Presentation on theme: "A multicenter, randomized, prospective DKCRUSH-III study"— Presentation transcript:
1 A multicenter, randomized, prospective DKCRUSH-III study Comparison of DK crush versus culotte stenting for unprotected distal left main bifurcation lesions:A multicenter, randomized, prospective DKCRUSH-III study(ChiCTR-TRC )Shao-Liang Chen, MD, FACCJun-Jie Zhang, MD, FSCAINanjing First HosptialNanjing Medical UniversityNanjing, ChinaOn behalf of the DKCRUSH-III InvestigatorsDisclosures: DKCRUSH-III study was funded by the Jiangsu Provincial Outstanding Medical Program (JPOMP ).
2 DKCRUSH-IIIBackgroundULMCA distal bifurcation lesions are technically demanding, often requiring double-stenting and resulting in less favorable long-term outcomes.Previous studies showed that double kissing (DK) crush and culotte stenting were effective for bifurcation lesions.Their durability and safety have never been randomly compared.
3 DKCRUSH-IIIObjectivesTo investigate the difference in major cardiac adverse event (MACE) at 1-year after double kissing (DK) crush vs. Culotte stenting for ULMCA distal bifurcation lesions
4 Sample size estimation DKCRUSH-IIISample size estimationWe hypothesized that the rate of a 1-year MACE rate would be 5% in the DK crush and 15% in the Culotte group, respectively. A total sample size of 358 was needed to detect the difference with 80% power (Type II error=0.20, α=0.05, 2-sided tailed). The enrollment was extended to 420 patients (15% increment) because of the considerable uncertainty.
5 Inclusion criteria Age ≥18 years DKCRUSH-IIIInclusion criteriaAge ≥18 yearsPatient has silent ischemia/stable/unstable angina or NSTEMIPatient has STEMI>24-hour from the onset of chest pain to admissionLMb (Medina 0,1,1 or 1,1,1 ) with/without ostial/shaft lesionsDiameter of LAD or LCX ≥2.5mm by visual estimationDownstream lesions in LAD or LCX could be covered by two stentsLMb with CTO lesion in LAD, or LCX or RCA after recanalization
6 Exclusion criteria Pregnant Life expectancy <12 months DKCRUSH-IIIExclusion criteriaPregnantLife expectancy <12 monthsAllergy to the drugs usedLVEF<30%eGFR<40ml/minLM RVD>5.0mm by visual estimationDifference in RVD between LAD and LCX >1.0mm by visual estimationSevere calcification needing rotational atherectomyLMb restenosis lesion
7 Study endpoints Primary endpoint Secondary endpoint Safety endpoint DKCRUSH-IIIStudy endpointsPrimary endpointMACE (cardiac death, MI and TVR) at 1-yearSecondary endpointIn-stent restenosis (ISR) at 8-monthSafety endpointStent thrombosis (ST) at 1-year
8 DKCRUSH-IIIStatistical analysisThe t test or Wilcoxon rank sum scores was used to analyze continuous variables.The 2 test or the Fisher’s exact test was used to analyze categorical variables.Survival rate-free from events were generated by Kaplan-Meier analysis.Pre-specified subgroup analyses were performed by Forest Plot.Statistical significance was taken as a P value <0.05.All analyses were performed with the statistical program SPSS 16.0.
9 DKCRUSH-III study Flow Chart Between Mar 24,2009 and Oct 22,2011863 pts (18 centers of 4 countries)with ULMCA dist-bifurcation lesions1 pt refused to PCIpost randomization419 pts includedDKCRDUSH-III studyDK crush (n=210)Clinical FU (n=210,100%)Angiographic FU (n=176,83.8%)Culotte (n=209)Clinical FU(n=209,100%)Angiographic FU (n=174,83.3%)326 ptsclinically excluded117 ptsangiographically excluded
10 Baseline clinical characteristics (1) DKCRUSH-IIIBaseline clinical characteristics (1)DK crush(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)0.298Current smoking, n (%) 58(27.6) 54(25.8)0.914Body mass index24.63±3.4624.83±3.200.314Baseline clinical characteristics were well matched between two treatment groups.
11 Baseline clinical characteristics (2) DKCRUSH-IIIBaseline clinical characteristics (2)DK crush(n=210)Culotte(n=209)p>2-week acute MI, n (%)18(8.6)12(5.7)0.344Previous MI, n (%)32(15.2)29(13.9)0.258Unstable angina, n (%)165(78.6)174(83.3)0.263Stable angina, n (%)21(10.0)20(9.6)1.000Silent ischemia, n (%)6(2.9)3(1.4)0.503Previous PCI, n (%)47(22.4)31(14.8)0.059LVEF, %<40%, n (%)58.7±11.358.8±10.69(4.3)0.2960.110eGFR, ml/min<60ml/min, n (%)84.97±21.8928(13.3)83.39±22.0927(12.9)0.4630.560More than 85% enrolled patients were ACS, among them 8% patients was acute MI >2-week from the onset of chest pain to admission.
12 Lesion characteristics (1) DKCRUSH-IIILesion characteristics (1)DK crush(n=210)Culotte(n=209)pThree vessel disease, n (%)149(71.3)145(69.5)0.130 Left main trunk, n (%)Chronic total occlusionOstialMid shaftWhole trunkDistal bifurcationMedina 1,1,1Medina 0,1,11(0.4)31(15.2)71(34.8)45(21.8)207(98.7)3(1.3)42(20.4)60(28.7)39(18.9)198(94.8)11(5.2)0.6530.1970.1020.1590.89670% patients were with 3-vessel disease. 96% lesions belong to Medina Classification 1,1,1.
13 Lesion characteristics (2) DKCRUSH-IIILesion characteristics (2)DK crush(n=210)Culotte(n=209)pDistal main vessel*, n (%)Severe tortuousMild-moderate calcificationThrombus-containingChronic total occlusionTIMI Grade 0~225(11.9)30(14.3)10(4.8)23(10.9)28(13.4)30(14.4)12(5.7)20(9.6)0.6621.000NS0.2090.320Side branch, n (%)38(18.1)19(9.1)9(4.3)45(21.5)22(10.5)0.3930.7860.5120.280* left anterior descending artery was treated as main vessel in all patients, with exceptionfor 2 in DK group and 1 in Culotte group, for whom left circumflex was considered asmain vessel.
14 Lesion characteristics (3) DKCRUSH-IIILesion characteristics (3)DK crush(n=210)Culotte(n=209)pSyntax score (points)0~22, n (%)30.67±12.8969(32.9)31.51±15.6054(25.8)0.2540.462NERS score (points)<20, n (%)26.03±10.7055(26.2)26.12±10.5547(22.5)0.6770.241
15 Procedural characteristics (1) DKCRUSH-IIIProcedural characteristics (1)DK crush(n=210)Culotte(n=209)pTrans-radial approach, n (%)122(58.1)123(58.9)0.976IIb/IIIa used, n (%)35(16.7)39(18.7)0.834Supported device, n (%)IABPImpella6(2.9)3(1.4)7(3.3)3(1.5)0.8600.989IVUS assessment, n (%)145(69.0)154(73.7)0.331Stent types, n (%)Firebird-2Xience V78(37.1)132(62.9)75(35.9)134(64.1)0.703
17 Procedural characteristics (3) DKCRUSH-IIIProcedural characteristics (3)DK crush(n=210)Culotte(n=209)pAngiographic success, n (%)204(97.1)208(99.5)0.122Procedural success, n (%)203(96.7)201(96.2)0.800Complete revascularization, n (%)180(85.7)171(82.0)0.351Procedural time, min.56.88±33.1154.87±32.090.529Fluoroscopy time, min.26.57±14.3927.66±17.530.487Contrast volume, ml184.40±22.01170.10±7.220.048Non-left main lesionsStent number, nStent diameter, mmStent length, mm1.41±0.732.89±0.4236.86±27.331.26±0.532.99±0.4632.33±15.340.4100.468Staged procedures, n (%)82(39.0)72(34.4)0.711
18 QCA of LM Days from indexed procedure (d) 223.0.±15.3 211.9±14.1 0.109 DKCRUSH-IIIQCA of LMDK cursh(n=176)Culotte(n=174)pDays from indexed procedure (d)223.0.±15.3211.9±14.10.109Left main trunkLesion length, mmMinimal lumen diameter, mmPrior-stentingAcute gain, mmLate loss, mm6.36±3.691.47±0.432.34±0.470.18±0.296.97±3.861.49±0.422.34±0.490.23±0.34 0.1000.7190.9800.378Diameter stenosis, %Follow-upRestenosis, n (%)59.84±9.3511.08±7.2459.18±8.4711.81±6.830.7720.401NS
19 QCA of distal main vessel (LAD) DKCRUSH-IIIQCA of distal main vessel (LAD)DK crush(n=176)Culotte(n=174)pDays from indexed procedure (d)223.0.±15.3211.9±14.10.109Distal main vessel*Lesion length, mmMinimal lumen diameter, mmPrior-stentingAcute gain, mmLate loss, mm 16.67±9.231.09±0.421.79±0.410.19±0.32 18.65±12.261.07±0.441.79±0.420.20±0.33 0.0670.9840.9880.938Diameter stenosis, %Follow-upRestenosis, n (%)64.62±5.6616.15±8.332(1.14)65.69±6.4615.41±7.101(0.57)0.4140.6221.000left anterior descending artery was treated as main vessel in all patients, with exceptionfor 2 in DK group and 1 in Culotte group, for whom left circumflex was considered asmain vessel.
20 QCA of side branch (LCX) DKCRUSH-IIIQCA of side branch (LCX)DK crush (n=176)Culotte(n=174)pSide branch*Lesion length, mmMinimal lumen diameter, mmPrior-stentingAcute gain, mmLate loss, mmIn-stentIn-segment16.48±11.091.01±0.431.58±0.430.20±0.300.09±0.2116.97±13.011.07±0.491.58±0.490.39±0.360.21±0.300.8040.5970.9900.0010.048Diameter stenosis, %Follow-upRestenosis, n (%)Ostial65.29±7.3416.39±7.4512(6.82)4(2.27)9(5.11)63.36±7.7525.50±7.3622(12.64)6(3.45)19(10.92)16(9.19)0.6400.0370.5400.0340.045* left anterior descending artery was treated as main vessel in all patients, with exceptionfor 2 in DK group and 1 in Culotte group, for whom left circumflex was considered asmain vessel.
24 TLR/TVR-free Survival Rate at 12-month DKCRUSH-IIITLR/TVR-free Survival Rate at 12-month
25 MACE-free Survival Rate at 12-month DKCRUSH-IIIMACE-free Survival Rate at 12-month
26 Forest plots of 12-month MACE rate in pre-specified subgroups DKCRUSH-IIIForest plots of 12-month MACE rate in pre-specified subgroups
27 Major findingsCulotte stenting was associated with significantly increased 1-year MACE rate , mainly because of the increment of TVR rate.Restenotic lesions most localized in the SB, DK crush was associated with less ISR.The efficacy of DK crush was demonstrated in patients at intermediate- and high-risk stratified by either SYNTAX or NERS score, also maintained in patients with distal bifurcation angle≥700.
28 DKCRUSH-IIILimitationsSome kinds of angle restriction should have been applied in the design of the study.We did not include a CABG group to contrast with the stenting techniques.The results were achieved in very high volume operators performing these procedures. It remains unclear whether lower volume centers could reproduce these results.The present study has several limitations. Some kinds of angle restriction should have been applied in the design of the study. Next, we did not include a CABG group to contrast with the stenting techniques. However, the promising results achieved by DK crush technique were comparable with those after CABG. Finally, the results were achieved in very high volume operators performing these procedures. It remains unclear whether lower volume centers could reproduce these results.
29 Conclusion Compared to the DK crush, Culotte stenting is associated DKCRUSH-IIIConclusionCompared to the DK crush, Culotte stenting is associatedwith significantly increased MACEs in patients withULMCA bifurcation lesions.DK crush was associated with:less in-stent restenosis of SBless TLR/TVR
30 Thanks for your attention DKCRUSH-IIIThanks for your attention