1. ENDEAVOR III Multicenter Randomized Trial Clinical/MACE Angio/IVUS
3:1 Randomization
Single Blind – Single Vessel – No Staging
Single De Novo Native Coronary Lesions
Vessel Diameter: mm
Lesion Length: mm
Stent Lengths: mm (8/9) mm bailout
Pre-dilatation required
Endeavor Stent
n = 327
N = 436 patients
30 U.S. sites
Cypher Stent
n = 109
Clinical
Endpoints
30d
6mo
4yr
3yr
2yr
9mo
12mo
QCA
IVUS
8mo
5yr
Clinical/MACE
Angio/IVUS
Primary Endpoint: In-segment late lumen loss by QCA at 8 months
Secondary Endpoints: TLR, TVR, TVF at 9 months & ABR at 8 months
Antiplatelet therapy for ³3 months 10 g Zotarolimus per mm stent length

2. ENDEAVOR III
Study Objectives (2003)
To determine whether results of the Endeavor DES in a United States PCI population were similar to those observed in Endeavor trials conducted internationally
To determine whether 8 month angiographic outcomes (in-segment late loss) with the Endeavor DES are non-inferior to the FDA-approved Cypher DES

3. ENDEAVOR III
Outstanding Questions (2010)
Does higher late loss with Endeavor ZES stent (compared with Cypher SES) translate into greater late-term TLR beyond the period of angiographic follow-up?
What are the late-term safety outcomes of Endeavor ZES and Cypher SES?
Are Endeavor ZES outcomes consistent with late-term follow up observed in the overall Endeavor Clinical Trial program?

4. ENDEAVOR III Patient Flowchart Randomized Patients Enrolled N = 436
Cypher
n = 113
Randomized
Angio F/U (8 mo)
277/323
85.8%
Angio F/U (8 mo)
94/113
83.2%
Clinical F/U
(24 mo)
317/323
98.1%
(12 mo)
321/323
99.4%
(36 mo)
314/323
97.2%
(48 mo)
310/323
96.0%
(60 mo)
307/323
95.0%
Clinical F/U
(24 mo)
112/113
99.1%
(12 mo)
(36 mo)
110/113
97.3%
(48 mo)
(60 mo)
108/113
95.6%

5. ENDEAVOR III Selected Baseline Characteristics Endeavor n = 323 Cypher
value
Age – years (mean ± SD)
61.4 ± 10.6
61.7±11.6
0.80
Males (%)
65.3
81.4
0.001
Diabetics (%)
29.7
28.3
0.81
Unstable Angina (%)
51.1
56.1
0.41
RVD (mm)
2.75
2.79
0.49
Lesion length (mm)
15.0
0.99
B2/C lesions (%)
67.2
56.6
0.05

6. ENDEAVOR III Dual Antiplatelet Therapy (DAPT) Patients On DAPT At:
1 Year
2 Years
3 Years
4 Years
5 Years
Endeavor
17.5 (54/308)
5.6 (17/304)
7.5 (22/293)
6.9 (20/289)
7.0 (20/286)
Cypher
16.5 (18/109)
9.3 (10/108)
9.8 (10/102)
9.3
(9/97)
6.4
(6/94)
Data presented as percentages.

7. 1º Non-inferiority Endpoint Not Met
ENDEAVOR III
Angiographic and IVUS Results at 8 Months
Endeavor
n = 277
Cypher
n = 94 P
value
BAR (%) In-Stent
9.7
2.1
0.01
In-Segment
12.3
4.3
0.03
Late Loss (mm) In-Stent
0.62
0.15
<0.001
0.36
0.13
Volume Obstruction (%)
15.9
2.7
1º Non-inferiority Endpoint Not Met

8. ENDEAVOR III Clinical Outcomes to 60 Months Endeavor N = 307 Cypher
P value
Death (all) – % (n)
5.2 (16)
13.0 (14)
.015
Cardiac
0.3 (1)
2.8 (3)
.056
MI (all) – % (n)
1.0 (3)
4.6 (5)
.031
Q Wave
0.9 (1)
.453
Non Q wave
0.7 (2)
3.7 (4)
.042
Death (cardiac) + MI (all) – % (n)
1.3 (4)
6.5 (7)
.009
Stent Thrombosis (def/prob) – % (n)
1.000
0-360 days
days
TLR – % (n)
8.1 (25)
.678
TVR (non-TL) – % (n)
11.4 (35)
8.3 (9)
.468
TVR – % (n)
16.9 (52)
.363
MACE – % (n)
14.0 (43)
22.2 (24)
.050
TVF – % (n)
17.9 (55)
18.5 (20)
.885

9. ENDEAVOR III TLR, Cardiac Death/MI and MACE at 9 and 60 Months TLR
Δ 6.5% vs. 15.1%
Δ 1.9% vs. 3.0%
Δ 0.7% vs. 3.0%
9 months
60 months

10. Cumulative Incidence of Time after Initial Procedure (days)
ENDEAVOR III
Cardiac Death/MI to 60 Months
15%
£ 1 year Endeavor Cardiac Death/MI = 0.62%
> 1 year through 5 years Endeavor Cardiac
Death/MI = 0.67%
Cypher
Endeavor
P = 0.003
10%
Cumulative Incidence of
Cardiac Death or MI
6.5% 5%
1.3% 0%
360
720
1080
1440
1800
Time after Initial Procedure (days)
CD/MI
360
720
1080
1440
1800
Endeavor
323
321
314
306
298
290
Events n (CI%)
2 (0.6)
3 (1.0)
4 (1.3)
Cypher
113
109
107
103 98 94
# Events n (CI%)
4 (3.5)
6 (5.5)
7 (6.5)

11. Cumulative Incidence of Time after Initial Procedure (days)
ENDEAVOR III
ARC ST Def/Prob to 60 Months 5%
£ 1 year Endeavor ARC ST = 0.32%
> 1 year through 5 years Endeavor ARC ST = 0.34 %
Cypher
Endeavor
P = 0.756 4% 3%
Cumulative Incidence of
Def/Prob Thrombosis 2% 1%
1.0%
0.7% 0%
360
720
1080
1440
1800
Time after Initial Procedure (days)
ARC ST
360
720
1080
1440
1800
Endeavor
323
315
308
300
292
Events n (CI%)
0 (0.0)
1 (0.3)
2 (0.7)
Cypher
113
111
106
101 97
1 (1.0)

12. Cumulative Incidence from TLR Time after Initial Procedure (days)
ENDEAVOR III
TLR to 60 Months
35%
£ 1 year Endeavor TLR = 6.6%
> 1 year through 5 years Endeavor TLR = 1.4%
Cypher
Endeavor
P = 0.547
30%
25%
20%
Cumulative Incidence from TLR
15%
10%
8.0%
6.5% 5% 0%
360
720
1080
1440
1800
Time after Initial Procedure (days)
TLR
360
720
1080
1440
1800
Endeavor
323
280
272
263
257
Events n (CI%)
0 (0.0)
21 (6.6)
22 (6.9)
23 (7.3)
24 (7.7)
25 (8.0)
Cypher
113
107
101 97 91
4 (3.5)
5 (4.5)
7 (6.5)

13. Cumulative Incidence from MACE Time after Initial Procedure (days)
ENDEAVOR III
MACE to 60 Months
35%
£ 1 year Endeavor MACE = 7.8%
1 year through 5 years
Endeavor MACE = 5.8%
Cypher
Endeavor
P = 0.054
30%
25%
21.8%
20%
Cumulative Incidence from MACE
15%
13.6%
10% 5% 0%
360
720
1080
1440
1800
Time after Initial Procedure (days)
MACE
360
720
1080
1440
1800
Endeavor
323
321
293
284
275
268
Events n (CI%)
2 (0.6)
25 (7.8)
29 (9.0)
35 (11.0)
39 (12.3)
43 (13.6)
Cypher
113
109
103 98 94 88
4 (3.5)
9 (8.0)
13 (11.5)
16 (14.3)
21 (18.9)
24 (21.8)

14. ENDEAVOR III Conclusion at 5 Years
In a trial designed to evaluate a primary angiographic endpoint, late lumen loss is greater with Endeavor ZES compared with the Cypher SES
Despite initially higher angiographic late loss with ZES,
Rates of TLR beyond period of protocol-mandated angiographic surveillance remain stable
Absolute differences between DES in clinical restenosis temporally decrease over late term
Recognizing limitations in sample size, late term (5y) follow up of the Endeavor stent demonstrates
Durability in efficacy (TLR)
Very low rate of VLST (1 event)
Compared with Cypher SES, emerging differences in cardiac death/MI and MACE achieving statistical significance
Late term EIII outcomes with the Endeavor ZES parallel the consistent safety and efficacy observed across the Endeavor Clinical Trials Program