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

Ischemic Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123981
• Other study ID #: DTS-0001
• Status: Completed
• Phase: N/A
• First received: July 25, 2005
• Last updated: November 5, 2013
• Start date: January 2005
• Est. completion date: January 2011

Study information

• Verified date: November 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Off-Pump Coronary Artery Bypass Grafting

Locations

Country	Name	City	State
Denmark	Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Kim Houlind

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Houlind KC, Kjeldsen BJ, Terp KA, Madsen SN, Schmidt TA, Holme SJ, Mortensen PE. [Coronary artery bypass surgery without the use of a heart-lunch machine]. Ugeskr Laeger. 2005 May 9;167(19):2037-41. Review. Danish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A combined endpoint of death + stroke + myocardial infarction within 30 days from operation		30 days	Yes
Secondary	A combined endpoint of death + stroke + myocardial infarction during follow-up		3 years	Yes
Secondary	Patency of bypass grafts assessed by coronary angiography 6 months after the operation		6 months	No
Secondary	Total mortality and cardiac mortality during follow-up		3 years	No
Secondary	Need of new intervention for cardiac angina during follow-up		3 years	No
Secondary	Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation		6 months and 3 years	No
Secondary	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		6 months and 3 years	No

External Links

•   home page of the Danish Heart Foundation