1. on behalf of the International e-Cypher Investigators
The e–Cypher Registry
Sirolimus-Eluting Stent in Routine Clinical Practice P. Urban, AH. Gershlick, G. Guagliumi, P. Guyon, C. Lotan, J. Schofer, A. Seth, JE. Sousa, W. Wijns
on behalf of the International e-Cypher Investigators
May 2004

2. Goals and design Post-marketing surveillance registry to determine:
Safety and reliability of SES in routine clinical use
Reproducibility of RCT results
Use of SES world-wide in daily practice
Identification of MACE predictors
All patients receiving > 1 SES are enrolled
Both on- and off-label use are recorded
Clinical FU at one, six and twelve months
No mandatory angiographic follow-up
Target recruitement = 15,000 patients
May 2004

3. Structure Independent Advisory Board
Independent Endpoint Committee (Chair M. Bertrand)
Independent data management (Eminent - PPD)
Independent data analysis (Hesperion Ltd)
Audit: ongoing check of ca. 3% of entries against patient chart and PCI report for data entry accuracy
On-site data input via Internet
Queries in a HTML format
May 2004

4. Online enrollment + FU checks
May 2004

5. 275 Sites EUROPE 121 Austria 7 Belgium 3 France 25 Germany 1 Italy 10
Latvia 1
Luxembourg 1
Morocco 5
Netherlands 1
Portugal 9
Russian Federation 4
UK 4
Spain 36
Switzerland 9
Lithuania 2
Yugoslavia 1
Tunisia 2
MIDDLE EAST 15
Bahrain 1
Israel 11
Lebanon 2
Saudi Arabia 1
LATIN AMERICA 98
Argentina 14
Brazil 18
Chile 8
Colombia 9
Costa Rica 2
Dominican Republic 2
Guatemala 1
Mexico 31
Panama 3
Uruguay 3
Venezuela 7
ASIA PACIFIC 41
Australia 11
India 18
Malaysia 2
Pakistan 2
Thailand 3
Vietnam 2
New Zealand 2
Philippines 1

6. Validity of PCI registry data
Multicenter enrollment of unselected patients yes
Large numbers representing current PCI practice yes
Absence of bias from compulsory angio follow-up yes
Independent data management and analysis yes
Independent data reporting yes
Random site auditing for data accuracy ongoing
Independent Endpoint Committee yes
Safety: FU of > 80% of patients at 6 months yes
Efficacy: FU of > 80% of patients at 12 months targeted
May 2004

7. Patient enrollment n. of patients 81.0 % of target 83 % of eligible
May 2004

8. Baseline Characteristics
12,108 patients
Age
Male 77.9 %
Prior AMI %
Prior PCI 29.0 %
Prior CABG 10.9 %
Diabetes 29.0 %
Non-ID: 19 %
ID: %
Diseased vessels
May 2004

9. Indications for PCI
n = 12,108 patients
May 2004

10. PCI Procedure Number of procedures/patient 1.1 + 0.3
Number of lesions/patient
Number of SES/patient ± 0.7
Number of SES/lesion
RVD (on-site visual estimate, mm)  0.4
Lesion length (on-site visual estimate, mm)  8.9
Direct stenting %
Pressure deployment (atm)  2.8
Post-dilation %
May 2004

11. Number of SES/patient 1.3  0.7
PCI Approach (per patient)
Number of SES/patient 1.3  0.7 %
May 2004

12. Lesions Treated n =14,559 (1.2 + 0.5 lesions/patient) %
* 222 unprotected LM
** 361 older than 3 months
May 2004

13. Indication and lesion type
5901 patients (48.7%) treated for
at least one “off-label” indication
CTO unprotected LM SVG AMI ostial lesion bifurcation thrombus present restenotic lesion lesion length > 30mm lesion diameter <2.25 or >5mm
May 2004

14. SES lengths used (n=16251)
May 2004

15. SES diameters used (n=16251)
May 2004

16. 30 days Follow-up CEC-adjudicated events 10579 patients%
CEC-adjudicated events
10579 patients
(88% of those eligible)
May 2004

17. 6 months follow-up: MACE
CEC-adjudicated events %
9473 patients
(83% of those eligible)
May 2004

18. 6 months follow-up: Stent thrombosis
CEC-adjudicated events* %
Overall stent thrombosis rate = 0,53% at 6 months
n=32
n=14
n=9
*all cases with reported death, AMI, TLR or stent thrombosis were reviewed and adjudicated
May 2004

19. MACE-free survival curve (6 months)
97.7%
May 2004

20. Diabetics (n=3438)
Selected baseline characteristics
May 2004

21. 6 months follow-up in diabetics
CEC-adjudicated events %
*p<0.001
**p<0.0001
May 2004

22. 6 months follow-up in diabetics vs. IDDM Patients
CEC-adjudicated events %
*p<0.001
**p<0.0001
May 2004

23. MACE-free survival in diabetics vs. non-diabetics
98.0%
96.7%
May 2004

24. Stent thrombosis in diabetics%
Overall ST at 6 months:
diabetics 0,77%vs. non-diabetics 0,50%
CEC - adjudicated events: all cases with death, AMI, TLR or reported stent thrombosis were reviewed
May 2004

25. Stent thrombosis in diabetics vs. IDDM Patients%
CEC - adjudicated events: all cases with death, AMI, TLR or reported stent thrombosis were reviewed
May 2004

26. MACE predictors at 6 months
Multivariate analysis, odds ratio (95% CI)
age (1 year older) ( ) p=0.055
diabetes ( ) p=0.034
hypertension ( ) p=0.040
stable angina ( ) p=0.008
pre-proc. MLD (1mm) ( ) p=0.023
Logistic fixed model - Predictors chosen by stepwise procedure using an entry criterion of 0.20 with a stay criterion of of 0.10
May 2004

27. Conclusions (May 2004)
e-CYPHER is the largest single registry of DES use in routine clinical practice worldwide, and is becoming a very powerful clinical tool.
Off-label use is quite prevalent, and represents 49% of procedures worldwide
Six month data confirm the very good medium-term safety record of the SES, with low MACE and stent thrombosis rates, comparable to those observed in RCTs
Definitive conclusions concerning efficacy (TLR) in routine clinical practice will have to await obtention of the twelve months follow-up data
May 2004