Ischemic Heart Disease Clinical Trial
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
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.
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 0.10) and a significance level of 0.05, the sample size for each
group would be n=150.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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