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PredictingSuccessfulGuideWireCrossing
ThroughChronicTotalOcclusionofNativeCoronaryLesionswithin30Minutes:theJ-CTOScoreasaDifficultyGradingandTimeAssessmentToolYoshihiroMorino,MD,MitsuruAbe,MD,TakeshiMorimoto,MD,TakeshiKimura,MD,YasuhikoHayashi,MD,ToshiyaMuramatsu,MD,MasahikoOchiai,MD,YuichiNoguchi,MD,KenichiKato,MD,YoshisatoShibata,MD,YoshikazuHiasa,MD,OsamuDoi,MD,TakehiroYamashita,MD,TomoakiHinohara,MD,HiroyukiTanaka,MD,KazuakiMitsudo,MD,FortheJ-CTORegistryInvestigatorsDisclosureThereisnothingtodiscloseforalltheauthors.BackgroundCurrently,thereisagreatdealofinterestinpercutaneouscoronaryintervention(PCI)fortreatingchronictotalocclusion(CTO),primarilyduetothemarkedimprovementsobservedintheacuteandlong-termresultsnowachievable.However,ahighproportionofpatientswithCTOsarestillbeing
managedmedicallyorreferredforcoronaryarterybypassgrafting(CABG)ratherthanPCI,becauseofuncertaintyofsuccessoftheprocedure,difficultiesinselectingsuitablecases,andits“time-consuming”nature.PurposeToestablishamodelforgradinglesiondifficultyininterventionalCTOtreatmentMethodsPopulationsThestudypopulationconsistedofconsecutive494nativecoronaryCTOlesionsin465patientsenrolledintheJapanesemulticenterCTOregistry(theJ-CTOregistry,MorinoY,etalJAmCollCardiolIntv2010;3:143-51).“SuccessfulGWcrossingwithin30minutes”1.Whycommonly-used“finalproceduralsuccess”wasnotused?Becauseitmightbesignificantlyinfluencedbyuncountablefactorslikeoperator’sskill,experience,judgment,effort,andperseverance,whichshouldbeminimizedinordertoinvestigatethelevelofdifficultyintrinsictotreatingthelesions.TheSetEndpointtoDetermineLesionDifficulty2.Why30minuteswereusedasthecut-off?Becausemanipulationwithin30minutes,thatwasthemedianofGWtimeinthistrial,maybeacceptableforthemajorityofoperatorsandpatientsfromtheclinicalandpracticalstandpoints.Step1: SelectionofpatientandoptimalangiographicvariablesStep2: Allobservationswererandomlyassignedtothederivationsetor thevalidationsetataratioof2:1.Step3: TheunivariaterelationshipsbetweensuccessfulGWcrossing within30minutesandcategoricalvariablesinthederivationset wereevaluated.Step4: Wethereafterincludedselectedvariablessimultaneouslyina multivariablemodel.Step5: Theresultsofthemultivariateanalysiswerethenusedtodevelop aclinicalpredictionmodelStep6: Thediscriminatoryperformanceofthemodelwasvalidatedby comparingthereceiver-operatingcharacteristics(ROC)curve analysisofthederivationsetwiththatofthevalidationset.StepsofDevelopingaPredictionRuleforDifficultyGradingResultsPatientandLesionCharacteristicsintheDerivationandValidationSets
DerivationSet(n=329)ValidationSet(n=165)PValueAge≥75MalePriorPCIPriorCABGEjectionfraction≤40%HeartfailurePriormyocardialinfarctionMulti-vesseldiseaseStrokeHemodialysisHypertensionDyslipidemiaCurrentsmokerDiabetesInsulintreatedFamilyhistoryofIHDTargetlesionLCxLADLMCARCAPreviouslyfailedlesionOstiallocationSidebranchesBluntstumptypeatentryCalcificationBridgecollateralBendingOcclusionlength≥20mmRetrogradecollateral(≥grade3)SuccessfulGWcrossingin30minutes26.4%79.9%42.9%8.5%14.0%12.5%45.9%65.1%12.2%4.3%73.9%52.0%18.8%41.3%11.6%13.1%
20.7%37.1%0.3%42.0%11.6%10.6%82.4%40.4%54.7%23.4%43.5%13.0+-12.321.9%84.2%48.6%27.3%84.9%44.2%12.1%14.6%17.0%43.6%69.1%11.5%4.9%75.8%57.6%23.6%44.9%13.9%10.9%
17.0%34.6%1.2%47.3%9.1%12.1%76.4%36.4%61.2%23.6%48.5%13.1+-13.720.0%87.9%47.3%0.70.80.20.80.90.20.60.40.80.80.60.20.20.50.50.50.4
0.40.60.10.40.21.00.30.90.60.30.8UnivariateCorrelatesofSuccessfulGWCrossing<30MinutesintheDerivationSet
Success(n=160)Unsuccess(n=169)PValueAge≥75MalePriorPCIPriorCABGEF≤40%HeartfailurePriormyocardialinfarctionMulti-vesseldiseaseStrokeHemodialysisHypertensionDyslipidemiaCurrentsmokerDiabetesInsulintreatedFamilyhistoryofIHDTargetlesionLCxLADLMCARCAPreviouslyfailedlesionOstiallocationSidebranchesBluntstumptypeatentryCalcificationBridgecollateralBending>45degreeOcclusionlength≥20mmRetrogradecollateral(≥grade3)30.0%75.6%38.8%4.4%11.3%11.9%42.5%62.5%12.5%1.9%70.0%51.3%16.9%42.5%13.8%13.8%
21.9%40.6%0.0%37.5%5.6%10.6%79.4%28.1%35.0%21.3%23.8%8.8%90.0%23.1%84.0%46.8%12.4%16.6%13.0%49.1%67.5%11.8%6.5%77.5%52.7%20.7%40.2%9.5%12.4%
19.5%33.7%0.6%46.2%17.2%10.7%85.2%52.1%73.4%25.4%62.1%34.3%78.7%0.20.0570.10.0070.20.80.20.30.90.030.10.80.40.70.20.70.3
0.00081.00.2<0.0001<0.00010.4<0.0001<0.00010.005DifficultyscoreforCTOlesions(J-CTOScore):5selectedindependentpredictorsidentifiedbytheforward/backwardprocedureVariablesOddsRatio(95%CI)Beta-coefficientPointPreviouslyfailedlesion0.39(0.15to0.97)0.931Bending>45degree0.34(0.20to0.58)1.091Bluntstumptype0.32(0.18to0.55)1.141Calcification0.26(0.15to0.44)1.361Occlusionlength≥200.19(0.09to0.39)1.651J-CTOScore=Σeachpoint4RiskGroupsofModelbyJ-CTOScoreandGWSuccess<30Minutes6592908226464548Patientnumber329165GWsuccess<30minutes,%derivationvalidationEasyIntermediateDifficultVerydifficult
Riskgroups:012>=3J-CTOscore:010203040506070809010087.792.367.158.342.434.810.022.2ROCCurvesforProbabilityofGWSuccess<30MinutesFalsepositiverate0.000.100.200.300.400.500.600.700.800.901.000.000.200.400.600.801.00TruepositiveratederivationvalidationAUC0.82AUC0.7691138135130PatientnumberEasyIntermediateDifficultVerydifficult
Riskgroups:012>=3J-CTOscore:4941020304050607080901
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