Trial Outcomes & Findings for Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (NCT NCT00023595)
NCT ID: NCT00023595
Last Updated: 2019-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2136 participants
Primary outcome timeframe
5 years post randomization
Results posted on
2019-09-19
Participant Flow
Pts were assigned to 1 of 3 strata before randomization. All pts in stratum C and some pts in stratum B were randomly assigned to med therapy + CABG or med therapy + CABG + SVR (Hypothesis 2 component of the trial-HO2). 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02.
Stratum A: eligible for med. therapy alone or med therapy + CABG; Stratum C: eligible for med therapy + CABG or med therapy + CABG + SVR; Stratum B: eligible for all 3 treatment options. All pts in stratum A and some of the pts in stratum B were randomized to either med therapy alone or med therapy + CABG (Hypothesis 1 of the STICH trial--H01).
Participant milestones
| Measure |
H01: Medication
50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
H01: Medication + CABG
50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H01+H02: Medication + CABG
This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
|
H02: Medication+CABG
50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H02: Medication+CABG+SVR
50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
|
|---|---|---|---|---|---|
|
5 Year Follow up
STARTED
|
602
|
534
|
76
|
423
|
501
|
|
5 Year Follow up
COMPLETED
|
600
|
532
|
75
|
416
|
498
|
|
5 Year Follow up
NOT COMPLETED
|
2
|
2
|
1
|
7
|
3
|
|
10 Year Follow up
STARTED
|
602
|
534
|
76
|
0
|
0
|
|
10 Year Follow up
COMPLETED
|
590
|
524
|
73
|
0
|
0
|
|
10 Year Follow up
NOT COMPLETED
|
12
|
10
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
H01: Medication
50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
H01: Medication + CABG
50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H01+H02: Medication + CABG
This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
|
H02: Medication+CABG
50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H02: Medication+CABG+SVR
50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
|
|---|---|---|---|---|---|
|
5 Year Follow up
Lost to Follow-up
|
2
|
2
|
1
|
7
|
3
|
|
10 Year Follow up
Lost to Follow-up
|
12
|
10
|
3
|
0
|
0
|
Baseline Characteristics
Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
H01: Medication
n=602 Participants
50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
H01: Medication + CABG
n=534 Participants
50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H01+H02: Medication + CABG
n=76 Participants
This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
|
H02: Medication+CABG
n=423 Participants
50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
|
H02: Medication+CABG+SVR
n=501 Participants
50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
|
Total
n=2136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
60 years
n=7 Participants
|
61 years
n=5 Participants
|
62 years
n=4 Participants
|
62 years
n=21 Participants
|
60 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
286 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
527 Participants
n=5 Participants
|
470 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
354 Participants
n=4 Participants
|
432 Participants
n=21 Participants
|
1850 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All Cause Mortality
|
244 participants
|
218 participants
|
PRIMARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All Cause Mortality
|
398 participants
|
359 participants
|
PRIMARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=501 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=499 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality or Cardiovascular Hospitalization
|
289 participants
|
292 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=610 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=602 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
|
247 participants
|
297 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=610 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=602 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
|
168 participants
|
201 participants
|
SECONDARY outcome
Timeframe: up to 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Mortality or Cardiovascular Hospitalization
|
411 participants
|
351 participants
|
SECONDARY outcome
Timeframe: up to 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Mortality or Cardiovascular Hospitalization
|
524 participants
|
467 participants
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality
|
141 participants
|
138 participants
|
SECONDARY outcome
Timeframe: 30 days post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality Within 30 Days After Randomization
|
7 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 30 days post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality Within 30 Days After Randomization
|
22 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality or Heart-failure Hospitalization
|
324 participants
|
290 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality or Heart-failure Hospitalization
|
211 participants
|
214 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality or Heart-failure Hospitalization
|
450 participants
|
404 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Heart Failure Hospitalization
|
169 participants
|
127 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Heart Failure Hospitalization
|
95 participants
|
99 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Heart Failure Hospitalization
|
201 participants
|
157 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Heart Transplant
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cardiac Procedure: Heart Transplant
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Heart Transplant
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
|
98 participants
|
76 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
|
100 participants
|
86 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
|
118 participants
|
105 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Stroke
|
34 participants
|
41 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Stroke
|
41 participants
|
47 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Stroke
|
31 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality or Revascularization (CABG or PCI)
|
333 participants
|
237 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality or Revascularization (CABG or PCI)
|
174 participants
|
152 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality or Revascularization (CABG or PCI)
|
478 participants
|
388 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
LVAD=Left Ventricular Assist Device
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality, Heart Transplant or LVAD
|
245 participants
|
218 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause Mortality, Heart Transplant or LVAD
|
148 participants
|
145 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
LVAD=Left Ventricular Assist Device
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause Mortality, Heart Transplant or LVAD
|
400 participants
|
361 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause (Unplanned and Elective) Hospitalization
|
340 participants
|
290 participants
|
SECONDARY outcome
Timeframe: 5 years post randomizationPopulation: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=499 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=501 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: All-cause (Unplanned and Elective) Hospitalization
|
272 participants
|
268 participants
|
SECONDARY outcome
Timeframe: 10 years post randomizationPopulation: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
Outcome measures
| Measure |
H01: Medication
n=602 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=610 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: All-cause (Unplanned and Elective) Hospitalization
|
383 participants
|
349 participants
|
SECONDARY outcome
Timeframe: From randomization to 24 month follow-upPopulation: Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.
Outcome measures
| Measure |
H01: Medication
n=559 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=552 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: 6 Minute Walk Distance
Baseline
|
333.97 meters
Standard Deviation 117.76
|
333.04 meters
Standard Deviation 117.06
|
|
H01: 6 Minute Walk Distance
4 month
|
364.25 meters
Standard Deviation 111.24
|
376.46 meters
Standard Deviation 118.87
|
|
H01: 6 Minute Walk Distance
Changed from baseline to 4 months
|
28.2 meters
Standard Deviation 102.44
|
37.76 meters
Standard Deviation 108.93
|
|
H01: 6 Minute Walk Distance
24 month
|
381.55 meters
Standard Deviation 120.86
|
377.84 meters
Standard Deviation 122.62
|
|
H01: 6 Minute Walk Distance
Change from baseline to 24 Months
|
34.11 meters
Standard Deviation 112.9
|
31.18 meters
Standard Deviation 128.99
|
SECONDARY outcome
Timeframe: From randomization to 24 month follow-upPopulation: Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.
Outcome measures
| Measure |
H01: Medication
n=420 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=429 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: 6 Minute Walk Distance
Baseline
|
339.38 meters
Standard Deviation 126.11
|
357.23 meters
Standard Deviation 116.91
|
|
H02: 6 Minute Walk Distance
4 month
|
385.89 meters
Standard Deviation 123.49
|
407.03 meters
Standard Deviation 121.38
|
|
H02: 6 Minute Walk Distance
Changed from baseline to 4 months
|
44.42 meters
Standard Deviation 122.64
|
46.09 meters
Standard Deviation 113.67
|
|
H02: 6 Minute Walk Distance
24 month
|
400.66 meters
Standard Deviation 121.67
|
425.18 meters
Standard Deviation 121.46
|
|
H02: 6 Minute Walk Distance
Change from baseline to 24 Months
|
51.51 meters
Standard Deviation 125.65
|
55.6 meters
Standard Deviation 112.66
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with exercise duration data at baseline or 24 months were analyzed.
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Outcome measures
| Measure |
H01: Medication
n=269 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=242 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Exercise Duration
Baseline
|
6.85 minutes
Standard Deviation 3.4
|
6.3 minutes
Standard Deviation 3.39
|
|
H01: Exercise Duration
24 month
|
7.78 minutes
Standard Deviation 3.32
|
7.97 minutes
Standard Deviation 3.32
|
|
H01: Exercise Duration
Change from baseline to 24 Months
|
0.71 minutes
Standard Deviation 3.51
|
0.83 minutes
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with exercise duration data at baseline or 24 months were analyzed.
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Outcome measures
| Measure |
H01: Medication
n=119 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=138 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Exercise Duration
Baseline
|
6.19 meters
Standard Deviation 3.42
|
7.16 meters
Standard Deviation 3.47
|
|
H02: Exercise Duration
24 month
|
7.67 meters
Standard Deviation 3.3
|
8.41 meters
Standard Deviation 3.41
|
|
H02: Exercise Duration
Change from baseline to 24 Months
|
1.15 meters
Standard Deviation 3.01
|
0.47 meters
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Outcome measures
| Measure |
H01: Medication
n=584 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=589 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: LVEF by ECHO Core Lab During Follow-up
Baseline
|
28.69 Percent ejection fraction
Standard Deviation 8.33
|
28.43 Percent ejection fraction
Standard Deviation 8.24
|
|
H01: LVEF by ECHO Core Lab During Follow-up
4 month
|
30.83 Percent ejection fraction
Standard Deviation 9.41
|
30.66 Percent ejection fraction
Standard Deviation 10.73
|
|
H01: LVEF by ECHO Core Lab During Follow-up
Changed from baseline to 4 months
|
2.21 Percent ejection fraction
Standard Deviation 8.8
|
2.06 Percent ejection fraction
Standard Deviation 10.06
|
|
H01: LVEF by ECHO Core Lab During Follow-up
24 month
|
31.39 Percent ejection fraction
Standard Deviation 10.75
|
31.15 Percent ejection fraction
Standard Deviation 11.14
|
|
H01: LVEF by ECHO Core Lab During Follow-up
Change from baseline to 24 Months
|
2.2 Percent ejection fraction
Standard Deviation 11.31
|
2.22 Percent ejection fraction
Standard Deviation 10.67
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Outcome measures
| Measure |
H01: Medication
n=484 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=484 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: LVEF by ECHO Core Lab During Follow-up
Baseline
|
29.13 Percent ejection fraction
Standard Deviation 7.74
|
29.49 Percent ejection fraction
Standard Deviation 8.23
|
|
H02: LVEF by ECHO Core Lab During Follow-up
4 month
|
31.47 Percent ejection fraction
Standard Deviation 10.4
|
33.35 Percent ejection fraction
Standard Deviation 9.79
|
|
H02: LVEF by ECHO Core Lab During Follow-up
Changed from baseline to 4 months
|
2.16 Percent ejection fraction
Standard Deviation 10.23
|
3.04 Percent ejection fraction
Standard Deviation 9.7
|
|
H02: LVEF by ECHO Core Lab During Follow-up
24 month
|
31.89 Percent ejection fraction
Standard Deviation 11.38
|
33.55 Percent ejection fraction
Standard Deviation 10.91
|
|
H02: LVEF by ECHO Core Lab During Follow-up
Change from baseline to 24 Months
|
2.24 Percent ejection fraction
Standard Deviation 11.11
|
2.93 Percent ejection fraction
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Outcome measures
| Measure |
H01: Medication
n=250 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=255 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: LVEF by RN Core Lab During Follow-up
Baseline
|
26.83 Percent ejection fraction
Standard Deviation 8.66
|
26.66 Percent ejection fraction
Standard Deviation 8.41
|
|
H01: LVEF by RN Core Lab During Follow-up
4 month
|
27.2 Percent ejection fraction
Standard Deviation 9.5
|
27.81 Percent ejection fraction
Standard Deviation 9.73
|
|
H01: LVEF by RN Core Lab During Follow-up
Changed from baseline to 4 months
|
0.99 Percent ejection fraction
Standard Deviation 5.88
|
2.65 Percent ejection fraction
Standard Deviation 6.36
|
|
H01: LVEF by RN Core Lab During Follow-up
24 month
|
30.65 Percent ejection fraction
Standard Deviation 10.74
|
27.79 Percent ejection fraction
Standard Deviation 9.05
|
|
H01: LVEF by RN Core Lab During Follow-up
Change from baseline to 24 Months
|
3.99 Percent ejection fraction
Standard Deviation 8.24
|
1.77 Percent ejection fraction
Standard Deviation 5.63
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Outcome measures
| Measure |
H01: Medication
n=214 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=216 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: LVEF by RN Core Lab During Follow-up
Baseline
|
27.14 Percent ejection fraction
Standard Deviation 8.18
|
26.55 Percent ejection fraction
Standard Deviation 7.83
|
|
H02: LVEF by RN Core Lab During Follow-up
4 month
|
30.65 Percent ejection fraction
Standard Deviation 10.41
|
33.5 Percent ejection fraction
Standard Deviation 9.42
|
|
H02: LVEF by RN Core Lab During Follow-up
Changed from baseline to 4 months
|
2.23 Percent ejection fraction
Standard Deviation 7.11
|
6.49 Percent ejection fraction
Standard Deviation 7.91
|
|
H02: LVEF by RN Core Lab During Follow-up
24 month
|
29.95 Percent ejection fraction
Standard Deviation 10.97
|
34.2 Percent ejection fraction
Standard Deviation 10.3
|
|
H02: LVEF by RN Core Lab During Follow-up
Change from baseline to 24 Months
|
2.01 Percent ejection fraction
Standard Deviation 9.58
|
6.79 Percent ejection fraction
Standard Deviation 9.12
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Outcome measures
| Measure |
H01: Medication
n=50 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=68 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: LVEF by CMR Core Lab During Follow-up
Baseline
|
29.51 Percent ejection fraction
Standard Deviation 11.02
|
23.35 Percent ejection fraction
Standard Deviation 9.49
|
|
H01: LVEF by CMR Core Lab During Follow-up
4 month
|
28.6 Percent ejection fraction
Standard Deviation 11.11
|
28.63 Percent ejection fraction
Standard Deviation 13.16
|
|
H01: LVEF by CMR Core Lab During Follow-up
Changed from baseline to 4 months
|
0.07 Percent ejection fraction
Standard Deviation 8.82
|
2.85 Percent ejection fraction
Standard Deviation 12.87
|
|
H01: LVEF by CMR Core Lab During Follow-up
24 month
|
32.72 Percent ejection fraction
Standard Deviation 14.7
|
31.47 Percent ejection fraction
Standard Deviation 9.06
|
|
H01: LVEF by CMR Core Lab During Follow-up
Change from baseline to 24 Months
|
-1.09 Percent ejection fraction
Standard Deviation 10.63
|
2.13 Percent ejection fraction
Standard Deviation 13.27
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Outcome measures
| Measure |
H01: Medication
n=207 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=196 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: LVEF by CMR Core Lab During Follow-up
Baseline
|
27.82 Percent ejection fraction
Standard Deviation 10.26
|
27.25 Percent ejection fraction
Standard Deviation 11.47
|
|
H02: LVEF by CMR Core Lab During Follow-up
4 month
|
31.65 Percent ejection fraction
Standard Deviation 13.53
|
34.37 Percent ejection fraction
Standard Deviation 13.41
|
|
H02: LVEF by CMR Core Lab During Follow-up
Changed from baseline to 4 months
|
2.84 Percent ejection fraction
Standard Deviation 11.86
|
7.1 Percent ejection fraction
Standard Deviation 11.86
|
|
H02: LVEF by CMR Core Lab During Follow-up
24 month
|
28.46 Percent ejection fraction
Standard Deviation 10.57
|
33.1 Percent ejection fraction
Standard Deviation 13.79
|
|
H02: LVEF by CMR Core Lab During Follow-up
Change from baseline to 24 Months
|
-0.51 Percent ejection fraction
Standard Deviation 14.61
|
5.39 Percent ejection fraction
Standard Deviation 13.23
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with BNP data at baseline or 4 months were analyzed.
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Outcome measures
| Measure |
H01: Medication
n=314 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=325 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: B-type Natriuretic Peptide (BNP)
Baseline
|
497.29 pg/mL
Standard Deviation 627.49
|
478.73 pg/mL
Standard Deviation 521.11
|
|
H01: B-type Natriuretic Peptide (BNP)
4 month
|
408.69 pg/mL
Standard Deviation 413.27
|
484.39 pg/mL
Standard Deviation 554.42
|
|
H01: B-type Natriuretic Peptide (BNP)
Changed from baseline to 4 months
|
-20.65 pg/mL
Standard Deviation 405.44
|
33.37 pg/mL
Standard Deviation 566.62
|
SECONDARY outcome
Timeframe: From randomization to 24 months follow-upPopulation: Only patients with BNP data at baseline or 4 months were analyzed.
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Outcome measures
| Measure |
H01: Medication
n=386 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=392 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: B-type Natriuretic Peptide (BNP)
Baseline
|
453.73 pg/mL
Standard Deviation 563.1
|
452.45 pg/mL
Standard Deviation 665.06
|
|
H02: B-type Natriuretic Peptide (BNP)
4 month
|
460.14 pg/mL
Standard Deviation 508.35
|
467.83 pg/mL
Standard Deviation 579.42
|
|
H02: B-type Natriuretic Peptide (BNP)
Changed from baseline to 4 months
|
19.75 pg/mL
Standard Deviation 600.26
|
72.23 pg/mL
Standard Deviation 554.2
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=597 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=584 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: SF-36 Mental Health Subscale
12 Months
|
48.8 units on a scale
Standard Deviation 11.1
|
47.0 units on a scale
Standard Deviation 11.8
|
|
H01: SF-36 Mental Health Subscale
24 Months
|
48.6 units on a scale
Standard Deviation 10.5
|
46.8 units on a scale
Standard Deviation 11.8
|
|
H01: SF-36 Mental Health Subscale
36 Months
|
48.5 units on a scale
Standard Deviation 11.1
|
48.2 units on a scale
Standard Deviation 10.8
|
|
H01: SF-36 Mental Health Subscale
Baseline
|
43.7 units on a scale
Standard Deviation 11.8
|
44.4 units on a scale
Standard Deviation 11.8
|
|
H01: SF-36 Mental Health Subscale
4 Months
|
48.2 units on a scale
Standard Deviation 10.2
|
47.2 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=489 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=481 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-36 Mental Health Subscale
24 Months
|
50 units on a scale
Interval 41.0 to 57.0
|
50 units on a scale
Interval 41.0 to 57.0
|
|
H02: SF-36 Mental Health Subscale
36 Months
|
50 units on a scale
Interval 41.0 to 60.0
|
50 units on a scale
Interval 44.0 to 57.0
|
|
H02: SF-36 Mental Health Subscale
Baseline
|
41 units on a scale
Interval 32.0 to 50.0
|
41 units on a scale
Interval 35.0 to 50.0
|
|
H02: SF-36 Mental Health Subscale
4 Months
|
50 units on a scale
Interval 39.0 to 57.0
|
50 units on a scale
Interval 41.0 to 57.0
|
|
H02: SF-36 Mental Health Subscale
12 Months
|
53 units on a scale
Interval 44.0 to 60.0
|
50 units on a scale
Interval 41.0 to 57.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=581 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=569 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:SF-36 Role Physical Subscale
Baseline
|
36.1 units on a scale
Standard Deviation 10.9
|
36.6 units on a scale
Standard Deviation 11.2
|
|
H01:SF-36 Role Physical Subscale
4 Months
|
43.0 units on a scale
Standard Deviation 11.8
|
42.6 units on a scale
Standard Deviation 11.8
|
|
H01:SF-36 Role Physical Subscale
12 Months
|
45.7 units on a scale
Standard Deviation 11.4
|
43.1 units on a scale
Standard Deviation 12.2
|
|
H01:SF-36 Role Physical Subscale
24 Months
|
46.6 units on a scale
Standard Deviation 11.4
|
44.7 units on a scale
Standard Deviation 12.2
|
|
H01:SF-36 Role Physical Subscale
36 Months
|
46.0 units on a scale
Standard Deviation 11.2
|
44.8 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=466 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=466 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-36 Role Physical Subscale
Baseline
|
28 units on a scale
Interval 28.0 to 35.0
|
28 units on a scale
Interval 28.0 to 42.0
|
|
H02: SF-36 Role Physical Subscale
4 Months
|
42 units on a scale
Interval 28.0 to 56.0
|
42 units on a scale
Interval 28.0 to 56.0
|
|
H02: SF-36 Role Physical Subscale
12 Months
|
49 units on a scale
Interval 35.0 to 56.0
|
49 units on a scale
Interval 35.0 to 56.0
|
|
H02: SF-36 Role Physical Subscale
24 Months
|
49 units on a scale
Interval 28.0 to 56.0
|
49 units on a scale
Interval 35.0 to 56.0
|
|
H02: SF-36 Role Physical Subscale
36 Months
|
49 units on a scale
Interval 35.0 to 56.0
|
56 units on a scale
Interval 35.0 to 56.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=588 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=582 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:SF-36 Role Emotional Subscale
Baseline
|
39.0 units on a scale
Standard Deviation 14.2
|
40.0 units on a scale
Standard Deviation 14.4
|
|
H01:SF-36 Role Emotional Subscale
4 Months
|
45.3 units on a scale
Standard Deviation 13.2
|
44.6 units on a scale
Standard Deviation 13.4
|
|
H01:SF-36 Role Emotional Subscale
12 Months
|
46.4 units on a scale
Standard Deviation 12.8
|
45.9 units on a scale
Standard Deviation 13.3
|
|
H01:SF-36 Role Emotional Subscale
24 Months
|
47.5 units on a scale
Standard Deviation 12.1
|
46.8 units on a scale
Standard Deviation 12.8
|
|
H01:SF-36 Role Emotional Subscale
36 Months
|
48.0 units on a scale
Standard Deviation 11.8
|
47.0 units on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=482 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=477 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-36 Role Emotional Subscale
Baseline
|
34 units on a scale
Interval 24.0 to 55.0
|
34 units on a scale
Interval 24.0 to 55.0
|
|
H02: SF-36 Role Emotional Subscale
4 Months
|
55 units on a scale
Interval 34.0 to 55.0
|
55 units on a scale
Interval 34.0 to 55.0
|
|
H02: SF-36 Role Emotional Subscale
12 Months
|
55 units on a scale
Interval 45.0 to 55.0
|
55 units on a scale
Interval 45.0 to 55.0
|
|
H02: SF-36 Role Emotional Subscale
24 Months
|
55 units on a scale
Interval 45.0 to 55.0
|
55 units on a scale
Interval 34.0 to 55.0
|
|
H02: SF-36 Role Emotional Subscale
36 Months
|
55 units on a scale
Interval 45.0 to 55.0
|
55 units on a scale
Interval 45.0 to 55.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=601 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=588 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:SF-36 Social Functioning Subscale
Baseline
|
41.8 units on a scale
Standard Deviation 12.0
|
42.1 units on a scale
Standard Deviation 12.0
|
|
H01:SF-36 Social Functioning Subscale
4 Months
|
47.0 units on a scale
Standard Deviation 11.1
|
45.8 units on a scale
Standard Deviation 11.3
|
|
H01:SF-36 Social Functioning Subscale
12 Months
|
48.7 units on a scale
Standard Deviation 10.4
|
46.1 units on a scale
Standard Deviation 11.7
|
|
H01:SF-36 Social Functioning Subscale
24 Months
|
48.3 units on a scale
Standard Deviation 9.9
|
46.1 units on a scale
Standard Deviation 11.1
|
|
H01:SF-36 Social Functioning Subscale
36 Months
|
47.8 units on a scale
Standard Deviation 10.3
|
47.1 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=490 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=485 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-36 Social Functioning Subscale
Baseline
|
41 units on a scale
Interval 30.0 to 52.0
|
35 units on a scale
Interval 30.0 to 46.0
|
|
H02: SF-36 Social Functioning Subscale
4 Months
|
52 units on a scale
Interval 35.0 to 57.0
|
52 units on a scale
Interval 41.0 to 57.0
|
|
H02: SF-36 Social Functioning Subscale
12 Months
|
52 units on a scale
Interval 41.0 to 57.0
|
52 units on a scale
Interval 41.0 to 57.0
|
|
H02: SF-36 Social Functioning Subscale
24 Months
|
52 units on a scale
Interval 41.0 to 57.0
|
52 units on a scale
Interval 41.0 to 57.0
|
|
H02: SF-36 Social Functioning Subscale
36 Months
|
52 units on a scale
Interval 41.0 to 57.0
|
52 units on a scale
Interval 41.0 to 57.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=598 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=586 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:SF-36 Vitality Subscale
Baseline
|
46.4 units on a scale
Standard Deviation 10.3
|
47.5 units on a scale
Standard Deviation 10.9
|
|
H01:SF-36 Vitality Subscale
4 Months
|
51.6 units on a scale
Standard Deviation 9.8
|
50.5 units on a scale
Standard Deviation 10.5
|
|
H01:SF-36 Vitality Subscale
12 Months
|
52.2 units on a scale
Standard Deviation 10.1
|
49.9 units on a scale
Standard Deviation 10.9
|
|
H01:SF-36 Vitality Subscale
24 Months
|
51.9 units on a scale
Standard Deviation 9.9
|
49.4 units on a scale
Standard Deviation 10.5
|
|
H01:SF-36 Vitality Subscale
36 Months
|
51.4 units on a scale
Standard Deviation 10.0
|
50.6 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Outcome measures
| Measure |
H01: Medication
n=489 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=480 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-36 Vitality Subscale
Baseline
|
44 units on a scale
Interval 37.0 to 51.0
|
44 units on a scale
Interval 37.0 to 49.0
|
|
H02: SF-36 Vitality Subscale
4 Months
|
51 units on a scale
Interval 42.0 to 59.0
|
51 units on a scale
Interval 44.0 to 59.0
|
|
H02: SF-36 Vitality Subscale
12 Months
|
53 units on a scale
Interval 44.0 to 59.0
|
51 units on a scale
Interval 44.0 to 59.0
|
|
H02: SF-36 Vitality Subscale
24 Months
|
51 units on a scale
Interval 44.0 to 59.0
|
51 units on a scale
Interval 44.0 to 61.0
|
|
H02: SF-36 Vitality Subscale
36 Months
|
51 units on a scale
Interval 44.0 to 59.0
|
51 units on a scale
Interval 44.0 to 61.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Outcome measures
| Measure |
H01: Medication
n=534 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=530 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:SF-12 Physical Component Summary (PCS) Scale
Baseline
|
37.8 units on a scale
Standard Deviation 6.1
|
38.4 units on a scale
Standard Deviation 5.7
|
|
H01:SF-12 Physical Component Summary (PCS) Scale
4 Months
|
40.2 units on a scale
Standard Deviation 5.9
|
39.9 units on a scale
Standard Deviation 5.8
|
|
H01:SF-12 Physical Component Summary (PCS) Scale
12 Months
|
41.0 units on a scale
Standard Deviation 5.3
|
40.0 units on a scale
Standard Deviation 6.0
|
|
H01:SF-12 Physical Component Summary (PCS) Scale
24 Months
|
41.3 units on a scale
Standard Deviation 5.7
|
40.9 units on a scale
Standard Deviation 5.8
|
|
H01:SF-12 Physical Component Summary (PCS) Scale
36 Months
|
40.8 units on a scale
Standard Deviation 5.5
|
41.3 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Outcome measures
| Measure |
H01: Medication
n=433 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=426 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-12 Physical Component Summary (PCS) Scale
Baseline
|
37 units on a scale
Interval 33.0 to 41.0
|
37 units on a scale
Interval 33.0 to 41.0
|
|
H02: SF-12 Physical Component Summary (PCS) Scale
4 Months
|
40 units on a scale
Interval 36.0 to 43.0
|
40 units on a scale
Interval 36.0 to 43.0
|
|
H02: SF-12 Physical Component Summary (PCS) Scale
12 Months
|
41 units on a scale
Interval 37.0 to 43.0
|
41 units on a scale
Interval 38.0 to 45.0
|
|
H02: SF-12 Physical Component Summary (PCS) Scale
24 Months
|
41 units on a scale
Interval 37.0 to 44.0
|
41 units on a scale
Interval 37.0 to 44.0
|
|
H02: SF-12 Physical Component Summary (PCS) Scale
36 Months
|
40 units on a scale
Interval 36.0 to 44.0
|
41 units on a scale
Interval 38.0 to 45.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Outcome measures
| Measure |
H01: Medication
n=534 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=530 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: SF-12 Mental Component Summary (MCS) Scale
Baseline
|
44.6 units on a scale
Standard Deviation 12.6
|
45.5 units on a scale
Standard Deviation 13.0
|
|
H01: SF-12 Mental Component Summary (MCS) Scale
4 Months
|
50.5 units on a scale
Standard Deviation 11.8
|
49.2 units on a scale
Standard Deviation 12.3
|
|
H01: SF-12 Mental Component Summary (MCS) Scale
12 Months
|
51.8 units on a scale
Standard Deviation 12.1
|
50.3 units on a scale
Standard Deviation 12.6
|
|
H01: SF-12 Mental Component Summary (MCS) Scale
24 Months
|
51.6 units on a scale
Standard Deviation 11.1
|
49.7 units on a scale
Standard Deviation 12.6
|
|
H01: SF-12 Mental Component Summary (MCS) Scale
36 Months
|
51.6 units on a scale
Standard Deviation 11.4
|
50.9 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Outcome measures
| Measure |
H01: Medication
n=433 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=426 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: SF-12 Mental Component Summary (MCS) Scale
Baseline
|
42 units on a scale
Interval 32.0 to 53.0
|
41 units on a scale
Interval 33.0 to 53.0
|
|
H02: SF-12 Mental Component Summary (MCS) Scale
4 Months
|
54 units on a scale
Interval 41.0 to 62.0
|
55 units on a scale
Interval 44.0 to 61.0
|
|
H02: SF-12 Mental Component Summary (MCS) Scale
12 Months
|
57 units on a scale
Interval 46.0 to 63.0
|
54 units on a scale
Interval 45.0 to 62.0
|
|
H02: SF-12 Mental Component Summary (MCS) Scale
24 Months
|
56 units on a scale
Interval 44.0 to 61.0
|
55 units on a scale
Interval 44.0 to 62.0
|
|
H02: SF-12 Mental Component Summary (MCS) Scale
36 Months
|
56 units on a scale
Interval 45.0 to 62.0
|
56 units on a scale
Interval 46.0 to 62.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=597 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=585 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Physical Limitation Scale
Baseline
|
64.2 units on a scale
Standard Deviation 24.7
|
64.7 units on a scale
Standard Deviation 26.1
|
|
H01: KCCQ Physical Limitation Scale
4 Months
|
75.2 units on a scale
Standard Deviation 23.6
|
73.1 units on a scale
Standard Deviation 23.6
|
|
H01: KCCQ Physical Limitation Scale
12 Months
|
77.8 units on a scale
Standard Deviation 23.0
|
73.4 units on a scale
Standard Deviation 24.3
|
|
H01: KCCQ Physical Limitation Scale
24 Months
|
76.6 units on a scale
Standard Deviation 23.1
|
73.1 units on a scale
Standard Deviation 25.4
|
|
H01: KCCQ Physical Limitation Scale
36 Months
|
76.8 units on a scale
Standard Deviation 22.0
|
74.9 units on a scale
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=484 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=480 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Physical Limitation Scale
Baseline
|
63 units on a scale
Interval 38.0 to 83.0
|
63 units on a scale
Interval 45.0 to 80.0
|
|
H02: KCCQ Physical Limitation Scale
4 Months
|
83 units on a scale
Interval 58.0 to 95.0
|
83 units on a scale
Interval 64.0 to 96.0
|
|
H02: KCCQ Physical Limitation Scale
12 Months
|
84 units on a scale
Interval 65.0 to 100.0
|
88 units on a scale
Interval 67.0 to 96.0
|
|
H02: KCCQ Physical Limitation Scale
24 Months
|
88 units on a scale
Interval 60.0 to 100.0
|
85 units on a scale
Interval 66.0 to 96.0
|
|
H02: KCCQ Physical Limitation Scale
36 Months
|
88 units on a scale
Interval 69.0 to 100.0
|
88 units on a scale
Interval 67.0 to 96.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. .
Outcome measures
| Measure |
H01: Medication
n=604 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=590 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Symptom Stability
Baseline
|
53.3 units on a scale
Standard Deviation 23.3
|
55.5 units on a scale
Standard Deviation 23.8
|
|
H01: KCCQ Symptom Stability
4 Months
|
58.6 units on a scale
Standard Deviation 20.5
|
55.7 units on a scale
Standard Deviation 19.1
|
|
H01: KCCQ Symptom Stability
12 Months
|
52.8 units on a scale
Standard Deviation 15.7
|
51.1 units on a scale
Standard Deviation 17.4
|
|
H01: KCCQ Symptom Stability
24 Months
|
51.7 units on a scale
Standard Deviation 14.5
|
49.3 units on a scale
Standard Deviation 15.5
|
|
H01: KCCQ Symptom Stability
36 Months
|
50.7 units on a scale
Standard Deviation 14.4
|
50.8 units on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
Outcome measures
| Measure |
H01: Medication
n=494 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=492 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Symptom Stability
Baseline
|
50 units on a scale
Interval 25.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: KCCQ Symptom Stability
4 Months
|
50 units on a scale
Interval 50.0 to 75.0
|
50 units on a scale
Interval 50.0 to 75.0
|
|
H02: KCCQ Symptom Stability
12 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: KCCQ Symptom Stability
24 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: KCCQ Symptom Stability
36 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=606 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=592 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Symptom Frequency
Baseline
|
70.5 units on a scale
Standard Deviation 24.6
|
71.5 units on a scale
Standard Deviation 25.7
|
|
H01: KCCQ Symptom Frequency
4 Months
|
79.8 units on a scale
Standard Deviation 21.6
|
79.1 units on a scale
Standard Deviation 21.8
|
|
H01: KCCQ Symptom Frequency
12 Months
|
82.4 units on a scale
Standard Deviation 22.2
|
79.2 units on a scale
Standard Deviation 23.5
|
|
H01: KCCQ Symptom Frequency
24 Months
|
82.2 units on a scale
Standard Deviation 20.9
|
79.3 units on a scale
Standard Deviation 23.3
|
|
H01: KCCQ Symptom Frequency
36 Months
|
81.7 units on a scale
Standard Deviation 22.7
|
80.4 units on a scale
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=493 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=491 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Symptom Frequency
Baseline
|
67 units on a scale
Interval 50.0 to 88.0
|
71 units on a scale
Interval 50.0 to 88.0
|
|
H02: KCCQ Symptom Frequency
4 Months
|
83 units on a scale
Interval 63.0 to 100.0
|
88 units on a scale
Interval 67.0 to 100.0
|
|
H02: KCCQ Symptom Frequency
12 Months
|
90 units on a scale
Interval 67.0 to 100.0
|
90 units on a scale
Interval 71.0 to 100.0
|
|
H02: KCCQ Symptom Frequency
24 Months
|
92 units on a scale
Interval 67.0 to 100.0
|
92 units on a scale
Interval 69.0 to 100.0
|
|
H02: KCCQ Symptom Frequency
36 Months
|
92 units on a scale
Interval 67.0 to 100.0
|
92 units on a scale
Interval 69.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=606 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=591 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Symptom Burden
Baseline
|
72.6 units on a scale
Standard Deviation 22.5
|
73.4 units on a scale
Standard Deviation 24.4
|
|
H01: KCCQ Symptom Burden
4 Months
|
81.4 units on a scale
Standard Deviation 20.4
|
79.6 units on a scale
Standard Deviation 21.0
|
|
H01: KCCQ Symptom Burden
12 Months
|
83.7 units on a scale
Standard Deviation 20.6
|
79.8 units on a scale
Standard Deviation 22.5
|
|
H01: KCCQ Symptom Burden
24 Months
|
83.3 units on a scale
Standard Deviation 20.2
|
80.0 units on a scale
Standard Deviation 23.1
|
|
H01: KCCQ Symptom Burden
36 Months
|
83.1 units on a scale
Standard Deviation 21.2
|
80.7 units on a scale
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=494 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=492 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Symptom Burden
Baseline
|
67 units on a scale
Interval 50.0 to 92.0
|
75 units on a scale
Interval 50.0 to 83.0
|
|
H02: KCCQ Symptom Burden
4 Months
|
83 units on a scale
Interval 67.0 to 100.0
|
83 units on a scale
Interval 67.0 to 100.0
|
|
H02: KCCQ Symptom Burden
12 Months
|
92 units on a scale
Interval 67.0 to 100.0
|
92 units on a scale
Interval 67.0 to 100.0
|
|
H02: KCCQ Symptom Burden
24 Months
|
92 units on a scale
Interval 67.0 to 100.0
|
92 units on a scale
Interval 67.0 to 100.0
|
|
H02: KCCQ Symptom Burden
36 Months
|
92 units on a scale
Interval 67.0 to 100.0
|
92 units on a scale
Interval 67.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=606 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=592 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Total Symptoms
Baseline
|
71.7 units on a scale
Standard Deviation 22.5
|
72.6 units on a scale
Standard Deviation 24.2
|
|
H01: KCCQ Total Symptoms
4 Months
|
80.8 units on a scale
Standard Deviation 20.0
|
79.5 units on a scale
Standard Deviation 20.5
|
|
H01: KCCQ Total Symptoms
12 Months
|
83.2 units on a scale
Standard Deviation 20.5
|
79.6 units on a scale
Standard Deviation 22.1
|
|
H01: KCCQ Total Symptoms
24 Months
|
82.9 units on a scale
Standard Deviation 19.8
|
79.8 units on a scale
Standard Deviation 22.6
|
|
H01: KCCQ Total Symptoms
36 Months
|
82.5 units on a scale
Standard Deviation 21.3
|
80.7 units on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=494 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=492 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Total Symptoms
Baseline
|
68 units on a scale
Interval 48.0 to 86.0
|
71 units on a scale
Interval 52.0 to 88.0
|
|
H02: KCCQ Total Symptoms
4 Months
|
84 units on a scale
Interval 65.0 to 100.0
|
88 units on a scale
Interval 71.0 to 100.0
|
|
H02: KCCQ Total Symptoms
12 Months
|
90 units on a scale
Interval 68.0 to 100.0
|
88 units on a scale
Interval 71.0 to 100.0
|
|
H02: KCCQ Total Symptoms
24 Months
|
90 units on a scale
Interval 71.0 to 100.0
|
90 units on a scale
Interval 71.0 to 100.0
|
|
H02: KCCQ Total Symptoms
36 Months
|
90 units on a scale
Interval 70.0 to 100.0
|
92 units on a scale
Interval 68.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=606 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=591 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Quality-of-Life Scale
Baseline
|
47.9 units on a scale
Standard Deviation 25.0
|
50.1 units on a scale
Standard Deviation 27.0
|
|
H01: KCCQ Quality-of-Life Scale
4 Months
|
68.7 units on a scale
Standard Deviation 24.5
|
63.3 units on a scale
Standard Deviation 25.6
|
|
H01: KCCQ Quality-of-Life Scale
12 Months
|
72.9 units on a scale
Standard Deviation 23.5
|
65.6 units on a scale
Standard Deviation 25.8
|
|
H01: KCCQ Quality-of-Life Scale
24 Months
|
71.9 units on a scale
Standard Deviation 22.6
|
66.9 units on a scale
Standard Deviation 26.0
|
|
H01: KCCQ Quality-of-Life Scale
36 Months
|
71.2 units on a scale
Standard Deviation 23.3
|
69.1 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=493 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=490 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Quality-of-Life Scale
Baseline
|
42 units on a scale
Interval 17.0 to 58.0
|
33 units on a scale
Interval 25.0 to 58.0
|
|
H02: KCCQ Quality-of-Life Scale
4 Months
|
75 units on a scale
Interval 50.0 to 92.0
|
75 units on a scale
Interval 58.0 to 92.0
|
|
H02: KCCQ Quality-of-Life Scale
12 Months
|
75 units on a scale
Interval 50.0 to 92.0
|
75 units on a scale
Interval 58.0 to 92.0
|
|
H02: KCCQ Quality-of-Life Scale
24 Months
|
75 units on a scale
Interval 58.0 to 92.0
|
75 units on a scale
Interval 58.0 to 92.0
|
|
H02: KCCQ Quality-of-Life Scale
36 Months
|
75 units on a scale
Interval 58.0 to 92.0
|
83 units on a scale
Interval 58.0 to 92.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=570 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=554 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Social Limitation
Baseline
|
56.4 units on a scale
Standard Deviation 29.9
|
57.3 units on a scale
Standard Deviation 29.7
|
|
H01: KCCQ Social Limitation
4 Months
|
72.3 units on a scale
Standard Deviation 27.4
|
69.0 units on a scale
Standard Deviation 27.0
|
|
H01: KCCQ Social Limitation
12 Months
|
76.4 units on a scale
Standard Deviation 26.0
|
69.5 units on a scale
Standard Deviation 28.4
|
|
H01: KCCQ Social Limitation
24 Months
|
75.4 units on a scale
Standard Deviation 25.9
|
71.0 units on a scale
Standard Deviation 28.8
|
|
H01: KCCQ Social Limitation
36 Months
|
75.4 units on a scale
Standard Deviation 27.0
|
72.8 units on a scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=465 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=467 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Social Limitation
Baseline
|
44 units on a scale
Interval 19.0 to 75.0
|
44 units on a scale
Interval 25.0 to 75.0
|
|
H02: KCCQ Social Limitation
4 Months
|
75 units on a scale
Interval 50.0 to 94.0
|
75 units on a scale
Interval 50.0 to 100.0
|
|
H02: KCCQ Social Limitation
12 Months
|
81 units on a scale
Interval 58.0 to 100.0
|
83 units on a scale
Interval 63.0 to 94.0
|
|
H02: KCCQ Social Limitation
24 Months
|
81 units on a scale
Interval 50.0 to 100.0
|
86 units on a scale
Interval 56.0 to 100.0
|
|
H02: KCCQ Social Limitation
36 Months
|
83 units on a scale
Interval 58.0 to 100.0
|
83 units on a scale
Interval 56.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=607 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=592 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Clinical Summary Score
Baseline
|
68.2 units on a scale
Standard Deviation 21.8
|
68.8 units on a scale
Standard Deviation 23.1
|
|
H01: KCCQ Clinical Summary Score
4 Months
|
78.2 units on a scale
Standard Deviation 20.0
|
76.4 units on a scale
Standard Deviation 20.4
|
|
H01: KCCQ Clinical Summary Score
12 Months
|
80.6 units on a scale
Standard Deviation 20.3
|
76.4 units on a scale
Standard Deviation 21.9
|
|
H01: KCCQ Clinical Summary Score
24 Months
|
80.1 units on a scale
Standard Deviation 19.5
|
76.6 units on a scale
Standard Deviation 22.6
|
|
H01: KCCQ Clinical Summary Score
36 Months
|
79.9 units on a scale
Standard Deviation 20.2
|
78.0 units on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=496 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=492 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Clinical Summary Score
Baseline
|
65 units on a scale
Interval 46.0 to 83.0
|
68 units on a scale
Interval 49.0 to 84.0
|
|
H02: KCCQ Clinical Summary Score
4 Months
|
84 units on a scale
Interval 63.0 to 95.0
|
84 units on a scale
Interval 67.0 to 96.0
|
|
H02: KCCQ Clinical Summary Score
12 Months
|
88 units on a scale
Interval 66.0 to 97.0
|
86 units on a scale
Interval 70.0 to 96.0
|
|
H02: KCCQ Clinical Summary Score
24 Months
|
88 units on a scale
Interval 65.0 to 97.0
|
87 units on a scale
Interval 69.0 to 96.0
|
|
H02: KCCQ Clinical Summary Score
36 Months
|
88 units on a scale
Interval 67.0 to 98.0
|
88 units on a scale
Interval 69.0 to 98.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=607 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=592 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: KCCQ Overall Summary Score
Baseline
|
60.3 units on a scale
Standard Deviation 22.3
|
61.3 units on a scale
Standard Deviation 23.2
|
|
H01: KCCQ Overall Summary Score
4 Months
|
74.3 units on a scale
Standard Deviation 21.0
|
71.2 units on a scale
Standard Deviation 21.3
|
|
H01: KCCQ Overall Summary Score
12 Months
|
77.5 units on a scale
Standard Deviation 20.4
|
72.2 units on a scale
Standard Deviation 22.7
|
|
H01: KCCQ Overall Summary Score
24 Months
|
76.9 units on a scale
Standard Deviation 20.1
|
72.9 units on a scale
Standard Deviation 23.4
|
|
H01: KCCQ Overall Summary Score
36 Months
|
76.6 units on a scale
Standard Deviation 20.9
|
74.5 units on a scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Outcome measures
| Measure |
H01: Medication
n=496 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=492 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: KCCQ Overall Summary Score
Baseline
|
53 units on a scale
Interval 36.0 to 70.0
|
54 units on a scale
Interval 38.0 to 72.0
|
|
H02: KCCQ Overall Summary Score
4 Months
|
79 units on a scale
Interval 56.0 to 92.0
|
79 units on a scale
Interval 63.0 to 92.0
|
|
H02: KCCQ Overall Summary Score
12 Months
|
84 units on a scale
Interval 59.0 to 95.0
|
82 units on a scale
Interval 66.0 to 94.0
|
|
H02: KCCQ Overall Summary Score
24 Months
|
84 units on a scale
Interval 60.0 to 95.0
|
84 units on a scale
Interval 64.0 to 94.0
|
|
H02: KCCQ Overall Summary Score
36 Months
|
85 units on a scale
Interval 65.0 to 95.0
|
84 units on a scale
Interval 63.0 to 95.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. .
Outcome measures
| Measure |
H01: Medication
n=594 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=584 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
Baseline
|
74.3 units on a scale
Standard Deviation 26.7
|
77.0 units on a scale
Standard Deviation 26.2
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
4 Months
|
90.5 units on a scale
Standard Deviation 16.9
|
84.0 units on a scale
Standard Deviation 23.2
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
12 Months
|
90.6 units on a scale
Standard Deviation 16.5
|
84.0 units on a scale
Standard Deviation 22.4
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
24 Months
|
90.5 units on a scale
Standard Deviation 17.2
|
86.5 units on a scale
Standard Deviation 19.7
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
36 Months
|
89.8 units on a scale
Standard Deviation 17.5
|
88.5 units on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
Outcome measures
| Measure |
H01: Medication
n=488 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=482 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
Baseline
|
70 units on a scale
Interval 40.0 to 90.0
|
80 units on a scale
Interval 50.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
4 Months
|
100 units on a scale
Interval 90.0 to 100.0
|
100 units on a scale
Interval 90.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
12 Months
|
100 units on a scale
Interval 90.0 to 100.0
|
100 units on a scale
Interval 90.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
24 Months
|
100 units on a scale
Interval 80.0 to 100.0
|
100 units on a scale
Interval 90.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
36 Months
|
100 units on a scale
Interval 90.0 to 100.0
|
100 units on a scale
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. .
Outcome measures
| Measure |
H01: Medication
n=575 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=565 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
Baseline
|
56.0 units on a scale
Standard Deviation 27.1
|
57.8 units on a scale
Standard Deviation 25.0
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
4 Months
|
58.3 units on a scale
Standard Deviation 20.3
|
55.8 units on a scale
Standard Deviation 20.6
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
12 Months
|
55.4 units on a scale
Standard Deviation 17.3
|
53.3 units on a scale
Standard Deviation 17.6
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
24 Months
|
52.9 units on a scale
Standard Deviation 14.9
|
52.9 units on a scale
Standard Deviation 17.4
|
|
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
36 Months
|
53.9 units on a scale
Standard Deviation 16.9
|
53.6 units on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
Outcome measures
| Measure |
H01: Medication
n=477 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=462 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
Baseline
|
50 units on a scale
Interval 25.0 to 50.0
|
50 units on a scale
Interval 25.0 to 50.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
4 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
12 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
24 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
36 Months
|
50 units on a scale
Interval 50.0 to 50.0
|
50 units on a scale
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. .
Outcome measures
| Measure |
H01: Medication
n=585 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=574 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
Baseline
|
53.6 units on a scale
Standard Deviation 25.9
|
57.6 units on a scale
Standard Deviation 26.6
|
|
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
4 Months
|
74.5 units on a scale
Standard Deviation 22.1
|
67.5 units on a scale
Standard Deviation 24.4
|
|
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
12 Months
|
75.8 units on a scale
Standard Deviation 21.2
|
69.1 units on a scale
Standard Deviation 24.0
|
|
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
24 Months
|
75.5 units on a scale
Standard Deviation 21.5
|
68.7 units on a scale
Standard Deviation 24.9
|
|
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
36 Months
|
75.3 units on a scale
Standard Deviation 22.1
|
72.9 units on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
Outcome measures
| Measure |
H01: Medication
n=484 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=478 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
Baseline
|
42 units on a scale
Interval 25.0 to 67.0
|
42 units on a scale
Interval 25.0 to 67.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
4 Months
|
83 units on a scale
Interval 67.0 to 100.0
|
83 units on a scale
Interval 58.0 to 92.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
12 Months
|
83 units on a scale
Interval 67.0 to 100.0
|
83 units on a scale
Interval 67.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
24 Months
|
83 units on a scale
Interval 58.0 to 100.0
|
83 units on a scale
Interval 67.0 to 100.0
|
|
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
36 Months
|
83 units on a scale
Interval 67.0 to 100.0
|
83 units on a scale
Interval 67.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. .
Outcome measures
| Measure |
H01: Medication
n=593 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=585 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: EQ-5D Visual Analog Scale
Baseline
|
56.7 units on a scale
Standard Deviation 19.0
|
59.5 units on a scale
Standard Deviation 18.8
|
|
H01: EQ-5D Visual Analog Scale
4 Months
|
68.5 units on a scale
Standard Deviation 18.1
|
65.4 units on a scale
Standard Deviation 17.7
|
|
H01: EQ-5D Visual Analog Scale
12 Months
|
69.2 units on a scale
Standard Deviation 17.9
|
65.4 units on a scale
Standard Deviation 18.5
|
|
H01: EQ-5D Visual Analog Scale
24 Months
|
68.6 units on a scale
Standard Deviation 17.8
|
65.9 units on a scale
Standard Deviation 18.4
|
|
H01: EQ-5D Visual Analog Scale
36 Months
|
69.0 units on a scale
Standard Deviation 17.9
|
67.1 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
Outcome measures
| Measure |
H01: Medication
n=488 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=487 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: EQ-5D Visual Analog Scale
Baseline
|
50 units on a scale
Interval 40.0 to 70.0
|
50 units on a scale
Interval 40.0 to 70.0
|
|
H02: EQ-5D Visual Analog Scale
4 Months
|
70 units on a scale
Interval 60.0 to 80.0
|
70 units on a scale
Interval 60.0 to 80.0
|
|
H02: EQ-5D Visual Analog Scale
12 Months
|
72 units on a scale
Interval 60.0 to 80.0
|
70 units on a scale
Interval 60.0 to 80.0
|
|
H02: EQ-5D Visual Analog Scale
24 Months
|
70 units on a scale
Interval 50.0 to 80.0
|
70 units on a scale
Interval 50.0 to 80.0
|
|
H02: EQ-5D Visual Analog Scale
36 Months
|
70 units on a scale
Interval 50.0 to 80.0
|
70 units on a scale
Interval 52.0 to 80.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale. .
Outcome measures
| Measure |
H01: Medication
n=584 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=570 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: EQ-5D Health Status Index Score
Baseline
|
69.3 units on a scale
Standard Deviation 25.8
|
72.3 units on a scale
Standard Deviation 24.4
|
|
H01: EQ-5D Health Status Index Score
4 Months
|
78.9 units on a scale
Standard Deviation 24.5
|
77.4 units on a scale
Standard Deviation 22.6
|
|
H01: EQ-5D Health Status Index Score
12 Months
|
80.5 units on a scale
Standard Deviation 22.3
|
77.6 units on a scale
Standard Deviation 24.0
|
|
H01: EQ-5D Health Status Index Score
24 Months
|
79.6 units on a scale
Standard Deviation 24.6
|
78.1 units on a scale
Standard Deviation 25.9
|
|
H01: EQ-5D Health Status Index Score
36 Months
|
81.4 units on a scale
Standard Deviation 23.4
|
81.5 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
Outcome measures
| Measure |
H01: Medication
n=475 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=477 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: EQ-5D Health Status Index Score
Baseline
|
69 units on a scale
Interval 52.0 to 81.0
|
69 units on a scale
Interval 59.0 to 81.0
|
|
H02: EQ-5D Health Status Index Score
4 Months
|
85 units on a scale
Interval 69.0 to 100.0
|
85 units on a scale
Interval 69.0 to 100.0
|
|
H02: EQ-5D Health Status Index Score
12 Months
|
85 units on a scale
Interval 73.0 to 100.0
|
85 units on a scale
Interval 73.0 to 100.0
|
|
H02: EQ-5D Health Status Index Score
24 Months
|
85 units on a scale
Interval 69.0 to 100.0
|
85 units on a scale
Interval 69.0 to 100.0
|
|
H02: EQ-5D Health Status Index Score
36 Months
|
85 units on a scale
Interval 69.0 to 100.0
|
85 units on a scale
Interval 69.0 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. .
Outcome measures
| Measure |
H01: Medication
n=595 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=583 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
Baseline
|
42.9 percentage of participants
|
43.4 percentage of participants
|
|
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
4 Months
|
26.6 percentage of participants
|
27.5 percentage of participants
|
|
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
12 Months
|
25.0 percentage of participants
|
26.9 percentage of participants
|
|
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
24 Months
|
24.1 percentage of participants
|
31.1 percentage of participants
|
|
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
36 Months
|
22.4 percentage of participants
|
29.5 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
Outcome measures
| Measure |
H01: Medication
n=496 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=495 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
Baseline
|
50.5 percentage of participants
|
53.2 percentage of participants
|
|
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
4 Months
|
29.6 percentage of participants
|
27.0 percentage of participants
|
|
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
12 Months
|
24.4 percentage of participants
|
27.0 percentage of participants
|
|
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
24 Months
|
28.1 percentage of participants
|
24.3 percentage of participants
|
|
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
36 Months
|
20.8 percentage of participants
|
24.8 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Outcome measures
| Measure |
H01: Medication
n=596 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=581 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
Baseline
|
46.8 units on a scale
Standard Deviation 24.3
|
49.3 units on a scale
Standard Deviation 24.9
|
|
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
4 Months
|
56.0 units on a scale
Standard Deviation 25.0
|
53.8 units on a scale
Standard Deviation 24.8
|
|
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
12 Months
|
56.7 units on a scale
Standard Deviation 25.9
|
53.9 units on a scale
Standard Deviation 26.7
|
|
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
24 Months
|
55.3 units on a scale
Standard Deviation 25.2
|
53.3 units on a scale
Standard Deviation 26.4
|
|
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
36 Months
|
56.2 units on a scale
Standard Deviation 26.0
|
54.9 units on a scale
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Outcome measures
| Measure |
H01: Medication
n=487 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=481 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
Baseline
|
45 units on a scale
Interval 25.0 to 63.0
|
45 units on a scale
Interval 25.0 to 67.0
|
|
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
4 Months
|
61 units on a scale
Interval 38.0 to 75.0
|
63 units on a scale
Interval 40.0 to 75.0
|
|
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
12 Months
|
65 units on a scale
Interval 42.0 to 80.0
|
64 units on a scale
Interval 45.0 to 75.0
|
|
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
24 Months
|
63 units on a scale
Interval 44.0 to 78.0
|
65 units on a scale
Interval 45.0 to 80.0
|
|
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
36 Months
|
58 units on a scale
Interval 40.0 to 75.0
|
63 units on a scale
Interval 45.0 to 75.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Outcome measures
| Measure |
H01: Medication
n=599 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=583 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
Baseline
|
62.9 units on a scale
Standard Deviation 22.5
|
64.8 units on a scale
Standard Deviation 21.2
|
|
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
4 Months
|
69.2 units on a scale
Standard Deviation 20.6
|
68.7 units on a scale
Standard Deviation 20.5
|
|
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
12 Months
|
68.7 units on a scale
Standard Deviation 20.3
|
67.4 units on a scale
Standard Deviation 21.8
|
|
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
24 Months
|
68.3 units on a scale
Standard Deviation 20.4
|
66.2 units on a scale
Standard Deviation 21.3
|
|
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
36 Months
|
69.7 units on a scale
Standard Deviation 21.0
|
68.3 units on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Outcome measures
| Measure |
H01: Medication
n=487 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=482 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
Baseline
|
63 units on a scale
Interval 47.0 to 75.0
|
63 units on a scale
Interval 47.0 to 75.0
|
|
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
4 Months
|
75 units on a scale
Interval 62.0 to 91.0
|
75 units on a scale
Interval 61.0 to 88.0
|
|
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
12 Months
|
75 units on a scale
Interval 63.0 to 91.0
|
75 units on a scale
Interval 63.0 to 88.0
|
|
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
24 Months
|
75 units on a scale
Interval 63.0 to 92.0
|
75 units on a scale
Interval 61.0 to 88.0
|
|
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
36 Months
|
75 units on a scale
Interval 63.0 to 84.0
|
75 units on a scale
Interval 63.0 to 91.0
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. .
Outcome measures
| Measure |
H01: Medication
n=579 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=554 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: General Health Rating Scale
Baseline
|
56.0 units on a scale
Standard Deviation 19.4
|
57.6 units on a scale
Standard Deviation 19.0
|
|
H01: General Health Rating Scale
4 Months
|
67.3 units on a scale
Standard Deviation 19.1
|
64.0 units on a scale
Standard Deviation 18.1
|
|
H01: General Health Rating Scale
12 Months
|
68.7 units on a scale
Standard Deviation 18.7
|
63.7 units on a scale
Standard Deviation 19.1
|
|
H01: General Health Rating Scale
24 Months
|
68.1 units on a scale
Standard Deviation 19.2
|
65.0 units on a scale
Standard Deviation 19.6
|
|
H01: General Health Rating Scale
36 Months
|
69.1 units on a scale
Standard Deviation 31.6
|
67.1 units on a scale
Standard Deviation 33.7
|
SECONDARY outcome
Timeframe: From enrollment to 3-year follow-upPopulation: Only patients with questionnaire data were analyzed.
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
Outcome measures
| Measure |
H01: Medication
n=466 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=458 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: General Health Rating Scale
Baseline
|
50 units on a scale
Interval 40.0 to 70.0
|
50 units on a scale
Interval 40.0 to 70.0
|
|
H02: General Health Rating Scale
4 Months
|
70 units on a scale
Interval 50.0 to 80.0
|
70 units on a scale
Interval 60.0 to 80.0
|
|
H02: General Health Rating Scale
12 Months
|
70 units on a scale
Interval 50.0 to 80.0
|
70 units on a scale
Interval 60.0 to 80.0
|
|
H02: General Health Rating Scale
24 Months
|
70 units on a scale
Interval 50.0 to 80.0
|
70 units on a scale
Interval 50.0 to 80.0
|
|
H02: General Health Rating Scale
36 Months
|
70 units on a scale
Interval 60.0 to 80.0
|
70 units on a scale
Interval 55.0 to 80.0
|
SECONDARY outcome
Timeframe: index hospital admissionPopulation: US patients with hospital bills
Hospital costs and physician fees for US patients
Outcome measures
| Measure |
H01: Medication
n=66 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=54 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H01: Cost of Care
Hospital Costs
|
50,032 2009 US Dollars
Standard Deviation 41,622
|
8,315 2009 US Dollars
Standard Deviation 19,719
|
|
H01: Cost of Care
Physician Fees
|
5,405 2009 US Dollars
Standard Deviation 2,377
|
408 2009 US Dollars
Standard Deviation 819
|
|
H01: Cost of Care
Total Index Cost
|
55,437 2009 US Dollars
Standard Deviation 43,460
|
8,723 2009 US Dollars
Standard Deviation 20,506
|
SECONDARY outcome
Timeframe: index hospital admissionPopulation: US patients with hospital bills
Hospital costs and physician fees for US patients
Outcome measures
| Measure |
H01: Medication
n=100 Participants
H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
|
Total H01: Medication + CABG
n=96 Participants
H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
|
|---|---|---|
|
H02: Cost of Care
Hospital Costs
|
50,939 2008 US Dollars
Standard Deviation 46,458
|
64,202 2008 US Dollars
Standard Deviation 49,172
|
|
H02: Cost of Care
Physician Fees
|
5,183 2008 US Dollars
Standard Deviation 2,306
|
6,515 2008 US Dollars
Standard Deviation 2,463
|
|
H02: Cost of Care
Total Index Cost
|
56,122 2008 US Dollars
Standard Deviation 48,552
|
70,717 2008 US Dollars
Standard Deviation 51,367
|
Adverse Events
H01: Medication
Serious events: 84 serious events
Other events: 0 other events
Deaths: 0 deaths
H01: Medication + CABG
Serious events: 85 serious events
Other events: 0 other events
Deaths: 0 deaths
H01 & H02: Medication+CABG
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
H02: Medication+CABG
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
H02: Medication+CABG+SVR
Serious events: 53 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
H01: Medication
n=602 participants at risk
|
H01: Medication + CABG
n=534 participants at risk
|
H01 & H02: Medication+CABG
n=76 participants at risk
|
H02: Medication+CABG
n=423 participants at risk
|
H02: Medication+CABG+SVR
n=501 participants at risk
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
CHRONIC SUBDURAL HAEMATOMA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
CLAUDICATION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
CMV INFECTION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Psychiatric disorders
CONFUSION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ACUTE HEART FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.75%
4/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY EDEMA
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Renal and urinary disorders
ACUTE RENAL FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
7/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.95%
4/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.8%
9/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY INSUFFICIENCY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
ALS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ANGINAL DISCOMFORT
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
ANOXIC ENCEPHALOPATHY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
AORTIC RUPTURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ARRHYTHMIA
|
1.00%
6/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
7/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.80%
4/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
ARTERIAL EMBOLISM (LIMBS)
|
0.66%
4/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.56%
3/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
ASCITES
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION PNEUMONIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ASYSTOLIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.47%
2/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
BACTEREMIA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
BOWEL ISCHEMIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN TUMOR
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
BRONCHITIS
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Investigations
BUN INCREASED
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER OF LUNG
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.83%
5/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.94%
5/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Hepatobiliary disorders
CARDIAC CIRRHOSIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC FAILURE AGGRAVATED
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIAC VENTRICULAR THROMBOSIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.50%
3/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.56%
3/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.47%
2/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIOPULMONARY INSUFFICIENCY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CONGESTIVE CARDIAC FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CONGESTIVE HEART FAILURE
|
0.50%
3/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.37%
2/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
CORONARY OCCLUSION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Investigations
CREATININE INCREASED
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
CYSTITIS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
DECOMPENSATED HEART FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
DECOMPENSATION CARDIAC
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
DEVICE LEAD ISSUE
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
EDEMA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
EDEMA PULMONARY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
EMBOLIC CEREBRAL INFARCTION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
END STAGE CARDIAC FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.47%
2/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Hepatobiliary disorders
GALLSTONES
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATED
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Metabolism and nutrition disorders
GOUT
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
HAEMODYNAMIC INSTABILITY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
HEART FAILURE
|
1.8%
11/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.1%
6/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.71%
3/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
HEMODYNAMIC INSTABILITY
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
HEMORRHAGE BRAIN
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Blood and lymphatic system disorders
HEPARIN-INDUCED THROMBOCYTOPENIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Hepatobiliary disorders
HEPATIC INSUFFICIENCY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
HERNIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Surgical and medical procedures
HOSPITALIZATION NOS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Metabolism and nutrition disorders
HYPOVOLEMIA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
IMPLANT SITE INFECTION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
INFECTION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
INSUFFICIENCY CARDIAC
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
ISCHEMIC CARDIOMYOPATHY
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
LOW BLOOD PRESSURE
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
LOW CARDIAC OUTPUT SYNDROME
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
MALIGNANT VENTRICULAR ARRHYTHMIAS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL HEMORRHAGE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
MEDIASTINITIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.75%
4/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA MALIGNANT
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
MITRAL VALVE DISEASE
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
MULTI ORGAN FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
MULTIORGAN FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
MULTIPLE ORGAN FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.56%
3/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.47%
2/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Skin and subcutaneous tissue disorders
NECROSIS SKIN
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
NECROTIZING FASCIITIS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
OTHER CARDIAC
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
PAROXYSMAL ATRIAL FIBRILLATION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
PERIPHERAL VASCULAR DISEASE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.37%
2/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
PNEUMONIA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE HEMORRHAGE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Injury, poisoning and procedural complications
POSTPERICARDIOTOMY SYNDROME
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERY THROMBOSIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLUS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY THROMBOEMBOLISM
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
PULSELESS ELECTRICAL ACTIVITY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Musculoskeletal and connective tissue disorders
SCLERODERMA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
SEPSIS
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
General disorders
SIRS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Skin and subcutaneous tissue disorders
SKIN TROPHIC ULCER
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Injury, poisoning and procedural complications
STERNAL DEHISCENCE
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.37%
2/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Nervous system disorders
STROKE
|
2.8%
17/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
3.0%
16/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
2.6%
2/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
2.1%
9/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
2.0%
10/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Vascular disorders
SUPERFICIAL PHLEBOTHROMBOSIS
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
SUSTAINED VENTRICULAR TACHYCARDIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
1.3%
1/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
SVT
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.19%
1/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
UNSTABLE ANGINA
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.33%
2/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.75%
4/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.24%
1/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
1.00%
6/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.56%
3/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
2.6%
2/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.20%
1/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.40%
2/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Metabolism and nutrition disorders
VOLUME OVERLOAD
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
|
Gastrointestinal disorders
VOMITING
|
0.17%
1/602 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/534 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/76 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/423 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
0.00%
0/501 • No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The agreement is that all publications need to be reviewed and approved by the Policy and Publication Committee and the Sponsor prior to publication.
- Publication restrictions are in place
Restriction type: OTHER