Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159991
Status:
UNKNOWN
Last Update Posted:
2008-02-15
First Post:
2005-09-08
Brief Title:
Copenhagen Arterial Revascularization Randomized Patency and Outcome Trial
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Arterial Revascularization for Coronary Bypass Surgery A Randomized Trial Comparing the Outcome After Using LIMA Vein Grafts Versus Total Arterial Revascularization With LIMA RIMA Radial Artery Grafts
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARRPO
Brief Summary:
There is a remarkable lack of randomized trials concerning the potential benefit of using arterial conduits for coronary bypass surgery This is the purpose of the present trial Exclusive use of arterial conduits might result in improved conduit viability reduced risk of recurrent angina myocardial infarction and other cardiac events reduced need for antianginal medication improved functional status and possibly improved long term survival The patients will be followed for ten years after surgery
Detailed Description:
I Background
There is a remarkable lack of randomized studies concerning the potential benefit of using arterial grafts for coronary revascularization Numerous observational reports consistently confirm that the use of a LIMA-LAD grafts is not associated with increased peroperative mortality or morbidity and will result in an approximately 10 improved survival at 10 years postoperatively
The average patency for LIMA-LAD grafts is 80-85 after 10 years 50 of the vein grafts are occluded LIMA-LAD grafting reduces the risk of of late myocardial infarction other cardiac events and reoperation however the effect on recurrent angina or need of antianginal medication is less certain
The question whether bilateral IMA grafting has long term benefits compared to single IMA grafts is controversial Numerous observational retrospective studies fail to demonstrate convincingly that bilateral IMA grafting reduces long term mortality and improves the frequency of late cardiac events and recurrent angina but these data are difficult to compare due to selection bias It is not quite clear if a minimal benefit represents a true difference in outcome or if two different populations are compared
Whether an increased degree of arterial revascularization including radial artery RA and IMA grafts will result in an improved long term survival reduced risk for recurrent angina reinfarction antianginal medication and improved quality of life is unclear
A randomized trial has not yet been performed and current observational 5 year follow-up data are promising but cannot document an anticipated benefit from a more stringent scientific point of view
II Hypothesis
Coronary bypass grafting with the use of LIMA RIMA RA total arterial revascularization vs LIMA saphenous vein grafts will result in equal peroperative mortality and morbidity rates and improve long term outcome in terms of improved patency rates reduced risk of recurrent angina infarction and other cardiac events reduced need for antianginal medication improved functional status and possibly improved long term survival
III Aim of the study
Prospective randomized trial comparing coronary bypass grafting with the use of LIMA RIMA RA vs LIMA saphenous vein grafts in patients with 2 or 3 vessel disease more than 1 graft anticipated with respect to
1 Graft patency rates at 1 5 and 10 years postoperatively
2 Cardiac event free survival 1 5 and 10 years postoperatively risk of hospital readmission due to infarction suspicion of infarction unstable angina arrythmias heart insufficiency need for renewed angiography angioplasty redo surgery
3 Peroperative mortality and morbidity
4 Risk of recurrent angina and need for antianginal medication 1 5 and 10 years postoperatively
5 Data on functional status and social rehabilitation at clinical controls 3 months 1 5 and 10 years postoperatively
IV Design methods
1 Design
Prospective randomized trial Patients will be randomized into 2 groups
Group A Arterial revascularization with LIMA RIMA RA
Group B LIMA and saphenous vein grafts are used as graft material
2 Inclusion criteria
Patients with 2 or 3 vessel coronary artery disease where more than 1 coronary bypass graft is anticipated
Elective or subacute operation unstable AP with surgery within a few days
Inclusion is independent of ventricular function recent MI degree and type of coronary lesions and secondary risk factors as diabetes hyperlipidemia hypertension lung function chronic obstructive lung disease peripheral atherosclerotic disease kidney function earlier cerebrovascular disease
Age 70 years
Sufficient collateral blood supply to the hand by the ulnar artery evaluated by the Allen test
Patients must be able to give informed consent
3 Exclusion criteria
Concurrent malignant disease with expected survival of 5 years
Unsuitable saphenous vein grafts evaluated preoperatively
Unsuitable saphenous vein grafts with a diameter 6mm evaluated peroperatively
Acute operation unstable hemodynamics in terms of need of inotropic support ongoing MI with dynamic ECG changes cardiogenic shock
Concommitant operation for valve disease or other forms of heart surgery
Redo operations
4 Surgery anaesthesia and postoperative care
Surgery anaesthesia and postoperative care are performed according to current guidelines at our institution
5 Endpoints and follow-up
The study is designed with respect to two primary endpoints
1 Distal anastomotic patency rates at 1 5 and 10 years postoperatively
2 Cardiac event free survival 1 5 and 10 years postoperatively Cardiac event free survival is defined as survival without readmission due to infarction suspicion of infarction unstable angina arrythmias heart insufficiency need for renewed angiography angioplasty redo surgery
Secondary endpoints
1 Peroperative mortality and morbidity frequency of peroperative postoperative infarction arrythmias use of IABP inotropic support pulmonary renal and cerebral complications length of stay in the ICU etc according to registration schemes
2 Risk of recurrent angina and need for antianginal medication 1 5 and 10 years postoperatively
3 Data on functional status and social rehabilitation at clinical controls 3 months 1 5 and 10 years postoperatively
According to these endpoints the follow-up is planned as
3 month clinical control at referring hospitals
1 year control including angiography which can be performed on an outpatient basis
5 year control including conventional angiography and computed tomography angiography
10 year control including computed tomography angiography which can be performed on an outpatient basis
6 Statistics
Sample size is calculated with respect to the primary endpoint graft patency at 1 and 5 years A difference of 10-15 of patency in favour of the radial artery as bypass graft is regarded as clinically relevant Observational data on radial artery patency indicate patency rates of 90-95 at 1 year and 85 at 5 years while saphenous vein graft patency is 80-90 at 1 year and 60-70 at 5 years
To detect such a difference 15 improved patency for RA grafts 85 vs 70 with a 90 probability type 2 error 010 and a significance level of 005 the sample size for each group would be n150
A 15 difference in patency rates at 5 years is in our opinion an assumption that probably overestimates the vein graft patency which means that a sample size of 150 patients in each group should guarantee with a high probability a statistically significant outcome
There is a remarkable lack of randomized studies concerning the potential benefit of using arterial grafts for coronary revascularization Numerous observational reports consistently confirm that the use of a LIMA-LAD grafts is not associated with increased peroperative mortality or morbidity and will result in an approximately 10 improved survival at 10 years postoperatively
The average patency for LIMA-LAD grafts is 80-85 after 10 years 50 of the vein grafts are occluded LIMA-LAD grafting reduces the risk of of late myocardial infarction other cardiac events and reoperation however the effect on recurrent angina or need of antianginal medication is less certain
The question whether bilateral IMA grafting has long term benefits compared to single IMA grafts is controversial Numerous observational retrospective studies fail to demonstrate convincingly that bilateral IMA grafting reduces long term mortality and improves the frequency of late cardiac events and recurrent angina but these data are difficult to compare due to selection bias It is not quite clear if a minimal benefit represents a true difference in outcome or if two different populations are compared
Whether an increased degree of arterial revascularization including radial artery RA and IMA grafts will result in an improved long term survival reduced risk for recurrent angina reinfarction antianginal medication and improved quality of life is unclear
A randomized trial has not yet been performed and current observational 5 year follow-up data are promising but cannot document an anticipated benefit from a more stringent scientific point of view
II Hypothesis
Coronary bypass grafting with the use of LIMA RIMA RA total arterial revascularization vs LIMA saphenous vein grafts will result in equal peroperative mortality and morbidity rates and improve long term outcome in terms of improved patency rates reduced risk of recurrent angina infarction and other cardiac events reduced need for antianginal medication improved functional status and possibly improved long term survival
III Aim of the study
Prospective randomized trial comparing coronary bypass grafting with the use of LIMA RIMA RA vs LIMA saphenous vein grafts in patients with 2 or 3 vessel disease more than 1 graft anticipated with respect to
1 Graft patency rates at 1 5 and 10 years postoperatively
2 Cardiac event free survival 1 5 and 10 years postoperatively risk of hospital readmission due to infarction suspicion of infarction unstable angina arrythmias heart insufficiency need for renewed angiography angioplasty redo surgery
3 Peroperative mortality and morbidity
4 Risk of recurrent angina and need for antianginal medication 1 5 and 10 years postoperatively
5 Data on functional status and social rehabilitation at clinical controls 3 months 1 5 and 10 years postoperatively
IV Design methods
1 Design
Prospective randomized trial Patients will be randomized into 2 groups
Group A Arterial revascularization with LIMA RIMA RA
Group B LIMA and saphenous vein grafts are used as graft material
2 Inclusion criteria
Patients with 2 or 3 vessel coronary artery disease where more than 1 coronary bypass graft is anticipated
Elective or subacute operation unstable AP with surgery within a few days
Inclusion is independent of ventricular function recent MI degree and type of coronary lesions and secondary risk factors as diabetes hyperlipidemia hypertension lung function chronic obstructive lung disease peripheral atherosclerotic disease kidney function earlier cerebrovascular disease
Age 70 years
Sufficient collateral blood supply to the hand by the ulnar artery evaluated by the Allen test
Patients must be able to give informed consent
3 Exclusion criteria
Concurrent malignant disease with expected survival of 5 years
Unsuitable saphenous vein grafts evaluated preoperatively
Unsuitable saphenous vein grafts with a diameter 6mm evaluated peroperatively
Acute operation unstable hemodynamics in terms of need of inotropic support ongoing MI with dynamic ECG changes cardiogenic shock
Concommitant operation for valve disease or other forms of heart surgery
Redo operations
4 Surgery anaesthesia and postoperative care
Surgery anaesthesia and postoperative care are performed according to current guidelines at our institution
5 Endpoints and follow-up
The study is designed with respect to two primary endpoints
1 Distal anastomotic patency rates at 1 5 and 10 years postoperatively
2 Cardiac event free survival 1 5 and 10 years postoperatively Cardiac event free survival is defined as survival without readmission due to infarction suspicion of infarction unstable angina arrythmias heart insufficiency need for renewed angiography angioplasty redo surgery
Secondary endpoints
1 Peroperative mortality and morbidity frequency of peroperative postoperative infarction arrythmias use of IABP inotropic support pulmonary renal and cerebral complications length of stay in the ICU etc according to registration schemes
2 Risk of recurrent angina and need for antianginal medication 1 5 and 10 years postoperatively
3 Data on functional status and social rehabilitation at clinical controls 3 months 1 5 and 10 years postoperatively
According to these endpoints the follow-up is planned as
3 month clinical control at referring hospitals
1 year control including angiography which can be performed on an outpatient basis
5 year control including conventional angiography and computed tomography angiography
10 year control including computed tomography angiography which can be performed on an outpatient basis
6 Statistics
Sample size is calculated with respect to the primary endpoint graft patency at 1 and 5 years A difference of 10-15 of patency in favour of the radial artery as bypass graft is regarded as clinically relevant Observational data on radial artery patency indicate patency rates of 90-95 at 1 year and 85 at 5 years while saphenous vein graft patency is 80-90 at 1 year and 60-70 at 5 years
To detect such a difference 15 improved patency for RA grafts 85 vs 70 with a 90 probability type 2 error 010 and a significance level of 005 the sample size for each group would be n150
A 15 difference in patency rates at 5 years is in our opinion an assumption that probably overestimates the vein graft patency which means that a sample size of 150 patients in each group should guarantee with a high probability a statistically significant outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None