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The e–Cypher Registry

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. Goals and design.

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The e–Cypher Registry

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  1. The e–Cypher Registry Sirolimus-Eluting Stent in Routine Clinical PracticeP. 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 56 % of eligible 81.0 % of target 83 % of eligible May 2004

  8. Baseline Characteristics • 12,108 patients • Age 61.1 + 11.3 • Male 77.9 % • Prior AMI 31.5 % • Prior PCI 29.0 % • Prior CABG 10.9 % • Diabetes 29.0 % • Non-ID: 19 % • ID: 10 % 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 1.2 + 0.5 • Number of SES/patient 1.3 ± 0.7 • Number of SES/lesion 1.1 + 0.4 • RVD (on-site visual estimate, mm) 2.9  0.4 • Lesion length (on-site visual estimate, mm) 17.3  8.9 • Direct stenting % 31.5 • Pressure deployment (atm) 14.3  2.8 • Post-dilation % 23.6 May 2004

  11. 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) n = 12656 1905 295 831 310* 1145** 1226 ** 361 older than 3 months * 222 unprotected LM 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 (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 • age (1 year older) 1.03 (0.99 - 1.06) p=0.055 • diabetes 2.00 (1.05 - 3.82) p=0.034 • hypertension 2.30 (1.09 - 5.44) p=0.040 • stable angina 0.33 (0.13 - 0.70) p=0.008 • pre-proc. MLD (1mm) 0.42 (0.18 - 0.82) p=0.023 Multivariate analysis, odds ratio (95% CI) 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

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