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Martin B. Leon, MD for the T ryton Bif u rcati o n T rial I n vestig a tors

The T ryton Bifurcation T ria l : A ra n domi z ed co mp a ri s on of a p r o visi o n a l one - s t e n t v s. a d e d ic at e d t w o - s t e n t stra te g y for tru e bifurc at i on c o r o n a r y l es i o ns. Martin B. Leon, MD for the T ryton Bif u rcati o n T rial I n vestig a tors

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Martin B. Leon, MD for the T ryton Bif u rcati o n T rial I n vestig a tors

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  1. TheTrytonBifurcationTrial: Arandomizedcomparisonofaprovisional one-stent vs. a dedicated two-stent strategy fortrue bifurcationcoronarylesions MartinB.Leon,MD fortheTrytonBifurcationTrialInvestigators ColumbiaUniversityMedicalCenter CardiovascularResearchFoundation NewYorkCity Wednesday,October 30,2013

  2. DisclosureStatementofFinancialInterest TCT25: SanFrancisco,CA;Oct27-Nov1,2013 MartinB.Leon,MD Withinthepast12months,Iormyspouse/partnerhavehada financial interest/arrangementoraffiliationwiththeorganization(s)listedbelow. Affiliation/FinancialRelationship Company • Abbott,BostonScientific,Medtronic • ResearchSupport(CUMC) • ConsultingFees/Honoraria • None • MajorStockShareholder/Equity • None

  3. PurposeoftheStudy • Tocomparetheclinical outcomesand angiographicresultsoftheaccepted provisionalone-stentstrategyvs. the Trytonbifurcationtwo-stentapproachina randomizedcontrolledtrialoftrue coronarybifurcationlesions.

  4. TrytonSideBranchStent 8 mm 4.5mm 6.5mm MainBranchZone TransitionZone SideBranchZone TrytonisaCobaltalloybaremetalstent

  5. Stentlength 19mm (18mm*) rger-Stent diametersites 3.0•3.Snvnand3.S•4.0mm. MainBranchDiameter(mm) 2.5 3.0 3.5 SideBranchDiameter(mm) 2.5 2.5 2.5 3.5 3.0 RecentlyAdded 4.0 3.5

  6. TrytonDeploymentSequence Trytonpositioned anddeployedafter pre-dilatation (securesandprotects sidebranch) Mainvesseltreated withapprovedDES throughmain vessel portionofTryton Kissingballoon post-dilatationtoinsure completelesion& ostiumcoverage

  7. TrytonStudyDesign BaselineAngiography –EligibleforRandomization    Trytonsidebranch+ DES (main vessel)  ClinicalF/U at9months  AngiographicF/U at 9months  IVUSF/U at9months DES (main vessel) + Provisionalsidebranch  ClinicalF/U at9months  AngiographicF/U at 9months  IVUSF/U at9months N = 704 TVF PrimaryEndpoint %DS side branch n~374 IVUSCohort n~96

  8. InclusionCriteria • Singledenovo“true”bifurcationlesionina native coronaryarteryinvolvingboththemainvesselandthe sidebranch(Medinaclassification1.1.1,1.0.1,or 0.1.1 byvisualassessment) • Symptomsor objectiveevidenceofischemia • Vessel diameter:mainvessel≥2.5mmand≤4.0mm; sidebranch≥2.5mmand≤3.5mm • Lesionlength:mainvessel≤28mm; sidebranch≤5 mm • Limitedtreatmentofmulti-vesseldiseaseandstaging, per protocol(aftersuccessfultreatmentof≤2 non- complex,non-targetlesions)

  9. KeyExclusionCriteria • Clinical… • STEMI<72 hoursorSTEMI/non-STEMI> 72 hoursand • increasedCK-MB • Hemodynamicinstability • Creatinine>2.5mg/dLor dialysis • Bleedingdiathesisor hypersensitivitytoanticoagulantmeds • LVEF<30% • Anatomic… • Left maindisease (unprotectedor protected) • Trifurcationlesion • Complexmorphology:severeCa++,thrombus,TIMI0/1flow, severetortuosity

  10. PrimaryandSecondary Endpoints • Studydesign:Intention-to-treat(ITT)isprimary analysiscohort,1:1randomization • PrimaryEndpoint:Targetvesselfailure • @9 monthsfollow-up(allpatients):non-inferiority • cardiacdeath • targetvesselMI(peri-procedural>3XCK-MB) • targetvesselrevascularization(ischemia-driven, • mainvesselor sidebranch) • SecondaryEndpoint:% diameterstenosis (in-segment)ofsidebranchat9 months • follow-up(angiographiccohortonly):superiority

  11. OperatorTechniqueRecommendations • Tryton • Pre-dilation(optimallesionpreparation) • TrytonplacementfollowedbyPOT(atostium) • DESplacementfollowedbyfinalkissingballoon dilation(withNCballoons) • Provisional • Standardoperatortechniquefor pre-dilationandDES placement • Sidebranchintervention(balloonsor stents)onlyif… • < TIMI3 flow,≥typeBdissection,or >80%stenosis • Finalkissingballoondilation(withNCballoons)

  12. TrialAdministration DataSafetyMonitoringBoard Chairman:RobertS.SafianMD BeaumontHealthSystem Clinical EventsCommittee DonaldE. CutlipMD Harvard ClinicalResearchInstitute AngiographicCoreLab PhilippeGénéreuxMD CardiovascularResearchFoundation IVUS& 3DAngiographicCoreLab HectorGarcia-GarciaMD,PhD Cardialysis,Rotterdam, TheNetherlands Sponsor AaronV. KaplanMD, LinnLaak TrytonMedical,Inc. PrincipalInvestigator MartinB. LeonMD ColumbiaUniversityMedicalCenter StudyChairman PatrickW.SerruysMD,PhD ErasmusMC,Rotterdam ImperialCollege,London ExecutiveCommittee AntonioBartorelliMD,ThierryLefèvreMD PieterStellaMDPhD, WilliamFearonMD JamesHermillerMD,Dean KereiakesMD DavidWilliamsMD DataManagementand Biostatistics DonaldE. CutlipMD Harvard ClinicalResearchInstitute

  13. EnrollmentCadence 23monthstocompleteenrollment 207 Enrollment:28U.S.sites(32%) 30non-U.S.sites(68%) 2011 2012 OCT

  14. EnrollmentbySite

  15. EnrollmentbySite

  16. PatientFlow Randomized N=704 Tryton+ DES N=355 Provisional+ DES N=349 9 MonthFollow-up N=681 Tryton= 345 Provisional= 336 Tryton 4=LosttoF/U 2=Patientwithdrawal 4= Death Provisional 6=LosttoF/U 5=Patientwithdrawal 4= Death Angiographic N=326 Tryton=158 Provisional=168 IVUS N=94 Tryton=59 Provisional=35 • ClinicalFUat9months=97% • AngiographicFU at9 months=87%

  17. PatientDemographics

  18. PatientDemographics

  19. MainVesselCharacteristics

  20. SideBranchCharacteristics

  21. MedinaClassification(SiteReported) “True” Bifurcation T:14.6% P: 18.7% T:73.2% P: 68.7% T:11.5% P: 12.4% T:99.3% P:99.8% T:0% P: 0% T:0% P: 0% T:0.3% P: 0% T:0.3% P: 0.3% P= Provisional T =Tryton

  22. MedinaClassification(Core Lab) “True” Bifurcation T:24.9% P: 28.1% T:49.2% P:42.1% T:15.8% P:16.0% T:89.9% P:86.2% T:1.4% P: 2.6% T:2.3% P: 4.9% T:3.4% P:2.3% T:2.8% P: 4.0% P= Provisional T =Tryton

  23. ProceduralDetails Provisional (N=349 Patients) Tryton (N=355 Patients) Non-targetlesionstreated(%) Non-balloonlesionpreparation(%) Trytonstentimplanted(%) 16.9 1.4 0.6 12.1 1.7 96.1 SideBranch Pre-dilation(%) Maximumballoondiameter(mm) Maximumballoonpressure(atm) 60.8 2.4±0.39 10.4±3.62 95.8 2.6±0.37 10.8±4.10 MainVessel Pre-dilation(%) Maximumballoondiameter(mm) Maximumballoonpressure(atm) 79.8 3.1±0.42 11.3±3.90 89.2 3.1±0.41 11.2±4.20 Final“kissingballoon”dilation(%) 86.2 85.1

  24. AdditionalSide BranchStents (SiteReported) Provisional(n= 349) Tryton(n=355)

  25. AdditionalSideBranchStents Indications(site-reported) units 9 8 7 6 5 4 3 2 1 0 Provisional Tryton 8.0 4.0 2.8 2.6 2.3 1.7 1.4 0 SBStent Dissection >B TIMI<3 Stenosis≥80%

  26. TrytonBifurcationStudy MainStudy Results

  27. TargetVesselFailure(TVF)* PrimaryEndpoint % Provisional 30 Tryton 25 P=0.108 20 17.4 15 12.8 10 5 0 *TVF=Cardiacdeath,TV–MIandTVR

  28. PrimaryEndpoint TargetVesselFailureat 9 Months Tryton (N=355) Provisional (N=349) Non- inferiority P value = 0.4167 17.4% 12.8% Zoneof non-inferioritypre-specified margin= 5.5% Non-inferior 0 1.0 2.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0% 11.0 3.0 PrimaryNon-InferiorityEndpointNot Met

  29. TargetVesselFailure(TVF) PrimaryEndpoint % 20 18 16 14 12 10 8 6 4 2 0 Provisional P=0.108 Tryton P=0.109 17.4 15.1 12.8 10.7 P=0.564 4.7 3.6 0 0 CardiacDeath TVF Target VesselMI ClinicallyDriven TVR Non Hierarchical

  30. StentThrombosis(ARC) 9-monthFollow-up Overall= 0.4%

  31. AngiographicResults(QCA) Follow-up(9 months)

  32. SideBranch%DS(In-segment) SecondaryEndpoint % Provisional 60 Tryton 50 P=0.002 40 38.6 30 31.6 20 10 0 SecondarySuperiorityEndpointMet

  33. SideBranch% DS(In-segment) Baseline 100% ProvisionalTryton 80% 60% 40% 20% 0 PercentofPatients 100 80 40 60 % DiameterStenosis 20 0

  34. SideBranch% DS(In-segment) Final 100% ProvisionalTryton 80% 60% 40% 20% 0 PercentofPatients 100 80 40 60 % DiameterStenosis 20 0

  35. SideBranch% DS(In-segment) 9-MonthFU 100% ProvisionalTryton 80% 60% 40% 20% 0 PercentofPatients 100 80 40 60 % DiameterStenosis 20 0

  36. AngiographicResults BinaryRestenosis(9months)

  37. Restenosis Location(QCA) Provisional Proximal 9 (5.4%) Restenosis@SBostium:75%Provisional 62%Tryton Tryton Proximal 10 (6.3%)

  38. TrytonBifurcationStudy Post-hocSubset Analyses

  39. Target Vessel-MI 3X,5X,10XCK-MBOnly Criteria % 20 18 16 14 12 10 8 6 4 2 0 Provisional Tryton P=0.162 9.6 P=0.256 6.6 5.2 P=0.123 0.3 1.7 3.3 3X 5X 10X

  40. OcculostenoticParadox Restenosis vs. TLR % 50 45 40 35 30 25 20 15 10 5 0 (SideBranch) 24.5 91.5% 2.2 Combined Tryton Provisional

  41. TargetVesselFailure(TVF) SideBranch≥ 2.25 mm Diff(95%CI)= -4.3%(-12.2,3.7%) % 18 16 14 12 10 8 6 4 2 0 Provisional P=0.383 Tryton 15.6 P=0.563 12.1 11.3 9.2 P=0.769 4.3 3.5 0 0 CardiacDeath TVF Target VesselMI ClinicallyDriven TVR Non Hierarchical Provisional(N=141) Tryton(N=141)

  42. AngiographicOutcomes(QCA) SideBranch≥ 2.25 mm % 50 45 40 35 30 25 20 15 10 5 0 Provisional Tryton P=0.260 32.1 22.2 P=0.004 40.6 30.4 SBIn-segment% DS Binary Restenosis Provisional(N=81) Tryton(N=63)

  43. Conclusions • TheTrytontwo-stentstrategy in truebifurcations (88%) comparedwiththeprovisionalstrategy (8.0% sidebranchstents)did notmeetthenon-inferiority clinicalendpoint(TVF),due toa relativelyhigher frequencyofsmallperi-proceduralCK-MBelevations. • However,bothstrategies were safe(rare clinically significantMIsandstentthrombosis)andboth hadlow 9-monthclinically-drivenTVR(P:3.6%,T:4.7%). • DES in themainvesselperformedwellinbotharms. • Trytonimprovedsidebranch%diameterstenosisat FU(secondaryendpoint;P=0.002)

  44. Conclusions • Post-hocsubsetanalysesindicated: • Astrikingdisparitybetweenbinaryrestenosisand clinically-drivenTVRforbotharms,indicatingthat sidebranchangiographicrestenosisis uncommonly expressedclinically. • Improvedclinicaland angiographicoutcomeswith Trytonin larger sidebranches(>2.25 mmside branches=41%ofenrolledpatients).

  45. ClinicalImplications • It’s difficult toenrollcomplex“high-risk”bifurcation • lesionsinclinicaltrials(only41% hadsidebranches • ≥ 2.25mm). • Smallperi-proceduralCK-MBelevations occurmore frequentlywithatwo-stentstrategyanddominatethe clinicalendpoint(TVF). • Moderate stenosesin smallersidebranchesare not clinicallyactive(occulostenoticparadox). • Inlargerside branches(≥2.25mm),a Tryton two-stentstrategy improved sidebranch angiographicresultsandclinicaloutcomes.

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