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1、外科治疗缺血性心力衰竭（STICH）的研究：CABG 对照 CABG+SVRSurgical Treatment for IschemicHeart Failure(STICH)Trial:CABG versus CABG+SVRRobert H.Jones,M.D.March 29,2009,STICH Financial Disclosures,Core STICH Study Organization,Principal Investigator:Robert H JonesCo-Principal investigator:Eric VelazquezDCC Principal Inv
2、estigator:Kerry L LeeStudy Chair:Jean L RouleauExecutive Committee:Robert H Jones,Eric Velazquez,Kerry L Lee,Jean L Rouleau,Patrice Desvigne-Nickens,George Sopko,Chris OConnor,Robert Michler,and Jae Oh.DSMB chair:Sid GoldsteinPublications Committee chair:James HillClinical Endpoints Committee:Peter
3、Carson,Hypothesis 2 Enrollment by Country,1000 patients 96 clinical sites 23 countries 1231 days,Hypothesis 2,Surgical ventricular reconstruction(SVR)combined with CABG and evidence-based medical therapy(MED)decreases death or cardiac hospitalization compared to CABG and MED without SVR.90%power for
4、 20%reduction assuming 45%3-year event rate allowing for 20%treatment crossovers.7%of CABG and 9%of CABG+SVR patients did not receive assigned operation.Follow-up 99%complete over median of 48 months.All outcomes reported by operation assigned by randomization.Conduct of operation reported by proced
5、ure received.,Baseline Clinical Characteristics,Mitral Regurgitation by Treatment in 1,000 Hypothesis 2 Patients,18%,Site Reported Left Ventricular Function for 1,000 Hypothesis 2 Patients by Treatment,Coronary Anatomy by Treatment for 1,000 Hypothesis 2 Patients,*0=coronary angiogram shows no coron
6、ary disease,100=95%LM stenosis,Medication at Baseline,Operative Conduct by Operation Received in 979 Hypothesis 2 Patients,Efficiency of Operative Care in 979 Hypothesis 2 Patients,Baseline and Four Month End-Systolic Volume Index(ESVI)in 373 Hypothesis 2 Patients With Quantitative Echocardiogram at
7、 Both Intervals,ESVI,82 ml/m2,77 ml/m2,83 ml/m2,67 ml/m2,P0.001,Canadian Cardiovascular Society Angina Class in Hypothesis 2 Patients at Baseline and Latest Follow-up,Patients,No Angina121,Class I-II130,Class III-IV248,No Angina339,Class I-II88,Class III-IV8,No Angina128,Class I-II129,Class III-IV24
8、4,No Angina339,Class I-II83,Class III-IV6,Angina symptoms improved by an average of 1.7 classes in both cohorts(P=0.84).,New York Heart Association Heart Failure Class in Hypothesis 2 Patients at Baseline and Latest Follow-up,Patients,Class I 36,Class II222,Class III-IV241,Class I165,Class II190,Cla
9、ss III-IV80,Class I 50,Class II207,Class III-IV244,Class I179,Class II188,Class III-IV62,Heart failure symptoms improved by an average of one classIn both cohorts(P=0.70).,Baseline and Four Month 6-Minute Walk in 693 Hypothesis 2 Patients with Baseline Assessment,Patients,30-Day Mortality,0,0.1,0.2,
10、0.3,0.4,0.5,0.6,0.7,0,1,2,3,4,5,Event Rate,Years from Randomization,CABG,499,501,319,319,270,275,220,216,99,11,23,23,CABG,CABG+SVR,No.at Risk,Death or Cardiac Hospitalization Kaplan-Meier Estimates of Primary Endpoint,292 events,0,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0,1,2,3,4,5,Event Rate,Years from Randomi
11、zation,CABG,CABG+SVR,HR 0.99(95%CI:0.84,1.17),P=0.90,499,501,319,319,270,275,220,216,99,11,23,23,CABG,CABG+SVR,No.at Risk,Death or Cardiac Hospitalization Kaplan-Meier Estimates of Primary Endpoint,292 events,289 events,Mortality(All-Cause)Kaplan-Meier Estimates,0,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0,1,2,3
12、,4,5,Mortality Rate,Years from Randomization,CABG,499,501,434,429,417,404,363,352,201,193,59,53,CABG,CABG+SVR,No.at Risk,141 deaths,Mortality(All-Cause)Kaplan-Meier Estimates,0,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0,1,2,3,4,5,Mortality Rate,Years from Randomization,CABG+SVR,HR 1.00(95%CI:0.79,1.26),P=0.98,49
13、9,501,434,429,417,404,363,352,201,193,59,53,CABG,CABG+SVR,No.at Risk,141 deaths 138 deaths,CABG,Summary of Outcomes in STICH H2,Hazard Ratios,Confidence Intervals,and Tests for Interaction,SubgroupNHR(95%CI)P ValueAll Subjects10000.99(0.84,1.17)Age0.48 653911.06(0.83,1.35)656090.94(0.76,1.17)Gender0
14、.60 Male8531.01(0.84,1.20)Female1470.90(0.58,1.39)Race0.44 Minority1240.83(0.51,1.36)Non-minority8761.01(0.85,1.20)Current NYHA HF class0.97 I or II5150.99(0.78,1.25)III or IV4850.99(0.79,1.24),SubgroupNHR(95%CI)P ValueCCS angina class0.39 Class II5080.92(0.73,1.16)Class III or IV4921.06(0.85,1.34)B
15、aseline diabetes0.20 Yes3441.14(0.87,1.50)No6560.92(0.75,1.12)LVEF(site reported)0.33 285341.07(0.86,1.31)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 Val
16、ueMitral regurgitation 0.44 None or trace3630.89(0.68,1.17)Mild(2+)4491.12(0.88,1.43)Mod.or severe 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),
17、Conclusions,The STICH trial definitively shows adding SVR to CABG provides no clinical benefit beyond that of CABG alone in the study population.Both operative strategies provided similar short-and long-term relief of angina and HF and improvement in 6-minute walk test performance.SVR added to CABG
18、decreased LV size significantly more than CABG alone and confirms the anatomic change reported in prior SVR studies.Further analyses of STICH Hypothesis 2 data may identify patient characteristics associated with benefit or harm from adding SVR to CABG.,To learn more about STICH and ongoing Hypothesis 1,after the session look for investigators wearing STICH name tags.Visit NEJM.org to read the Hypothesis 2 primary outcome article.,
