1. Composite outcome of death, stroke, MI, renal failure, or repeat coronary revascularization at 5 years was not significantly different between on-pump and off-pump groups.
2. The mean cost associated with each type of coronary-artery bypass grafting (CABG) per patient was not significantly different between the two groups.
Evidence Rating: 1 (Excellent)
Study Rundown: Severe coronary artery disease (CAD) can be effectively treated with CABG procedures. The initial technique required use of a cardiopulmonary bypass (on-pump), while a subsequent iteration of the procedure can be performed on a beating heart (off-pump). The off-pump technique was developed with the hope of improving health outcomes. While many small and large trials have been performed comparing on- and off-pump CABG, none report long-term outcomes. This study aimed to assess 5-year outcomes of a randomized control trial comparing on- and off-pump CABG.
This was a multicenter project where patients were eligible to participate if they required isolated CABG with median sternotomy and had 1 or more risk factors CAD. Surgeons with substantial expertise in the CABG procedures performed the operations. Patients were followed for 5 years to assess for related health outcomes and costs related to their CABG. At the end point there was a similar prevalence of significant health outcomes such as death, stroke, MI, new renal failure requiring dialysis, or repeat coronary revascularization between the two groups. Furthermore, there were no significant differences between the two groups in regards to the cost-per-patient.
In-Depth [randomized controlled trial]: From 2006 to 2011, from 79 hospitals in 19 countries, 4752 patients were enrolled in this study. Patients were assigned to on-pump or off-pump CABG groups in a randomized fashion. Those included in the study required an isolated CABG with median sternotomy and had to have had 1 or more risk factors related to CAD. Surgeons performing the CABG procedures were required to have extensive, verifiable experiences. Patients were followed for 5 years after their procedure to assess for serious related health outcomes (death, stroke, MI, new renal failure requiring dialysis, or repeat coronary revascularization), quality of life, and healthcare costs associated with their CABG. Statistical analysis was done via intention-to-treat. After a mean of 4.8 years following randomization, 23.1% on-pump and 23.6% off-pump patients had experienced related health outcomes (HR with off-pump CABG 0.98; 95%CI 0.87 to 1.10; p = 0.72). For each specific health outcome assessed no significant between-group differences were found. A total of 1531 patients reported quality of life scores throughout the study, and at no point was there a significant difference between the groups. Economic analysis showed no significant difference in cost-per-patient in 2016 US dollars ($15 107 in the off-pump group and $14 992 in the on-pump group; difference, $115; 95%CI −$697 to $927). Both CABG approaches appear to have similar outcomes.
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