1. ENDEAVOR II Five-Year Clinical Follow-up
Ian T. Meredith, MBBS, PhD MonashHEART Monash Medical Centre Melbourne, Australia On Behalf of the Endeavor II Investigators

2. Potential Conflicts Of Interest
Speaker’s name: Ian T. Meredith
I have the following potential conflicts of interest to report:
Research contracts
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest 2

3. Driver Cobalt Alloy Stent
Endeavor DES System
Driver Cobalt Alloy Stent
Stent Delivery System
PC Technology
Drug: Zotarolimus

4. Polymer and Drug Matrix
PC overspray
(~0.1 µm thick)
Stent strut
Post-elution
~1-µm coating of PC polymer
Drug layer
90% zotarolimus (10 µg/mm)
10% PC (~2–3 µm thick)
Stent strut
PC basecoat
(~1 µm thick)
ENDEAVOR
CYPHER
TAXUS Liberté
XIENCE V
Strut Thickness
91 µm
140 µm
97 µm
81 µm
Polymer
Thickness
4.8 µm
12.6 µm
17.8 µm
7.8 µm

5. ENDEAVOR II Double-Blind, Randomized Clinical Trial vs Driver
PI: Jean Fajadet, William Wijns et. al.
Single De Novo Native Coronary Artery Lesions
Reference Vessel Diameter 2.25 mm-3.5 mm
Lesion Length: mm
Pre-dilatation required
N = 1,200 patients
72 sites
Europe, Asia Pacific, Israel,
New Zealand and Australia
Endeavor Stent
Active Arm
n=600
Driver Stent
Control Arm
n=600
Clinical/MACE
30d
6mo
8mo
9mo
12mo
2yr
3yr
4yr
5yr
Angiography/IVUS
Angio = first 600 pts
IVUS = first 300 pts (plus IVUS for overlapping stents)
Primary Endpoint: TVF at 9 months Secondary Endpoints: MACE at 30 days and 9 months, BR at 8 months
Drug Therapy: ASA and Clopidogrel >3 months
Zotarolimus Dose: 10 g per mm stent length
Fajadet et al. Circulation. 2006;114:

6. ENDEAVOR Clinical Program
ENDEAVOR I
First in Human
5 Years n = 97/100 (97%)
ENDEAVOR II
Double-blind Randomized Trial
5 Years n = 577/598 (97%)
ENDEAVOR II CA
Continued Access Registry
4 Years n = 287/296 (97%)
ENDEAVOR III
Confirmatory Trial vs. Cypher
4 Years n = 307/323 (95%)
ENDEAVOR IV
Confirmatory Trial vs. Taxus
2 Years n = 742/773 (96%)
ENDEAVOR PK
Pharmacokinetic Trial
2 Years n = 42/43 (98%)
E-Five
Post Market Surveillance
2 Years n = 2054/2116 (97%)

7. ENDEAVOR II Patient Flowchart Patients Enrolled N = 1197 Endeavor
Driver
n = 599
Randomized
Angio F/U (8 mo)
264/298
88.6%
Angio F/U (8 mo)
265/302
87.7%
Clinical Follow-up
Clinical Follow-up
(1yr)
590/598
98.7%
(2yr)
588/598
98.3%
(3yr)
585/598
97.8%
(4yr)
583/598
97.5%
(5yr) 577/ %
(1yr)
590/599
98.5%
(2yr)
588/599
98.2%
(3yr)
587/599
98.0%
(4yr)
584/599
97.5%
(5yr) 582/ %

8. ENDEAVOR II TVF and TLR at 9 Months Primary Endpoint
Target Vessel Failure*
TLR
P<0.001
P<0.001
47%
61%
Driver
Endeavor
Driver
Endeavor
*Target Vessel Failure is a composite of target vessel revascularization, MI, or cardiac death.

9. Time after Initial Procedure (years)
ENDEAVOR II
Cumulative Incidence of TVF to 5 years
Endeavor
Driver
Log rank P = <0.001
24.3%
15.3%
30%
25%
20%
15%
10% 5% 0% 9m 1 2 3 4 5
Time after Initial Procedure (years)
Cumulative Incidence
TVF
Δ 7.1%
Δ 9.0%
Days
270
360
720
1080
1440
1800
Endeavor
597
584
541
525
515
497
487
% CI
2.2
7.9
10.0
11.0
12.6
13.5
15.3
Driver
596
580
501
465
446
435
2.7
15.0
16.5
19.6
21.2
22.4
24.3

10. Cumulative Incidence TLR Time after Initial Procedure (years)
ENDEAVOR II
Cumulative Incidence of TLR to 5 years
Cumulative Incidence TLR
Log rank P = <0.001
16.5%
7.4%
30%
Time after Initial Procedure (years)
Endeavor
Driver
25%
20%
15%
10% 5% 0% 9m 1 2 3 4 5
Δ 7.2%
Δ 9.1%
Days
270
360
720
1080
1440
1800
Endeavor
597
595
552
538
529
515
505
% CI
0.3
4.6
6.0
6.5
7.2
7.4
Driver
596
504
489
474
456
445
0.2
11.9
13.2
14.2
14.8
15.9
16.5

11. ENDEAVOR II TLR at 5 years TLR (%) P<0.001 P<0.001 P<0.001

12. ENDEAVOR II Summary of Clinical Events at 5 years Endeavor N = 598
Driver
N = 599
P Value
Death (all) - % (n)
6.2 (36)
7.6 (44)
0.418
Cardiac
3.1 (18)
3.6 (21)
0.745
MI (all) – % (n)
3.8 (22)
4.8 (28)
0.470
Q Wave -% (n)
0.3 (2)
1.2 (7)
0.178
Non Q Wave - % (n)
3.5 (20)
1.000
Death (cardiac) + MI (all) – % (n)
6.6 (38)
8.4 (49)
0.265
TLR – % (n)
7.5 (43)
16.3 (95)
<0.001
TVR (non-TL) – % (n)
4.3 (25)
0.188
TVR – % (n)
10.7 (62)
20.1 (117)
MACE – % (n)
15.4 (89)
24.6 (143)
TVF – % (n)
24.4 (142)
Table 4h

13. ENDEAVOR II Clinical Performance at 5 years (%) P<0.001 P<0.001
38% TVF
54% TLR

14. ENDEAVOR II Summary of ARC Stent Thrombosis to 5 years Endeavor
Driver
n = 599
P Value
Stent Thrombosis (ARC Def/prob) - %(n)
0.9 (5)
1.7 (10)
0.299
Early: 0-30 days
0.5 (3)
1.2 (7)
0.342
Late: days
0.2 (1)
1.000
Very Late: days
0.3 (2)

15. Pivotal Trials TLR: DES Arms
Rates of TLR Over Time
ENDEAVOR II (n=577/598)
SIRIUS (n=501/533)
TAXUS IV (n=618/662)
9.4
9.1
7.9
7.8
7.5
7.2
7.2
6.5
6.8
6.9
5.9
6.3
TLR (%)
TLR (%)
TLR (%)
5.6
4.9
4.4 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5
Years of Follow-up
Years of Follow-up
Years of Follow-up
5 Year Clinical Results of TAXUS IV, Stone, ACC 2007
5 year Outcomes in the Sirius Trial, Weisz et al. JACC Vol. 53, No. 17, 2009
Results come from separate clinical trials. Data may differ in a head-to-head comparison.

16. ENDEAVOR II Conclusions
Sustained clinical benefit out to 5 years with a excellent safety profile with no new (ARC) stent thrombosis events
These long term outcomes could be due in part to the unique biocompatible nature of the PC polymer
The Endeavor ZES when compared with the Driver stent demonstrated: