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1、Himeji Cardiovascular CenterHimeji Cardiovascular CenterChronic Total Occlusion(CTO) Case Presentation: Key Concepts and TechniquesTakatoshi Hayashi MD Himeji Cardiovascular Center, Japan2008.4.12 GuangzhouHimeji Cardiovascular CenterHimeji Cardiovascular CenterRole of DES for CTO angioplatyImprove
2、the prognosis?Recent concepts and techniquesCan we treat a patient smartly?CTO angioplastyHimeji Cardiovascular CenterHimeji Cardiovascular CenterRole of DES for CTO angioplatyHimeji Cardiovascular CenterHimeji Cardiovascular CenterCTO angioplasty in DES eraBMSDES(SES)SICCOGISSOCSTOPTOSCANakamuraHoy
3、e0605040103020(%)Re-occlusionRestenosis24%47%34% 32%20%12%8%8%8%3%6%Nakamura2%Ge3%9%9%Himeji Cardiovascular CenterHimeji Cardiovascular CenterSES for CTO lesions:CTO vs Non-CTO Cypher Post Marketing Study (PMS) in JapanHimeji Cardiovascular CenterHimeji Cardiovascular CenterStudy Design (Cypher PMS
4、in Japan) BackgroundPost market evaluation to fulfill a Regulatory Approval Condition Purpose To evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in routine daily practice in the Japanese population Target Enrollment 2,000 patients (1st year=1,000 patients, 2nd year =1
5、,000patients) No of Sites50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals) Method Prospective Non-randomized Registry Inclusion CriteriaConsecutive patients treated with the Cypher stent(including off abel use) Follow-up In-Hospital
6、,3,8 months and 1,2,3,4,5 years clinical follow-up data ：Angiographic follow-up is mandated at 8 months（Analysis:Core lab)Himeji Cardiovascular CenterHimeji Cardiovascular CenterEnrollment Period1st Year: 9/1/043/31/052nd Year: 4/1/059/30/05Intent-to- treatActual Enrollment8M Angiographic F/U12M Cli
7、nical F/U2,054 cases2,051 cases1,752 cases1,857 casesFollow up Rate：85.490.5Delivery Success Rate: 99.8%Study Profile of Cypher PMS in JapanHimeji Cardiovascular CenterHimeji Cardiovascular CenterCTONon-CTOP Value No of lesions109(105pts)2,350(1946pts) RVD, mm 2.280.702.570.6012Mo Consecutive 181 pa
8、tients with 185 lesionsBMS groupSES groupSES available(2004.8-)(Himeji CVC)Himeji Cardiovascular CenterHimeji Cardiovascular CenterCTO angioplasty: BMS vs SES Angiographic results (6Mo-)9.3%BMS (n=74) (Angio F/U 72%)Re-occlusionRestenosis37.8% * :P3.5mm2.25.230mm3.36.90.0010.463Diabetes3.35.70.0120.
9、563In Stent Restenosis3.45.60.0280.596Multi- vessel disease3.55.40.0430.631Prior to PCI3.35.10.0520.625Bifurcation3.45.00.0600.661ACC/AHA Type B2C2.44.30.0710.545Multi- lesion Treatment 4.25.80.3170.707LAD4.33.50.3811.213Prior to MI4.54.10.7021.095TLR Predictors： Japan PMS (1 year)Himeji Cardiovascu
10、lar CenterHimeji Cardiovascular CenterPurposeWe evaluated the clinical results of complex lesions after Cypher Sirolimus-eluting stent implantation as sub-analysis of Cypher Post Marketing Study (PMS) Interim data to 1 year.A Fight with CADA Fight with CADHimeji Cardiovascular CenterHimeji Cardiovas
11、cular CenterStudy Design (Cypher PMS in Japan)BackgroundPost market evaluation to fulfill a Regulatory Approval Condition Purpose To evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in routine daily practice in the Japanese populationTarget Enrollment 2,000 patients (1
12、st year=1,000 patients, 2nd year =1,000patients)No of Sites50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals)MethodProspective Non-randomized RegistryInclusion CriteriaConsecutive patients treated with the Cypher stent (including off
13、 label use)Follow-up In-Hospital,3,8 months and 1,2,3,4,5 years clinical follow-up data Angiographic follow-up is mandated at 8 months（Analysis:Core lab)Himeji Cardiovascular CenterHimeji Cardiovascular CenterPMS siteHokuto Cardiovascular HospitalSunagawa City HospitalIwate Prefectural Central Hospi
14、tal South Miyagi Medical CenterKatta Hospital Hoshi General HospitalOhra Nishinouchi HospitalNiigata City General HospitalTsukuba Medical Center HospitalSaiseikai Kurihashi HospitalKimitsu Central HospitalShowa University HospitalTeikyo University HospitalMitsui Memorial HospitalInternational Medica
15、l Center of JapanToranomon HospitalItabashi chuo Medical CenterToho University Ohashi Medical CenterSakakibara Heart InstituteMetropolitan Bokutou HospitalShonan Kamakura General HospitalTokai University Hospital Yokohama Sakae Kyosai HospitalKanagawa Cardiovascular and Respiratory CenterComfort Hos
16、pital Toyohashi Heart Center Shizuoka City Shizuoka HospitalAichi Medical UniversityAnjo Kosei Hospital Nagoya Diini Red Cross HospitalShiga Medical Center for AdultsKyoto-Katura HospitalKyoto Second Red Cross HospitalKyoto Universtiy HospitalOtowa HospitalNational Cardiocascular CenterRinku General Medical CenterOsaka Red Cross HospitalOsaka City University HospitalKansai Rosai HospitalHimeji Cardiovascu
