Trial Outcomes & Findings for A Prospective Randomized Study for Comparison of Y-Composite Grafts (NCT NCT01051986)
NCT ID: NCT01051986
Last Updated: 2014-01-10
Results Overview
1 year graft patency of second limb conduits measured by 1 year coronary angiography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
one year
Results posted on
2014-01-10
Participant Flow
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
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
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
107
|
108
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
Baseline Characteristics
A Prospective Randomized Study for Comparison of Y-Composite Grafts
Baseline characteristics by cohort
| Measure |
RITA Group
n=112 Participants
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
|
SVG Group
n=112 Participants
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
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
112 participants
n=5 Participants
|
112 participants
n=7 Participants
|
224 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one year1 year graft patency of second limb conduits measured by 1 year coronary angiography
Outcome measures
| Measure |
RITA Group
n=204 distal anastomosis
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
|
SVG Group
n=245 distal anastomosis
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
|
|---|---|---|
|
1 Year Graft Patency Rates
|
97.1 percentage of distal anastomoses
|
97.1 percentage of distal anastomoses
|
SECONDARY outcome
Timeframe: 4 yearsOverall survival rate at 4 years
Outcome measures
| Measure |
RITA Group
n=112 Participants
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
|
SVG Group
n=112 Participants
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
|
|---|---|---|
|
Overall Survival
|
97.8 percentage of participiciants
|
97.6 percentage of participiciants
|
SECONDARY outcome
Timeframe: 4 yearsFreedom rate from cardiac death at 4 years
Outcome measures
| Measure |
RITA Group
n=112 Participants
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
|
SVG Group
n=112 Participants
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
|
|---|---|---|
|
Freedom From Cardiac Death
|
100 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: 4 yearsfreedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Outcome measures
| Measure |
RITA Group
n=112 Participants
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
|
SVG Group
n=112 Participants
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
|
|---|---|---|
|
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
|
91.1 percentage of participants
|
94.4 percentage of participants
|
SECONDARY outcome
Timeframe: 1.4daysThe patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG
Outcome measures
| Measure |
RITA Group
n=208 number of distal anastomoses
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
|
SVG Group
n=248 number of distal anastomoses
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
|
|---|---|---|
|
Early Angiographic Patency Rates
|
99.5 percentage of distal anastomoses
|
98.8 percentage of distal anastomoses
|
Adverse Events
RITA Group
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
SVG Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RITA Group
n=112 participants at risk
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
|
SVG Group
n=112 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Early death
|
0.89%
1/112 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Recurrent angina
|
7.1%
8/112 • Number of events 8
|
3.6%
4/112 • Number of events 4
|
|
Cardiac disorders
Reintervefntion
|
3.6%
4/112 • Number of events 4
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Late death
|
0.89%
1/112 • Number of events 1
|
1.8%
2/112 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place