1、冠心病介入治疗进展 - 2008,高润霖 Cardiovascular Institute Fu Wai Hospital CAMS, PUMC,Safety of DES Revascularization: CABG or PCI Treatment for bifurcation: sample is better? Fractional flow-reserve for guiding New generation of DES,Kirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized tria
2、ls and registries; March 28, 2008; Chicago, IL.,MEGA meta-analysis,a. Fixed-effects model b. Random-effects model,All-cause mortality,Kirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2008; Chicago, IL.,MI,a. Fixed-effects model b. Random-eff
3、ects model,MEGA meta-analysis,Kirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2008; Chicago, IL.,Target-vessel revascularization,*Random-effects model,MEGA meta-analysis,Safety of DES Revascularization: CABG or PCI Treatment for bifurcation
4、: sample is better? Fractional flow-reserve for guidingPCI in multi-vessel disease New 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 co
5、ronary 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 with moderate or severe calcification in the lesion or a chronic total occlusion; or patients with
6、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 Heart team (surgeon & interventional cardiologist) assessed each patient in regards to: Patients o
7、perative 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 strategies for patients with high risk lesions,Sianos et al, EuroIntervention 2005;1:219-227 Valgimi
8、gli et al, Am J Cardiol 2007;99:1072-1081 Serruys et al, EuroIntervention 2007;3:450-459 Coronary tree segments based on the classification proposed by the AHA and modified for the ARTS study Circulation 1975; 51:31-3 4:209-19,Leaman score, Circ 1981;63:285-299 Lesions classification ACC/AHA , Circ
9、2001;103:3019-3041 Bifurcation classification, CCI 2000;49:274-283 CTO classification, J Am Coll Cardiol 1997;30:649-656,Tortuosity,Thrombus,Bifurcation,Total Occlusion,3 Vessel,Left Main,Dominance,Calcification,Number & location of lesions,23 US Sites,62 EU Sites,+,SYNTAX Trial Design,Adverse Event
10、s to 12 Months,ITT population,Event Rate 1.5 SE, *Fisher exact test,All Death,Revascularization,CVA (Stroke),Myocardial Infarction,TAXUS* (N=903),CABG (N=897),MACCE to 12 Months,P=0.0015*,ITT population,12.1%,17.8%,Event Rate 1.5 SE. *Fishers Exact Test,Symptomatic Graft Occlusion & Stent Thrombosis
11、 to 12 Months,MACCE to 12 Months Left Main Subset,P=0.44*,13.6%,15.8%,Event rate 1.5 SE, *Fisher exact test,ITT population,P=0.19*,7.7%,13.0%,Event rate 1.5 SE, *Fisher exact test,Calculated by core laboratory; ITT population,MACCE to 12 Months by SYNTAX Score Tertile Low Scores (0-22) LM Subset,P=0
12、.008*,25.3%,12.9%,Event rate 1.5 SE, *Fisher exact test,Calculated by core laboratory; ITT population,MACCE to 12 Months by SYNTAX Score Tertile High Scores (33) Left Main Subset,Overall MACCE at 12 Months Left Main Subset,ITT population,(n=705),(n=91),(n=138),(n=218),(n=258),P=0.44,P=1.0,P=0.27,P=0
13、.29,P=0.42,Patients (%),MACCE to 12 Months 3VD Subset,P0.001*,19.1%,11.2%,ITT population,Event Rate 1.5 SE, *Fisher exact test,MACCE Components 3VD to 30 Days,P=0.08*,30 Day Event Rate, %,P=0.03*,P=0.02*,P=0.20,TAXUS* (n=546),CABG (n=549),P=0.45*,*chi-square test; Fisher exact test,CABG,TAXUS*,P=0.3
14、9,3 Vessel Disease*,n=34,n=43,*per protocol and ITT populations had same outcome,Combined Safety (Death/CVA/MI) 3VD,Patients (%),MACCE to 12 Months vs SYNTAX Score,SYNTAX Score 22,P=0.10,P0.001,P=0.71,12-month MACCE, %,SYNTAX Score,KM Estimates, Event Rate 1.5 SE; *chi square test; raw SYNTAX score
15、for illustrative purposes only,RCT ITT pts; site-reported data,SYNTAX Score 23-32,SYNTAX Score 33,Safety of DES Revascularization: CABG or PCI Treatment for bifurcation: sample is better? Fractional flow-reserve for guidingPCI in multi-vessel disease New generation of DES,BBC ONE,The British Bifurca
16、tion Coronary study: Old, New and Evolving strategies a randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions,Techniques,Simple stepwise provisional T-stentingComplex total lesion coverage: crush or culotte (according to operator preference),Technique (simple),
17、Following main vessel stenting, the side branch should not be treated further unless there is:90%) of the side branch Threatened side vessel closure Side-branch dissection type Aif any of these applies, the operator may Stage 2 Kissing bolloon, T-stent, culotte stent, crush,PRIMARY ENDPOINT Composit
18、e (9months) Death, MI, TVF,In-hospital MACCE,CONCLUSIONS,For unselected bifurcation lesions, a stepwise provisional T stent trategy is superior to a systematic dual tenting strategy in all domains:procedural success procedural complications in-hospital and 9-month MACE,Safety of DES Revascularizatio
19、n: CABG or PCI Treatment for bifurcation: sample is better? Fractional flow-reserve for guidingPCI in multi-vessel disease New generation of DES,FRACTIONAL FLOW RESERVE versus ANGIOGRAPHY FOR GUIDING PCI IN PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASE,FAME,Angiography-guided PCI,FFR-guided PCI,
20、Measure FFR in all indicated stenoses,Stent all indicated stenoses,Stent only those stenoses with FFR 0.80,Randomization,Indicate all stenoses 50% considered for stenting,Patient with stenoses 50% in at least 2 of the 3 major epicardial vessels,1-year follow-up,FLOW CHART,FAME study: Procedural Resu
21、lts,30 days 2.9%,90 days 3.8%,180 days 4.9%,360 days 5.3%,Angio-guided,absolute difference in MACE-free survival,FAME study: Event-free Survival,Adverse Events at 1 year,Routine measurement of FFR during DES-stenting in patients with multivessel disease is superior to current angiography guided trea
22、tment.It improves outcome of PCI significantlyIt supports the evolving paradigm of “Functionally Complete Revascularization”, i.e. stenting of ischemic lesions and medical treatment of non-ischemic ones.,FAME study: CONCLUSIONS,Safety of DES Revascularization: CABG or PCI Treatment for bifurcation:
23、sample is better? Fractional flow-reserve for guidingPCI in multi-vessel disease New generation of DES,Drug-eluting Stents 2008,Endeavor,Phosphorylcholine,Zotarolimus,Driver,Drug,Polymer,Xience V*,VDF + HFP copolymer,Everolimus,Vision,*AKA Promus,Stent,SPIRIT II + III: Cardiac Death or MI,0,2,4,6,8,
24、10,0,3,6,9,12,15,18,21,24,Cardiac Death or MI (%),Months,Stone GW,SPIRIT II + III: All Death or MI,0,2,4,6,8,10,0,3,6,9,12,15,18,21,24,All Death or MI (%),Months,Stone GW,SPIRIT II + III: Ischemic MACE,Stone GW,SPIRIT II + III: Ischemic TVF,Ischemic TVF = Cardiac death, MI, or ischemic TVR,Stone GW,
25、SPIRIT II + III: All TLR,All TLR = Ischemic TLR + non ischemic TLR,Stone GW,Zotarolimus-Eluting Stent: Analysis of Six Clinical Trials,Kandzari D,Euro-PCR2009,Zotarolimus-Eluting Stent: Analysis of Six Clinical Trials,Kandzari D,Euro-PCR2009,Zotarolimus-Eluting Stent: Analysis of Six Clinical Trials
26、,Kandzari D,Euro-PCR2009,NEVO RES-ELUTION 1 Trial,Spaulding C, Euro-PCR 2009,NEVO RES-ELUTION 1 Trial,Spaulding C, Euro-PCR 2009,NEVO RES-ELUTION 1 Trial,Spaulding C, Euro-PCR 2009,NEVO RES-ELUTION 1 Trial,Spaulding C, Euro-PCR 2009,ABSORB,The goal of this trial was to evaluate the use of a bioabsor
27、bable drug-eluting stent (DES) platform among patients undergoing elective percutaneous coronary intervention (PCI) for a de novo coronary lesion.,BVS 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.
28、85 0.36mm (N=27),BVS: 0.44 0.35mm (N=26),EES*: 0.07 0.23mm (N=22),ABSORB Angiographic Late Loss,ACC 2007,IVUS results (24 pts),Serial IVUS,ABSORB Trial: Baseline Characteristics,ACC 2007,ABSORB Trial: Post-procedure Data,ACC 2007,ABSORB Trial: Six Month Follow-up Characteristics,Conclusion,The safety DES has been confirmed by RCT and real world registries PCI could be considered in selected Patients with L M and triple vessel disease. New generation of DES is emerging and revealed advantages.,Thank you,
