1. Washington Hospital Center, Division of Cardiology
REWARDS
Ron Waksman, Kimberly Kaneshige, Rebecca Torguson, Probal Roy, Zhenyi Xue, William Suddath, Lowell F. Satler, Kenneth M. Kent, Augusto D. Pichard
Washington Hospital Center, Division of Cardiology
Washington DC

2. Disclosures
Advisory Board: Medtronic Boston Scientific, Abbott Vascular, Biotronik
Speaker bureau: Medtronic Boston Scientific, Abbott Vascular, Biotronik
Research grants: Medtronic Boston Scientific, Abbott Vascular, Biotronik, Shering Plaugh, GSK, Medicine company, Sanofi BMS
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3. REWARDS
Trial Aim
The objective of this analysis was to compare the long-term outcomes up to 3 years (Efficacy and Safety) of patients receiving Cypher stents to those receiving Taxus stents with nonrestrictive use for all subset of patients and lesions.

4. Trial Structure REWARDS Investigator Sponsor Study
Single Center with 11 cath labs
30 independent attending investigators
Conducted under local IRB approval
Clinical Follow-up at 1 month, 6 month, 1, 2, and 3 years via telephone or clinic office visit
All events were adjudicated by independent
physicians committee
Data Management CRI, Washington Hospital Center

5. REWARDS
Trial Design
Successful PCI with DES &
Complete 3 year follow up
n = 3157
Cypher Stents n = 2192 pts
Taxus Stents n = 965 pts
Plavix Rx at least 3 M for Cypher and 6 M for Taxus
Complete 3 year clinical follow-up all patients

6. REWARDS
Definitions
MACE: Composite of Death, Q wave Myocardial Infarction, Target Vessel Revascularization
Stent Thrombosis: Angiographically documented stent thrombosis
In hospital: prior to discharge
Sub-acute: ≤ 30 days from stent implantation
Late: > 30 days from stent implantation

7. Clinical Presentation
REWARDS
Clinical Presentation %
Cypher
n=2192
Taxus
n=965
P value
Stable Angina
34.4
26.5
<0.001
Unstable Angina
41.6
49.9
Acute MI
11.5
9.4
0.151
Cardiogenic Shock
3.0
2.0
0.150

8. Baseline Characteristics
REWARDS
Baseline Characteristics
Clinical Characteristics (%)
Cypher
(n=2192)
Taxus
(n=965)
p Value
Age (yrs)
65.35 ± 11.43
66.21 ± 12.16
0.063
Male gender
62.6
67.8
0.005
Hypertension
81.3
79.7
0.293
Diabetes mellitus
35.5
36.2
0.730
Insulin treated diabetes
11.2
12.0
0.548
Hypercholesterolemia
86.7
83.0
0.007
Smokers at time of procedure
18.1
16.9
0.430
Previous myocardial infarction
32.0
34.6
0.151
Previous CABG
16.7
19.4
0.069
Previous PCI
25.4
28.0
0.120
History of chronic renal failure
11.8
14.4
0.041
Ejection fraction
0.48 ± 0.14
0.48 ± 0.13
0.858

9. In-Hospital Complications
REWARDS
In-Hospital Complications %
Cypher
pt=2192
les=4002
Taxus
pt=965
les=1650
p Value
Angiographic Success
97.6
98.1
0.275
Dissection
0.7
1.0
0.218
Abrupt Closure
0.3
0.084
No Reflow
0.5
0.8
0.162
Death
1.5
1.6
0.838
Myocardial infarction, Q-wave
0.4
0.259
Repeat TVR
2.8
1.8
0.088
Major bleeding
2.3
0.127
Stent thrombosis
1.000

10. 1 Year Clinical Outcomes 2 Year Clinical Outcomes
REWARDS
Clinical Outcomes
1 Year Clinical Outcomes
2 Year Clinical Outcomes
p=0.012
p=0.016

11. Unadjusted 3 Year Clinical Outcomes
REWARDS
Unadjusted 3 Year Clinical Outcomes
Cypher
n=2192
Taxus
n=965
p Value
MACE
27.7
28.7
0.58
Death
13.9
17.0
0.03
Myocardial infarction, Q-wave
0.7
1.7
0.02
Target vessel revascularization
16.7
14.4
0.12
Target lesion revascularization
13.3
10.6
0.05
ARC Definite Stent thrombosis
1.8
1.3
0.34

12. Adjusted 3 Year Clinical Outcomes
REWARDS
Adjusted 3 Year Clinical Outcomes
P values
0.885
0.214
0.168
0.054
0.080

13. REWARDS
K-M Curve for 3 Year MACE
Logrank p=0.52
Overall

14. Independent Predictors of MACE within 3 years
REWARDS
Hazard Ratio
95% CI
P value
Male gender
0.9
0.121
Acute MI, presentation
1.3
0.005
Diabetes
1.5
<0.001
Hypercholesterolemia
1.0
0.897
Chronic Renal Insufficiency
2.4
Smoking
1.1
0.111
Age
Cypher Stent Usage
0.885

15. Cumulative Definite Stent Thrombosis – 3 Years
REWARDS
Cumulative Definite Stent Thrombosis – 3 Years
Overall stent thrombosis for both stents at 3 years 1.7%

16. Cumulative Rates of Definite ST
REWARDS
Cumulative Rates of Definite ST %

17. Diabetic Sub-analyses
REWARDS
Diabetic Sub-analyses
1) All Diabetics
2) Insulin Dependent Diabetes Mellitus

18. Successful PCI with DES & Complete 3 year follow up
REWARDS
Diabetic Breakdown
Successful PCI with DES &
Complete 3 year follow up
n = 3157
Cypher Stents n = 2192 pts
Taxus Stents n = 965 pts
All Diabetes Mellitus
n = 770
All Diabetes Mellitus
n = 348
IDDM
n = 243
IDDM
n = 115

19. REWARDS
36 Month MACE
P=0.178
P=0.140
P=0.577

20. 36 Month Clinical Outcomes
REWARDS
36 Month Clinical Outcomes
IDDM
Overall DM
P=0.245
Overall
P=0.038
P=0.026
P=0.252
P=0.651
P=0.023

21. 36 Month Cumulative Definite ST
REWARDS
36 Month Cumulative Definite ST
P=0.752
P=0.937
P=0.336 %

22. 36 Month Cumulative Definite Late ST
REWARDS
36 Month Cumulative Definite Late ST
P=0.597
P=0.881
P=1.0 %

23. REWARDS
Adjusted 3 Year MACE
P Value
0.885
0.610
0.152

24. Independent Predictors of MACE within 3 years
REWARDS
Variable
All DM
IDDM
HR [95%CI]
P value
Male gender
0.9 [ ]
0.390
1.0 [ ]
0.993
Acute MI, presentation
1.3 [ ]
0.153
1.4 [ ]
0.207
Hypercholesterolemia
1.1 [ ]
0.535
1.0 [ ]
0.969
Chronic Renal Insufficiency
2.5 [ ]
<0.001
2.3 [ ]
Smoking
1.0 [ ]
0.849
1.2 [ ]
0.235
Age
1.0 [ ]
0.006
0.130
Cypher Stent Usage
0.9 [ ]
0.610
0.8 [ ]
0.152

25. Adjusted 3 Year Death & Q waveMI
REWARDS
Adjusted 3 Year Death & Q waveMI
P Value
0.080
0.274
0.283

26. Independent Predictors of Death& Qwave MI within 3 years
REWARDS
Variable
All DM
IDDM
HR [95%CI]
P value
Male gender
0.8 [ ]
0.181
1.0 [ ]
0.889
Acute MI, presentation
1.3 [ ]
0.259
1.1 [ ]
0.741
Hypercholesterolemia
0.985
1.0 [ ]
0.982
Chronic Renal Insufficiency
3.8 [ ]
<0.001
4.0 [ ]
Smoking
1.2 [ ]
0.192
1.4 [ ]
0.094
Age
1.0 [ ]
1.0 [ ]
Cypher Stent Usage
0.9 [ ]
0.274
0.8 [ ]
0.283

27. REWARDS
Summary
In an unselected patients population and lesions receiving DES there was no significant difference between patients receiving Cypher or Taxus stents with respect to MACE at 3 years.
This similarity remained after adjustment for baseline characteristic differences.
Death and Q wave MI were significantly higher in patients receiving Taxus than Cypher stents at 3 years. This significance, however, did not remain after adjustment.

28. REWARDS
Conclusions
The present study demonstrated that the use of Cypher and Taxus stents in unrestricted, contemporary practice had a comparable outcome in terms of low rates of revascularization and clinical events through 3 years.
Cumulative stent thrombosis, (1.7% at three years for the entire cohort), remains a serious concern for both Cypher and Taxus Stent. These concerns are heightened for the insulin-dependent patients.