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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
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 Institute
University of Missouri-Kansas City
Kansas City, Missouri
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
Methods: Quality of Life
Instrument
Description/Role
Seattle Angina
Questionnaire (SAQ)
CAD-specific QOL
Domains: Angina Frequency, Physical
Limitations, Disease Perception/QOL
Scores: 0-100 (higher = better)
SF-36
General physical and mental health
Scores: 0-100 (higher = better)
EQ-5D (EuroQOL)
Generic instrument for assessment of
utilities and QALYs
Scores: 0-1 (0=death; 1=perfect health)
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 Perspective
US healthcare system
Patient Population
All patients with complete 1 yr follow-up, regardless
of country of origin
General approach
Multiply 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
Costing Methods:
Revascularization Procedures/Hospitalizations
Cath lab and OR costs based on measured resource
utilization (procedure duration, balloons, stents, wires,
etc.) and current unit costs
Drug-eluting stent cost =$2000/stent
Ancillary hospital costs based on event-based (rather
than resource-based) regression models of SYNTAXeligible U.S. patients using 2006 MedPAR data
Avoids distortions due to marked differences in LOS
across different health care systems
Costs also included for-- other CV and non-CV
hospitalizations, MD fees, outpatient CV care/testing,
cardiac rehabilitation, and outpatient medications
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 6
Economic Analysis Plan
Primary Endpoints
Total 1-year medical care costs
Incremental Cost-Effectiveness Ratio ($/QALY gained)
Secondary Endpoints
Individual components of cost
Disease-specific C/E ratios ($/repeat revascularization
avoided, $/death, MI, or stroke avoided)
Prespecified Subgroups
Left main vs. 3-vessel disease
Diabetes
SYNTAX score tertiles
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 7
Baseline QOL
PCI
(n=837)
CABG
(n=802)
7026
6927
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
4623
4523
SF-36 PCS
4010
4010
SF-36 MCS
4512
4512
0.750.19
0.740.19
SAQ Angina Frequency
EQ-5D Utility
P=NS for all comparisons
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 8
Primary QOL Endpoint:
SAQ-Angina Frequency
100
95
PCI
CABG
90
85
80
75
= +1.3
P=0.17
70
= -1.7
P=0.04
= -1.7
P=0.03
6 months
12 months
65
60
Baseline
SYNTAX · Health Economics/Quality of Life
1 month
ACC 2009 · Orlando, FL · 9
SAQ-AF: Substantial Improvement*
80%
PCI
CABG
P = NS for all timepoints
60%
54.7%
56.5%
57.4%
57.6%
58.3%
52.4%
40%
20%
0%
1 month
6 months
12 months
* Defined as improvement ≥ 20 points vs. baseline
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 10
SAQ-AF: Angina-Free*
100%
PCI
CABG
P=0.05
P=NS
80%
P=NS
60%
68.5%
64.4%
72.0%
76.3%
71.6%
61.6%
40%
20%
0%
1 month
6 months
12 months
* Defined as SAQ-AF score = 100
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 11
Generic QOL and Utilities
SF-36 Physical Component Summary
SF-36 Mental Component Summary
55
50
50
45
40
40
P<0.001
35
P=0.50
P<0.001
P=0.07
30
P=0.23
P=0.43
30
Baseline
1 month
6 months
12 months
Baseline
1 month
6 months
12 months
EQ-5D Utilities (US)
1
PCI
CABG
0.9
0.8
0.7
P<0.001
P=0.16
P=0.99
0.6
0.5
SYNTAX · Health Economics/Quality of Life
Baseline
1 month
6 months
12 months
ACC 2009 · Orlando, FL · 12
Initial Hospitalization Costs
$50,000
=$5693 (p<0.001)
Physician
Fees
Room +
Ancillary
Repeat
Procedures
Index
Procedure
$40,000
$33,254
$30,000
$27,560
$20,000
$10,909
$20,536
$10,000
Revascularized
Population
$14,318
$8,108
$0
PCI
SYNTAX · Health Economics/Quality of Life
CABG
ACC 2009 · Orlando, FL · 13
Follow-up Costs
$6,000
=$1502
=$1502
PCI $8425
$4,000
4,457
PCI
Total F/U Costs
CABG $6144
CABG
 = $2282
p<0.001
=$1247
=$1247
2,954
=$368
=$368
$2,000
=($834)
=($834)
2,253
1,051
1,499
1,131
1,006
218
$0
Hospitalizations
SYNTAX · Health Economics/Quality of Life
MD fees
Rehab
Services
Outpatient
Medications
ACC 2009 · Orlando, FL · 14
Total 1-Year Costs
$60,000
1-Year
Follow-up
=$3590 (P<0.001)
$50,000
Initial
Hospitalization
$39,581
$40,000
$35,991
$30,000
$20,000
$10,000
$0
SYNTAX · Health Economics/Quality of Life
PCI
CABG
ACC 2009 · Orlando, FL · 15
Cost-Effectiveness of CABG vs. PCI*
Overall Population
$10,000
 Cost
 QALYs
CABG
CABG Dominated
Dominated
 cost
cost == $3590
$3590
 effect
effect == -- 0.02
0.02 QALYs
QALYs
(CABG-PCI)
 1-yr cost
$5,000
$0
-$5,000
$50,000
$50,000 per
per QALY
QALY
 Cost
 QALYs
 Cost
 QALYs
-$10,000
-0.10
*$/QALY
SYNTAX · Health Economics/Quality of Life
-0.05
0.00
0.05
0.10
 Quality Adjusted Life-Years (CABG-PCI)
ACC 2009 · Orlando, FL · 16
Subgroup Analysis:
SYNTAX Score Tertiles
Total 1-Year Cost
$50,000
=$6154
=$6154
=$3889
=$3889
=$467
=$467
$40,000
$39,973
$38,446
$39,765
$40,232
$36,084
$30,000
$32,292
$20,000
$10,000
P
P == 0.001
0.001 for
for interaction
interaction
$0
Low (≤22)
PCI
CABG
SYNTAX · Health Economics/Quality of Life
Middle 23-32
High (≥33)
ACC 2009 · Orlando, FL · 17
Cost-Effectiveness of CABG vs. PCI ($/QALY)
SYNTAX Score Tertiles
Low (≤22)
Mid (23-32)
High (≥33)
$10,000
$7,500
$5,000
$2,500
$0
-$2,500
-0.10
-0.05
0.00
0.05
0.10 -0.10
-0.05
0.00
0.05
0.10
-0.10
-0.05
0.00
0.05
 Cost
$6154
 Cost
$3889
 Cost
$467
 QALY
-0.047
QALY
-0.013
 QALY
+0.010
ICER
Dominated
ICER
Dominated
ICER
$43,000/QALY
Pr <$50K/QALY = 0.0%
SYNTAX · Health Economics/Quality of Life
Pr <$50K/QALY = 0.3%
0.10
Pr <$50K/QALY = 49%
ACC 2009 · Orlando, FL · 18
Limitations
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
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 costeffectiveness for these challenging populations
SYNTAX · Health Economics/Quality of Life
ACC 2009 · Orlando, FL · 22