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 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

Multi-Center Registry of Excel BiodegrAdable Polymer Drug EluTing StEnt CREATE

StentS-stent DrugSirolimus (195~376μg/stent) Polymer Asymmetric Biodegradable PLA New Generation DES Focus on Reducing Late Adverse Events Excel TM stent: biodegradable polymer coated SES fully degraded within 6 months

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 objectives

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

Study Organization P.I. Yaling Han, Shenyang Northern Hospital P.I. Yaling Han, Shenyang Northern Hospital Study consultant Runlin Gao, Beijing Fuwai Hospital Study consultant Runlin Gao, Beijing Fuwai Hospital Angiographic core lab Bo Xu, Beijing Fuwai Hospital Angiographic core lab Bo Xu, Beijing Fuwai Hospital Clinical events committee Clinical events committee Runlin Gao, Beijing Fuwai Hospital Runlin Gao, Beijing Fuwai Hospital Jingxuan Guo, 3 rd affiliated Hospital, Peking University Jingxuan Guo, 3 rd affiliated Hospital, Peking University Yawei Xu, Shanghai Tenth Hospital Yawei Xu, Shanghai Tenth Hospital Xuchen zhou, 1 st affiliated Hospital, Dalian Medical University Xuchen zhou, 1 st affiliated Hospital, Dalian Medical University Sponsored by JWMS Co. Ltd. Sponsored by JWMS Co. Ltd.

Shenyang Northern Hospital Harerbin Medical University 1st Hospital Tangshan Worker’s Hospital Sland Heart Center, Island Hospital, Penang, Malaysia Liaoning People’s HospitalGeneral Hospital of PLAXinqiao HospitalGeneral Hospital of Armed Police Harerbin Medical University 4th Hospital Dalian Medical University 2nd Hospital Affiliated Hospital of Tianjin Armed Police Medical university Jilin University 2nd Hospital Liaoning Medical University 1st Hospital General Hospital of Daqing Oil field Zhujiang HospitalCapital University Xuanwu Hospital Daping HospitalChinese Medical University 1st Hospital Guangzhou General Hospital Wulumuqi General Hospital Shijiazhuang International Peace Hospital Southwest HospitalSririraj Hospital, Bangkok, Thailand China-Japan Friendship Hospital Medistra Hospital, Jakarta, Indonesia General Hospital of Air Force Chinese Medical University 2nd Hospital Shanxi Armed Police General Hospital Luoyang HospitalKunming General HospitalXian 1st Hospital Wuhan General Hospital 59 centers (56 China, 1 Indonesia, 1 Malaysia & 1 Thailand) Main Study Centers

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

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

Baseline Clinical Characteristics Baseline Clinical Characteristics

Baseline Angiographic Characteristics Baseline Angiographic Characteristics

Procedural Results Procedural Results

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

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

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

Thrombotic Events days 3 thrombotic events developed after discontinuation of clopidogrel

Baseline QCA Results 974 lesions(31.6%) analyzed In-segmentIn-stent Pre-procedure Reference vessel diameter, mm2.77±0.47- Lesion length, mm22.4±13.1- Diameter stenosis, %73.5±15.1- Minimal lumen diameter, mm0.74±0.45- Post-procedure Reference vessel diameter, mm3.19±0.45- Diameter stenosis, %25.0± ±4.7 Minimal lumen diameter, mm2.34± ±0.44 Acute gain, mm1.60± ±0.50

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

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

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

Thank You