Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

BACKGROUND: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. METHODS: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. RESULTS: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89-1.19; P=0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89-1.18; P=0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: P=0.02) after off-pump CABG and 72% (95% CI, 67-76) versus 77% (95% CI, 74-80) after on-pump CABG (log-rank test: P=0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01-1.39; P=0.04). CONCLUSIONS: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

Off-pump versus on-pump coronary-artery bypass grafting in elderly patients.

BACKGROUND: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined. METHODS: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery. RESULTS: A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P=0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P=0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P=0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment. CONCLUSIONS: In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667.).