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

1. CREATE Multi-Center Clinical Registry 9-month Angiographic and 12-month Clinical Results Yaling Han MD, FSCAI On behalf of the CREATE investigators March 31, 2008 LBCT of ACC

2. Presenter Disclosure Information Name: Yaling Han NOTHING TO DISCLOSE

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 disolved 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 • Targeted angio f/u on ~35% of patients • Independent CEC and core cath lab

7. Study Organization • P.I. Yaling Han MD, Shenyang Northern Hospital • Study consultant Runlin Gao MD, Beijing Fuwai Hospital • Angiographic core lab Bo Xu MBBS, Beijing Fuwai Hospital • Clinical events committee Runlin Gao MD, Beijing Fuwai Hospital Jingxuan Guo MD, 3rd affiliated Hospital, Peking University Yawei Xu MD, Shanghai Tenth Hospital Xuchen Zhou MD, 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) 9±3 Months (653 pts) 6-month Clopidogrel Aspirin Indefinitely 6 Months (2068 pts) 12Months (2063 pts) Major Adverse Cardiac Events (Cardiac Death, MI, TLR) Thrombotic Events Late Lumen Loss Binary Restenosis 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. Baseline QCA Results 974 lesions(31.6%) analyzed

14. Procedural Results

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

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

17. Cumulative Percentage of Patients Discontinuing Dual Antiplatelet Therapy over Time 1652 pts (80.5%) Cumulative patient numbers Discontinuation of Clopidogrel (Aspirin Indefinitely)

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

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 Lesions Long Lesions Diabetes Mellitus

21. Conclusions • Current data suggests a high degree of safety of the ExcelTM biodegradable polymer coated SES, even when used in “real world” settings • The 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

22. Study Limitations • Single Arm Registry, No Control Group • Post-procedure changes of cardiac biochemical markers were not routinely surveilled in many participated centers, therefore asymptomatic non-Q-wave MI might be underreported. • Long-term (>1 yr) safety need further investigation

23. Thank You