CREATE Multi-Center Clinical Registry9-month Angiographic and 12-month Clinical Results

Yaling Han MD, FSCAIOn 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-Multi-CCenter enter RRegistry of egistry of EExcel xcel BiodegrBiodegrAAdable Polymer Drug dable Polymer Drug EluEluTTing Sting StEEntnt

CREATECREATE

StentStentS-stentS-stent

DrugDrugSirolimusSirolimus

(195~376(195~376μμg/stentg/stent))

PolymerPolymerAsymmetric Asymmetric

Biodegradable PLABiodegradable PLA

New Generation DESNew Generation DESFocus on Reducing Late Adverse EventsFocus on Reducing Late Adverse Events

ExcelExcelTM TM stent: biodegradable polymer coated SESstent: biodegradable polymer coated SES

fully degraded within 6 monthsfully 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

objectivesobjectives

Study DesignStudy Design

Prospective, multi-center, post-marketing Prospective, multi-center, post-marketing

surveillance registrysurveillance registry

Unselected “real world” patientsUnselected “real world” patients

6-month dual antiplatelet therapy6-month dual antiplatelet therapy

Anticipated angio f/u rate 35% Anticipated angio f/u rate 35%

Independent CEC and core cath labIndependent CEC and core cath lab

Study OrganizationStudy OrganizationP.I. P.I. Yaling Han,Yaling Han, Shenyang Northern Hospital Shenyang Northern Hospital

Study consultant Study consultant Runlin Gao,Runlin Gao, Beijing Fuwai Hospital Beijing Fuwai Hospital

Angiographic core lab Angiographic core lab Bo Xu,Bo Xu, Beijing Fuwai Hospital Beijing Fuwai Hospital

Clinical events committeeClinical events committee Runlin Gao, Beijing Fuwai HospitalRunlin Gao, Beijing Fuwai Hospital

Jingxuan Guo, 3Jingxuan Guo, 3rdrd affiliated Hospital, Peking University affiliated Hospital, Peking University

Yawei Xu, Shanghai Tenth HospitalYawei Xu, Shanghai Tenth Hospital

Xuchen zhou, 1Xuchen zhou, 1stst affiliated Hospital, Dalian Medical University affiliated Hospital, Dalian Medical University

Sponsored by Sponsored by JWMS Co. Ltd.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 Hospital

General Hospital of PLA Xinqiao Hospital General Hospital of Armed Police

Harerbin Medical University 4th Hospital

Dalian Medical University 2nd Hospital

Affiliated Hospital ofTianjin Armed Police Medical university

Jilin University 2nd Hospital

Liaoning Medical University 1st Hospital

General Hospital of Daqing Oil field

Zhujiang Hospital Capital University Xuanwu Hospital

Daping Hospital Chinese Medical University 1st Hospital

Guangzhou General Hospital

Wulumuqi General Hospital

Shijiazhuang International Peace Hospital

Southwest Hospital Sririraj 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 Hospital Kunming General Hospital

Xian 1st Hospital Wuhan General Hospital

59 centers (56 China, 1 Indonesia, 1 Malaysia & 1 Thailand) 59 centers (56 China, 1 Indonesia, 1 Malaysia & 1 Thailand)

Main Study Main Study CentersCenters

Patients EnrollmentPatients Enrollment

Inclusion CriteriaInclusion Criteria Candidates for coronary stentingCandidates for coronary stenting Treated with Excel stent exclusivelyTreated with Excel stent exclusively Informed consentInformed consent

Exclusion CriteriaExclusion Criteria Hybrid stentingHybrid 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 surgeryPlanned upcoming surgery

Patients Recruitment(2006.6-2006.11)

2077 Pts Enrolled

90 pts Excluded for Hybrid Stenting

Clinical Follow-up Angio Follow-up

6-month ClopidogrelAspirin Indefinitely

30 Days (2077 pts)6 Months (2068 pts)

6-12 Months(653 pts)

12 Months (2063 pts)

Major Adverse Cardiac Events(Cardiac Death, MI, TLR)

Late Lumen LossBinary Restenosis

Thrombotic Events

Study FlowchartStudy Flowchart

Primary End Point: MACE at 12 monthsSecondary End Points: MACE at 1- and 6 months; Late Loss; Binary Restenosis; Thrombotic Events

Baseline Clinical CharacteristicsBaseline Clinical Characteristics

Baseline Angiographic CharacteristicsBaseline Angiographic Characteristics

Procedural ResultsProcedural Results

Follow-up Clinical OutcomesFollow-up Clinical Outcomes(%)

12-month Clinical Follow-up Rate 99.3% 12-month Clinical Follow-up Rate 99.3%

Impact of Off-label Indications Impact of Off-label Indications on 12-month Clinical Outcomes on 12-month Clinical Outcomes (%)

P=0.049

P=0.081

P=1.0

(n=1745)

(n=318)

ST=stent thrombosisST=stent thrombosis

*

*

Dual Antiplatelet Dual Antiplatelet TreatmentTreatment

Cum

ulat

ive

patie

nt n

umbe

rs

1652 pts (80.5%)

Discontinuation of Discontinuation of ClopidogrelClopidogrel

Thrombotic EventsThrombotic Events

days

3 thrombotic events developed after discontinuation of clopidogrel3 thrombotic events developed after discontinuation of clopidogrel

Baseline QCA ResultsBaseline QCA Results974 lesions(31.6%) analyzed

In-segment In-stentPre-procedure Reference vessel diameter, mm 2.77±0.47 - Lesion length, mm 22.4±13.1 - Diameter stenosis, % 73.5±15.1 - Minimal lumen diameter, mm 0.74±0.45 -Post-procedure Reference vessel diameter, mm 3.19±0.45 - Diameter stenosis, % 25.0±9.5 14.3±4.7 Minimal lumen diameter, mm 2.34±0.52 2.74±0.44 Acute gain, mm 1.60±0.55 2.0±0.50

9-month QCA Results9-month QCA Results974 lesions(31.6%) analyzed

9-month QCA Results 9-month QCA Results Subgroup AnalysisSubgroup Analysis

P=0.1 P=0.002 P<0.001 P=0.005 P=0.829 P=0.963

Small Vessel Lesion Long Lesion Diabetes Mellitus

Bina

ry re

sten

osis

(%)

Current data suggests a high degree of safety of the Current data suggests a high degree of safety of the ExcelExcelTMTM biodegradable polymer coated SES, even biodegradable polymer coated SES, even though being used in “real world” settings though being used in “real world” settings

ExcelExcelTMTM stent is effective in reducing restenosis, stent is effective in reducing restenosis, similar to the results from pivotal DES trialssimilar to the results from pivotal DES trials

6-month dual antiplatelet treatment seems safe after 6-month dual antiplatelet treatment seems safe after ExcelExcelTMTM stent implantation stent implantation

Long-term (>1 yr) safety need further investigationLong-term (>1 yr) safety need further investigation

ConclusionsConclusions

Thank Thank YouYou