Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery

Sponsor

Medical University of Vienna (Other)

Overall Status

Terminated

CT.gov ID

NCT00317265

Collaborator

(none)

2,000

Enrollment

Locations

Duration (Months)

142.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Coronary bypass surgery	N/A

Detailed Description

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:

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.
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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study

Study Start Date :

Jan 1, 1999

Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

All cause mortality perioperatively, one year, five and ten years. []

Secondary Outcome Measures

Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient eligible for surgical myocardial revascularization
Age 70 years or less
Triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
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:

No informed consent
Age > 65 years
Participation in another study with any investigational drug or coronary revascularization procedure
When follow up over a period of five years is difficult or unlikely
Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
One or two vessel coronary disease and isolated left main stenosis
Estimated left ventricular ejection fraction < 25%
Myocardial infarction within seven days
Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
Redo-cardiac surgery
Presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
Renal insufficiency requiring dialysis
Presence of the combination of severe adiposity and insulin dependent diabetes mellitus
Presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
Severe hepatic disease
Emergent operation for coronary artery disease with signs of ischemia (e.g. failed PTCA, ongoing myocardial infarction)
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)
Inadequate quality of saphenous vein material
Inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery)
Recent (< 2weeks) cerebrovascular event (TIA, RIND, stroke)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dept. of Surgery I, AKH Linz	Linz	Austria	4020
2	Dept Cardiothoracic Surgery, Medical Univ. of Vienna	Vienna	Austria	A-1090
3	Clinic for Cardiovascular Surgery, IKEM	Prague	Czech Republic	14000
4	Kardiochirurgie, Nemocnice Podlesi	Trinec	Czech Republic	73961
5	Kerckhoff-Klinik	Bad Nauheim	Germany
6	Dept.of Cardiac Surg, Ruhr University	Bochum	Germany	44789
7	Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University	Frankfurt	Germany	60590
8	HKZ Rotenburg	Rothenburg an der Fulda	Germany	36199
9	Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim	Trondheim	Norway	7018
10	Dept Cardiothoracic Surg, Univ. of Gdansk	Gdansk	Poland	80211
11	Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona	Barcelona	Spain	08036
12	Dept of Cardiac Surg, Hospital de Cruces	Bilbao	Spain	48190
13	Dept. of Cardiovascular Surgery, University of Salamanca	Salamanca	Spain
14	Department of Cardiothoracic Surgery, University Hospital	Linköping	Sweden	58185