1. Two-Year Extended Follow-up in Patients Receiving a Zotarolimus-eluting Stent in the E-Five Registry
Martin T. Rothman, Ian T. Meredith, Keyur Parikh, Peter Sick, Fausto Feres, Chaim Lotan, For the E-FIVE Registry Investigators

2. E-Five Registry
Prospective, Multicenter Registry PI: Chaim Lotan, Ian Meredith and Martin Rothman
Single and Multiple Coronary Artery Lesions
Stent Diameters: mm
Stent Length: 8/9-30 mm
N = 8,000 patients N = 2000 at 2 years
200 sites
Europe, Asia Pacific, Israel, New Zealand, South America
Clinical/MACE
30d
6mo
12mo
2yr*
Primary Endpoint: MACE at 12 months
Secondary Endpoints: MACE at 30 days and 6 mo, stent thrombosis, procedure success rate; device success rate; lesion success rate
Drug Therapy: ASA and clopidogrel ≥3 months Zotarolimus Dose: 10 g per mm stent length
*Limited number of centers.

3. E-Five Registry Background
Drug-eluting stents for PCI effectively reduce restenosis rates in patients with symptomatic ischemic heart disease and de novo coronary artery lesions. Long-term safety and late stent thrombosis rates remain a concern.
The Endeavor zotarolimus-eluting stent (ZES) has been found to successfully treat patients with a range of clinical and angiographic characteristics.
Long-term follow-up in real-world populations is essential to establish the safety of the Endeavor ZES in patients with both simple and complex lesions.
Extended two year follow-up was planned for a prespecified subset of approximately 2000 patients undertaken in 26 centers to determine the durability of the safety and efficacy of the Endeavor ZES in the “real world” patient population of the E-Five study.

4. E-Five Registry Data System and Quality Control
Clinical Event Committee:
Cardialysis (Rotterdam, The Netherlands)
Independent adjudication of all reported MACE and stent thrombosis (protocol and ARC definite/probable) events
Data Monitoring:
10% monitoring aimed at detecting underreporting of events (CRO and Medtronic)
Electronic Data Collection (KIKA, Boston, MA)

5. E-Five Registry Clinical Outcomes to 1 Year All Patients 30 days
1 Year n = 7832
Death (all) – % (n)
0.6 (52)
2.4 (191)
Cardiac
0.6 (46)
1.7 (135)
MI (all) – % (n)
0.9 (75)
1.6 (128)
Q Wave
0.2 (16)
0.4 (31)
Non Q wave
0.7 (59)
1.3 (98)
Death (cardiac) + MI (all) – % (n)
1.4 (115)
3.0 (238)
ARC def/prob ST – % (n)
1.1 (88)
0-30 days
0.8 (59)
days
TLR – % (n)
0.4 (35)
4.5 (349)
TVR (non-TL) – % (n)
0.0 (4)
0.7 (52)
TVR – % (n)
0.5 (38)
4.9 (387)
MACE – % (n)
1.6 (135)
7.5 (587)
TVF – % (n)
1.6 (132)
7.2 (565)

6. E-Five Registry Two Year Follow-up Cohort Country Patients Total 2116
Brazil
100
China 40
Germany
199
Greece
138
India
Italy
480
Latvia
Malaysia
176
Netherlands
Portugal
Spain
256
Switzerland UK 64
Uruguay 87
Total
2116

7. E-Five Registry Patient Demographics All Patients N = 8314
2-Yr Subset N = 2116
Male (%)
76.7
77.3
Age (years)
63.3±11.1
62.1±11.0
Prior MI (%)
32.2
35.3
Non Q Wave
12.2
12.8
Q Wave
21.3
23.5
Prior PCI (%)
25.3
24.1
Prior CABG (%)
7.5
6.9
Diabetes Mellitus (%)
32.7
30.1
Acute Coronary Syndrome (%)
47.8
40.7
Recent MI (< 72 hours) (%)
13.9
11.4
Unstable Angina (%)
33.9
29.3
Moderate/Severe Renal Impairment* (%)
6.5
5.6
* Serum creatinine ≥ 140 µmol/L and no renal transplant.

8. E-Five Registry Clinical Outcomes to 2 Years (Prespecified Subset)
2 Years n = 2054
Death (all) – % (n)
1.7 (36)
2.9 (60)
Cardiac
1.2 (25)
1.5 (31)
MI (all) – % (n)
1.5 (30)
Q Wave
0.2 (5)
0.3 (7)
Non Q wave
1.0 (20)
1.1 (23)
Death (cardiac) + MI (all) – % (n)
2.3 (48)
2.8 (57)
ARC Def/ Prob ST – % (n)
0.6 (13)
0.7 (15)
0-30 days
0.5 (10)
days
0.1 (3)
days
0.1 (2)
TLR – % (n)
4.5 (94)
5.1 (105)
TVR (non-TL) – % (n)
0.9 (18)
1.0 (21)
TVR – % (n)
5.2 (108)
5.9 (121)
MACE – % (n)
6.7 (140)
8.5 (174)
TVF – % (n)
6.7 (141)
7.9 (162)

9. E-Five Registry Clinical Outcomes to 2 Years (Prespecified Subset)
8.5%
E-Five (n=2054)
Death
Cardiac
Death MI
Protocol ST
ARC ST
Def/Prob
TLR
TVR
TVF
MACE
n=60
n=31
n=30
n=15
n=15
n=105
n=121
n=162
n=174
n = number of events

10. E-Five Registry
Adverse Events Between 1-2 Years (Prespecified Subgroup)
Year 1
Year 2
TLR
Death
Cardiac
Death MI
Protocol ST
ARC Def/Prob ST
TVR
TVF
MACE

11. Cumulative Incidence MACE Time after initial Procedure (days)
E-Five Registry
Cumulative Incidence of MACE to 2 Years (Prespecified Subset)
Cumulative Incidence MACE
Time after initial Procedure (days) 0% 2% 4% 6% 8%
10% 90
180
270
360
450
720
E-Five
540
630
Type 90
180
270
360
450
540
630
720
730
# at Risk
2116
2085
2067
2030
1980
1936
1917
1906
1889
1791
# of Events 12 15 36 40 25 7 8
%CI
0.6%
1.8%
3.6%
5.5%
6.7%
7.0%
7.4%
8.0%
8.3%

12. Cumulative Incidence TLR Time after initial Procedure (days)
E-Five Registry
Cumulative Incidence of TLR to 2 Years (Prespecified Subset)
Cumulative Incidence TLR
Time after initial Procedure (days) 0% 2% 4% 6% 8%
10% 90
180
270
360
450
720
E-Five
540
630
Type 90
180
270
360
450
540
630
720
730
# at Risk
2116
2098
2082
2046
1995
1956
1933
1924
1913
1816
# of Events 9 32 34 12 2 4 3
%CI
0.0%
0.8%
2.3%
3.9%
4.5%
4.6%
4.8%
4.9%
5.0%

13. E-Five Registry
Cumulative Incidence of ARC Def/Prob ST to 2 Years (Prespecified Subset)
Cumulative Incidence ARC Def/Prob
Time after initial Procedure (days) 0% 2% 4% 6% 8%
10% 90
180
270
360
450
720
Cumulative Incidence ARC Def/Prob ST
E-Five
540
630
Type 90
180
270
360
450
540
630
720
730
# at Risk
2116
2097
2091
2086
2070
2041
2020
2014
2003
1906
# of Events 1
%CI
0.0%
0.5%
0.6%
0.7%

14. Percent of patients on DAPT at:
E-Five Registry
Dual Antiplatelet Therapy (DAPT) Usage
(Prespecified Subset)
Percent of patients on DAPT at:
6 months
12 months
24 months
81.8% (1705/2084)
52.6% (1077/2049)
22.1%
(439/1989)

15. E-Five Registry Conclusions (Prespecified Subset)
The Endeavor ZES was associated with a low and durable TLR rate regardless of lesion complexity with very few events between 1-2 years (Δ 0.6%).
In this prespecified subset of patients followed to 2 years, the cardiac death, MI and ST rates (protocol and ARC def/prob) were stable.
These results are consistent with the safety and efficacy findings from the ENDEAVOR Clinical Program despite the “real world” nature of the patient population.