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CREATE Multi-Center Clinical Registry 9-month Angiographic and 12-month Clinical Results

CREATE Multi-Center Clinical Registry 9-month Angiographic and 12-month Clinical Results. Yaling Han MD, FSCAI On behalf of the CREATE investigators ACC 2008 . Presenter Disclosure Information. Name: Yaling Han.

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CREATE Multi-Center Clinical Registry 9-month Angiographic and 12-month Clinical Results

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  1. CREATE Multi-Center Clinical Registry 9-month Angiographic and 12-month Clinical Results Yaling Han MD, FSCAI On behalf of the CREATE investigators ACC 2008

  2. Presenter Disclosure Information Name: Yaling Han Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below Company name: Relationship: None

  3. CREATE Multi-Center Registry of Excel BiodegrAdable Polymer Drug EluTingStEnt

  4. New Generation DES Focus on Reducing Late Adverse Events ExcelTM stent: biodegradable polymer coated SES Polymer Asymmetric Biodegradable PLA Stent S-stent Drug Sirolimus (195~376μg/stent) fully degraded within 6 months

  5. objectives • To assess the safety and efficacy of Excel biodegradable polymer coated sirolimus eluting stent in “real world” PCI practice • To assess the safety of 6-month dual antiplatelet therapy after Excel stent implantation

  6. Study Design • Prospective, multi-center, post-marketing surveillance registry • Unselected “real world” patients • 6-month dual antiplatelet therapy • Anticipated angio f/u rate 35% • Independent CEC and core cath lab

  7. Study Organization • P.I. Yaling Han, Shenyang Northern Hospital • Study consultant RunlinGao, Beijing Fuwai Hospital • Angiographic core lab Bo Xu, Beijing Fuwai Hospital • Clinical events committee RunlinGao, Beijing Fuwai Hospital JingxuanGuo, 3rd affiliated Hospital, Peking University YaweiXu, Shanghai Tenth Hospital Xuchenzhou, 1st affiliated Hospital, Dalian Medical University • Sponsored by JWMS Co. Ltd.

  8. Main Study Centers 59 centers (56 China, 1 Indonesia, 1 Malaysia & 1 Thailand)

  9. Patients Enrollment • Inclusion Criteria • Candidates for coronary stenting • Treated with Excel stent exclusively • Informed consent • Exclusion Criteria • Hybrid stenting • Contraindicated to dual antiplatelet therapy • Severe congestive heart failure (NYHA class IV) • Planned upcoming surgery

  10. Study Flowchart Patients Recruitment (2006.6-2006.11) 90 pts Excluded for Hybrid Stenting 2077 Pts Enrolled Clinical Follow-up Angio Follow-up 30 Days (2077 pts) 6-12 Months (653 pts) 6-month Clopidogrel Aspirin Indefinitely 6 Months (2068 pts) 12Months (2063 pts) Thrombotic Events Late Lumen Loss Binary Restenosis Major Adverse Cardiac Events (Cardiac Death, MI, TLR) Primary End Point:MACE at 12 months Secondary End Points:MACE at 1- and 6 months; Late Loss; Binary Restenosis; Thrombotic Events

  11. Baseline Clinical Characteristics

  12. Baseline Angiographic Characteristics

  13. Procedural Results

  14. Follow-up Clinical Outcomes (%) 12-month Clinical Follow-up Rate 99.3%

  15. Impact of Off-label Indications on 12-month Clinical Outcomes (%) (n=1745) (n=318) P=0.081 P=0.049 P=1.0 * ST=stent thrombosis *

  16. Dual Antiplatelet Treatment 1652 pts (80.5%) Cumulative patient numbers Discontinuation of Clopidogrel

  17. Thrombotic Events 3 thrombotic events developed after discontinuation of clopidogrel days

  18. Baseline QCA Results 974 lesions(31.6%) analyzed

  19. 9-month QCA Results 974 lesions(31.6%) analyzed

  20. 9-month QCA Results Subgroup Analysis Binary restenosis (%) P=0.829 P=0.963 P=0.1 P=0.002 P<0.001 P=0.005 Small Vessel Lesion Long Lesion Diabetes Mellitus

  21. Conclusions • Current data suggests a high degree of safety of the ExcelTM biodegradable polymer coated SES, even though being used in “real world” settings • ExcelTM stent is effective in reducing restenosis, similar to the results from pivotal DES trials • 6-month dual antiplatelet treatment seems safe after ExcelTM stent implantation • Long-term (>1 yr) safety need further investigation

  22. Thank You

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