1、Chronic Total Occlusion(CTO)Case Presentation:Key Concepts and Techniques Takatoshi Hayashi MD Himeji Cardiovascular Center, Japan2008.4.12 GuangzhouRole of DES for CTO angioplaty Improve the prognosis?Recent concepts and techniques Can we treat a patient smartly?CTO angioplastyRole of DES for CTO a

2、ngioplatyCTO angioplasty in DES eraBMSDES(SES)SICCOGISSOCSTOPTOSCANakamura Hoye 0605040103020(%)Re-occlusionRestenosis24%47%34%32%20%12%8%8%8%3%6%Nakamura2%Ge 3%9%9%SES for CTO lesions:CTO vs Non-CTOCypher Post Marketing Study(PMS) in JapanStudy Design (Cypher PMS in Japan) BackgroundPost market eva

3、luation to fulfill a Regulatory Approval Condition PurposeTo 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 =1,000patients) No of Sites 50 sites (

4、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,3,8 months and 1,2,3,4,5 years cli

5、nical follow-up data：Angiographic follow-up is mandated at 8 months（Analysis:Core lab)Enrollment Period 1st Year: 9/1/043/31/05 2nd Year: 4/1/059/30/05Intent-to-treatActual Enrollment8M Angiographic F/U12M Clinical F/U2,054 cases2,051 cases1,752 cases1,857 casesFollow up Rate： 85.490.5Delivery Succe

6、ss Rate: 99.8%Study Profile of Cypher PMS in JapanCTONon-CTOP ValueNo of patients991,758MACE5 (5.1)137 (7.8)0.421 Death1 (1.0)47 (2.7)0.491 MI0 (0.0)24 (1.4)0.476 Emergent CABG0 (0.0)3 (0.2)0.382 TLR by patient4 (4.0)76 (4.3)0.905Stent Thrombosis* Definite+Probable0 (0.00)8* (0.46)0.908MACE to 12 Mo

7、nths Follow-upValues are n (%).*:Based on ARC Definition*:Excluding 1 case with procedure failure （MI occurred during PCI procedure）SES for CTO lesions:BMS vs SESHimeji CVCExperienceCTO angioplasty:BMS vs SESBMS group : 103 pts, 105 lesionsSES group : 78 pts, 80 lesionsClinical follow-up: 12MoConsec

8、utive 181 patients with 185 lesionsBMSgroupSESgroupSES available(2004.8-)(Himeji CVC)Recent concepts and techniquesfor CTO angioplasty 65 y.o M EAP DM, HT Retry Case (unsuccessful； 3 month before) Case A PCI Case of LAD-CTO, treated in a certain country in East-South Asia with arguingwith a doctor i

9、n charge.Control angiography AP-CranialRAOT.H 65 y.o M EAP LAD-CTOControl angiography Spider viewT.H 65 y.o M EAP LAD-CTOWiring at LADT.H 65 y.o M EAP LAD-CTORe-wiring and dilation with a 2.5mmballoon by the physicianT.H 65 y.o M EAP LAD-CTOChange theOperatorT.H 65 y.o M EAP LAD-CTORe-wiringParallel

10、 wire techniqueGuidewire: Conquest, FielderT.H 65 y.o M EAP LAD-CTORecent advance in CTO angioplasty: Procedural view Guidewire handling: Parallel guidewire technique Retrograde approach (selected case) IVUS-guided (if possible)Visualization of coronary vessels before PCI MDCTAnchor balloon techniqu

11、e:Back-up forceGuidewires for CTO lesionK.S 64 y.o M EAPRCALADCxLADCxMDCT(64):CoronaryarteryK.S 64 y.o M EAPPre PCIPre PCIPost PCI (SES implanted)K.S 64 y.o M EAP The stiffness of a guide wire : expressed as the resistance of the tip to bending (1cm from tip) against force (g)(measured by Asahi Inte

12、cc.Co)Guide wireA guide wire is insertedin a tube and its tip is advanced toward an electronic scale.The reading on the electronic scale increases when the guide wire is pressed against the sale.The reading increases more when the guide wire is advanced further. The reading decreasesWhen the guide w

13、ireis advanced much further(0.3g)(0.5g)(0.7g)(0.0g)10mmComparison of Tip Stiffness(Guidewire) （）First WireSecond WireParallel Guidewire Techniquemodified; Tamai, 2007LAD: Cranial viewLAD: RAO viewFirst WireSecond WireSecond Wire: position ASecond Wire: position BSecond Wire: position BSecond Wire: p

14、osition ADistal fibrous capFirst WireSecond WireSub-intimal spaceSub-intimal spaceParallel Guidewire Techniquemodified; Tsuchikane et al, 2007Second wire: stiff, tapered wireSeptal Br.Diagnal Br.Septal Br.Diagnal Br.Parallel guidewire technique:AdvantageAvoid 2nd guidewire advance into the sub-intim

15、al space made by 1st guidewireAvoid more dilation of sub-intimal spacemade by 1st guidewireLandmark for guidewire handlingLess use of contrast agentChange the geometry of lesions or vesselO.T 64 y.o EAPControl angiography: Cx CTOO.T 64 y.o EAPPCI: Cx CTOO.T 64 y.o EAPIVUS after first wiringO.T 64 y.

16、o EAPIVUS guided wiringGuidewire: Conquest proIVUS cathetherO.T 64 y.o EAPAfter re-wiringRAO viewGuiding cathether:Brite tip 7F JL4 (Cordis- Miami US; Rt. transfemoral)Contralateral angiography:HT-HAYASHI 5F (L-R)(Goodtec; Lt. transradial)Retrograde approach : LAD ostial CTOLADLCxLMTGuidewiresMiracl

17、e primo(2.5g), Conquest （Confianza) Pro (9g；) :Asahi Intecc, Proneur ST(9g):Zeon could not be placed the entry of CTO lesion with IVUS guidance. Retrograde approachS.K 67 y.o EAPIVUSGuidewire:GW at high lateral branchLAD ostialLCxDistal tip of the wire support catheterSeptal vesselsGuidewire (GW) at

18、 LAD Runthrough NS (floppy)Retrograde WiringGuiding cathether: XB RCA 6F(Lt. Transradial:Cordis)Guidewire: Runthrough NS floppy (1：Terumo) - Hydrophilic wireWire support cathether - RapidTransit (Cordis) 150cmS.K 67 y.o EAPPOBA and StentingAfter ballooning (1.5mm:Ryujin Plus;Terumo, 1.25mm, 2.5mm :V

19、ENT speeder; INVATec), two long (3.0mm*33mm) Sirolimus eluting stents (Cypher; Cordis) were implanted.Final angiography(Post SES stenting)S.K 67 y.o EAPCTO : Strategy of procedureAntegrade approachRetrogrde approachFirst guidewireSecond guidewirePararell wire techniqueSuccessSee-Saw wiringIVUS-guide

20、d wiringRetry caseWell collateral flowConclusions Now, CTO angioplasty is still challenging, recent development of technology and efforts for CTO angioplasty may lead it a front-line therapy. Drug eluting stent and some proceduraltechniques may improve the prognosis of patients with CTO lesions. A l

21、ot of RCTs data have shown the good safety and efficacy of Sirolimus-Eluting StentCardiacDeathNon-CardiacDeathQ-MINon-Q-MITLRMACE2068410%1.50.61.52.90.80.70.80.80.60.82.30.75.34.93.19.58.35.8Japan PMS（Post Marketing Study)SIRIUSe-CypherClinical follow-up to 1 year (12 months)In daily practice, more

22、than 20% of treatments are complex lesions like in stent restenosis, etc.TLR%PValueOddsRatioNYDialysis3.715.20.0010.215RVD 3.5mm2.25.20.0010.414Mod/Sev Calcification3.36.930mm3.36.90.0010.463Diabetes3.35.70.0120.563In Stent Restenosis3.45.60.0280.596Multi- vessel disease3.55.40.0430.631Prior to PCI3

23、.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 MI4.54.10.7021.095TLRPredictors：Japan PMS(1 year)Purpose We evaluated the clinical results of complex lesions after Cypher Sirolimus-eluting stent implantatio

24、n as sub-analysis of Cypher Post Marketing Study (PMS) Interim data to 1 year.A Fight with CADStudy Design (Cypher PMS in Japan) BackgroundPost market evaluation to fulfill a Regulatory Approval Condition PurposeTo evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in ro

25、utine daily practice in the Japanese population Target Enrollment 2,000 patients (1st year=1,000 patients, 2nd year =1,000patients) No of Sites 50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals) Method Prospective Non-randomized Regi

26、stry Inclusion CriteriaConsecutive patients treated with the Cypher stent (including off label use) Follow-up In-Hospital,3,8 months and 1,2,3,4,5 years clinical follow-up dataAngiographic follow-up is mandated at 8 months（Analysis:Core lab)PMS siteHokuto Cardiovascular HospitalSunagawa City Hospita

27、lIwate Prefectural Central Hospital South Miyagi Medical CenterKatta Hospital Hoshi General HospitalOhra Nishinouchi HospitalNiigata City General HospitalTsukuba Medical Center HospitalSaiseikai Kurihashi HospitalKimitsu Central HospitalShowa University HospitalTeikyo University HospitalMitsui Memor

28、ial HospitalInternational Medical 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 Hospital Toyohashi Heart Center Shizuoka City Shizuoka HospitalAichi