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

Area of Science:

• Cardiovascular Surgery
• Minimally Invasive Cardiac Procedures
• Clinical Trial Research

Background:

• Growing popularity of off-pump coronary artery bypass (CAB) surgery without robust randomized trial evidence.
• Need to evaluate the efficacy and safety of off-pump revascularization in unselected patient populations.

Purpose of the Study:

• To prospectively assess the role and outcomes of off-pump coronary artery bypass surgery in nonselected patients.
• To compare the clinical safety and effectiveness of off-pump versus on-pump CAB surgery.

Main Methods:

• Prospective, randomized, single-center study of 400 nonselected patients undergoing isolated coronary revascularization.
• Patients randomized to on-pump (Group A) or off-pump (Group B) CAB surgery; intraoperative conversion allowed.
• Primary endpoint: composite of death, myocardial infarction, stroke, or new renal failure within 30 days; intention-to-treat analysis.

Main Results:

• No significant difference in the primary endpoint between off-pump (2.9%) and on-pump (4.9%) groups.
• Off-pump surgery showed significantly less intraoperative conversion (1.1% vs 9.8%), fewer distal anastomoses, less blood loss, lower postoperative creatine kinase MB levels, and reduced hospital costs.
• Mortality rates were not significantly different (2.0% off-pump vs 1.1% on-pump).

Conclusions:

• Off-pump coronary artery bypass surgery is applicable in 85% of nonselected patients.
• The off-pump technique demonstrated comparable clinical safety and effectiveness to on-pump surgery.
• Off-pump CAB surgery offers potential benefits including reduced complications and lower costs.