
3f73f0ae909e4d18d29de9ce2d09b4c6.ppt
- Количество слайдов: 27
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 § 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
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
Online enrollment + FU checks May 2004
275 Sites 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 EUROPE 121 Austria 7 Belgium 3 MIDDLE EAST 15 France 25 Bahrain 1 Germany 1 Israel 11 Italy 10 Lebanon 2 Latvia 1 Saudi Arabia 1 Luxembourg 1 Morocco 5 ASIA PACIFIC 41 Netherlands 1 Australia 11 Portugal 9 India 18 Russian Federation 4 Malaysia 2 UK 4 Pakistan 2 Spain 36 Thailand 3 Switzerland 9 Vietnam 2 Lithuania 2 New Zealand 2 Yugoslavia 1 Philippines 1 Tunisia 2
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
Patient enrollment n. of patients 81. 0 % of target May 2004 83 % of eligible 56 % of eligible
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 % May 2004 Diseased vessels
Indications for PCI n = 12, 108 patients May 2004
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
PCI Approach (per patient) Number of SES/patient 1. 3 0. 7 % May 2004
Lesions Treated % n =14, 559 (1. 2 + 0. 5 lesions/patient) n= May 2004 12656 1905 295 * 222 unprotected LM 831 310* 1145** ** 361 older than 3 months 1226
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 length > 30 mm lesion diameter <2. 25 or >5 mm May 2004
SES lengths used (n=16251) May 2004
SES diameters used (n=16251) May 2004
30 days Follow-up % CEC-adjudicated events 10579 patients (88% of those eligible) May 2004
6 months follow-up: MACE CEC-adjudicated events % 9473 patients (83% of those eligible) May 2004
6 months follow-up: Stent thrombosis CEC-adjudicated events* % Overall stent thrombosis rate = 0, 53% at 6 months n=32 n=9 n=14 *all cases with reported death, AMI, TLR or stent thrombosis were reviewed and adjudicated May 2004
MACE-free survival curve (6 months) 97. 7% May 2004
Diabetics (n=3438) Selected baseline characteristics May 2004
6 months follow-up in diabetics % May 2004 CEC-adjudicated events *p<0. 001 **p<0. 0001
6 months follow-up in diabetics vs. IDDM Patients CEC-adjudicated events % May 2004 *p<0. 001 **p<0. 0001
MACE-free survival in diabetics vs. non-diabetics 98. 0% 96. 7% May 2004
Stent thrombosis in diabetics % May 2004 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
Stent thrombosis in diabetics vs. IDDM Patients % May 2004 CEC - adjudicated events: all cases with death, AMI, TLR or reported stent thrombosis were reviewed
MACE predictors at 6 months Multivariate analysis, odds ratio (95% CI) § 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 (1 mm) 0. 42 (0. 18 - 0. 82) 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
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