On-Pump versus Off-Pump Coronary Artery Bypass Surgery in Elderly Patients: Results from the Danish On-Pump versus Off-Pump Randomization Study (DOORS)
Background—Conventional coronary artery bypass grafting (CCABG), performed with the use of cardiopulmonary bypass, is a well-validated treatment of patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perio-operative complications, especially in elderly patients.
Methods and Results—In a multicenter, randomized trial, we assigned 900 patients above 70 years old to CCABG or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined endpoint of death, stroke, or myocardial infarction had occurred. At baseline and six months postoperatively, self-assessed quality of life (QoL) was measured using MOS SF-36 and EuroQol-5D questionnaires. Six months follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined endpoint within 30 days was 10.2% for CCABG and 10.7 % for OPCAB. Implied risk difference of 0.4 % with a CI of (-3.6 %; 4.4 %) showed non-significance in a standard test for equality (p=0.83) as well as for non-inferiority with an inferiority margin of 0.5 % (p=0.49). At six months follow-up, mortality was 4.7% versus 4.2% (p=0.75). Both groups showed significant improvement in self-assessed, health related quality of life.
Conclusions—Both CCABG and OPCAB are safe procedures improving quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However non-inferiority of OPCAB with the pre-specified margin could not be confirmed.
Clinical Trial Registration Information— http://ClinicalTrials.gov/; Identifier: NCT00123981
- Received June 29, 2011.
- Accepted April 4, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited