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

This study has been terminated.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00317265
First received: April 20, 2006
Last updated: October 12, 2006
Last verified: March 2006
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Coronary bypass surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Complete Arterial Revascularization and Conventional Coronary Artery Surgery Study (CARACCASS)-European Multicenter Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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.

Estimated Enrollment: 2000
Study Start Date: January 1999
Estimated Study Completion Date: January 2005
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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317265

Locations
Austria
Dept. of Surgery I, AKH Linz
Linz, Austria, 4020
Dept Cardiothoracic Surgery, Medical Univ. of Vienna
Vienna, Austria, A-1090
Czech Republic
Clinic for Cardiovascular Surgery, IKEM
Prague, Czech Republic, 14000
Kardiochirurgie, Nemocnice Podlesi
Trinec, Czech Republic, 73961
Germany
Kerckhoff-Klinik
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
HKZ Rotenburg
Rothenburg an der Fulda, Germany, 36199
Norway
Hjerteklinikken St. Elisabeth, Regionsykehuset Trondheim
Trondheim, Norway, 7018
Poland
Dept Cardiothoracic Surg, Univ. of Gdansk
Gdansk, Poland, 80211
Spain
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
Salamanca, Spain
Sweden
Department of Cardiothoracic Surgery, University Hospital
Linköping, Sweden, 58185
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Paul Simon, MD Dept. of Cardiothoracic Surgery, Medical Univ. of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00317265     History of Changes
Other Study ID Numbers: EK NR-348/98
Study First Received: April 20, 2006
Last Updated: October 12, 2006
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
coronary artery disease
coronary bypass surgery
complete arterial coronary surgery
internal mammary artery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014