Coronary Artery Disease
Conditions
Keywords
coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery
Brief summary
The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.
Detailed description
The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.
Interventions
PROCEDUREsaphenous vein composite grafting
use saphenous vein as a composite graft connected to the left internal thoracic artery
PROCEDUREright internal thoracic artery composite grafting
right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age equal or more than 40 * age equal or less than 75 * patients who agree to the enrollment
Exclusion criteria
* Patients with heart failure (left ventricular ejection fraction \< 25%) * patients who have intractable ventricular arrhythmia * patients who has been treated for cancer * patients who has infectious disease * patients who are planned to undergo combined cardiac surgery * patients who has medical co-morbidity with expected survival less than 1 year * patients who has a problem using right internal thoracic artery or saphenous vein * patients with a history of previous cardiac surgery * Patients with chronic renal failure * patients who undergo emergency operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 Year Graft Patency Rates | one year | 1 year graft patency of second limb conduits measured by 1 year coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 4 years | Overall survival rate at 4 years |
| Freedom From Cardiac Death | 4 years | Freedom rate from cardiac death at 4 years |
| Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | 4 years | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years |
| Early Angiographic Patency Rates | 1.4days | The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG |
Countries
South Korea
Participant flow
Recruitment details
Patients, 40 to 75 years of age, who were scheduled to between September 2008 and October 2011 patients who undergo off-pump CABG (OPCAB) for multivessel coronary artery disease using a Y-composite graft based on the in situ left ITA were evaluated for eligibility
Pre-assignment details
Exclusion criteria included patients with ineligible Y-composite graft revascularization, unavailable RITA or SV, left ventricular dysfunction, chronic renal failure requiring renal replacement therapy, a history of previous cardiac operation, emergency, or a medical history that might limit the possibility of mid-term follow-up
Participants by arm
| Arm | Count |
|---|---|
| RITA Group patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery
use right internal thoracic artery as a composite graft connected to the left internal thoracic artery
right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery | 112 |
| SVG Group patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery
use saphenous vein as a composite graft connected to the left internal thoracic artery
saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery | 112 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | SVG Group | RITA Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 49 Participants | 103 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 63 Participants | 121 Participants |
| Age, Continuous | 63.3 years STANDARD_DEVIATION 7.8 | 62.8 years STANDARD_DEVIATION 8 | 63.0 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment Korea, Republic of | 112 participants | 112 participants | 224 participants |
| Sex: Female, Male Female | 30 Participants | 21 Participants | 51 Participants |
| Sex: Female, Male Male | 82 Participants | 91 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 112 |
| serious Total, serious adverse events | 8 / 112 | 6 / 112 |
Outcome results
Primary
1 Year Graft Patency Rates
1 year graft patency of second limb conduits measured by 1 year coronary angiography
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RITA Group | 1 Year Graft Patency Rates | 97.1 percentage of distal anastomoses |
| SVG Group | 1 Year Graft Patency Rates | 97.1 percentage of distal anastomoses |
Secondary
Early Angiographic Patency Rates
The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
Time frame: 1.4days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RITA Group | Early Angiographic Patency Rates | 99.5 percentage of distal anastomoses |
| SVG Group | Early Angiographic Patency Rates | 98.8 percentage of distal anastomoses |
Secondary
Freedom From Cardiac Death
Freedom rate from cardiac death at 4 years
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RITA Group | Freedom From Cardiac Death | 100 percentage of participants |
| SVG Group | Freedom From Cardiac Death | 99.1 percentage of participants |
Secondary
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RITA Group | Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | 91.1 percentage of participants |
| SVG Group | Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | 94.4 percentage of participants |
Secondary
Overall Survival
Overall survival rate at 4 years
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RITA Group | Overall Survival | 97.8 percentage of participiciants |
| SVG Group | Overall Survival | 97.6 percentage of participiciants |