外科治疗缺血性心力衰竭(STICH)的研究概要课件.ppt

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1、外科治疗缺血性心力衰竭（外科治疗缺血性心力衰竭（外科治疗缺血性心力衰竭（外科治疗缺血性心力衰竭（STICHSTICHSTICHSTICH）的研究：）的研究：）的研究：）的研究：CABG CABG CABG CABG 对照对照对照对照 CABG+SVRCABG+SVRCABG+SVRCABG+SVRSurgical Treatment for IschemicSurgical Treatment for IschemicSurgical Treatment for IschemicHeart Failure(STICH)Trial:Heart Failure(STICH)Trial:Heart

2、Failure(STICH)Trial:CABG versus CABG+SVRCABG versus CABG+SVRCABG versus CABG+SVRRobert H.Jones,M.D.Robert H.Jones,M.D.Robert H.Jones,M.D.March 29,2009March 29,2009March 29,2009STICH Financial DisclosuresSTICH Financial DisclosuresOriginal Recipient InstitutionOriginal Recipient InstitutionPrincipal

3、InvestigatorPrincipal InvestigatorActivityActivityDuke University Medical CenterDuke University Medical CenterRobert H.JonesRobert H.JonesClinical Coordinating CtrClinical Coordinating CtrDuke University Medical CenterDuke University Medical CenterKerry L.LeeKerry L.LeeStatistical and Data CCStatist

4、ical and Data CCDuke University Medical CenterDuke University Medical CenterDaniel B.MarkDaniel B.MarkEQOL Core LaboratoryEQOL Core LaboratoryUniv of Alabama-BirminghamUniv of Alabama-BirminghamGerald M.PohostGerald M.PohostCMR Core LaboratoryCMR Core LaboratoryMayo ClinicMayo ClinicJae K.OhJae K.Oh

5、ECHO Core LaboratoryECHO Core LaboratoryUniversity of PittsburghUniversity of PittsburghArthur M.FeldmanArthur M.FeldmanNCG Core LaboratoryNCG Core LaboratoryNorthwestern UniversityNorthwestern UniversityRobert O.BonowRobert O.BonowRN Core LaboratoryRN Core LaboratoryWashington Hospital CenterWashin

6、gton Hospital CenterJulio A.PanzaJulio A.PanzaDECIPHER SubstudyDECIPHER SubstudyBaylor University Medical CtrBaylor University Medical CtrPaul GrayburnPaul GrayburnMR TEE SubstudyMR TEE SubstudyFunding Sources:Funding Sources:National Heart,Lung and Blood Institute 97.3%National Heart,Lung and Blood

7、 Institute 97.3%Chase Medical 0.3%Chase Medical 0.3%Abbott Laboratories 2.3%Abbott Laboratories 2.3%CV Therapeutics 0.1%CV Therapeutics 0.1%Core STICH Study Organizationn nPrincipal Investigator:Robert H JonesPrincipal Investigator:Robert H Jonesn nCo-Principal investigator:Eric VelazquezCo-Principa

8、l investigator:Eric Velazquezn nDCC Principal Investigator:Kerry L LeeDCC Principal Investigator:Kerry L Leen nStudy Chair:Jean L RouleauStudy Chair:Jean L Rouleaun nExecutive Committee:Robert H Jones,Eric Velazquez,Kerry L Executive Committee:Robert H Jones,Eric Velazquez,Kerry L Lee,Jean L Rouleau

9、,Patrice Desvigne-Nickens,George Sopko,Lee,Jean L Rouleau,Patrice Desvigne-Nickens,George Sopko,Chris OConnor,Robert Michler,and Jae Oh.Chris OConnor,Robert Michler,and Jae Oh.n nDSMB chair:Sid GoldsteinDSMB chair:Sid Goldsteinn nPublications Committee chair:James HillPublications Committee chair:Ja

10、mes Hilln nClinical Endpoints Committee:Peter CarsonClinical Endpoints Committee:Peter CarsonHypothesis 2 Enrollment by CountryHypothesis 2 Enrollment by Country 1000 patients1000 patients 96 clinical sites96 clinical sites 23 countries23 countries 1231 days1231 daysRandomized PatientsRandomized Pat

11、ientsNumbers for AnalysisNumbers for Analysisby Hypothesisby HypothesisMED+CABG(610)MED+CABG(499)CAD,EF CAD,EF 0.35 0.35Eligible for MED-only treatment?Eligible for MED-only treatment?Eligible for SVR?Eligible for SVR?Not in trialNot in trialNoNoHypothesis 1Hypothesis 1n=1212n=1212Hypothesis 2Hypoth

12、esis 2n=1000n=1000MED(602)MED+CABG+SVR(501)Stratum An=10611MED(527)2MED+CABG(534)Eligible for SVR?Eligible for SVR?Stratum Cn=859YesYes6MED+CABG(423)7MED+CABG+SVR(436)Stratum Bn=2163MED(75)5MED+CABG+SVR(65)4MED+CABG(76)+21362136Randomized ptsRandomized pts=+602602MED onlyMED only10331033CABG addedCA

13、BG added 501 501CABG+SVR addedCABG+SVR added=+NoNoYesYesYesYesNoNo Hypothesis 2n nSurgical ventricular reconstruction(SVR)combined with Surgical ventricular reconstruction(SVR)combined with CABG and evidence-based medical therapy(MED)CABG and evidence-based medical therapy(MED)decreases death or car

14、diac hospitalization compared to decreases death or cardiac hospitalization compared to CABG and MED without SVR.CABG and MED without SVR.n n90%power for 20%reduction assuming 90%power for 20%reduction assuming 45%3-year event 45%3-year event rate allowing for 20%treatment crossovers.rate allowing f

15、or 20%treatment crossovers.n n7%of CABG and 9%of CABG+SVR patients did not 7%of CABG and 9%of CABG+SVR patients did not receive assigned operation.receive assigned operation.n nFollow-up 99%complete over median of 48 months.Follow-up 99%complete over median of 48 months.n nAll outcomes reported by o

16、peration assigned by All outcomes reported by operation assigned by randomization.randomization.n nConduct of operation reported by procedure receivedConduct of operation reported by procedure received.Baseline Clinical CharacteristicsCharacteristicCABGN=499CABG+SVRN=501Age,median 25Age,median 25tht

17、h,75,75thth,years,years62(54,66)62(54,66)62(56,69)62(56,69)FemaleFemale78(16%)78(16%)69(14%)69(14%)WhiteWhite90%90%92%92%DiabetesDiabetes35%35%34%34%Creatinine,0.5 mg/dLCreatinine,0.5 mg/dL8%8%9%9%Prior stroke6%6%Mitral Regurgitation by Treatment in 1,000 Mitral Regurgitation by Treatment in 1,000 H

18、ypothesis 2 PatientsHypothesis 2 PatientsMitral Regurgitation SeverityCABGN=499CABG+SVRN=501None or trace173(35%)190(38%)Mild(2+)233(47%)216(44%)Moderate(3+)72(15%)70(14%)Severe(4+)16(3%)20(4%)Not assessed5(4%)5(3%)18%18%18%Site Reported Left Ventricular Function for Site Reported Left Ventricular F

19、unction for 1,000 Hypothesis 2 Patients by Treatment1,000 Hypothesis 2 Patients by TreatmentLV FunctionCABGN=499CABG+SVRN=501Site Qualifying Study Echocardiogram(%)66%63%Contrast ventriculogram13%18%CMR11%9%Gated SPECT10%10%LVEF,median(25th,75th).28(.23,.31).28(.24,.31)ESVI,median(25th,75th),mL/m282

20、(65,102)82(66,105)%anterior wall with akinesia/dyskinesia,median(25th,75th)56(40,60)50(40,60)Coronary Anatomy by Treatment for Coronary Anatomy by Treatment for 1,000 Hypothesis 2 Patients1,000 Hypothesis 2 PatientsMajor Coronary Major Coronary Arteries with Arteries with StenosisStenosis%Stenosis%S

21、tenosisCABGCABGN=499N=499CABG+SVRCABG+SVRN=501N=501OneOne 50%50%7%7%10%10%LM stenosisLM stenosis50-74%50-74%14%14%12%12%OneOne 75%75%17%17%20%20%TwoTwo 75%75%41%41%42%42%ThreeThree 75%75%41%41%36%36%Proximal LADProximal LAD 75%75%78%78%74%74%LM stenosisLM stenosis 75%75%6%6%7%7%Duke coronary Duke co

22、ronary disease index*disease index*MedianMedian(25(25thth,75,75thth)65(43,91)65(43,91)65(39,91)65(39,91)*0=coronary angiogram shows no coronary disease,100=0=coronary angiogram shows no coronary disease,100=0=coronary angiogram shows no coronary disease,100=95%LM stenosis95%LM stenosis95%LM stenosis

23、Medication at BaselineMedicationCABGN=499CABG+SVRN=501Beta blockerBeta blocker85%85%87%87%ACE inhibitor or angiotensin ACE inhibitor or angiotensin receptor blockerreceptor blocker87%87%89%89%ACE inhibitorACE inhibitor80%80%82%82%DigoxinDigoxin17%17%14%14%DiureticDiuretic69%69%66%66%AspirinAspirin77

24、%77%77%77%Aspirin or warfarinAspirin or warfarin81%81%83%83%StatinStatin79%79%75%75%Operative Conduct by Operation Received Operative Conduct by Operation Received in 979 Hypothesis 2 Patientsin 979 Hypothesis 2 PatientsVariableVariableCABGCABGN=490N=490CABG+SVRCABG+SVRN=489N=489P PStatus at Operati

25、on Elective operation84%83%0.54 Urgent13%13%Emergency3%4%Bypass Grafts0.34 1 or more arterial grafts93%89%2 or less total grafts27%30%3 or more total grafts73%70%Mitral surgery17%19%0.50SVR patch59%Efficiency of Operative Care Efficiency of Operative Care in 979 Hypothesis 2 Patientsin 979 Hypothesi

26、s 2 PatientsDuration of OperationDuration of OperationCABGCABGN=490N=490CABG+SVRCABG+SVRN=489N=489P PTotal time in operating room(median,25th,75th),hours4.9(4.1,6.0)5.5(4.7,6.6)0.001Cardiopulmonary bypass time(median,25th,75th),minutes99(73,125)124(99,158)0.001Aortic occlusion(median,25th,75th),minu

27、tes62(45,84)80(62,106)0.001Requirements for Postoperative Care Endotracheal intubation (median,25th,75th),hours15.1(10.9,22.1)16.6(12.0,25.2)0.002 Acute care(median,25th,75th),hours49.8(28.8,95.5)69.5(42,137)30 days22(5%)31(6%)0.20Baseline and Four Month End-Systolic Volume Baseline and Four Month E

28、nd-Systolic Volume Index(ESVI)in 373 Hypothesis 2 Patients With Index(ESVI)in 373 Hypothesis 2 Patients With Quantitative Echocardiogram at Both IntervalsQuantitative Echocardiogram at Both IntervalsESVI82 ml/m277 ml/m283 ml/m267 ml/m2P0.001P0.001P0.001Canadian Cardiovascular Society Angina Class in

29、 Canadian Cardiovascular Society Angina Class in Hypothesis 2 Patients at Baseline and Latest Follow-upHypothesis 2 Patients at Baseline and Latest Follow-upPatientsNo Angina121Class I-II130Class III-IV248No Angina339Class I-II88Class III-IV8No Angina128Class I-II129Class III-IV244No Angina339Class

30、I-II83Class III-IV6Angina symptoms improved by an average of 1.7 classes Angina symptoms improved by an average of 1.7 classes in both cohorts(P=0.84).in both cohorts(P=0.84).New York Heart Association Heart Failure Class in New York Heart Association Heart Failure Class in Hypothesis 2 Patients at

31、Baseline and Latest Follow-upHypothesis 2 Patients at Baseline and Latest Follow-upPatientsClass I 36Class II222Class III-IV241Class I165Class II190Class III-IV80Class I 50Class II207Class III-IV244Class I179Class II188Class III-IV62Heart failure symptoms improved by an average of one classHeart fai

32、lure symptoms improved by an average of one classIn both cohorts(P=0.70).In both cohorts(P=0.70).Baseline and Four Month 6-Minute Walk in 693 Baseline and Four Month 6-Minute Walk in 693 Hypothesis 2 Patients with Baseline AssessmentHypothesis 2 Patients with Baseline AssessmentPatients30-Day Mortal

33、ity30-Day MortalityOutcomeOutcomeCABGCABGN=499N=499CABG+SVRCABG+SVRN=501N=501P PDeath Within 30 Days After Randomization All patients by intention to treat22/499(4.4%)30/501(6.0%)0.26Death During or Within 30 Days of Operation Operated patients by intention to treat25/490(5.1%)26/489(5.3%)0.88 Opera

34、ted patients by operation received23/498(4.6%)28/481(5.8%)0.4000.10.20.30.40.50.60.7012345Event RateYears from RandomizationCABG49950131931927027522021699112323CABGCABG+SVRNo.at Risk Death or Cardiac Hospitalization Death or Cardiac Hospitalization Kaplan-Meier Estimates of Primary Endpoint Kaplan-M

35、eier Estimates of Primary Endpoint292 events00.10.20.30.40.50.60.7012345Event RateYears from RandomizationCABGCABG+SVRHR 0.99(95%CI:0.84,1.17),P=0.90 49950131931927027522021699112323CABGCABG+SVRNo.at Risk Death or Cardiac HospitalizationDeath or Cardiac Hospitalization Kaplan-Meier Estimates of Prim

36、ary Endpoint Kaplan-Meier Estimates of Primary Endpoint 292 events289 events Mortality(All-Cause)Mortality(All-Cause)Kaplan-Meier Estimates Kaplan-Meier Estimates00.10.20.30.40.50.60.7012345Mortality RateYears from RandomizationCABG4995014344294174043633522011935953CABGCABG+SVRNo.at Risk141 deaths M

37、ortality(All-Cause)Mortality(All-Cause)Kaplan-Meier Estimates Kaplan-Meier Estimates00.10.20.30.40.50.60.7012345Mortality RateYears from RandomizationCABG+SVRHR 1.00(95%CI:0.79,1.26),P=0.98 4995014344294174043633522011935953CABGCABG+SVRNo.at Risk141 deaths 138 deathsCABGSummary of Outcomes in STICH

38、H2OutcomesOutcomesCABGCABGN=499N=499CABG+SVRCABG+SVRN=501N=501Hazard RatioHazard Ratio95%CI95%CIP PDeath or cardiac Death or cardiac hospitalizationhospitalization292(59%)292(59%)289(58%)289(58%)0.99(0.84,1.17)0.99(0.84,1.17)0.900.90DeathDeath141(28%)141(28%)138(28%)138(28%)1.00(0.79,1.26)1.00(0.79,

39、1.26)0.980.98Hospitalization Hospitalization(cardiac)(cardiac)211(42%)211(42%)204(41%)204(41%)0.97(0.80,1.18)0.97(0.80,1.18)0.730.73Hospitalization Hospitalization(all cause)(all cause)272(55%)272(55%)268(53%)268(53%)0.98(0.83,1.16)0.98(0.83,1.16)0.820.82Acute MIAcute MI22(4%)22(4%)20(4%)20(4%)1.01(

40、0.54,1.87)1.01(0.54,1.87)0.960.96StrokeStroke31(6%)31(6%)23(5%)23(5%)0.77(0.45,1.32)0.77(0.45,1.32)0.350.35Hazard Ratios,Confidence Intervals,and Tests for InteractionHazard Ratios,Confidence Intervals,and Tests for InteractionSubgroupNHR(95%CI)P ValueAll Subjects10000.99(0.84,1.17)Age0.48 653911.06

41、(0.83,1.35)284660.90(0.70,1.17)#of diseased vessels 50%0.21 1 or 23620.87(0.65,1.13)36381.07(0.87,1.31)Left main 50%or proximal LAD 75%0.53 No1790.89(0.61,1.30)Yes8211.02(0.85,1.22)SubgroupNHR(95%CI)P ValueMitral regurgitation 0.44 None or trace3630.89(0.68,1.17)Mild(2+)4491.12(0.88,1.43)Mod.or seve

42、re 1780.94(0.65,1.36)Stratum0.44 B1411.15(0.76,1.76)C8590.96(0.81,1.15)Region0.41 Poland2881.02(0.76,1.37)USA2001.10(0.79,1.54)Canada1540.77(0.50,1.18)West Europe1640.80(0.53,1.22)Other1941.24(0.81,1.91)Conclusionsn nThe STICH trial definitively shows adding SVR to CABG The STICH trial definitively

43、shows adding SVR to CABG provides no clinical benefit beyond that of CABG alone in provides no clinical benefit beyond that of CABG alone in the study population.the study population.n nBoth operative strategies provided similar short-and long-Both operative strategies provided similar short-and lon

44、g-term relief of angina and HF and improvement in 6-minute term relief of angina and HF and improvement in 6-minute walk test performance.walk test performance.n nSVR added to CABG decreased LV size significantly more SVR added to CABG decreased LV size significantly more than CABG alone and confirm

45、s the anatomic change than CABG alone and confirms the anatomic change reported in prior SVR studies.reported in prior SVR studies.n nFurther analyses of STICH Hypothesis 2 data may identify Further analyses of STICH Hypothesis 2 data may identify patient characteristics associated with benefit or h

46、arm patient characteristics associated with benefit or harm from adding SVR to CABG.from adding SVR to CABG.n nTo learn more about STICH and ongoing To learn more about STICH and ongoing Hypothesis 1,after the session look for Hypothesis 1,after the session look for investigators wearing STICH name tags.investigators wearing STICH name tags.n nVisit Visit NEJM.orgNEJM.org to read the Hypothesis 2 to read the Hypothesis 2 primary outcome article.primary outcome article.