There was no significant difference between off-pump and on-pump CABG with respect to the 30-day rate of death, myocardial infarction, stroke, or renal failure requiring dialysis. The use of off-pump CABG resulted in reduced rates of transfusion, reoperation for perioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
C oronary artery bypass grafting (CABG) can be performed on-pump (use of cardiopulmonary bypass [CPB]) or with the technique of operating on a beating heart (off-pump) to decrease the perioperative complications associated with CPB and cross-clamping of the aorta. This randomized controlled trial was designed to compare off-pump and on-pump CABG in patients undergoing isolated CABG surgery to ascertain the relative benefits and risks of the 2 techniques.The study was conducted at 79 centers in 19 countries. Patients (n = 4752) were randomly assigned to either off-or onpump CABG; all patients and investigators were aware of the patient's study-group assignment. Coronary artery bypass grafting was performed using a standard median sternotomy in all patients. Crossovers from the assigned procedure were recorded as were the reasons for and timing of the crossovers. Patients were seen at 30 days for short-term follow-up. Subsequent follow-up, still ongoing, will include clinic visits at 1 and 5 years and telephone follow-up at 6 months and 2, 3, and 4 years. The first coprimary outcome was a composite of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days after randomization. The second coprimary outcome was the first plus repeat coronary revascularization at a mean of 5 years. Secondary outcomes included rates of blood transfusion, recurrent angina, and death from cardiovascular causes. All deaths in the first 30 days were considered the result of cardiovascular causes. All analyses by a blinded adjudication committee were conducted on an intention-to-treat basis. Cox regression was used to report the 30-day outcomes. Comparisons between the study groups were assessed using the log-rank test.Of the 4752 patients, 2375 were assigned to off-pump and 2377 to on-pump CABG. Eighty-one percent of the patients were men (mean age, 68 years), and 33% of the patients had had a previous myocardial infarction. Other baseline clinical and demographic characteristics were similar. Thirty-four patients did not undergo surgery, including 6 patients who died. For crossovers, 184 (7.9%) of 2332 patients who were assigned to the off-pump CABG underwent on-pump surgery; 150 (6.4%) of 2333 patients assigned for on-pump surgery underwent offpump surgery. In the off-pump group, 3.0 grafts were performed compared with 3.2 in the on-pump group. The respective rates of incomplete revascularization were 11.8% and 10.0%. The rates for transfusion were 50.7% in the off-pump group compared with 63.3% in the on-pump group. Perioperative repeat operations for bleeding were necessary in 34 patients (1.4%) in the off-pump group compared with 56 (2.4%) in the on-pump group. The primary outcome at 30 days occurred in 233 patients (9.8%) in the off-pump group and 245 (10.3%) in the on-pump group (hazard ratio for the off-pump group, 0.95). The individual components of the composite did not differ between the groups. No interactions were seen between the effects of the procedures and any of the subgr...
BACKGROUND: Previously, we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death, myocardial infarction, stroke, or new renal failure requiring dialysis between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report results on quality of life and cognitive function and on clinical outcomes at 1 year. METHODS: We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and randomly assigned them to undergo the procedure off-pump or on-pump. Patients were enrolled at 79 centers in 19 countries. We assessed quality of life and cognitive function at discharge, at 30 days, and at 1 year and clinical outcomes at 1 year. RESULTS: At 1 year, there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% and 13.3%, respectively; hazard ratio with off-pump CABG, 0.91; 95% confidence interval [CI], 0.77 to 1.07; P=0.24). The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year (hazard ratio, 0.79; 95% CI, 0.55 to 1.13; P=0.19). The rate of repeat coronary revascularization at 1 year was 1.4% in the off-pump group and 0.8% in the on-pump group (hazard ratio, 1.66; 95% CI, 0.95 to 2.89; P=0.07). There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function. CONCLUSIONS: At 1 year after CABG, there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome, the rate of repeat coronary revascularization, quality of life, or neurocognitive function. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
BACKGROUND: Previously, we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death, myocardial infarction, stroke, or new renal failure requiring dialysis between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report results on quality of life and cognitive function and on clinical outcomes at 1 year. METHODS: We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and randomly assigned them to undergo the procedure off-pump or on-pump. Patients were enrolled at 79 centers in 19 countries. We assessed quality of life and cognitive function at discharge, at 30 days, and at 1 year and clinical outcomes at 1 year. RESULTS: At 1 year, there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% and 13.3%, respectively; hazard ratio with off-pump CABG, 0.91; 95% confidence interval [CI], 0.77 to 1.07; P=0.24). The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year (hazard ratio, 0.79; 95% CI, 0.55 to 1.13; P=0.19). The rate of repeat coronary revascularization at 1 year was 1.4% in the off-pump group and 0.8% in the on-pump group (hazard ratio, 1.66; 95% CI, 0.95 to 2.89; P=0.07). There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function. CONCLUSIONS: At 1 year after CABG, there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome, the rate of repeat coronary revascularization, quality of life, or neurocognitive function. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
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