Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery
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|ClinicalTrials.gov Identifier: NCT00317265|
Recruitment Status : Terminated
First Posted : April 24, 2006
Last Update Posted : October 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Coronary bypass surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study|
|Study Start Date :||January 1999|
|Study Completion Date :||January 2005|
- All cause mortality perioperatively, one year, five and ten years.
- Combined cardiac death, non-fatal myocardial infarction and repeat revascularisation at one, five and ten years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317265
|Dept. of Surgery I, AKH Linz|
|Linz, Austria, 4020|
|Dept Cardiothoracic Surgery, Medical Univ. of Vienna|
|Vienna, Austria, A-1090|
|Clinic for Cardiovascular Surgery, IKEM|
|Prague, Czech Republic, 14000|
|Kardiochirurgie, Nemocnice Podlesi|
|Trinec, Czech Republic, 73961|
|Bad Nauheim, Germany|
|Dept.of Cardiac Surg, Ruhr University|
|Bochum, Germany, 44789|
|Dept of Cardiothoracic and Vascular Surgery, J-W-Goethe University|
|Frankfurt, Germany, 60590|
|Rothenburg an der Fulda, Germany, 36199|
|Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim|
|Trondheim, Norway, 7018|
|Dept Cardiothoracic Surg, Univ. of Gdansk|
|Gdansk, Poland, 80211|
|Dept of Cardiovasc Surg, Hospital Clinico, University of Barcelona|
|Barcelona, Spain, 08036|
|Dept of Cardiac Surg, Hospital de Cruces|
|Bilbao, Spain, 48190|
|Dept. of Cardiovascular Surgery, University of Salamanca|
|Department of Cardiothoracic Surgery, University Hospital|
|Linköping, Sweden, 58185|
|Principal Investigator:||Paul Simon, MD||Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna|