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stents

CENTROCUORECOLUMBUSCHINA INTERVENTIONAL THERAPEUTICS – CIT 2008Beijing: 19-23 March 2008TCT @ CIT – Part 2 – Critical appraisals,controversies and debatesDedicated bifurcation stentsand two stent approacheswill predominate in the future!Antonio ColomboCentro Cuore Columbus Milan, ItalyS. Raffaele Hospital Milan, ItalySpeaker – 12’


Disclosure Statement of Financial InterestWithin the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) ) listed below.Affiliation/Financial RelationshipCompanyMajor Stock Shareholder/EquityCAPPELLA INC.Co-Founder


In the Spirit of Antonio!


CENTROCUORECOLUMBUSAdvocates for provisional stenting:in a French Registry with 291 pts with left main stenosis whereprovisional side branch stenting was the default technique• Stenting on the side branch was performed in 66% ofpts. with bifurcation lesions• Lesson: Despite an attempt to minimize side branchstenting the implantation of a second stent was themost frequently used approach in bifurcation lesionswhen the side branch was sufficiently important anddiseased at it ostium


CENTROCUORECOLUMBUSThis lesion has a high probability to be treated with 1 stent


CENTROCUORECOLUMBUSCypher 3.5x18mmCypher 3.5x18mm


CENTROCUORECOLUMBUS


CENTROCUORECOLUMBUSIVUS Images Post RotablatorLAD OsCx Os


CENTROCUORECOLUMBUS• Crush technique: 3.0x33 Cypher in Cx and 3.5x18 Cypher inLAD.


Medina Bifurcation Classification0 , 1MB,(Distal),MB(Proximal)SB0 , 10 , 11,1,1 1,1,0 1,0,1 0,1,11,0,0 0,1,0 0,0,1


Medina Bifurcation Classification0 , 1MB,(Distal),MB(Proximal)SB0 , 10 , 117% 9% 18% 13%1,1,1 1,1,0 1,0,1 0,1,117% 14% 12%1,0,0 0,1,0 0,0,1


Medina Bifurcation ClassificationMB,(Distal),MB(Proximal)SB0 , 10 , 160% of bifurcation cases0 , 117% 18% 13%have disease involvementof the sidebranch!1,1,1 1,1,0 1,0,1 0,1,112%1,0,0 0,1,0 0,0,1


CENTROCUORECOLUMBUSSYNTAX ClassificationPlaque Plaque Distribution*Type A Type B Type C Type D Type E Type F Type Gproximaldistal7.1% 17.6% 15.7% 43.0 %7.1% 2.2 %7.3 %True bifurcation lesion* Sianos G, et al. Eurointervention 2005; 1:2


CENTROCUORECOLUMBUSAn important information which is missingin all classifications about bifurcationslesions is the extent of disease on theside branchFocal lesions in the side branch: ProvisionalLong lesions on the side branch: 2 stents


CENTROCUORECOLUMBUSApproach to Bifurcational Lesions including LMThe bifurcation is a True Bifurcation(significant stenosis on the MB and SB)NoYesProvisional SB stentingNoThe SB is suitable for stentingYesStent on MBThe disease on the SB extends formore than 3 mm from the ostium ofthe side branch:NoYesProvisional SB stentingElective implantation of twostents (MB and SB)


CENTROCUORECOLUMBUSBifurcation stenting in any bifurcation(including Left Main)123In Milan Experience use of double stent in distal ULMbifurcation is 55.8%(100/179 Distal LM – 207 pts total)In Multicentric Registry the same use is 49.4%(276/559 Distal LM – 731 pts total)In CACTUS Study, non left main bifurcations, , the useof 2 stents in provisional arm was 31%(173 pts)


CENTROCUORECOLUMBUSAnother example:Provisional could be Ok2 Stents better


CENTROCUORECOLUMBUSMini-Crush Case1BaselineMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Pre-dilatationMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Result after pre-dilatationMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Xience 2.5x18mmPromus 3.0x28mmMini-CrushMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Promus 3.0x28mmStent on LADMin12870


CENTROCUORECOLUMBUSMini-Crush Case1After Stent on LADMin12870


CENTROCUORECOLUMBUSMini-Crush Case12 Quantum3.0 x15 mm 28 AtmKissing BalloonMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Result post KissingMin12870


CENTROCUORECOLUMBUSMini-Crush Case1Promus 2.5x28mmDistal StentFinal ResultMin12870


CENTROCUORECOLUMBUSWhen two stents are implantedan optimal result needs to be verifiedwith IVUS on the main branchand on the side branch


CENTROCUORECOLUMBUSExperience with bifurcation lesions in Milanin different time periodsA more careful technique led to better results !TLR rates have decreased with similar rates of angiographic follow-up


CENTROCUORECOLUMBUSThrombosis in bifurcations


CENTROCUORECOLUMBUSNordic Bifurcation StudyIndividual End Points after 6 months1 Stent 2 Stents PPatients 207 206Cardiac death 2 (1.0) 2 (1.0) 1.00Myocardial infarction 0 (0.0) 1 (0.5) 0.31Stent thrombosis 1 (0.5) 0 (0.0) 0.31Steigen et al Circulation 2006


CENTROCUORECOLUMBUSNordic Bifurcation Study2 Stents Techniques Implemented50%%29%21%CrushCulotteOtherSteigen et al Circulation 2006


CENTROCUORECOLUMBUSWhy have interventionalists quicklyembraced a provisional strategy forbifurcations(including Left Main)123Interventionalist are “lazy” and a provisional strategy iseasier – dont want to spend the time and effort tooptimzie results with a two-stent strategyClinical trials, mostly underpowered and pooorly devised,have not shown a clear advantage for the two-stentstrategyThe techniques for a two stent strategy are toocomplex and dedicated bifurcation stents have been adisappointment thusfar


Dedicated Bifurcation StentsAST petalGuidant frontierYMed sidekickDevax (+ BA9)“true” bifurcationdesignssidebranchdesigns


Dedicated Bifurcation StentsGeneral Categories• Complete bifurcation “Y” stents• Sidebranch access MB stents• Sidebranch stents• Specialty designs (e.g. carina or for LMdisease)


Medtronic Bifurcation StentDual Balloon ConfigurationSide branchballoonMain branchballoon7 Fr. CompatibleMounted on Dual monorail delivery system, singleinflation lumenFIM in CY08


Cappella SideguardOstium Protection DeviceSelf-Expanding, Balloon-Actuated,Anatomically-Shaped Coronary Side Branch StentSelf-ExpandingSB StentAnatomically-ShapedDesignBalloon-ActuatedCatheter SystemFIM Ongoing


Stent DesignTriReme Bifurcation StentDesign Characteristics• Central “custom” cell with crownsextending into sidebranch ostium uponballoon expansion (ostial(coverage andsupport)• Low profile (6-7Fr guide compatible)Delivery System• Rx main branch wire• Custom “nested” side branch wireadvanced thru central cell whenproximal to side branch• Crown markers to assist with axial androtational alignmentFIM Ongoing


Y-Med Side-kickDesign Charactieristics• Low profile system (5 Fr guide compatible)• Steerable fixed wire for main branch• Rx movable wire for sidebranch access• Easily torquable for accurate positioning


Y-Med Side-kickDesign CharacteristicsMid exit portSteerable fixed wire5F GCRX side branch protection wireFIM Completed


Devax AXXESS PLUS Systemfor Bifurcations+AXXESSStentPLUSBiolimus-A9Anti-proliferative&Bioerodable Polymer


The AXXESS PLUS ConceptThe flared shape of the AXXESS PLUS stent matches theflared geometry of a bifurcationThe Axxess Plus stent expands into both the MB and SB,providing complete vessel coverage at the carina2 distal stentmarkers in D11 distal stentmarker in LAD


AXXESS PLUS FIM (outside US)Angiographic FU 124/136 (91.2%)Acute GainAxxess Plus stent only2.05 ± 0.48All stents in PV1.85 ± 0.49Late LossAxxess Plus0.09 ± 0.56All stents in PV0.21 ± 0.44In segment0.26 ± 0.53Binary RestenosisAxxess Plus only4.0%All stents (Axxess+DES)5.6%In segment10.5%


DIVERGE: : a Prospective, Single-arm,Multi-center RegistryDrug Stent Intervention for TreatinTeating Side BranchesEffectivelyPatients with de novo bifurcated lesions in nativecoronary arteries N=300PCI using Axxess stent SystemAngio F/U at 9 mo in 300 ptsAnnual clinical F/U for 5 yearsPRIMARY Endpoint: 9-mo MACE: death, MI, iTLRSECONDARY Endpoints: device success, binary restenosis, late loss


CENTROCUORECOLUMBUSConclusions• LM bifurcation vs. other bifurcations• Consider the importance of the SB: notevery SB needs treatment and not everySB needs optimal result• If you need 2 stents, elective isbetter than provisional and patientswill have good outcomes provided anoptimal result has been achieved


CENTROCUORECOLUMBUSApproach to Bifurcational Lesions including LMThe bifurcation is a True Bifurcation(significant stenosis on the MB and SB)NoYesProvisional SB stentingIn the Future,The SB is suitable for stentingElective No Two StentsYesStent on MBNoOrThe disease on the SB extends formore than 3 mm from the ostium ofthe side branch:Dedicated BifurcationStents in Most PatientsYesProvisional SB stentingElective implantation of twostents (MB and SB)

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