Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery
Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery
This is a randomized, prospective European Multicenter Study comparing complete arterial
 revascularization of the coronary arteries using arterial graft material exclusively and
 "conventional" coronary artery bypass surgery using the left internal thoracic artery as
 graft to the left anterior descending artery (LAD) and vein grafts to other vessels to be
 bypassed.
Coronary artery surgery effectively relieves angina and prolongs life in certain patient
 subsets. It is the most frequently performed major surgical procedure and therefore has
 profound economical impact. Unfortunately angina returns in 10 to 20 percent of patients by
 five years and in up to 50 percent at 10 years primarily because of graft failure and
 progression of atherosclerosis in the native coronary arteries. Serial angiography reveals
 that 15-30 percent of vein grafts are stenosed at one year and that nearly 50 percent are
 occluded at ten years. Recurrence of angina is associated with an increased risk of late
 myocardial infarction and reoperation. Reoperations after cardiac surgery carry a
 significantly increased risk of morbidity and mortality due to increased patient age,
 progression of coronary atherosclerosis, frequently reduced left ventricular function and
 technical difficulties. Thus prevention of restenosis by medical and surgical means is of
 eminent importance.The use of the IMA as a graft to the LAD is proven to reduce long-term
 mortality in patients after CABG throughout a 15 year follow-up period in all age groups.
 This data and the further improved survival with bilateral IMA grafting suggested by some
 have increased the interest of the surgical community in total arterial revascularization
 using both IMAs and various other arterial conduits.

 However to date there is no conclusive data demonstrating a clinical benefit of total
 arterial revascularization.Reports available on complete arterial revascularisation are
 either single institution / single surgeon, retrospective or non - randomized. Data on which
 we base our daily decision making is by and large from a different surgical period with
 different techniques used. Improved understanding of the pathogenic processes leading to
 graft occlusion have led to more rigorous use of antiplatelet drugs and lipid lowering which
 may significantly improve vein graft patency rates and slow or halt progression of native
 coronary artery atherosclerosis in the future.

 The scientific hypotheses underlying this randomized multicenter trial are:

 1. With respect to the primary outcome variable "total mortality" complete arterial
 revascularisation does not cause a significantly higher mortality over 5 years of
 follow-up (as compared to conventional coronary artery surgery) i.e. non-inferiority due
 to increased tecnical complexity of the surgical procedure.

 2. In terms of the combined secondary outcome variable "cardiac death, nonfatal myocardial
 infarction and re-revascularisation (PTCA or CABG)" and additional outcome variables
 "freedom from angina, functional status and quality of life" complete arterial
 revascularisation shows a clear benefit.
Inclusion Criteria:

 1. Patient eligible for surgical myocardial revascularization

 2. Age 70 years or less

 3. Triple vessel coronary disease with significant coronary artery stenosis defined as a
 stenosis of at least 50% in luminal diameter

 4. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3, or 4)
 or unstable angina pectoris (Braunwald Classification 1b, 2b, 3b) or proven silent
 myocardial ischemia.

 Exclusion Criteria:

 1. No informed consent

 2. Age > 65 years

 3. Participation in another study with any investigational drug or coronary
 revascularization procedure

 4. When follow up over a period of five years is difficult or unlikely

 5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)

 6. One or two vessel coronary disease and isolated left main stenosis

 7. Estimated left ventricular ejection fraction < 25%

 8. Myocardial infarction within seven days

 9. Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left
 ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)

 10. Redo-cardiac surgery

 11. Presence of the combination of insulin dependent diabetes mellitus and chronic
 obstructive pulmonary disease requiring therapy

 12. Renal insufficiency requiring dialysis

 13. Presence of the combination of severe adiposity and insulin dependent diabetes
 mellitus

 14. Presence of the combination of severe adiposity and chronic obstructive pulmonary
 disease requiring therapy

 15. Severe hepatic disease

 16. Emergent operation for coronary artery disease with signs of ischemia (e.g. failed
 PTCA, ongoing myocardial infarction)

 17. Unstable angina pectoris Class A and C according to Braunwald classification (i.e.
 secondary unstable angina and postinfarction unstable angina within one week after
 acute MI)

 18. Inadequate quality of saphenous vein material

 19. Inadequate quality or number of arterial conduits to achieve complete
 revascularization likely (e.g. chest irradiation, major abdominal surgery)

 20. Recent (< 2weeks) cerebrovascular event (TIA, RIND, stroke)