冠心病介入治疗进展高润霖

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1、冠心病介入治疗进展冠心病介入治疗进展 - 2008高润霖Cardiovascular Institute Fu Wai HospitalCAMS, PUMC Safety of DESRevascularization: CABG or PCI Treatment for bifurcation: sample is better?Fractional flow-reserve for guidingNew generation of DES Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sampl

2、e is better?Fractional flow-reserve for guiding PCI in multi-vessel diseaseNew generation of DES The safety and effectiveness of the *TAXUS Express2 Stent System have not been established in the following patient populations: patients with vessel thrombus at the lesion site; patients with coronary a

3、rtery lesions longer than 28 mm or requiring more than one TAXUS Stent; lesions located in the unprotected left main coronary artery, or lesions located at a bifurcation/trifurcation; patients with moderate or severe calcification in the lesion or a chronic total occlusion; or patients with multi-ve

4、ssel disease. The TAXUS Express Stent System has not been specifically indicated for patients with diabetes.SYNTAX (SYNergy between PCI with TAXUS* and cardiac surgery)Patient ProfilingPatient ProfilingPatient Profiling Local Heart team (surgeon & Local Heart team (surgeon & interventional cardiolog

5、ist) assessed each interventional cardiologist) assessed each patient in regards topatient in regards to: :n nPatients operative risk (EuroSCORE & Patients operative risk (EuroSCORE & Parsonnet score)Parsonnet score)n nCoronary lesion complexity (newly Coronary lesion complexity (newly developed SYN

6、TAX score)developed SYNTAX score)n nThe goal of the SYNTAX score is to The goal of the SYNTAX score is to provide a tool to assistprovide a tool to assist physicians in physicians in their revascularization strategies for their revascularization strategies for patients with high risk lesionspatients

7、 with high risk lesionsSianos et al, EuroIntervention 2005;1:219-227Valgimigli et al, Am J Cardiol 2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459Coronary tree segments based on the classification proposed by the AHA and modified for the ARTS study Circulation 1975; 51:31-3 & Semin I

8、nterv Cardiol 1999; 4:209-19 Leaman score, Circ 1981;63:285-299Lesions classification ACC/AHA , Circ 2001;103:3019-3041Bifurcation classification, CCI 2000;49:274-283CTO classification, J Am Coll Cardiol 1997;30:649-656TortuosityThrombusBifurcationTotal Occlusion3 VesselLeft MainDominanceCalcificati

9、onNumber & location of lesionsSYNTAXscore71% enrolled (N=3,075)All Pts with de novo 3VD and/or LM disease (N=4,337) Treatment preference (9.4%) Referring MD or pts. refused informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)TAXUSn=9

10、03PCIn=198CABGn=1077CABGn=897no f/un=4285yr f/un=649PCIall captured w/ follow upCABG2500750 w/ f/uvsvsTotal enrollment N=3075Stratification: LM and DiabetesTwo Registry ArmsRandomized Armsn=1800Two Registry ArmsN=1275Randomized ArmsN=1800Heart Team (surgeon & interventionalist)PCIN=198CABGN=1077Amen

11、able for only one treatment approachTAXUS*N=903 CABGN=897vsvsAmenable for bothtreatment optionsStratification: LM and DiabetesLM33.7%3VD66.3%LM34.6%3VD65.4%DM 28.5%Non DM71.5%NonDM71.8%DM28.2%23 US Sites62 EU Sites+ +SYNTAX Trial DesignSYNTAX Trial DesignSYNTAX Trial DesignAdverse Events to 12 Month

12、sAdverse Events to 12 Months ITT populationEvent Rate 1.5 SE, *Fisher exact testAll DeathRevascularizationCVA (Stroke)Myocardial InfarctionTAXUS* (N=903)CABG (N=897)MACCE to 12 MonthsP=0.0015*061210200Months Since AllocationCumulative Event Rate (%)ITT population12.1% 17.8% Event Rate 1.5 SE. *Fishe

13、rs Exact TestTAXUS* (N=903)CABG (N=897)Symptomatic Graft Occlusion & Stent Symptomatic Graft Occlusion & Stent Thrombosis to 12 MonthsThrombosis to 12 Months3.33.33.43.4CABGCABGTAXUSTAXUSP=0.89Patients (%)n=27n=27n=28n=28ITT populationTAXUS* (N=903)CABG (N=897)MACCE to 12 MonthsLeft Main SubsetP=0.4

14、4*061220400Months Since AllocationCumulative Event Rate (%)13.6% 15.8% TAXUS (N=357)CABG (N=348)Event rate 1.5 SE, *Fisher exact testITT population061220400Months Since AllocationCumulative Event Rate (%)TAXUS (N=118)CABG (N=103)P=0.19*7.7%13.0%Event rate 1.5 SE, *Fisher exact testCalculated by core

15、 laboratory; ITT populationMACCE to 12 Months by SYNTAX Score TertileLow Scores (0-22) LM SubsetMean baselineSYNTAX ScoreCABG15.5 4.3TAXUS15.7 4.4061220400Months Since AllocationCumulative Event Rate (%)TAXUS (N=135)CABG (N=150)P=0.008*25.3%12.9%Event rate 1.5 SE, *Fisher exact testCalculated by cor

16、e laboratory; ITT populationMACCE to 12 Months by SYNTAX Score TertileHigh Scores (33) Left Main SubsetMean baselineSYNTAX ScoreCABG42.1 7.6TAXUS43.8 9.1Overall MACCE at 12 MonthsOverall MACCE at 12 MonthsLeft Main SubsetITT populationTAXUS*CABG(n=705)(n=91)(n=138)(n=218)(n=258)P=0.44P=1.0P=0.27P=0.

17、29P=0.42Patients (%)MACCE to 12 Months 3VD Subset061220400Months Since AllocationCumulative Event Rate (%)P0.001*19.1%11.2%ITT populationEvent Rate 1.5 SE, *Fisher exact testTAXUS (n=546)CABG (n=549)CABGTAXUS*P=0.393 Vessel Disease*n=34n=43*per protocol and ITT populations had same outcomeCombined S

18、afetyCombined Safety (Death/CVA/MI) (Death/CVA/MI) 3VD Patients (%)MACCE to 12 Months vs SYNTAX ScoreSYNTAX Score22P P=0.10=0.10P P0.0010.001P P=0.71=0.7112-month MACCE, %SYNTAX ScoreKM Estimates, Event Rate 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes onlyRCT ITT pts; site-r

19、eported dataSYNTAX Score23-32SYNTAX Score33TAXUS* (N=903)CABG (N=897) Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding PCI in multi-vessel diseaseNew generation of DES BBC ONEThe British Bifurcation Coronary study: Old, New a

20、nd Evolving strategies a randomized comparison of simple versus complex drug-a randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesionseluting stenting for bifurcation lesionsTechniquesSimple stepwise provisional T-stentingComplex total lesion coverage: crush or c

21、ulotte (according to operator preference)(according to operator preference)Technique (simple)n nFollowing main vessel Following main vessel stentingstenting, the side branch should not , the side branch should not be treated further unless there is:be treated further unless there is:n nTIMI 3 flow i

22、n the side branch90%) of the side branch pinching (90%) of the side branchn nThreatened side vessel closureThreatened side vessel closuren nSide-branch dissection type ASide-branch dissection type An nif any of these applies, the operator if any of these applies, the operator may may Stage 2 Stage 2

23、 n nKissing Kissing bolloonbolloon, , T-stent, T-stent, culotteculotte stent, crush stent, crush PRIMARY ENDPOINTComposite (9months) Death, MI, TVFComplexComplexSimpleSimpleP valueP value DeathDeath2 2 (0.8%) (0.8%) 1 1 (0.4%) (0.4%)- - Myocardial infarctionMyocardial infarction28 28 (11.2%)(11.2%)9

24、 9 (3.6%)(3.6%)0.0010.001 Target vessel failureTarget vessel failure18 18 (7.2%)(7.2%)14 14 (5.6%)(5.6%)- - Primary endpointPrimary endpoint38 38 (15.2%)(15.2%)20 20 (8.0%)(8.0%)0.0090.009HR 2.0 (1.2 to HR 2.0 (1.2 to 3.5)3.5)In-hospital MACCEComplexComplexSimpleSimpleP valueP valueNo. patientsNo. p

25、atients20 20 (8.0%)(8.0%)5 5 (2.0%)(2.0%)0.0020.002RR 4.0 (1.5 to RR 4.0 (1.5 to 10.5)10.5) DeathDeath1 10 0 Myocardial infarctionMyocardial infarction18185 5 CABGCABG3 30 0CONCLUSIONSl lFor unselected bifurcation lesions, a stepwise provisional T stent trategy is superior to a systematic dual tenti

26、ng strategy in all domains:n nprocedural successprocedural successn nprocedural complicationsprocedural complicationsn nin-hospital and 9-month MACEin-hospital and 9-month MACE Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding

27、 PCI in multi-vessel diseaseNew generation of DES FRACTIONAL FLOW RESERVE FRACTIONAL FLOW RESERVE versusversus ANGIOGRAPHYANGIOGRAPHY FOR GUIDING PCI IN FOR GUIDING PCI IN PATIENTS WITH MULTIVESSEL CORONARY PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASEARTERY DISEASEFAMEAngiography-guided PCIFFR-

28、guided PCIMeasure FFR in all indicated stenosesStent all indicated stenosesStent only those stenoses with FFR 0.80RandomizationIndicate all stenoses 50% considered for stentingPatient with stenoses 50% in at least 2 of the 3 major epicardial vessels1-year follow-upFLOW CHART FAME study: Procedural R

29、esultsANGIO-groupANGIO-groupN=496N=496FFR-groupFFR-groupN=509N=509P-valueP-valueProcedure time (min)Procedure time (min)70 4470 4471 4371 430.510.51Contrast agent used (ml)Contrast agent used (ml)302 127302 127272 133272 1330.0010.001Materials used at procedure Materials used at procedure (US $)(US

30、$)60076007533253320.0010.001Length of hospital stay (days)Length of hospital stay (days)3.7 3.7 3.5 3.5 3.4 3.4 3.3 3.30.050.05stents per patientstents per patient2.7 1.22.7 1.21.9 1.31.9 1.30.0010.001FFR-guided30 days2.9%90 days3.8%180 days4.9%360 days5.3%Angio-guidedabsolute difference in MACE-fre

31、e survivalFAME study: Event-free Survival ANGIO-groupANGIO-groupN=496N=496FFR-groupFFR-groupN=509N=509P-valueP-valueEvents at 1 year, No (%)Events at 1 year, No (%)Death, MI, CABG, or repeat-PCIDeath, MI, CABG, or repeat-PCI91 (18.4)91 (18.4)67 (13.2)67 (13.2)0.020.02DeathDeath15 (3.0)15 (3.0)9 (1.8

32、)9 (1.8)0.190.19Death or myocardial infarctionDeath or myocardial infarction55 (11.1)55 (11.1)37 (7.3)37 (7.3)0.040.04CABG or repeat PCICABG or repeat PCI47 (9.5)47 (9.5)33 (6.5)33 (6.5)0.080.08Total no. of MACETotal no. of MACE11311376760.020.02Adverse Events at 1 yearl Routine measurement of FFR d

33、uring DES-Routine measurement of FFR during DES-stenting in patients with multivessel disease is stenting in patients with multivessel disease is superior to current angiography guided superior to current angiography guided treatment.treatment.l It improves outcome of PCI significantlyIt improves ou

34、tcome of PCI significantlyl It supports the evolving paradigm of It supports the evolving paradigm of “Functionally Complete Revascularization”,“Functionally Complete Revascularization”, i.e. i.e. stenting of ischemic lesions and medical stenting of ischemic lesions and medical treatment of non-isch

35、emic ones.treatment of non-ischemic ones.FAME study: CONCLUSIONS Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding PCI in multi-vessel diseaseNew generation of DES Drug-eluting Stents 2008EndeavorPhosphorylcholinePhosphorylcho

36、lineZotarolimusZotarolimusDriverDriverDrugPolymerXience V*VDF + HFP copolymerVDF + HFP copolymerEverolimusEverolimusVisionVision*AKA PromusO OOO OOO OOO OOHOHOHOO OOO OOO OOO OOH HHO OOO OOO OON NNO OOH HHO OOStentSPIRIT II + III: Cardiac Death or MINumber at riskNumber at riskXIENCE VXIENCE V892892

37、876876871871859859848848826826824824814814810810TAXUSTAXUS4094093903903883883813813753753613613573573553553523521-year HR0.60 0.33, 1.11p=0.10 4.2% 2.6% 1.6%2-year HR0.59 0.35, 0.99p=0.04 6.3% 3.8% 2.5% 0 2 4 6 8 1003691215182124Cardiac Death or MI (%)MonthsXIENCE VTAXUS Stone GW Stone GWSPIRIT II +

38、 III: All Death or MINumber at riskNumber at riskXIENCE VXIENCE V892892876876871871859859848848826826824824814814810810TAXUSTAXUS4094093903903883883813813753753613613573573553553523521-year HR0.62 0.35, 1.09p=0.09 4.4% 3.1% 1.3%2-year HR0.61 0.39, 0.95p=0.03 8.3% 5.1% 3.2% 0 2 4 6 8 1003691215182124

39、All Death or MI (%)MonthsXIENCE VTAXUS Stone GWStone GWSPIRIT II + III: All TLRAll TLR = Ischemic TLR + non ischemic TLRAll TLR = Ischemic TLR + non ischemic TLR Stone GW Stone GWZotarolimus-Eluting Stent:Analysis of Six Clinical TrialsKandzariKandzari D,Euro-PCR2009 D,Euro-PCR2009Zotarolimus-Elutin

40、g Stent:Analysis of Six Clinical TrialsKandzariKandzari D,Euro-PCR2009 D,Euro-PCR2009Zotarolimus-Eluting Stent:Analysis of Six Clinical TrialsKandzariKandzari D,Euro-PCR2009 D,Euro-PCR2009NEVO RES-ELUTION 1 TrialSpaulding C, Euro-PCR 2009NEVO RES-ELUTION 1 Trial Spaulding C, Euro-PCR 2009NEVO RES-EL

41、UTION 1 Trial Spaulding C, Euro-PCR 2009NEVO RES-ELUTION 1 Trial Spaulding C, Euro-PCR 2009ABSORBThe goal of this trial was to evaluate the use of The goal of this trial was to evaluate the use of a a bioabsorbablebioabsorbable drug-eluting stent (DES) drug-eluting stent (DES) platform among patient

42、s undergoing elective platform among patients undergoing elective percutaneouspercutaneous coronary intervention (PCI) for a coronary intervention (PCI) for a de novo coronary lesion.de novo coronary lesion.BVSBioabsorbable Stent PlatformML VISIONBalloon SDSBioabsorbablePolymer CoatingEverolimusBVS

43、Stent Components* BMS loss from SPIRIT FIRST ( n=27 )* EES loss of pts with 3.0 x 18mm for single lesion from SPIRIT FIRST and II ( n=22 )BMS*: 0.85 0.36mm (N=27)BVS: 0.44 0.35mm (N=26)EES*: 0.07 0.23mm (N=22)ABSORBAngiographic Late Loss ACC 2007IVUS results (24 pts)Post-Post-PCIPCIFollow-Follow-upu

44、p% % DifferenceDifferencep-valuep-valueVessel area Vessel area (mm(mm2 2) )13.5513.5513.4913.49-0.4-0.4NSNSEEM-Stent Area EEM-Stent Area (mm(mm2 2) )7.477.478.088.08+8.2+8.20.0030.003Stent area Stent area (mm(mm2 2) )6.086.085.375.37-11.7-11.70.0010.001NeointimalNeointimal hyperplasia hyperplasia ar

45、ea area (mm(mm2 2) )0 00.300.30NANANANALumen area Lumen area (mm(mm2 2) )6.086.085.075.07-16.6-16.60.0010.001Stent area Stent area obstruction obstruction (%)(%)0 05.545.54NANANANASerial IVUSCharacteristicCharacteristicEverolimusEverolimus eluting eluting stent platform (n=26)stent platform (n=26)In

46、-stent late loss (mm)In-stent late loss (mm)0.440.44Mean MLD (mm)Mean MLD (mm)1.881.88Stenosis (%)Stenosis (%)2727Volume Obstruction (%)Volume Obstruction (%)5.545.54NeointimalNeointimal volume (mm volume (mm3 3) )4.264.26Incomplete apposition at 6 mos. (% of patients)Incomplete apposition at 6 mos.

47、 (% of patients)23.123.1Late incomplete apposition (% of patients)Late incomplete apposition (% of patients)26.926.9ABSORB Trial: Six Month Follow-up CharacteristicsConclusionn nThe safety DES has been confirmed by RCT and real world registriesn nPCI could be considered in selected Patients with L M and triple vessel disease.n nNew generation of DES is emerging and revealed advantages.Thank you