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1、 Safety of DES Safety of DESRevascularization: CABG or PCI Revascularization: CABG or PCI Treatment for bifurcation: Treatment for bifurcation: sample is better?sample is better?Fractional flow-reserve for guidingFractional flow-reserve for guidingNew generation of DESNew generation of DESKirtane AJ
2、, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2021; Chicago, IL.a. Fixed-effects modelb. Random-effects modelAll-cause mortalityKirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2021; Chicag
3、o, IL.a. Fixed-effects modelb. Random-effects modelKirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2021; Chicago, IL.*Random-effects model Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional fl
4、ow-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 artery lesions longer than
5、 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-vessel disease. The TAXUS E
6、xpress Stent System has not been specifically indicated for patients with diabetes.revascularization strategies 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
7、segments based on the classification proposed by the AHA and modified for the ARTS study Circulation 1975; 51:31-3 & 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 cl
8、assification, J Am Coll Cardiol 1997;30:649-656TortuosityThrombusBifurcationTotal Occlusion3 VesselLeft MainDominanceCalcificationNumber & 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. ref
9、used informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)TAXUSn=903PCIn=198CABGn=1077CABGn=897no f/un=4285yr f/un=649PCIall captured w/ follow upCABG2500750 w/ f/uTotal enrollment N=3075Stratification: LM and DiabetesTwo Registry Arm
10、sRandomized Armsn=1800Two Registry ArmsN=1275Randomized ArmsN=1800Heart Team (surgeon & interventionalist)PCIN=198CABGN=1077Amenable for only one treatment approachTAXUS*N=903 CABGN=897Amenable for bothtreatment optionsStratification: LM and DiabetesLM33.7%3VD66.3%LM34.6%3VD65.4%DM 28.5%Non DM71
11、.5%NonDM71.8%DM28.2%23 US Sites62 EU Sites+ +ITT populationEvent Rate 1.5 SE, *Fisher exact testAll DeathRevascularizationCVA (Stroke)Myocardial InfarctionTAXUS* (N=903)CABG (N=897)P=0.0015*061210200Months Since AllocationCumulative Event Rate (%)ITT population12.1% 17.8% Event Rate 1.5 SE. *Fishers
12、 Exact TestTAXUS* (N=903)CABG (N=897)P=0.89Patients (%)ITT populationTAXUS* (N=903)CABG (N=897)P=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 population061220400Months Since AllocationCumulative Event Rate
13、 (%)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 populationMean baselineSYNTAX ScoreCABG15.5 4.3TAXUS15.7 4.4061220400Months Since AllocationCumulative Event Rate (%)TAXUS (N=)CABG (N=150)P=0.008*25.3%12.9%Event rate 1.5 SE, *Fisher
14、 exact testCalculated by core laboratory; ITT populationMACCE to 12 Months by SYNTAX Score TertileHigh Scores (33) Left Main SubsetMean baselineSYNTAX ScoreCABG42.1 7.6TAXUS43.8 9.1ITT populationTAXUS*CABG(n=705)(n=91)(n=)(n=218)(n=258)P=0.44P=1.0P=0.27P=0.29P=0.42Patients (%)061220400Months Since A
15、llocationCumulative Event Rate (%)P0.001*19.1%11.2%ITT populationEvent Rate 1.5 SE, *Fisher exact testTAXUS (n=546)CABG (n=549)P=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
16、ITT populations had same outcomePatients (%)SYNTAX Score2212-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) Safety of DES Revasculariz
17、ation: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding PCI in multi-vessel diseaseNew generation of DES Safety of DES Revascularization: CABG or PCITreatment for bifurcation: sample is better?Fractional flow-reserve for guiding PCI in multi-vessel diseaseNe
18、w generation of DES Angiography-guided PCIFFR-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-yea
19、r follow-upFLOW CHART FFR-guided30 days2.9%90 days3.8%180 days4.9%360 days5.3%Angio-guidedabsolute difference in MACE-free survival 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 *AKA Promus1-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
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