外科治療缺血性心力衰竭STICH的研究課件

1、外科治療缺血性心力衰竭STICH的研究外科治療缺血性心力衰竭STICH的研究外科治療缺血性心力衰竭STICH的研究STICH Financial Disclosures外科治療缺血性心力衰竭STICH的研究外科治療缺血性心力衰竭STICH Financial DisclosuresOriginal Recipient InstitutionPrincipal InvestigatorActivityDuke University Medical CenterRobert H. JonesClinical Coordinating CtrDuke University Medical Cente

2、rKerry L. LeeStatistical and Data CCDuke University Medical CenterDaniel B. MarkEQOL Core LaboratoryUniv of Alabama-BirminghamGerald M. PohostCMR Core LaboratoryMayo ClinicJae K. OhECHO Core LaboratoryUniversity of PittsburghArthur M. FeldmanNCG Core LaboratoryNorthwestern UniversityRobert O. BonowR

3、N Core LaboratoryWashington Hospital CenterJulio A. PanzaDECIPHER SubstudyBaylor University Medical CtrPaul GrayburnMR TEE SubstudyFunding Sources:National Heart, Lung and Blood Institute 97.3% Chase Medical 0.3%Abbott Laboratories 2.3% CV Therapeutics 0.1%STICH Financial DisclosuresOriCore STICH St

4、udy OrganizationPrincipal Investigator: Robert H JonesCo-Principal investigator: Eric VelazquezDCC Principal Investigator: 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, Ro

5、bert Michler, and Jae Oh. DSMB chair: Sid GoldsteinPublications Committee chair: James HillClinical Endpoints Committee: Peter CarsonCore STICH Study OrganizationPHypothesis 2 Enrollment by Country 1000 patients 96 clinical sites 23 countries 1231 daysHypothesis 2 Enrollment by CouRandomized Patient

6、sNumbers for Analysisby HypothesisMED+CABG(610)MED+CABG(499)CAD, EF 0.35Eligible for MED-only treatment?Eligible for SVR?Not in trialNoHypothesis 1n = 1212Hypothesis 2n = 1000MED(602)MED+CABG+SVR(501)Stratum An = 10611MED(527)2MED+CABG(534)Eligible for SVR?Stratum Cn = 859Yes6MED+CABG(423)7MED+CABG+

7、SVR(436)Stratum Bn = 2163MED(75)5MED+CABG+SVR(65)4MED+CABG(76)+2136Randomized pts=+ 602MED only1033CABG added 501CABG + SVR added=+NoYesYesNo Randomized PatientsNumbers for外科治療缺血性心力衰竭STICH的研究課件2020/11/472020/11/47Hypothesis 2Surgical ventricular reconstruction (SVR) combined with CABG and evidence-b

8、ased medical therapy (MED) decreases death or cardiac hospitalization compared to CABG and MED without SVR.90% power for 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% comple

9、te over median of 48 months.All outcomes reported by operation assigned by randomization.Conduct of operation reported by procedure received.Hypothesis 2Surgical ventriculBaseline Clinical CharacteristicsCharacteristicCABGN = 499CABG + SVRN = 501Age, median 25th, 75th, years62 (54, 66)62 (56, 69)Fem

10、ale78 (16%)69 (14%)White90%92%Diabetes35%34%Creatinine, 0.5 mg/dL8%9%Prior stroke6%6%Baseline Clinical CharacteristMitral Regurgitation by Treatment in 1,000 Hypothesis 2 PatientsMitral Regurgitation SeverityCABGN = 499CABG + SVRN = 501None or trace173 (35%)190 (38%)Mild (2+)233 (47%)216 (44%)Modera

11、te (3+)72 (15%)70 (14%)Severe (4+)16 (3%)20 (4%)Not assessed5 (4%)5 (3%)18%Mitral Regurgitation by TreatmSite Reported Left Ventricular Function for 1,000 Hypothesis 2 Patients by TreatmentLV FunctionCABGN = 499CABG + SVRN = 501Site Qualifying Study Echocardiogram (%)66%63% Contrast ventriculogram13

12、%18% CMR11%9% Gated SPECT10%10%LVEF, median (25th, 75th).28 (.23, .31).28 (.24, .31)ESVI, median (25th, 75th), mL/m282 (65, 102)82 (66, 105)% anterior wall with akinesia/dyskinesia, median (25th, 75th)56 (40, 60)50 (40, 60)Site Reported Left VentricularCoronary Anatomy by Treatment for 1,000 Hypothe

13、sis 2 PatientsMajor Coronary Arteries with Stenosis% StenosisCABGN = 499CABG + SVRN = 501One50%7%10%LM stenosis50-74%14%12%One 75%17%20%Two 75%41%42%Three 75%41%36%Proximal LAD 75%78%74%LM stenosis 75%6%7%Duke coronary disease index*Median(25th, 75th)65 (43, 91)65 (39, 91)* 0 = coronary angiogram sh

14、ows no coronary disease, 100 = 95% LM stenosisCoronary Anatomy by Treatment Medication at BaselineMedicationCABGN = 499CABG + SVRN = 501Beta blocker85%87%ACE inhibitor or angiotensin receptor blocker87%89%ACE inhibitor80%82%Digoxin17%14%Diuretic69%66%Aspirin77%77%Aspirin or warfarin81%83%Statin79%75

15、%Medication at BaselineMedicatiOperative Conduct by Operation Received in 979 Hypothesis 2 PatientsVariableCABGN = 490CABG + SVRN = 489PStatus at Operation 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

16、total grafts73%70%Mitral surgery17%19%0.50SVR patch59%Operative Conduct by OperationEfficiency of Operative Care in 979 Hypothesis 2 PatientsDuration of OperationCABGN = 490CABG + SVRN = 489PTotal time in operating room (median, 25th, 75th), hours4.9 (4.1, 6.0)5.5 (4.7, 6.6)0.001Cardiopulmonary bypa

17、ss time(median, 25th, 75th), minutes99 (73, 125)124 (99, 158)0.001Aortic occlusion (median, 25th, 75th), minutes62 (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),

18、hours49.8 (28.8, 95.5)69.5 (42, 137)30 days22 (5%)31 (6%)0.20Efficiency of Operative Care Baseline and Four Month End-Systolic Volume Index (ESVI) in 373 Hypothesis 2 Patients With Quantitative Echocardiogram at Both IntervalsESVI82 ml/m277 ml/m283 ml/m267 ml/m2P0.001Baseline and Four Month End-SyCa

19、nadian Cardiovascular Society Angina Class in Hypothesis 2 Patients at Baseline and Latest Follow-upPatientsNo Angina121Class I-II130Class III-IV248No Angina339Class I-II88Class III-IV8No Angina128Class I-II129Class III-IV244No Angina339Class I-II83Class III-IV6Angina symptoms improved by an average

20、 of 1.7 classes in both cohorts (P=0.84).Canadian Cardiovascular SocietNew York Heart Association Heart Failure Class in Hypothesis 2 Patients at Baseline and Latest Follow-upPatientsClass I 36Class II222Class III-IV241Class I165Class II190Class III-IV80Class I 50Class II207Class III-IV244Class I179

21、Class II188Class III-IV62Heart failure symptoms improved by an average of one classIn both cohorts (P = 0.70).New York Heart Association HeaBaseline and Four Month 6-Minute Walk in 693 Hypothesis 2 Patients with Baseline AssessmentPatientsBaseline and Four Month 6-Minu30-Day MortalityOutcomeCABGN =

22、499CABG + SVRN = 501PDeath 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 Operated patients by operation received23/498 (4.6%)28/481 (

23、5.8%)0.4030-Day MortalityOutcomeCABGCAB00.10.20.30.40.50.60.7012345Event RateYears from RandomizationCABG49950131931927027522021699112323CABGCABG+SVRNo. at Risk Death or Cardiac Hospitalization Kaplan-Meier Estimates of Primary Endpoint292 events00.10.20.30.40.50.60.7012345Ev00.10.20.30.40.50.60.701

24、2345Event RateYears from RandomizationCABGCABG+SVRHR 0.99 (95% CI: 0.84, 1.17), P=0.90 49950131931927027522021699112323CABGCABG+SVRNo. at Risk Death or Cardiac Hospitalization Kaplan-Meier Estimates of Primary Endpoint 292 events289 events 00.10.20.30.40.50.60.7012345Ev Mortality (All-Cause) Kaplan-

25、Meier Estimates00.10.20.30.40.50.60.7012345Mortality RateYears from RandomizationCABG4995014344294174043633522011935953CABGCABG+SVRNo. at Risk141 deaths Mortality (All- Mortality (All-Cause) Kaplan-Meier Estimates00.10.20.30.40.50.60.7012345Mortality RateYears from RandomizationCABG+SVRHR 1.00 (95%

26、CI: 0.79, 1.26), P=0.98 4995014344294174043633522011935953CABGCABG+SVRNo. at Risk141 deaths 138 deathsCABG Mortality (All-Summary of Outcomes in STICH H2OutcomesCABGN = 499CABG + SVRN = 501Hazard Ratio95% CIPDeath or cardiac hospitalization292 (59%)289 (58%)0.99 (0.84, 1.17)0.90Death141 (28%)138 (28

27、%)1.00 (0.79, 1.26)0.98Hospitalization (cardiac)211 (42%)204 (41%)0.97 (0.80, 1.18)0.73Hospitalization (all cause)272 (55%)268 (53%)0.98 (0.83, 1.16)0.82Acute MI22 (4%)20 (4%)1.01 (0.54, 1.87)0.96Stroke31 (6%)23 (5%)0.77 (0.45, 1.32)0.35Summary of Outcomes in STICH HHazard Ratios, Confidence Interva

28、ls, and Tests for InteractionSubgroupNHR (95% CI)P ValueAll Subjects10000.99 (0.84, 1.17)Age0.48 653911.06 (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 ValueSubgroupNHR (95% CI)P ValueMi