50,000 per QALY$50,000 per QALY
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 16
Cost QALYs
Cost QALYs
Cost QALYs
Subgroup Analysis: SYNTAX Score Tertiles
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 17
$39,765
$36,084
$32,292
$40,232$39,973$38,446
$0
$10,000
$20,000
$30,000
$40,000
$50,000
=$6154=$6154 =$3889=$3889 =$467=$467
Total 1-Year Cost
P = 0.001 for interactionP = 0.001 for interaction
Low (≤22) Middle 23-32 High (≥33)
PCI CABG
$39,765
$36,084
$32,292
$40,232$39,973$38,446
$0
$10,000
$20,000
$30,000
$40,000
$50,000
=$6154=$6154 =$3889=$3889 =$467=$467
Total 1-Year Cost
P = 0.001 for interactionP = 0.001 for interaction
Low (≤22) Middle 23-32 High (≥33)
PCI CABG
Cost-Effectiveness of CABG vs. PCI ($/QALY) SYNTAX Score Tertiles
DominatedICER
-0.047 QALY
$6154 Cost
-$2,500
$0
$2,500
$5,000
$7,500
$10,000
-0.10 -0.05 0.00 0.05 0.10
Low (≤22)
Pr <$50K/QALY = 0.0%
DominatedICER
-0.013QALY
$3889 Cost
-0.10 -0.05 0.00 0.05 0.10
Mid (23-32)
Pr <$50K/QALY = 0.3%
$43,000/QALYICER
+0.010 QALY
$467 Cost
-0.10 -0.05 0.00 0.05 0.10
High (≥33)
Pr <$50K/QALY = 49%
DominatedICER
-0.047 QALY
$6154 Cost
-$2,500
$0
$2,500
$5,000
$7,500
$10,000
-0.10 -0.05 0.00 0.05 0.10
Low (≤22)
Pr <$50K/QALY = 0.0%
DominatedICER
-0.047 QALY
$6154 Cost
-$2,500
$0
$2,500
$5,000
$7,500
$10,000
-0.10 -0.05 0.00 0.05 0.10
Low (≤22)
Pr <$50K/QALY = 0.0%
DominatedICER
-0.013QALY
$3889 Cost
-0.10 -0.05 0.00 0.05 0.10
Mid (23-32)
Pr <$50K/QALY = 0.3%
DominatedICER
-0.013QALY
$3889 Cost
-0.10 -0.05 0.00 0.05 0.10
Mid (23-32)
Pr <$50K/QALY = 0.3%
$43,000/QALYICER
+0.010 QALY
$467 Cost
-0.10 -0.05 0.00 0.05 0.10
High (≥33)
Pr <$50K/QALY = 49%
$43,000/QALYICER
+0.010 QALY
$467 Cost
-0.10 -0.05 0.00 0.05 0.10
High (≥33)
Pr <$50K/QALY = 49%SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 18
Analysis performed from a US perspective results likely to differ in other healthcare systems because of differences in patterns of resource use and costs
DES cost: US- $2000 UK- $1200 GER- $800
Hosp. day: US- $1500 UK- $400 GER- $320
1-year time horizon does not fully capture differences in long-term survival and QOL
5 yr economic and QOL analyses planned
Limitations
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 19
Summary: QOL
Among patients undergoing revascularization for left main or 3-vessel CAD, angina relief was slightly better with CABG than DES at 6 and 12 months. The magnitude of benefit was smaller than in previous CABG vs. PCI comparisons, however, and below the threshold that most patients would find clinically meaningful
All other QOL endpoints favored PCI at 1 month, although these differences were transient and largely resolved by 6 months
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 20
Summary: Cost-Effectiveness
Despite substantially higher procedural costs for PCI, initial treatment costs were ~$6000/pt higher with CABG – mainly due to differences in LOS, complications, and physician costs
Follow-up costs were ~$2500/pt lower with CABG, driven largely by differences in the need for additional revascularization procedures and lower medication costs
Although total 1-year costs remained significantly lower with PCI, the overall cost-effectiveness of PCI vs. CABG differed substantially according to pt characteristics-– particularly angiographic complexity
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 21
Summary: Cost-Effectiveness (2)
SYNTAX Score
Net Cost of PCI
1-Yr Cost-Effectiveness
Low (0-22) 20% PCI dominant
Med (23-32) 8% PCI dominant
High (≥33) Neutral CABG economically attractive
Longer-term follow-up is essential (and planned) to fully assess both QOL and cost-effectiveness for these challenging populations
SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 22