The Danish On-pump, Off-pump Randomization Study (DOORS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kim Houlind, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00123981
First received: July 25, 2005
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.

The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.


Condition Intervention
Ischemic Heart Disease
Procedure: Off-Pump Coronary Artery Bypass Grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • A combined endpoint of death + stroke + myocardial infarction within 30 days from operation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A combined endpoint of death + stroke + myocardial infarction during follow-up [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Patency of bypass grafts assessed by coronary angiography 6 months after the operation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total mortality and cardiac mortality during follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Need of new intervention for cardiac angina during follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation [ Time Frame: 6 months and 3 years ] [ Designated as safety issue: No ]
  • Total hospital costs and costs of public care provided 6 months and 3 years after the operation and difference in costs per quality adjusted life year [ Time Frame: 6 months and 3 years ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: January 2005
Study Completion Date: January 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CCABG
Coronary artery bypass surgery using cardiopulmonary bypass
Procedure: Off-Pump Coronary Artery Bypass Grafting
Experimental: OPCAB
Coronary artery bypass surgery NOT using cardiopulmonary bypass
Procedure: Off-Pump Coronary Artery Bypass Grafting

Detailed Description:

Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.

During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.

Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.

The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.

Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age seventy years or above
  • Admitted for first time coronary artery bypass operation

Exclusion Criteria:

  • Given information cannot be understood
  • Aortic crossclamping not safe due to calcification
  • Preoperative cardiac conditions demanding cardiopulmonary bypass
  • Re-do cardiac surgery
  • Patients requiring operation within the same day after conference
  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: NCT00123981

Locations
Denmark
Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
Kim Houlind
Investigators
Principal Investigator: Kim C Houlind, MD, PhD Aarhus University Hospital
Study Chair: Poul E Mortensen, MD Odense University Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Houlind, Senior consultant, Associate Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00123981     History of Changes
Other Study ID Numbers: DTS-0001
Study First Received: July 25, 2005
Last Updated: November 5, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Off-pump Coronary Artery By-pass Grafting
Randomization
stroke
myocardial infarction
mortality
graft patency
quality of life

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

ClinicalTrials.gov processed this record on August 18, 2014