Phase 3
N=2,136
Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Cardiovascular Diseases · Coronary Disease · Heart Failure, Congestive · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00023595 ↗Enrolled (actual)
2,136
Serious AEs
12.3%
Results posted
Jul 2017
Primary outcome: Primary: H01: All Cause Mortality — 244; 218 participants — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CABG surgery plus MED (Procedure); Active Medication Alone (Drug); CABG plus MED and SVR (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY H01: All Cause Mortality |
398; 359 | 0.02 sig |
| PRIMARY H01: All Cause Mortality |
398; 359 | 0.02 sig |
| PRIMARY H02: All-cause Mortality or Cardiovascular Hospitalization |
289; 292 | 0.90 |
| SECONDARY H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). |
168; 201 | 0.05 |
| SECONDARY H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). |
168; 201 | 0.05 |
| SECONDARY H01: Mortality or Cardiovascular Hospitalization |
524; 467 | <0.001 sig |
| SECONDARY H01: Mortality or Cardiovascular Hospitalization |
524; 467 | <0.001 sig |
| SECONDARY H02: All-cause Mortality |
141; 138 | 0.98 |
| SECONDARY H01: All-cause Mortality Within 30 Days After Randomization |
7; 22 | 0.008 sig |
| SECONDARY H02: All-cause Mortality Within 30 Days After Randomization |
22; 30 | 0.275 |
| SECONDARY H01: All-cause Mortality or Heart-failure Hospitalization |
450; 404 | 0.002 sig |
| SECONDARY H02: All-cause Mortality or Heart-failure Hospitalization |
211; 214 | 0.401 |
| SECONDARY H01: All-cause Mortality or Heart-failure Hospitalization |
450; 404 | 0.002 sig |
| SECONDARY H01: Heart Failure Hospitalization |
201; 157 | — |
| SECONDARY H02: Heart Failure Hospitalization |
95; 99 | — |
| SECONDARY H01: Heart Failure Hospitalization |
201; 157 | — |
| SECONDARY H01: Cardiac Procedure: Heart Transplant |
4; 1 | — |
| SECONDARY H02: Cardiac Procedure: Heart Transplant |
2; 7 | — |
| SECONDARY H01: Cardiac Procedure: Heart Transplant |
4; 1 | — |
| SECONDARY H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
2; 4 | — |
| SECONDARY H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
2; 2 | — |
| SECONDARY H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
2; 4 | — |
| SECONDARY H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
118; 105 | — |
| SECONDARY H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
100; 86 | — |
| SECONDARY H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
118; 105 | — |
| SECONDARY H01: Stroke |
41; 47 | — |
| SECONDARY H01: Stroke |
41; 47 | — |
| SECONDARY H02: Stroke |
31; 23 | — |
| SECONDARY H01: All-cause Mortality or Revascularization (CABG or PCI) |
478; 388 | <0.001 sig |
| SECONDARY H02: All-cause Mortality or Revascularization (CABG or PCI) |
174; 152 | 0.414 |
| SECONDARY H01: All-cause Mortality or Revascularization (CABG or PCI) |
478; 388 | <0.001 sig |
| SECONDARY H01: All-cause Mortality, Heart Transplant or LVAD |
400; 361 | 0.018 sig |
| SECONDARY H02: All-cause Mortality, Heart Transplant or LVAD |
148; 145 | 0.717 |
| SECONDARY H01: All-cause Mortality, Heart Transplant or LVAD |
400; 361 | 0.018 sig |
| SECONDARY H01: All-cause (Unplanned and Elective) Hospitalization |
383; 349 | — |
| SECONDARY H02: All-cause (Unplanned and Elective) Hospitalization |
272; 268 | — |
| SECONDARY H01: All-cause (Unplanned and Elective) Hospitalization |
383; 349 | — |
| SECONDARY H01: 6 Minute Walk Distance |
333.97; 333.04; 364.25; 376.46; 28.2; 37.76 | — |
| SECONDARY H02: 6 Minute Walk Distance |
339.38; 357.23; 385.89; 407.03; 44.42; 46.09 | — |
| SECONDARY H01: Exercise Duration |
6.85; 6.3; 7.78; 7.97; 0.71; 0.83 | — |
| SECONDARY H02: Exercise Duration |
6.19; 7.16; 7.67; 8.41; 1.15; 0.47 | — |
| SECONDARY H01: LVEF by ECHO Core Lab During Follow-up |
28.69; 28.43; 30.83; 30.66; 2.21; 2.06 | — |
| SECONDARY H02: LVEF by ECHO Core Lab During Follow-up |
29.13; 29.49; 31.47; 33.35; 2.16; 3.04 | — |
| SECONDARY H01: LVEF by RN Core Lab During Follow-up |
26.83; 26.66; 27.2; 27.81; 0.99; 2.65 | — |
| SECONDARY H02: LVEF by RN Core Lab During Follow-up |
27.14; 26.55; 30.65; 33.5; 2.23; 6.49 | — |
| SECONDARY H01: LVEF by CMR Core Lab During Follow-up |
29.51; 23.35; 28.6; 28.63; 0.07; 2.85 | — |
| SECONDARY H02: LVEF by CMR Core Lab During Follow-up |
27.82; 27.25; 31.65; 34.37; 2.84; 7.1 | — |
| SECONDARY H01: B-type Natriuretic Peptide (BNP) |
497.29; 478.73; 408.69; 484.39; -20.65; 33.37 | — |
| SECONDARY H02: B-type Natriuretic Peptide (BNP) |
453.73; 452.45; 460.14; 467.83; 19.75; 72.23 | — |
| SECONDARY H01: SF-36 Mental Health Subscale |
43.7; 44.4; 48.2; 47.2; 48.8; 47.0 | 0.015 sig |
| SECONDARY H02: SF-36 Mental Health Subscale |
41; 41; 50; 50; 53; 50 | 0.91 |
| SECONDARY H01:SF-36 Role Physical Subscale |
36.1; 36.6; 43.0; 42.6; 45.7; 43.1 | 0.31 |
| SECONDARY H02: SF-36 Role Physical Subscale |
28; 28; 42; 42; 49; 49 | 0.74 |
| SECONDARY H01:SF-36 Role Emotional Subscale |
39.0; 40.0; 45.3; 44.6; 46.4; 45.9 | 0.063 |
| SECONDARY H02: SF-36 Role Emotional Subscale |
34; 34; 55; 55; 55; 55 | 0.82 |
| SECONDARY H01:SF-36 Social Functioning Subscale |
41.8; 42.1; 47.0; 45.8; 48.7; 46.1 | 0.039 sig |
| SECONDARY H02: SF-36 Social Functioning Subscale |
41; 35; 52; 52; 52; 52 | 0.36 |
| SECONDARY H01:SF-36 Vitality Subscale |
46.4; 47.5; 51.6; 50.5; 52.2; 49.9 | <0.001 sig |
| SECONDARY H02: SF-36 Vitality Subscale |
44; 44; 51; 51; 53; 51 | 0.31 |
| SECONDARY H01:SF-12 Physical Component Summary (PCS) Scale |
37.8; 38.4; 40.2; 39.9; 41.0; 40.0 | 0.051 |
| SECONDARY H02: SF-12 Physical Component Summary (PCS) Scale |
37; 37; 40; 40; 41; 41 | 0.71 |
| SECONDARY H01: SF-12 Mental Component Summary (MCS) Scale |
44.6; 45.5; 50.5; 49.2; 51.8; 50.3 | 0.004 sig |
| SECONDARY H02: SF-12 Mental Component Summary (MCS) Scale |
42; 41; 54; 55; 57; 54 | 0.74 |
| SECONDARY H01: KCCQ Physical Limitation Scale |
64.2; 64.7; 75.2; 73.1; 77.8; 73.4 | 0.050 |
| SECONDARY H02: KCCQ Physical Limitation Scale |
63; 63; 83; 83; 84; 88 | 0.40 |
| SECONDARY H01: KCCQ Symptom Stability |
53.3; 55.5; 58.6; 55.7; 52.8; 51.1 | 0.005 sig |
| SECONDARY H02: KCCQ Symptom Stability |
50; 50; 50; 50; 50; 50 | 0.38 |
| SECONDARY H01: KCCQ Symptom Frequency |
70.5; 71.5; 79.8; 79.1; 82.4; 79.2 | 0.205 |
| SECONDARY H02: KCCQ Symptom Frequency |
67; 71; 83; 88; 90; 90 | 0.19 |
| SECONDARY H01: KCCQ Symptom Burden |
72.6; 73.4; 81.4; 79.6; 83.7; 79.8 | 0.050 |
| SECONDARY H02: KCCQ Symptom Burden |
67; 75; 83; 83; 92; 92 | 0.23 |
| SECONDARY H01: KCCQ Total Symptoms |
71.7; 72.6; 80.8; 79.5; 83.2; 79.6 | 0.085 |
| SECONDARY H02: KCCQ Total Symptoms |
68; 71; 84; 88; 90; 88 | 0.18 |
| SECONDARY H01: KCCQ Quality-of-Life Scale |
47.9; 50.1; 68.7; 63.3; 72.9; 65.6 | <0.001 sig |
| SECONDARY H02: KCCQ Quality-of-Life Scale |
42; 33; 75; 75; 75; 75 | 0.70 |
| SECONDARY H01: KCCQ Social Limitation |
56.4; 57.3; 72.3; 69.0; 76.4; 69.5 | 0.023 sig |
| SECONDARY H02: KCCQ Social Limitation |
44; 44; 75; 75; 81; 83 | 0.63 |
| SECONDARY H01: KCCQ Clinical Summary Score |
68.2; 68.8; 78.2; 76.4; 80.6; 76.4 | 0.033 sig |
| SECONDARY H02: KCCQ Clinical Summary Score |
65; 68; 84; 84; 88; 86 | 0.26 |
| SECONDARY H01: KCCQ Overall Summary Score |
60.3; 61.3; 74.3; 71.2; 77.5; 72.2 | <0.001 sig |
| SECONDARY H02: KCCQ Overall Summary Score |
53; 54; 79; 79; 84; 82 | 0.53 |
| SECONDARY H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale |
74.3; 77.0; 90.5; 84.0; 90.6; 84.0 | <0.001 sig |
| SECONDARY H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale |
70; 80; 100; 100; 100; 100 | 0.01 sig |
| SECONDARY H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale |
56.0; 57.8; 58.3; 55.8; 55.4; 53.3 | 0.029 sig |
| SECONDARY H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale |
50; 50; 50; 50; 50; 50 | 0.98 |
| SECONDARY H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale |
53.6; 57.6; 74.5; 67.5; 75.8; 69.1 | <0.001 sig |
| SECONDARY H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale |
42; 42; 83; 83; 83; 83 | 0.86 |
| SECONDARY H01: EQ-5D Visual Analog Scale |
56.7; 59.5; 68.5; 65.4; 69.2; 65.4 | <0.001 sig |
| SECONDARY H02: EQ-5D Visual Analog Scale |
50; 50; 70; 70; 72; 70 | 0.96 |
| SECONDARY H01: EQ-5D Health Status Index Score |
69.3; 72.3; 78.9; 77.4; 80.5; 77.6 | 0.007 sig |
| SECONDARY H02: EQ-5D Health Status Index Score |
69; 69; 85; 85; 85; 85 | 0.31 |
| SECONDARY H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale |
42.9; 43.4; 26.6; 27.5; 25.0; 26.9 | 0.86 |
| SECONDARY H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale |
50.5; 53.2; 29.6; 27.0; 24.4; 27.0 | 0.40 |
| SECONDARY H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale |
46.8; 49.3; 56.0; 53.8; 56.7; 53.9 | 0.002 sig |
| SECONDARY H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale |
45; 45; 61; 63; 65; 64 | 0.40 |
| SECONDARY H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale |
62.9; 64.8; 69.2; 68.7; 68.7; 67.4 | 0.036 sig |
| SECONDARY H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale |
63; 63; 75; 75; 75; 75 | 0.75 |
| SECONDARY H01: General Health Rating Scale |
56.0; 57.6; 67.3; 64.0; 68.7; 63.7 | 0.0002 sig |
| SECONDARY H02: General Health Rating Scale |
50; 50; 70; 70; 70; 70 | 0.60 |
| SECONDARY H01: Cost of Care |
50,032; 8,315; 5,405; 408; 55,437; 8,723 | <0.0001 sig |
| SECONDARY H02: Cost of Care |
50,939; 64,202; 5,183; 6,515; 56,122; 70,717 | 0.006 sig |
Summary
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).
Eligibility Criteria
Inclusion Criteria
- LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
- Coronary anatomy suitable for revascularization
Exclusion Criteria
- Failure to provide informed consent.
- Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
- Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
- Plan for percutaneous intervention of CAD.
- Recent acute MI judged to be an important cause of left ventricular dysfunction.
- History of more than 1 prior coronary bypass operation.
- Noncardiac illness with a life expectancy of less than 3 years.
- Noncardiac illness imposing substantial operative mortality.
- Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
- Previous heart, kidney, liver, or lung transplantation.
- Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
MED Therapy Eligibility Criteria
- Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
- Absence of CCS III angina or greater (angina markedly limiting ordinary activity).
SVR Eligibility Criterion
- Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.
Data sourced from ClinicalTrials.gov (NCT00023595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.