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term outcomes following drug-eluting stent implantation in unprotected left main bifurcation lesions

By Joanne Berry,2014-08-05 21:36
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term outcomes following drug-eluting stent implantation in unprotected left main bifurcation lesionsin,term,stent,left,drug

    term outcomes following drug-eluting stent

    implantation in unprotected left main

    bifurcation lesions

    ChineseMedicalJournal2007;1207):545-551545

    Originalarticle

    Long.termoutcomesfollowingdrug-elutingstentimplantationin

    unprotectedleftmainbifurcationlesions

    GELei,JohnCosgrave,IoannisIakovou,QIANJu

    ying,PierfrancescoAgostoni,GiuseppeM.Sangiorgi,

    FlavioAiroldi,IassenMichev,AlaideChieffo,NicolaCorvaja,AntonioColomboandGEJunbo

    Keywords:stents;revascularization;restenosis;thrombosis

    BackgroundThesafetyandefficacyofdrug?elutingstents(DES)implantationinunprotectedleftmain(LM)

    bifurcationIesionshasyettobedetermined.Theaimofthepresentreportwastoevaluatethelong-termoutcome

    followingimplantationofDESinunprotectedLMbifurcat:ionIesions.

    MethodsWeidentified70consecutivepatientstreatedwithDESinunprotectedLMbifurcationIesionsfr0mApril2003

    toJanuary2005.Ofthem,42patientsweretreatedwithsirolimus-elutingstent(SES)and28patientsweretreatedwith

    paclitaxel-elutingstent(PES).

    ResultsStentstotheIeftanteriordescendingandtothecircumflexwereimplantedin62patients.During1-year

    follow.up.3(4.3%)patientsdiedofcardiaccauses.OReofthemhadmyocardialinfarctionandadjudicatedaspossibly

    duetostentthrombosis.Angiographicfollow-upwasavailablein80%ofpatients.TheperIesionrestenosisratewas

    13.4%intheentirecohort.ofwhich10-7%occurredinIesionstreatedwithSESand16.1%inthosetreatedwithPES

    (0.58).AlIrestenosiswasfocaIandoccurredintheIesionstreatedwithastentwithstentsizetopost.proceduraI

    referencevesseIdiameterratio<1.0(17.6%vs0,P=-0.04).TheperpatienttargetIesionrevascularizationrateat1year

    was17.1%.oneyearsurvivaIfreefr0mmaioradversecardiaceventswas77.1%. ConclusionsTl_eatmentofLMbifurcationIesionsusingDESisasafeandfeasiblewaywithaIowone-yearmortality.

    TheneedforrevascuIarizati0nin17%ofpatientsdemandsforimprovement. ChinMedJ2O07:120(7):545-551

    everalstudiesofbaremetalstents(BMS)haveshown

    thesafetyandfeasibilityofpercutaneoustreatment

    forleftmain(L]M1disease.Yet,therestenosisratewith

    BMSwasashighas19%t031%..particularlywhen

    thedistalbifurcationisinvolved.Recently.sirolimus

    elutingstent(SES)(Cypher,Cordis/Johnson&Johnson,

    Warren,NJ,USA1hasremarkablydecreasedthe

    restenosisrateinbifurcationswithexclusionofL]M

    lesions.Thepurposeofthisstudywastoevaluatethe

    longtermclinicalandangiographicresultsfollowing

    drugelutingstents(DES)implantation,eitherSESor

    paclitaxelelutingstent(PES)(Taxus,BostonScientific,

    Natick,MA,USA1inunprotectedL]Mbifurcationlesions.

    MTHoDS

    Studypopulation

    Demographicandproceduraldataregardingallpatients

    undergoingangioplastyatourcentersareprospectively

    enteredintoadedicateddatabase.Allconsecutivepatients treatedwithDES.eitherSESorPESinunprotectedL]M bifurcationlesionsbetweenApril2003andJanuary20o5 wereidentified.L]MbifurcationwasdeftnedasdistalL]M disease(diameterstenosis?5O%1withorinvolvingthe

    ostiumofleftanteriordescendingartery(LAD)and/or theostiumofleftcircumflexartery(LCX.Thestenosis attheostiumofLADOrattheostiumofLCXinsome

    casesoccurredfollowingpredilatationofthemost

    diseasedbranchandthelesionwasthentreatedasa bifurcationalstenosisbyintentiontotreat.Patientswith acutemyocardialinfarction(AMI)werenotincludedin thepresentreport.

    Percutaneoustreatmentratherthansurgerywas consideredinanyofthefollowingsituations:(11suitable anatomyandlesioncharacteristicsforstentingwith contraindicationtosurgeryonthebasisofcomorbidity: (21suitableanatomyandlesioncharacteristicsfor stentingandpatientpreferencewiththeagreementofthe referringphysicianforapercutaneousapproach,bothof thembeingawareoftheproceduralrisks.'''.'European systemforcardiacoperativeriskevaluation(EuroSCORE1 wasusedinordertostratifytheriskofdeathincardiac surgicalpatients.TheSCOreiscalculatedasthesumof predefinednumericalvaluesassignedtoclinicalrisk factors.Ascorevalue?6wasconsideredashighrisk

    forsueDr..

    DepartmentofCardiology,ZhongshanHospital,FudanUniversity, ShanghaiInstituteofCardiovascularDiseases.Shanghai200032. Cllina(GeL.QianJYandGeJB)

    EMOCenlroCuoreColumbusandSanRaffaeleHospita1.Milan. Italy(CosgraveJ,IakovouI,AgostoniSangiorgiGM,AiroldiE MichevI,CllieffoA,CorvajaNandColomboA)

    Correspondenceto:Dr.GEJun-bo,DepartmentofCardiology, ZhongshanHospital.FudanUniversity,ShanghaiInstituteof CardiovascularDiseases.Shanghai200032.Cllina(Email: jbge@zshospita1.tom)

ChinMedJ2007:120(7l:545551

    Proceduresandpostinterventionmedications

    AUprocedureswereperformedwithstandard

    interventionaltechniques.Oneofthe5stenting techniqueswasused:"Crush",''V","T"ormcIdified"T''! provisional"rr''andoccasionally"Culotte"stenting.

    Theselectionofaspecificstrategywasattheoperators' discretion.Thedecisiontousetwostentswasbasedon thepresenceofatleastoneofthefollowingcriteria:(1) lesionsinvolvingtheostiumofbothbranches;(2)the anglebetweenbothbrancheswaslessthan45degreeand significantplaqueshiftcouldbeexpected;(3)either branchshowedresidualstenosisoradissectionfollowing placementofastentinonebranchandballoondilatation intheother.

    Kissingballoonpost-dilatationwasencouragedto achieveoptimalstentplacement.Theuseofintravascular ultrasound(IVUS)anddebulkingwerelefttothe operators'discretion.Anintraaorticballoonpumpwas

    usedinselectedpatientswithimpairedsystolicfunction. Anti??platelettherapyandperi??proceduralanti??coagulation

fclllowedourstandardprotoco1.Postprocedurecreatine

    kinasefCK1wasroutinelymeasuredinallpatients followingtheindexprocedure.A11patientswereon maintenanceaspirintherapyandthienopyridinewas administeredforatleast6monthsfollowingDES implantation.

    Clinicaldefinitionandfollow.up

    Clinicalfollowupwasperformedbytelephonecontactor officevisitthroughouttheentirefollowupperiod.

    Angiographicfollowupwasrecommendedbetween6

    and8monthspostprocedureunlessclinicallyindicated earlier.

    Al1ldeathswereconsideredascardiacunlessotherwise documented.AnonQwaveAM1wasdefinedas

    elevationOfCKlevels>2timestheupperlimitofthe normalvaluewithanelevatedCKMBlevelinthe

    absenceofpathologicalQwaves.Targetlesion

    revascularization(TLR1wasdefinedasarepeat revascularizationwithastenosis?5O%inthetreated

    lesions.Targetvesselrevascularization(TVR1was definedasrepeatrevascularizationwithinthetreated vessels.Inordertoidentifyanewprocedureperformed onthetargetvesselbutinanareaclearlyfarawayfrom thetargetlesion(afterthefirstseptalperforatorinthe LADand/orafterthefirstobtusemarginalbranchin LCX),weintroducetheterm"remoteTVR".Anyremote TVRwasnotconsideredmajoradversecardiacevents (MACE).Forthepurposesofthisstudy,MACEwere definedascardiacdeath.AMIandTLR.Cumulative MACEwereconsideredasthecumulativeoccurrenceof

MACEinhospitalandduringlyearfollowup.

    Stentthrombosiswasdefinedasanacutecoronary syndromewithangiographicdocumentationofeither vesselocclusionorthrombuswithinoradjacenttoa previouslysuccessfullystentedvesselor,intheabsence ofangiographicconfirmation.eitherAMIinthe distributionofthetreatedvesselordeathnotclearly attributabletoothercauses..Accordingtothetimingof theevents,stentthrombosiswascategorizedmto: intra.procedural,subacute(aftertheendoftheprocedure to30days)andlatestentthrombosisr>3Odays). Quantitativecoronaryangiographic(QCA)analysis Cineangiogramswereanalyzedwithavalidatededge detectionsystem(CMS,version5.2,MEDIS,Leiden,the Netherlands)atbaseline,aftertheprocedureandat followup.Allangiographicdatawereobtainedfromthe single''worst''intheleastforeshortenedview.Thetype ofbifurcationlesionswascategorizedbyLefevre's classification."Angiographicrestenosiswasdefinedas diameterstenosis?50%withinapreviouslytreated

    segment.

    Statistiealanalysis

    C:ontinuousvariableswerepresentedasmean?standard

    deviationSD1ormedianwithinterquartilerangesand comparedusingindependentsamplettestortheMann

    tneyUtest.Categoricalvariableswerepresentedas frequencies(%1andcomparedwithchisquarestatistics

    orFisherexacttest.Theinfluenceofclinical, angiographicandproceduralvariablesonrestenosiswas evaluatedbyunivariateandstepwiseLogisticregression

    analyses.AllvariableswithaPvalue<0.1Ointhe univariateanalysis(bifurcationlocation,lesionlengthand stentsizetopostproceduralRVDratio<l,wereentered intothemultivariatemodeltotestforindependenteffects. Theresultswerepresentedasadjustedoddsratios(DR1 with95%confidentinterval(CI1.Theratesofsurvival freeofMACEandTLRweregraphicallyrepresented witIltheKaplanMeiermethod.Theinfluencesof

    baselinevariablesonthe1yearTLRwereevaluatedwitIl Coxproportionalhazardsregressionanalysis.Onlythose variableswithaPvalue<0.10intheunivariateanalysis (bifurcationlocation,lesionlengthandstentsizeto postproceduralRVDratio<1,wereenteredintothe multivariablemode1.Theresultsarepresentedasadjusted hazardratios(HR1with95%CI.A11testswere2tailed

    andPvalue<o.O5wasconsideredstatisticallysignificant. StatisticalanalysiswasperformedwithSPSS11.5(SPSS Inc.,Chicago,IL,USA).

    RESUIS

    Basefineandproceduralcharacteriistics

    Atotalof70consecutivepatientswereenrolledinthis study,ofthem,42patientsweretreatedwithSES(SES group)and28patientswithPES(PESgroup).Thirtytwo

    (45.7%1patientshadotherlesionstreatedintheindex procedure.EuroSCORE?6waspresentin14(20.0%1

    patients(Table1,.Baselinelesionandprocedural characteristicsareshowninTlables2and3.The"Crush" and''V"stentingtechniqueswerethemostfrequently used(70.0%,.

Valuesanpresentedasnumber(%)ormean+_SD.SESgroupvsPESgroup.LVEF:leftventric

    ularejectionfraction;MI:myocardialinfarction Table2.Baselinelesioncharacteristics

    Valuesapresentedasnumber(%)ormean_+SD.SESgroupvsPESgroup.IVUS:intravascul

    arultrasound.LAD:leftanteriordescendingartery.LCX:left circumflexartery.LM:leftmain.

    QCAanalysis

    QCAanalysisresultsareshownins4and5.

    Angiographicfollowupwasavailablein56(80.0%1

    patients,ofthem34(81.O%)patientsinSESgroupand 22(78.6%1inPESgroupatmedianperiodof6.7months aftertheindexprocedure(interquartileranges:5.4to8.7 months1.Theperlesionrestenosisratewasl3.4% (15/112)ofwhichl1.8%(8,68)occurredintheSES groupand15.9%(7/44)inthePESgroup(P=O.73).There werenosignificantdifierencesregardinglatelumenloss andrestenosisratesbetweenIMLADandLCX(1ate

    lumenloss:(O.29?0.31)minvs(O_3O?0.35)min.

    P=0.87;restenosisrate:10.7%vs16.1%.P=O.58).A11 casesofrestenosiswerefocal(?10mininlength).Of

    theserestenoticlesions.3locatedonlyintheLM-LAD.6 inLCXand6inbothbranches.Perpatientrestenosisrate was21.4%(12/56)ofwhich2O.6%(7/34)occurredinthe SEsgroupand22.7%(5/22)inthePESgroup(P=1.O). ByLogisticregressionanalysis,lesionlength(:1.13, 95%CI1.O3to1.23,P=0.0o9)wasidentifiedasthe predictivefactorofrestenosis.

    Clinicaloutcomes

    Inhospitalresultsandclinicalfollowupoutcomesare

    showninTable5.OnepatientinthePE,Sgroupsuffered

    anintraproceduralstentthrombosisanddeveloped nonQwaveAMI.Clinicalfollowupwasavailableinall

    patientsatamedianperiodof12.3monthsaftertheindex procedure(interquartileranges:7.0to17.3months1. Cardiacdeathoccurredin3(4.3%)patients:thefirst patient(treatedwithSES)diedofaQwaveAMI7days

    afterprematurediscontinuationofantiplatelettherapy becauseofacutepancreatitis(55daysaftertheindex procedureandwasadjudicatedaslatestentthrombosis), thesecondpatientdiedofpulmonaryedemafll8days aftertheprocedure,thispatienthadsevereaorticand mitralregurgitation).thethirdpatientdiedof complicationsrelatedtoelectivebypasssurgery.One patientinPESgroupdevelopedanonQwaveAMI103

    daysaftertheindexprocedureandwasadjudicatedasa latestentthrombosis.

    TLRwasperformedin12(17.1%)ofpatients(9repeat percutaneoustreatmentand3bypasssurgery).Fourofthem

Valuesarepresentedasnumberf%1ormean+SD.SESgroupVSPESgroup.IABP:intra-aorti

    cballoonpump

    Table4.QuantitativecoronaryangiographyanalysisforLMLAD

    Valuesarepresentedasnumberf%1ormean+_

    SD.SESgroupVSPESgroup.MLD:minimallumendiameter.RVD:referencevesseldiamet

    er

    hadangina.1hadobjectiveevidenceofischemiawhile theother4asymptomaticpatientsweretreatedduetothe severityoftherestenoticlesionsfound.TVRwas performedin18(25.7%patients.12ofthemweredueto TLRandtheremaining6patientsfordistallesions

(remoteTVR.TherateofsurvivalfreefromTLRat

    1yearwas82.9%andMACEfreesurvivalratewas

    77.1%(Fig.,.Lesionlengthwasidentifiedasapredictor ofTLR(HR:1.09,95%CI1.03to1.15.P=0.005). DISCUSSION

    Themainfindingsofthisstudyare"(1)treatmentofLM bifurcationusingDESissafeandfeasible;(2)all restenosiswasfocalandoccurredinthelesionstreated withastentwithstentsizetopostproceduralreference

    vesseldiameterratio<1.0;(3)contrarytoprior experiencewithBMS,adverseeventsinthepresentstudy weremainlyduetoTLR,withalowincidenceofcardiac

Valuesarepresentedasnumber(%)ormean___SD.SESgroupVSPESgroup

    Table6.Clinicaloutcomes

    Valuesarepresentedasnumber(%)ormean+SD.SESgroupVSPESgroup.MACE:majorad

    versecardiacevents.TLR:targetlesionrevascularization.TVR:target

    vesselrevascularization.

    

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