1. What is the Optimal Rate of DES Use?
David J. Cohen, M.D., M.Sc.
Director, Cardiovascular Research Saint Luke’s Mid America Heart Institute
Professor of Medicine University of Missouri- Kansas City
TCT 2010
15 mins

2. Disclosures Grant Support/Drugs Grant Support/Devices
Eli Lilly/Daiichi-Sankyo - Merck/Schering Plough
Eisai Pharmaceuticals
Grant Support/Devices
MedRAD - Boston Scientific
Edwards Lifesciences - Abbott Vascular
Medtronic
Consulting/Advisory Boards
Medtronic - Eli Lilly/Daiichi-Sankyo
Cordis - Boehringer-Ingelheim
DJC: 9/10

3. International Variation in DES Use
Pooled analysis of trends in DES use in 4 countries (178,000 lesions)
Demonstrates marked variation in DES use both between countries and within countries over time
Reasons for variation:
Reimbursement
Economic impact of repeat procedures
Cultural/Sociological considerations
Austin D, et al. Am Heart J 2009;158:576-84

4. Optimizing DES Use Expert opinion/consensus statements
Cost-effectiveness modeling using predicted DES and BMS restenosis rates
Natural experiment– look for differences in outcome by region or time period

5. Proposed Guidelines for DES Use
Washington State
Any one of the following
Stent diameter ≤ 3.0 mm
Stent length ≥ 15 mm
Treatment of in-stent restenosis
Diabetes
Unprotected LM stenosis
Any one of the following
Vessel diameter <3.0 mm
Lesion length >15 mm
NICE (UK)
Diabetes plus
Lesion length >20 mm OR
Vessel diam ≤2.75 mm
Ontario

6. Implications of Guidelines for DES Utilization: Ontario Tech Assessment
Characteristic
Proportion of Lesions
Diabetes
35.2%
(A) Vessel diameter <=2.75 mm
39.1%
(B) Lesion length >20 mm
18.9%
Diabetes + (A or B)
18.7%
n = 3310 lesions
Lesion-Based Analysis

7. Implications of Guidelines for DES Utilization: NICE Guidance
Characteristic
Proportion of Lesions
Vessel diameter <3.0 mm
42.1%
Lesion length >15 mm
36.4%
Either of the above
61.8%
Lesion-Based Analysis

8. Implications of Guidelines for DES Utilization: Washington State
Characteristic
Proportion of Lesions
Stent diameter <3.0 mm
74.0%
Stent length >15 mm
70.2%
Treatment of ISR
6.6%
Diabetes
34.6%
Treatment of unprotected LM
0.8%
Any characteristic
93.4%
n=13,945 lesions
Lesion-Based Analysis

9. Optimizing DES Use Expert opinion/consensus statements
Cost-effectiveness modeling using predicted DES and BMS restenosis rates
Natural experiment– look for differences in outcome by region or time period

10. Cost-Effectiveness of DES (2010 data): Impact of Bare Metal Stent Restenosis Rate
Healthcare system perspective
Model Assumptions
Incremental cost per DES = $1000
DES per case = 1.6 (case-mix adjusted)
50% reduction in TVR with DES vs. BMS (Kirtane metaanalysis)
Conclusions: DES reasonably cost-effective when bare stent TVR rate > 11%

11. Distribution of Predicted TVR Rates with BMS
Proportion with p(TVR) > threshold
EVENT Waves 1-3
7447 patients/10,425 lesions
Predicted TVR rate with DES and BMS based on logistic regression
Age
Previous PCI
Reference diameter
Lesion length
SVG lesion
LM lesion
Implication Based on cost-effectiveness criteria, ~60% of U.S. PCI patients should receive DES
57%
Stolker JM et al. Circ Cardiovasc Interv 2010;3:327-34
55% RRR

12. Optimizing DES Use Expert opinion/consensus statements
Cost-effectiveness modeling using predicted DES and BMS restenosis rates
Natural experiment– look for differences in outcome by region or time period

13. Temporal trends in DES use
DES Firestorm
“Liberal” use
(N=7587)
“Selective” use
(N=2557)
N=2535
N=2515
N=2535
N=2557

14. Study Concept
Take advantage of this “natural experiment” in practice patterns to compare clinical outcomes and treatment costs between the “liberal” and “selective” DES eras
Primary endpoint: TLR (most specific for DES effect)
Secondary endpoints: death, MI, TVR, any revasc
Economic endpoints: cost per patient, cost-effectiveness
Should approximate the results of an RCT as long as there are no major differences in the overall PCI population or other aspects of care over the same time period

15. Clinical Outcomes: Death or MI
Liberal vs. Selective DES Use
Clinical Outcomes: Death or MI
Death
Death or MI
Liberal DES use
Selective DES use
Liberal DES use
Selective DES use
Plogrank = 0.99
Plogrank = 0.30
4.6%
2.9%
4.6%
2.5%

16. Clinical Outcomes: Repeat Revasc.
Liberal vs. Selective DES Use
Clinical Outcomes: Repeat Revasc.
TLR
5.1%
4.1%
Plogrank = 0.03
TVR
6.5%
5.6%
Plogrank = 0.07
Any Revasc
10.6%
10.1%
Liberal DES use
Selective DES use

17. Mean Cost per Patient Crude Cost-Effectiveness D = $454 (p<0.001)
Liberal vs. Selective DES Use
Mean Cost per Patient
D = $454 (p<0.001)
$15,104
$14,651
Repeat Revasc
Antiplatelet Therapy
Crude Cost-Effectiveness
D Cost = $454
D TLR = 0.019
ICER = $24,000 per TLR event avoided
Stents
Initial Procedure (except stents)
Liberal DES Use
Selective DES Use

18. C-E Acceptability Curve: $/QALY Gained
Liberal vs. Selective DES Use
C-E Acceptability Curve: $/QALY Gained
Risk-Adjusted Analysis
ICER = $432,000/QALY gained
Prob < $100,000 = 15%
Willingness to Pay Threshold

19. Conclusions
Currently, there is no clear consensus on the “optimal” rate of DES use
If health care resources are unlimited, universal DES use is appropriate since virtually all patients and lesions benefit to some degree
If health care resources are limited, both theoretical modeling and empirical data suggest that a more selective approach is reasonable-- aiming for 60-70% DES use across the PCI population (at current DES prices)
Future research should be directed at developing methods to ensure that the “right” 60-70% of patients are treated