冠心病介入治療進(jìn)展

1、冠心病介入治療進(jìn)展 Safety of DESRevascularization: CABG or PCI Treatment for bifurcation: sample is better?Fractional flow-reserve for guidingNew generation of DESKirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2008; Chicago, IL. MEGA meta-analysisS

2、tudy typePatients, nTrials, nRelative riskpRCT: all8867210.970.72aRCT: on-label4818101.050.69aRCT: off-label4049120.840.24aRegistries161232280.800.001ba. Fixed-effects modelb. Random-effects modelAll-cause mortalityKirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and

3、 registries; March 28, 2008; Chicago, IL.MIStudy typePatients, nTrials, nRelative riskpRCT: all 885020 0.940.54a RCT: on-label 43189 1.03 0.82a RCT: off-label 453212 0.77 0.19bRegistries 12995524 0.89 0.023ba. Fixed-effects modelb. Random-effects model MEGA meta-analysisKirtane AJ, Stone GW. Compreh

4、ensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2008; Chicago, IL.Target-vessel revascularizationStudy typePatients, nTrials, nRelative riskP*RCT: all 729116 0.450.001RCT: on-label 46189 0.53 0.001 RCT: off-label 26738 0.38 0.001Registries 73819170.530.001 *Random-effe

5、cts model MEGA meta-analysis 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 The safety and effectiveness of the *TAXUS Express2 Stent System have not been established in the

6、following patient populations: patients with vessel thrombus at the lesion site; patients with coronary artery 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 wi

7、th moderate or severe calcification in the lesion or a chronic total occlusion; or patients with multi-vessel 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 Profiling Local Hea

8、rt team (surgeon & interventional cardiologist) assessed each patient in regards to:Patients operative risk (EuroSCORE & Parsonnet score)Coronary lesion complexity (newly developed SYNTAX score)The goal of the SYNTAX score is to provide a tool to assist physicians in their revascularization strategi

9、es for patients 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

10、:31-3 & Semin Interv 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 MainDomin

11、anceCalcificationNumber & 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

12、 (1.2%)TAXUSn=903PCIn=198CABGn=1077CABGn=897no f/un=4285yr f/un=649PCIall captured w/ follow upCABG2500750 w/ f/uvsTotal enrollment N=3075Stratification: LM and DiabetesTwo Registry ArmsRandomized Armsn=1800Two Registry ArmsN=1275Randomized ArmsN=1800Heart Team (surgeon & interventionalist)PCIN=198C

13、ABGN=1077Amenable for only one treatment approachTAXUS*N=903 CABGN=897vsAmenable 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 DesignAdverse Events to 12 Months ITT populationEvent Rate 1.

14、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. *Fishers Exact TestTAXUS* (N=903)CABG (N=897)Symptomatic Graft

15、 Occlusion & Stent Thrombosis to 12 Months3.33.4CABGTAXUSP=0.89Patients (%)n=27n=28ITT populationTAXUS* (N=903)CABG (N=897)MACCE to 12 MonthsLeft Main SubsetP=0.44*061220400Months Since AllocationCumulative Event Rate (%)13.6% 15.8% TAXUS (N=357)CABG (N=348)Event rate 1.5 SE, *Fisher exact testITT p

16、opulation061220400Months 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 laboratory; ITT populationMACCE to 12 Months by SYNTAX Score TertileLow Scores (0-22) LM SubsetMean baselineSYNTAX ScoreCABG15.5 4.3TAXUS

17、15.7 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 core laboratory; ITT populationMACCE to 12 Months by SYNTAX Score TertileHigh Scores (33) Left Main SubsetMean baselineSYNTAX ScoreCABG42.1 7

18、.6TAXUS43.8 9.1Overall 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=0.29P=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

19、exact testTAXUS (n=546)CABG (n=549)MACCE Components 3VD to 30 DaysP=0.08*30 Day Event Rate, %P=0.03*P=0.02*P=0.20TAXUS* (n=546)CABG (n=549)P=0.45*chi-square test; Fisher exact testCABGTAXUS*P=0.393 Vessel Disease*n=34n=43*per protocol and ITT populations had same outcomeCombined Safety (Death/CVA/MI

20、) 3VD Patients (%)MACCE to 12 Months vs SYNTAX ScoreSYNTAX Score22P=0.10P0.001P=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-reported dataSYNTAX Score23-32SYNTAX Score33TAXUS* (N=903)CABG (N=897)

21、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 and Evolving strategies a randomized comparison of simple versus comple

22、x drug-eluting stenting for bifurcation lesionsTechniquesSimple stepwise provisional T-stentingComplex total lesion coverage: crush or culotte (according to operator preference)Technique (simple)Following main vessel stenting, the side branch should not be treated further unless there is:90%) of the

23、 side branchThreatened side vessel closureSide-branch dissection type Aif any of these applies, the operator may Stage 2 Kissing bolloon, T-stent, culotte stent, crush PRIMARY ENDPOINTComposite (9months) Death, MI, TVFComplexSimpleP value Death2 (0.8%) 1 (0.4%)- Myocardial infarction28 (11.2%)9 (3.6

24、%)0.001 Target vessel failure18 (7.2%)14 (5.6%)- Primary endpoint38 (15.2%)20 (8.0%)0.009HR 2.0 (1.2 to 3.5)In-hospital MACCEComplexSimpleP valueNo. patients20 (8.0%)5 (2.0%)0.002RR 4.0 (1.5 to 10.5) Death10 Myocardial infarction185 CABG30CONCLUSIONSFor unselected bifurcation lesions, a stepwise pro

25、visional T stent trategy is superior to a systematic dual tenting strategy in all domains:procedural successprocedural complicationsin-hospital and 9-month MACE Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding PCI in multi-ve

26、ssel diseaseNew generation of DES FRACTIONAL FLOW RESERVE versus ANGIOGRAPHY FOR GUIDING PCI IN PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASEFAMEAngiography-guided PCIFFR-guided PCIMeasure FFR in all indicated stenosesStent all indicated stenosesStent only those stenoses with FFR 0.80Randomizati

27、onIndicate 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 ResultsANGIO-groupN=496FFR-groupN=509P-valueProcedure time (min)70 4471 430.51Contrast agent used (ml)302 127272 1330.001Mater

28、ials used at procedure (US $)600753320.001Length of hospital stay (days)3.7 3.5 3.4 3.30.05stents per patient2.7 1.21.9 1.30.001FFR-guided30 days2.9%90 days3.8%180 days4.9%360 days5.3%Angio-guidedabsolute difference in MACE-free survivalFAME study: Event-free Survival ANGIO-groupN=496FFR-groupN=509P

29、-valueEvents at 1 year, No (%)Death, MI, CABG, or repeat-PCI91 (18.4)67 (13.2)0.02Death15 (3.0)9 (1.8)0.19Death or myocardial infarction55 (11.1)37 (7.3)0.04CABG or repeat PCI47 (9.5)33 (6.5)0.08Total no. of MACE113760.02Adverse Events at 1 year Routine measurement of FFR during DES-stenting in pati

30、ents with multivessel disease is superior to current angiography guided treatment. It improves outcome of PCI significantly It supports the evolving paradigm of “Functionally Complete Revascularization”, i.e. stenting of ischemic lesions and medical treatment of non-ischemic ones.FAME study: CONCLUS

31、IONS 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 2008EndeavorPhosphorylcholineZotarolimusDriverDrugPolymerXience V*VDF + HFP copolymerEverolimusVision*

32、AKA PromusOOOOHOOOOOHOOONOHOStentSPIRIT II + III: Cardiac Death or MINumber at riskXIENCE V892876871859848826824814810TAXUS4093903883813753613573553521-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 (%)MonthsXIEN

33、CE VTAXUS Stone GWSPIRIT II + III: All Death or MINumber at riskXIENCE V892876871859848826824814810TAXUS4093903883813753613573553521-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 1003691215182124All Death or MI (%)MonthsXIENCE VTAXUS Stone GWSPIRI

34、T II + III: Ischemic MACE Stone GWSPIRIT II + III: Ischemic TVFIschemic TVF = Cardiac death, MI, or ischemic TVRStone GWSPIRIT II + III: All TLRAll TLR = Ischemic TLR + non ischemic TLR Stone GWZotarolimus-Eluting Stent:Analysis of Six Clinical TrialsKandzari D,Euro-PCR2009Zotarolimus-Eluting Stent:

35、Analysis of Six Clinical TrialsKandzari D,Euro-PCR2009Zotarolimus-Eluting Stent:Analysis of Six Clinical TrialsKandzari D,Euro-PCR2009NEVO RES-ELUTION 1 TrialSpaulding C, Euro-PCR 2009NEVO RES-ELUTION 1 Trial Spaulding C, Euro-PCR 2009NEVO RES-ELUTION 1 Trial Spaulding C, Euro-PCR 2009NEVO RES-ELUTI

36、ON 1 Trial Spaulding C, Euro-PCR 2009ABSORBThe goal of this trial was to evaluate the use of a bioabsorbable drug-eluting stent (DES) platform among patients undergoing elective percutaneous coronary intervention (PCI) for a de novo coronary lesion.BVSBioabsorbable Stent PlatformML VISIONBalloon SDSBioabsorbablePolymer CoatingEverolimusBVS 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.