高润霖冠心病介入治疗的热点

1、会计学1高润霖冠心病介入治疗的热点高润霖冠心病介入治疗的热点第1页/共88页第2页/共88页From TCT 2006第3页/共88页From TCT 2006第4页/共88页CYPHER stent (n=870) Bare metal stent (n=878)TAXUS stent (n=1,755) Bare metal stent (n=1,758)P=0.2099.4% (5)98.8% (10)P=0.3099.1% (14)98.7% (20)第5页/共88页CYPHER stent (n=870) Bare metal stent (n=878)TAXUS stent (n=

2、1,755) Bare metal stent (n=1,758)P=0.2099.4% (5)98.8% (10)P=0.3099.1% (14)98.7% (20)5 vs. 0, P=0.0259 vs. 2, P=0.028第6页/共88页P=0.2394.7% (45)93.3% (57)CYPHER stent (n=870) Bare metal stent (n=878)P=0.6893.4% (92)93.9% (86)TAXUS stent (n=1,755) Bare metal stent (n=1,758)第7页/共88页P=0.8693.8% (53)93.6% (

3、55)CYPHER stent (n=870) Bare metal stent (n=878)P=0.6693.7% (105)93.0% (115)TAXUS stent (n=1,718) Bare metal stent (n=1,727)第8页/共88页P0.000176.4% (202)92.2% (66)CYPHER stent (n=870) Bare metal stent (n=878)P0.000180.0% (338)89.9% (166)TAXUS stent (n=1,755) Bare metal stent (n=1,758)第9页/共88页第10页/共88页M

4、auri, L. N Engl J Med 2007;356:1020-9.definite and probabledefinite and probable1.2%0.6%1.7%1.5%1.3%0.8%1.8%1.4%第11页/共88页 When DES are used for their approved indications, the risk of thrombosis does not outweigh their advantages over BMS in reducing TLR As compared with on-label use, off-label use

5、is associated with increased risks of both early and late stent thrombosis,as well as death or MI第12页/共88页第13页/共88页第14页/共88页第15页/共88页第16页/共88页第17页/共88页第18页/共88页第19页/共88页第20页/共88页第21页/共88页第22页/共88页第23页/共88页第24页/共88页第25页/共88页In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for

6、1 yr, DES resulted in: Non significant 3% and 6% reductions in mortality and MI respectively A highly significant 55% reduction in TVRIn 30 registries in which 174,302 pts were treated with either DES or BMS and followed for 1 yr, DES resulted in: A highly significant 20% reduction in mortality A si

7、gnificant 11% reduction in MI A highly significant 47% reduction in TVR第26页/共88页The favorable results of DES from the RCT and registry analysis populations were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 yearsThese findings, derived from more tha

8、n 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both RCTs and in the “real-world”第27页/共88页A 65-year old male with CAD, hypertension, MI, Status post x2 stents, RCA, A 65-year old male with CAD, hypertension,

9、 MI, Status post x2 stents, RCA, proximal BxVelocity and Cypher distal - 15 months prior to death (traumatic proximal BxVelocity and Cypher distal - 15 months prior to death (traumatic brain injury) brain injury) BxVelocityNeointimaStrutFibrinCypherFibrinNo endothelializationFrom Dr.R.Vermani第28页/共8

10、8页Incidence (%)Iakovou et al. JAMA. 2005;293:2126.Overall stent thrombosis = 1.3% (P=0.09, N=2229)1.4%2.0%2.5%3.3%3.6%6.2%8.7%29.0%Unstable anginaThrombusDiabetes Unprotected left mainBifurcationRenal failurePrior brachy RxPremature antiplateletdiscontdHow long should dual antiplatelet therapy conti

11、nue?第29页/共88页 计划中的非心脏手术计划中的非心脏手术 不适宜长期双重抗血小板治疗不适宜长期双重抗血小板治疗 置入置入DES后必须行非心脏手术者后必须行非心脏手术者 尽量不停阿斯匹林尽量不停阿斯匹林 术后尽早恢复氯吡格雷治疗术后尽早恢复氯吡格雷治疗 教育病人家属，与相关医师沟通、必要时咨询心脏科医生教育病人家属，与相关医师沟通、必要时咨询心脏科医生第30页/共88页第31页/共88页第32页/共88页第33页/共88页第34页/共88页第35页/共88页第36页/共88页第37页/共88页第38页/共88页第39页/共88页第40页/共88页第41页/共88页第42页/共88页第43

12、页/共88页第44页/共88页010300jt-os.ppt - On-screen 45第45页/共88页第46页/共88页TAPAS Trial: 1071 STEMI patients randomized535 were assigned tothrombus aspiration33 did not undergo PCI502 underwent primary PCI295 underwent TA followed bydirect stenting153 underwent TA with additionalballoon dilation 54 had crossover

13、 to conventionalPCI536 were assigned toconventional PCI33 did not undergo PCI503 underwent primary PCI485 underwent balloon dilationfollowed by stenting 12 underwent conventional PCIwith additional TA 6 had crossover to TA530 complete follow-up at 1 year530 complete follow-up at 1 yearZiljstra et al

14、, NEJM 2008第47页/共88页P 0.001 Patients (%)Thrombus aspirationConventional PCIZiljstra et al, NEJM 2008第48页/共88页Time (days)0100200300400Mortality (%)024681012Conventional PCIThrombus-AspirationLog-Rank p = 0.040*Unpublished resultsZiljstra et al, NEJM 2008第49页/共88页Time (days)0100200300400Death or Reinf

15、arction (%)024681012Conventional PCIThrombus-AspirationLog-Rank p = 0.016*Unpublished resultsZiljstra et al, NEJM 2008第50页/共88页第51页/共88页第52页/共88页第53页/共88页p=0.0002第54页/共88页第55页/共88页Composite of Death or Myocardial InfarctionNo./Total (%)Odds Ratio (95% Cl)Favors RoutineInvasiveFavors SelectiveInvasiv

16、eOR, 0.820.72-0.93P0.0010.11.010第56页/共88页CCS Class III-IV AnginaRehospitalizationOdds Ratio (95% Cl)0.11.0100.11.010OR, 0.66 0.60-0.72,P0.001Favors RoutineInvasiveFavors SelectiveInvasive第57页/共88页第58页/共88页Boden WE et al. Am Heart J. 2006;151:1173-9. Boden WE et al. N Engl J Med. 2007;356:1503-16.Opt

17、imal medical therapy* + PCI (n = 1149)Optimal medical therapy(n = 1138)AHA/ACC Class I/II indications for PCI, suitable coronary artery anatomy + 70% stenosis in 1 proximal epicardial vessel + objective evidence of ischemia (or 80% stenosis + CCS class III angina without provocation testing) Primary

18、 outcomes: All-cause mortality, nonfatal MIFollow-up: Median 4.6 yearsRandomized*Intensive pharmacologic therapy + lifestyle interventionCCS = Canadian Cardiovascular SocietySecondary outcomes: Death, MI, stroke; ACS hospitalization第59页/共88页Number at RiskMedical Therapy 1138 1017 959 834 638 408 192

19、 30PCI 1149 1013 952 833 637 417 200 35Years01234560.00.50.60.70.80.91.0PCI + OMTOptimal Medical Therapy (OMT)7Freedom fromDeath or MI (%)Death/MIat 4.6 yrs19.0%18.5%第60页/共88页HR 1.05(0.87-1.27)P = 0.62*Boden WE et al. N Engl J Med. 2007;356:1503-16.All-cause death, MI (time to first event)*Unadjuste

20、dNo. at riskMedical therapy1138101795983463840819230PCI1149101395283363741720035Medical therapy PCI + medical therapySurvival free of primaryoutcome024700.50.60.70.81.00.9Years6531第61页/共88页No. at riskMedical therapyPCI3844302312468488717733917929102910511073109411381149120134192200409418638637834833

21、9629541019101511381149Boden WE et al. N Engl J Med. 2007;356:1503-16.*UnadjustedAll-cause deathMyocardial infarctionOverall survival Survival free of MIPCI + medical therapy1.00.90.70.8Medical therapy1.00.90.70.8012345670YearsYears012345670HR 0.87(0.65-1.16)P = 0.38*HR 1.13(0.89-1.43)P = 0.33*第62页/共

22、88页Boden WE et al. N Engl J Med. 2007;356:1503-16.*UnadjustedHR 1.07(0.84-1.37)P = 0.56*No. at riskMedical therapyPCI1271342362464184316626678338359569571025102711381149Survival free of ACSYears0012345671.00.90.70.8PCI + medical therapyMedical therapy第63页/共88页01020304050607080Baseline1 year3 years5

23、yearsPCI + medical therapyMedical therapyBoden WE et al. N Engl J Med. 2007;356:1503-16.P 50%Previous CABGNoYes50%Baseline characteristicsHazard ratio (95% CI)第65页/共88页第66页/共88页第67页/共88页10.0 mo in the PCI group and 10.8 mo in the OMT groupBoden WE et al. N Engl J Med. 2007;356:1503-16.第68页/共88页第69页/

24、共88页010300jt-os.ppt - On-screen 70第70页/共88页第71页/共88页Odds Ratio (95% Confidence Interval)OverallTrialSievers et al.Dakik et al.ACIPACME-1TIMEALKKAVERTBech et al.MASSACME-2RITA-2Year of Publication19931998199719972004200319992001199919972003271/3675PCI0/441/212/19216/11545/1536/1491/1772/906/729/5143/

25、504335/3838Medical1/441/2320/36615/11240/14817/1511/1644/916/7210/5043/514Deaths/TotalSWISSI IIDANAMICOURAGEINSPIREHambrecht et al.MASS II2007200620072006200420066/9619/50385/11492/10428/20522/10524/50595/11381/10135/2030/500/511.110Random effects modelFixed effects modelPheterogeneity=0.263; I2=17%

26、Kastrati et al; TCT 20070.80 (0.64 to 0.99)0.80 (0.68 to 0.95)第72页/共88页Hypothesis: Reduction in Ischemia will be greater for patientsRandomized to PCI+OMT than for those Randomized to OMTSerial Rest/Stress Myocardial Perfusion SPECT (MPS)To Compare Patient Management Strategy for Ischemia Reduction

27、Pre-Rx = Off Meds 6-18m = On Meds* Timing Chosen toOccur BeyondWindow of In-StentRestenosis & Delayed to AllowEffects of MedicalRx to be ObservedDocumentedPre-Rx IschemiaPCI + OMT(n=159)OMT(n=155)Repeat MPS*at 6-18m Repeat MPS*at 6-18m Mean = 374 50 daysShaw, et al. J Nucl Cardiol. 2006;13:685-6

28、98.第73页/共88页第74页/共88页74%0.998.2%(7.2%-9.3%)8.6%(7.5%-9.8%)* CCS=Canadian Cardiovascular Society* 10% Ischemic MyocardiumShaw LA. AHA 2007第75页/共88页Death or MI Rate (%)0%(n=23)1%-4.9% (n=141)5%-9.9%(n=88)10%(n=62)Shaw LA. AHA 2007第76页/共88页0405101520253530Pre-Rx6-18m8.2%5.5%(4.7%-6.3%)0405101520253530P

29、re-Rx6-18m(6.9%-9.4%)8.6%8.1%Mean = -2.7% (95% CI = -3.8% to -1.7%)Mean = -0.5%(95% CI = -1.6% to 0.6%)Shaw LA. AHA 2007第77页/共88页Ischemia reduction 5%In 105 pts with moderate-to-severe baseline ischemiaShaw LA. AHA 2007第78页/共88页Death or MI Rate (%)Ischemia Reduction 5%(n=68)No Ischemia Reduction(n=37)Shaw LA. AHA 2007In 105 pts with moderate-to-severe baseline is