DKCRUSH III研究幻灯张俊杰

ComparisonofDKcrushversusculottestentingforunprotecteddistalleftmainbifurcationlesions:Amulticenter,randomized,prospectiveDKCRUSH-IIIstudyShao-LiangChen,MD,FACCJun-JieZhang,MD,FSCAINanjingFirstHosptialNanjingMedicalUniversityNanjing,ChinaOnbehalfoftheDKCRUSH-IIIInvestigatorsDisclosures:DKCRUSH-IIIstudywasfundedbytheJiangsuProvincialOutstandingMedicalProgram(JPOMP-20071230).

(ChiCTR-TRC-00000151)

DKCRUSH-IIIBackgroundULMCAdistalbifurcationlesionsaretechnicallydemanding,oftenrequiringdouble-stentingandresultinginlessfavorablelong-termoutcomes.Previousstudiesshowedthatdoublekissing(DK)crushandculottestentingwereeffectiveforbifurcationlesions.Theirdurabilityandsafetyhaveneverbeenrandomlycompared.DKCRUSH-IIIObjectives

Toinvestigatethedifferencein

majorcardiacadverseevent

(MACE)at1-yearafterdoublekissing(DK)crushvs.CulottestentingforULMCAdistalbifurcationlesionsDKCRUSH-IIIWehypothesizedthattherateofa1-yearMACE

ratewouldbe5%inthe

DKcrushand15%intheCulottegroup,respectively.

Atotalsamplesizeof358wasneededtodetectthedifferencewith80%power(TypeIIerror=0.20,α=0.05,2-sidedtailed).

Theenrollmentwasextendedto420patients(15%increment)becauseoftheconsiderableuncertainty.SamplesizeestimationDKCRUSH-IIIAge≥18yearsPatienthassilentischemia/stable/unstableanginaorNSTEMIPatienthasSTEMI>24-hourfromtheonsetofchestpaintoadmissionLMb(Medina0,1,1or1,1,1)with/withoutostial/shaftlesionsDiameterofLADorLCX≥2.5mmbyvisualestimationDownstreamlesionsinLADorLCXcouldbecoveredbytwostentsLMbwithCTOlesioninLAD,orLCXorRCAafterrecanalization

InclusioncriteriaDKCRUSH-IIIExclusioncriteriaPregnantLifeexpectancy<12monthsAllergytothedrugsusedLVEF<30%eGFR<40ml/minLMRVD>5.0mmbyvisualestimationDifferenceinRVDbetweenLADandLCX>1.0mmbyvisualestimationSeverecalcificationneedingrotationalatherectomyLMbrestenosislesionDKCRUSH-IIIStudyendpointsPrimaryendpointMACE

(cardiacdeath,MIandTVR)at1-yearSecondaryendpointIn-stentrestenosis(ISR)at8-monthSafetyendpointStentthrombosis(ST)at1-yearDKCRUSH-IIIStatisticalanalysis

Thettestor

Wilcoxonranksumscoreswasusedtoanalyzecontinuousvariables.The2testortheFisher’sexacttestwasusedtoanalyzecategorical

variables.Survivalrate-freefromeventsweregeneratedbyKaplan-Meieranalysis.Pre-specifiedsubgroupanalyseswereperformedbyForestPlot.StatisticalsignificancewastakenasaPvalue<0.05.AllanalyseswereperformedwiththestatisticalprogramSPSS16.0.DKCRUSH-IIIDKCRUSH-IIIstudyFlowChartDKCRUSH-IIIBaselineclinicalcharacteristics(1)DKcrush(n=210)Culotte(n=209)pMale,n(%)162(77.1)167(79.9)0.552Age,yr64.3±10.363.3±9.20.296Hypertension,n(%)148(70.5)128(61.2)0.055Hyperlipidemia,n(%)87(41.4)88(42.1)0.921Diabetes,n(%)67(31.9)63(30.1)0.298Currentsmoking,n(%)

58(27.6)

54(25.8)0.914

Bodymassindex24.63±3.46

24.83±3.20

0.314

DKCRUSH-IIIBaselineclinicalcharacteristics(2)DKcrush(n=210)Culotte(n=209)p>2-weekacuteMI,n(%)18(8.6)12(5.7)0.344PreviousMI,n(%)32(15.2)29(13.9)0.258Unstableangina,n(%)165(78.6)174(83.3)0.263Stableangina,n(%)21(10.0)20(9.6)1.000Silentischemia,n(%)6(2.9)3(1.4)0.503PreviousPCI,n(%)47(22.4)31(14.8)0.059LVEF,%

<40%,n(%)58.7±11.318(8.6)58.8±10.69(4.3)0.2960.110eGFR,ml/min<60ml/min,n(%)84.97±21.8928(13.3)83.39±22.0927(12.9)0.4630.560DKCRUSH-IIILesioncharacteristics(1)

DKcrush(n=210)Culotte(n=209)pThreevesseldisease,n(%)149(71.3)145(69.5)0.130

Leftmaintrunk,n(%)Chronictotalocclusion

OstialMidshaftWholetrunkDistalbifurcationMedina1,1,1

Medina0,1,1

1(0.4)31(15.2)71(34.8)45(21.8)

207(98.7)3(1.3)

042(20.4)60(28.7)39(18.9)

198(94.8)11(5.2)

0.6530.1970.1020.1590.896

DKCRUSH-IIILesioncharacteristics(2)DKcrush(n=210)Culotte(n=209)pDistalmainvessel*,n(%)SeveretortuousMild-moderatecalcificationThrombus-containingChronictotalocclusionTIMIGrade0~2

25(11.9)30(14.3)010(4.8)23(10.9)

28(13.4)30(14.4)012(5.7)20(9.6)

0.6621.000NS0.2090.320Sidebranch,n(%)

SeveretortuousMild-moderatecalcificationThrombus-containingChronictotalocclusionTIMIGrade0~2

38(18.1)19(9.1)09(4.3)19(9.1)

45(21.5)20(9.6)012(5.7)22(10.5)

0.3930.786NS0.5120.280DKCRUSH-IIILesioncharacteristics(3)DKcrush(n=210)Culotte(n=209)pSyntaxscore(points)

0~22,n(%)30.67±12.8969(32.9)31.51±15.6054(25.8)0.2540.462NERSscore(points)

<20,n(%)26.03±10.7055(26.2)26.12±10.5547(22.5)0.6770.241DKCRUSH-IIIProceduralcharacteristics(1)

DKcrush(n=210)Culotte(n=209)pTrans-radialapproach,n(%)122(58.1)123(58.9)0.976IIb/IIIaused,n(%)35(16.7)39(18.7)0.834Supporteddevice,n(%)

IABPImpella

6(2.9)3(1.4)

7(3.3)3(1.5)

0.8600.989IVUSassessment,n(%)145(69.0)154(73.7)0.331Stenttypes,n(%)

Firebird-2XienceV

78(37.1)132(62.9)

75(35.9)134(64.1)0.703

DKCRUSH-IIIProceduralcharacteristics(2)DKcrush(n=210)Culotte(n=209)pMainvesselstent

Number,nDiameter,mmLength,mm

1.38±0.453.40±0.3433.48±14.01

1.39±0.493.34±0.4035.74±15.99

0.5560.1060.124SidebranchStent

Number,nDiameter,mmLength,mm

1.20±0.393.04±0.4125.90±13.83

1.14±0.353.03±0.4126.72±11.86

0.1590.5870.519Post-dilation,n(%)

MainvesselSidebranch

205(97.6)202(96.2)

200(95.7)200(95.7)

0.6930.810FKBI,n(%)209(99.5)208(99.5)1.000DKCRUSH-IIIProceduralcharacteristics(3)DKcrush(n=210)Culotte(n=209)pAngiographicsuccess,n(%)204(97.1)208(99.5)0.122Proceduralsuccess,n(%)203(96.7)201(96.2)0.800Completerevascularization,n(%)180(85.7)171(82.0)0.351Proceduraltime,min.56.88±33.1154.87±32.090.529Fluoroscopytime,min.26.57±14.3927.66±17.530.487Contrastvolume,ml184.40±22.01170.10±7.220.048Non-leftmainlesions

Stentnumber,nStentdiameter,mm

Stentlength,mm

1.41±0.732.89±0.4236.86±27.33

1.26±0.532.99±0.4632.33±15.34

0.4100.4680.468Stagedprocedures,n(%)82(39.0)72(34.4)0.711DKCRUSH-IIIQCAofLM

DKcursh(n=176)Culotte(n=174)pDaysfromindexedprocedure(d)223.0.±15.3211.9±14.10.109LeftmaintrunkLesionlength,mmMinimallumendiameter,mm

Prior-stenting

Acutegain,mm

Lateloss,mm

6.36±3.69

1.47±0.432.34±0.470.18±0.29

6.97±3.86

1.49±0.422.34±0.490.23±0.34

0.100

0.7190.9800.378Diameterstenosis,%

Prior-stentingFollow-upRestenosis,n(%)59.84±9.3511.08±7.24059.18±8.4711.81±6.8300.7720.401NSDKCRUSH-IIIQCAofdistalmainvessel(LAD)

DKcrush(n=176)Culotte(n=174)pDaysfromindexedprocedure(d)223.0.±15.3211.9±14.10.109Distalmainvessel*

Lesionlength,

mmMinimallumendiameter,mm

Prior-stentingAcutegain,mmLateloss,mm

16.67±9.23

1.09±0.421.79±0.410.19±0.32

18.65±12.26

1.07±0.441.79±0.420.20±0.33

0.067

0.9840.9880.938Diameterstenosis,%

Prior-stentingFollow-upRestenosis,n(%)64.62±5.6616.15±8.332(1.14)65.69±6.4615.41±7.101(0.57)0.4140.6221.000DKCRUSH-IIIQCAofsidebranch(LCX)

DKcrush(n=176)Culotte(n=174)pSidebranch*Lesionlength,mmMinimallumendiameter,mm

Prior-stentingAcutegain,mmLateloss,mm

In-stentIn-segment

16.48±11.09

1.01±0.431.58±0.43

0.20±0.300.09±0.21

16.97±13.01

1.07±0.491.58±0.49

0.39±0.360.21±0.30

0.804

0.5970.990

0.0010.048

Diameterstenosis,%

Prior-stenting

Follow-up

Restenosis,n(%)

In-segment

In-stent

Ostial65.29±7.3416.39±7.4512(6.82)4(2.27)9(5.11)9(5.11)63.36±7.7525.50±7.3622(12.64)6(3.45)19(10.92)16(9.19)0.6400.0010.0370.5400.0340.045DKCRUSH-IIIClinicalfollow-up(in-hospital)

DKcrush(n=210)Culotte(n=209)pIn-hospitaldays,dCompositeMACE,n(%)CardiacdeathMITLRTVRCABGStentthrombosis,n(%)

6.58±4.317(3.3)1(0.5)7(3.3)0000

7.19±3.948(3.8)1(0.5)8(3.8)0000

0.1340.8001.0000.800NSNSNSNSDKCRUSH-IIIClinicalfollow-up(at1-month)

DKcrush(n=210)Culotte(n=209)pCompositeMACE,n(%)CardiacdeathMITLRTVRCABGStentthrombosis,n(%)DefiniteProbable

7(3.3)1(0.5)7(3.3)000000

9(4.3)1(0.5)9(4.3)1(0.5)1(0.5)01(0.5)1(0.5)0

0.6221.0000.6220.4990.499NS0.4990.499NSDKCRUSH-IIIClinicalfollow-up(at12-month)DKcrush(n=210)Culotte(n=209)pCompositeMACE,n(%)

CardiacdeathMITLRTVRFornon-leftmainForleftmainCABGStentthrombosis,n(%)

DefiniteProbablePossible

13(6.2)2(1.0)7(3.3)5(2.4)9(4.3)09(4.3)2(1.0)1(0.5)001(0.5)

34(16.3)2(1.0)11(5.3)14(6.7)23(11.0)4(1.9)20(9.6)02(1.0)2(1.0)00

0.0011.0000.3770.0370.0160.0610.0360.4990.6230.248NS1.000DKCRUSH-IIITLR/TVR-freeSurvivalRateat12-monthDKCRUSH-IIIMACE-freeSurvivalRateat12-monthDKCRUSH-IIIForestplotsof12-monthMACErate

inpre-specifiedsubgroups

DKCRUSH-IIIMajo