David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun Wang, Kate Robertus, Elizabeth M. Mahoney, Yueping

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


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


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


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


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


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


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


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%


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%


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%


PCI CABG

P=NSP=NS

P=0.05

Generic QOL and Utilities


0.5

0.6

0.7

0.8

0.9

1


30

40

50


SF-36 Mental Component Summary

P<0.001 P=0.23 P=0.43

30

35

40

45

50

55


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


30

40

50


SF-36 Mental Component Summary

P<0.001 P=0.23 P=0.43

30

35

40

45

50

55


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


$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


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


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



$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)









$50,000 per QALY$50,000 per QALY$50,000 per QALY$50,000 per QALY


Cost QALYs

Cost QALYs

Cost QALYs

Subgroup Analysis: SYNTAX Score Tertiles


$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


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


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


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


Documents

David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun Wang, Kate Robertus, Elizabeth M. Mahoney, Yueping