外科治疗缺血性心力衰竭STICH的研究
相关主题
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
外科治疗缺血性心力衰竭STICH 的研究
STICH Financial Disclosures
Original Recipient Institution Principal Investigator
Activity
Duke University Medical Center Robert H. Jonwenku.baidu.coms
MR TEE Substudy
Funding Sources: National Heart, Lung and Blood Institute 97.3% Abbott Laboratories 2.3%
Chase Medical 0.3% CV Therapeutics 0.1%
Core STICH Study Organization
No
Eligible for SVR?
No
Not in trial
No
Yes
Yes
Stratum A n = 1061 +
Stratum B n = 216
+
Stratum C n = 859
= 2136 Randomized pts
1
2
3
4
5
6
7
MED MED
MED MED MED
MED MED
602 MED only
N = 499
Hypothesis 2 Enrollment by Country
1000 patients 96 clinical sites 23 countries 1231 days
CAD, EF 0.35
Eligible for MED-only treatment?
Yes Eligible for SVR?
Follow-up 99% complete over median of 48 months.
All outcomes reported by operation assigned by randomization.
Conduct of operation reported by procedure received.
Clinical Coordinating Ctr
Duke University Medical Center Kerry L. Lee
Statistical and Data CC
Duke University Medical Center Daniel B. Mark
EQOL Core Laboratory
Principal Investigator: Robert H Jones Co-Principal investigator: Eric Velazquez DCC Principal Investigator: Kerry L Lee Study Chair: Jean L Rouleau Executive Committee: Robert H Jones, Eric Velazquez, Kerry L Lee, Jean L Rouleau, Patrice Desvigne-Nickens, George Sopko, Chris O’Connor, Robert Michler, and Jae Oh. DSMB chair: Sid Goldstein Publications Committee chair: James Hill Clinical Endpoints Committee: Peter Carson
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.
+ CABG +
+ CABG
+ CABG
+ + CABG
+ CABG
= 1033 CABG added
+ SVR
+ SVR
501 CABG + SVR added
(527) (534)
(75) (76) (65)
(423) (436)
Randomized Patients
MED MED +
CABG
(602) (610) Hypothesis 1
Univ of Alabama-Birmingham Gerald M. Pohost
CMR Core Laboratory
Mayo Clinic
Jae K. Oh
ECHO Core Laboratory
University of Pittsburgh
Arthur M. Feldman NCG Core Laboratory
Baseline Clinical Characteristics
Characteristic
Age, median 25th, 75th, years Female White Diabetes Creatinine, >0.5 mg/dL Prior stroke
CABG CABG + SVR
n = 1212
MED +
CABG (499)
MED +
CABG +
SVR (501)
Hypothesis 2 n = 1000
Numbers for Analysis by Hypothesis
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.
Northwestern University
Robert O. Bonow
RN Core Laboratory
Washington Hospital Center
Julio A. Panza
DECIPHER Substudy
Baylor University Medical Ctr Paul Grayburn
STICH Financial Disclosures
Original Recipient Institution Principal Investigator
Activity
Duke University Medical Center Robert H. Jonwenku.baidu.coms
MR TEE Substudy
Funding Sources: National Heart, Lung and Blood Institute 97.3% Abbott Laboratories 2.3%
Chase Medical 0.3% CV Therapeutics 0.1%
Core STICH Study Organization
No
Eligible for SVR?
No
Not in trial
No
Yes
Yes
Stratum A n = 1061 +
Stratum B n = 216
+
Stratum C n = 859
= 2136 Randomized pts
1
2
3
4
5
6
7
MED MED
MED MED MED
MED MED
602 MED only
N = 499
Hypothesis 2 Enrollment by Country
1000 patients 96 clinical sites 23 countries 1231 days
CAD, EF 0.35
Eligible for MED-only treatment?
Yes Eligible for SVR?
Follow-up 99% complete over median of 48 months.
All outcomes reported by operation assigned by randomization.
Conduct of operation reported by procedure received.
Clinical Coordinating Ctr
Duke University Medical Center Kerry L. Lee
Statistical and Data CC
Duke University Medical Center Daniel B. Mark
EQOL Core Laboratory
Principal Investigator: Robert H Jones Co-Principal investigator: Eric Velazquez DCC Principal Investigator: Kerry L Lee Study Chair: Jean L Rouleau Executive Committee: Robert H Jones, Eric Velazquez, Kerry L Lee, Jean L Rouleau, Patrice Desvigne-Nickens, George Sopko, Chris O’Connor, Robert Michler, and Jae Oh. DSMB chair: Sid Goldstein Publications Committee chair: James Hill Clinical Endpoints Committee: Peter Carson
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.
+ CABG +
+ CABG
+ CABG
+ + CABG
+ CABG
= 1033 CABG added
+ SVR
+ SVR
501 CABG + SVR added
(527) (534)
(75) (76) (65)
(423) (436)
Randomized Patients
MED MED +
CABG
(602) (610) Hypothesis 1
Univ of Alabama-Birmingham Gerald M. Pohost
CMR Core Laboratory
Mayo Clinic
Jae K. Oh
ECHO Core Laboratory
University of Pittsburgh
Arthur M. Feldman NCG Core Laboratory
Baseline Clinical Characteristics
Characteristic
Age, median 25th, 75th, years Female White Diabetes Creatinine, >0.5 mg/dL Prior stroke
CABG CABG + SVR
n = 1212
MED +
CABG (499)
MED +
CABG +
SVR (501)
Hypothesis 2 n = 1000
Numbers for Analysis by Hypothesis
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.
Northwestern University
Robert O. Bonow
RN Core Laboratory
Washington Hospital Center
Julio A. Panza
DECIPHER Substudy
Baylor University Medical Ctr Paul Grayburn