CONTEXT: Conventional coronary artery bypass graft surgery with use of cardiopulmonary bypass (on-pump CABG) is associated with excellent long-term cardiac outcomes but also with a high incidence of cognitive decline. The effect of avoiding cardiopulmonary bypass (off-pump CABG) on long-term cognitive and cardiac outcomes is unknown. OBJECTIVE: To compare the effect of off-pump CABG and on-pump CABG surgery on long-term cognitive and cardiac outcomes. DESIGN, SETTING, AND PARTICIPANTS: The Octopus Study, a multicenter randomized controlled trial conducted in the Netherlands, which enrolled 281 low-risk CABG patients between 1998 and 2000. Five years after their surgery, surviving patients were invited for a follow-up assessment. INTERVENTION: Patients were randomly assigned to receive either off-pump (n = 142) or on-pump (n = 139) CABG surgery. MAIN OUTCOME MEASURE: The primary measure was cognitive status 5 years after surgery, which was determined by a psychologist blinded to treatment allocation who administered 10 standardized validated neuropsychological tests. Secondary measures were occurrence of cardiovascular events (all-cause mortality, stroke, myocardial infarction, and coronary reintervention), anginal status, and quality of life. RESULTS: After 5 years, 130 patients were alive in each group. Cognitive outcomes could be determined in 123 and 117 patients in the off-pump and on-pump groups, respectively. When using a standard definition of cognitive decline (20% decline in performance in 20% of the neuropsychological test variables), 62 (50.4%) of 123 in the off-pump group and 59 (50.4%) of 117 in the on-pump group had cognitive decline (absolute difference, 0%; 95% confidence interval [CI], -12.7% to 12.6%; P>.99). When a more conservative definition of cognitive decline was used, 41 (33.3%) in the off-pump group and 41 (35.0%) in the on-pump group had cognitive decline (absolute difference, -1.7%; 95% CI, -13.7% to 10.3%; P = .79). Thirty off-pump patients (21.1%) and 25 on-pump patients (18.0%) experienced a cardiovascular event (absolute difference, 3.1%; 95% CI, -6.1% to 12.4%; P = .55). No differences were observed in anginal status or quality of life. CONCLUSION: In low-risk patients undergoing CABG surgery, avoiding the use of cardiopulmonary bypass had no effect on 5-year cognitive or cardiac outcomes. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN69438133.
RCT Entities:
CONTEXT: Conventional coronary artery bypass graft surgery with use of cardiopulmonary bypass (on-pump CABG) is associated with excellent long-term cardiac outcomes but also with a high incidence of cognitive decline. The effect of avoiding cardiopulmonary bypass (off-pump CABG) on long-term cognitive and cardiac outcomes is unknown. OBJECTIVE: To compare the effect of off-pump CABG and on-pump CABG surgery on long-term cognitive and cardiac outcomes. DESIGN, SETTING, AND PARTICIPANTS: The Octopus Study, a multicenter randomized controlled trial conducted in the Netherlands, which enrolled 281 low-risk CABG patients between 1998 and 2000. Five years after their surgery, surviving patients were invited for a follow-up assessment. INTERVENTION: Patients were randomly assigned to receive either off-pump (n = 142) or on-pump (n = 139) CABG surgery. MAIN OUTCOME MEASURE: The primary measure was cognitive status 5 years after surgery, which was determined by a psychologist blinded to treatment allocation who administered 10 standardized validated neuropsychological tests. Secondary measures were occurrence of cardiovascular events (all-cause mortality, stroke, myocardial infarction, and coronary reintervention), anginal status, and quality of life. RESULTS: After 5 years, 130 patients were alive in each group. Cognitive outcomes could be determined in 123 and 117 patients in the off-pump and on-pump groups, respectively. When using a standard definition of cognitive decline (20% decline in performance in 20% of the neuropsychological test variables), 62 (50.4%) of 123 in the off-pump group and 59 (50.4%) of 117 in the on-pump group had cognitive decline (absolute difference, 0%; 95% confidence interval [CI], -12.7% to 12.6%; P>.99). When a more conservative definition of cognitive decline was used, 41 (33.3%) in the off-pump group and 41 (35.0%) in the on-pump group had cognitive decline (absolute difference, -1.7%; 95% CI, -13.7% to 10.3%; P = .79). Thirty off-pump patients (21.1%) and 25 on-pump patients (18.0%) experienced a cardiovascular event (absolute difference, 3.1%; 95% CI, -6.1% to 12.4%; P = .55). No differences were observed in anginal status or quality of life. CONCLUSION: In low-risk patients undergoing CABG surgery, avoiding the use of cardiopulmonary bypass had no effect on 5-year cognitive or cardiac outcomes. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN69438133.
Authors: Christopher G Hughes; Mayur B Patel; James C Jackson; Timothy D Girard; Sunil K Geevarghese; Brett C Norman; Jennifer L Thompson; Rameela Chandrasekhar; Nathan E Brummel; Addison K May; Mark R Elstad; Mitzi L Wasserstein; Richard B Goodman; Karel G Moons; Robert S Dittus; E Wesley Ely; Pratik P Pandharipande Journal: Ann Surg Date: 2017-06 Impact factor: 12.969
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