Off-pump versus on-pump coronary surgery: Final results from a prospective randomized study PRAGUE-4

Background. Off-pump coronary artery bypass surgery is becoming increasingly popular despite the lack of sufficient evidence from randomized trials. The aim of our prospective, randomized, single-center study was to examine the role of off-pump revascularization among nonselected patients. Methods. A total of 400 consecutive nonselected patients (mean age 63 years) scheduled for isolated coronary revascularization were randomized by a cardiologist into two groups: A (on-pump) and B (off-pump). The cardiac surgeon was allowed to change the operative technique at any time after randomization. The only exclusion criterion was an emergency procedure. The primary end point was any of the following within 30 days: death, myocardial infarction, stroke, or new renal failure requiring hemodialysis. The study was analyzed m the intention-to-treat principle. Results. The primary end point occurred in 4.9% of patients in group A versus 2.9% in group B (not significant). Mortality was 1.1% in group A versus 2.0% in group B (not significant). Preoperative crossover occurred in 5.4% of patients in each group (not significant). Intraoperative conversion was necessary in 9.8% of patients in group B versus 1.1%, of patients in group A (p < 0.001). Group B patients had fewer distal anastomoses (2.3 versus 2.7 in group A; p < 0.001), less blood loss (560 versus 680 mL; p < 0.001). lower postoperative creatine kinase MB levels (0.15 versus 0.56 mukat/L; p < 0.001) and lower total hospital costs (E3,451 versus E4,387; p < 0.001). Conclusions. In our study off-pump technique was applicable in 85% of nonselected patients and is at least as clinically safe and effective as on-pump surgery. (C) 2004 by The Society of Thoracic Surgeons.