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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVG group | Active Comparator | patients who underwent off-pump coronary artery bypass using saphenous vein composite grafting based on the left internal thoracic artery use saphenous vein as a composite graft connected to the left internal thoracic artery |
|
| RITA group | Active Comparator | patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite grafting based on the left internal thoracic artery use right internal thoracic artery as a composite graft connected to the left internal thoracic artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saphenous vein composite grafting | Procedure | use saphenous vein as a composite graft connected to the left internal thoracic artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 Year Graft Patency Rates | 1 year graft patency of second limb conduits measured by 1 year coronary angiography | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival rate at 4 years | 4 years |
| Freedom From Cardiac Death | Freedom rate from cardiac death at 4 years | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki-Bong Kim, MD, PhD | Department of throacic and cardiovascular surgery, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Uinversity Hospital | Seoul | 110 744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24973924 | Derived | Kim KB, Hwang HY, Hahn S, Kim JS, Oh SJ. A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes. J Thorac Cardiovasc Surg. 2014 Sep;148(3):901-7; discussion 907-8. doi: 10.1016/j.jtcvs.2014.03.057. Epub 2014 May 16. |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1 Year Graft Patency Rates | 1 year graft patency of second limb conduits measured by 1 year coronary angiography | Posted | Number | percentage of distal anastomoses | one year | distal anastomosis | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early death | Cardiac disorders | Systematic Assessment | death after surgery during the same hospital stay |
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the current study is not a multicenter "all-comers" study, although it is a prospective, randomized, controlled trial.
The 1-year graft patency rates and clinical outcomes of 34 months do not provide sufficient data to reach a definite conclusion
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ki-Bong Kim | Seoul National University Hospital | +82-2-2072-3482 | kimkb@snu.ac.kr |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| right internal thoracic artery composite grafting | Procedure | right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery |
|
|
| Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years | 4 years |
| Early Angiographic Patency Rates | The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG | 1.4days |
| Protocol Violation |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival | Overall survival rate at 4 years | Posted | Number | percentage of participiciants | 4 years |
|
|
|
| Secondary | Freedom From Cardiac Death | Freedom rate from cardiac death at 4 years | Posted | Number | percentage of participants | 4 years |
|
|
|
| Secondary | Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years | Posted | Number | percentage of participants | 4 years |
|
|
|
| Secondary | Early Angiographic Patency Rates | The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG | Posted | Number | percentage of distal anastomoses | 1.4days | number of distal anastomoses | Participants |
|
|
|
| 8 |
| 112 |
| 0 |
| 112 |
| EG001 | 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 | 6 | 112 | 0 | 112 |
|
| Recurrent angina | Cardiac disorders | Systematic Assessment | angina recurrence during the follow up |
|
| Reintervefntion | Cardiac disorders | Systematic Assessment |
|
| Late death | Cardiac disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |