CONTEXT: Previous trials of off-pump coronary artery bypass (OPCAB) have enrolled selected patients and have not rigorously evaluated long-term graft patency. A preliminary report showed OPCAB achieved improved inhospital outcomes, similar completeness of revascularization, and shorter lengths of stay compared with conventional coronary artery bypass grafting (CABG). OBJECTIVE: To assess graft patency, clinical and quality-of-life outcomes, and cost among patients while in the hospital and at 1-year follow-up. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of patients unselected for coronary anatomy, ventricular function, or comorbidities between March 10, 2000, and August 20, 2001, at a US academic center. A total of 200 patients were enrolled; 3 patients were withdrawn after randomization for mitral valve repair or replacement. Follow-up was complete for 197 patients at 30 days; 185 at 1 year. INTERVENTIONS: One surgical session consisting of elective OPCAB or CABG with cardiopulmonary bypass. The surgeon had extensive experience performing off-pump surgery; patients were subsequently managed by blinded protocols. MAIN OUTCOME MEASURES: Coronary angiography documented graft patency prior to hospital discharge and at 1 year; health-related quality of life; and cost of the index and subsequent hospitalization(s). RESULTS:Graft patency was similar for OPCAB and conventional CABG with cardiopulmonary bypass at 30 days (absolute difference, 1.3%; 95% confidence interval [CI], -0.66% to 3.31%; P =.19) and at 1 year (absolute difference, -2.2%; 95% CI, -6.1% to 1.7%; P =.27). Rates of death, stroke, myocardial infarction, angina, and reintervention were similar at 30 days and 1 year. There were no significant differences in health-related quality of life. Mean total hospitalization cost per patient at hospital discharge was 2272 dollars (95% CI, 755 dollars-3732 dollars) less for OPCAB (P =.002) and 1955 dollars (95% CI, -766 dollars to 4727 dollars) less at 1 year (P =.08). CONCLUSIONS: In this randomized single-surgeon trial among unselected patients with angiographic follow-up, OPCAB achieved similar graft patency in the hospital and at 1 year. Cardiac outcomes and health-related quality of life at 30 days and 1 year were similar and patients incurred a lower cost. OPCAB may provide complete revascularization that is durable and cost-effective.
RCT Entities:
CONTEXT: Previous trials of off-pump coronary artery bypass (OPCAB) have enrolled selected patients and have not rigorously evaluated long-term graft patency. A preliminary report showed OPCAB achieved improved inhospital outcomes, similar completeness of revascularization, and shorter lengths of stay compared with conventional coronary artery bypass grafting (CABG). OBJECTIVE: To assess graft patency, clinical and quality-of-life outcomes, and cost among patients while in the hospital and at 1-year follow-up. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of patients unselected for coronary anatomy, ventricular function, or comorbidities between March 10, 2000, and August 20, 2001, at a US academic center. A total of 200 patients were enrolled; 3 patients were withdrawn after randomization for mitral valve repair or replacement. Follow-up was complete for 197 patients at 30 days; 185 at 1 year. INTERVENTIONS: One surgical session consisting of elective OPCAB or CABG with cardiopulmonary bypass. The surgeon had extensive experience performing off-pump surgery; patients were subsequently managed by blinded protocols. MAIN OUTCOME MEASURES: Coronary angiography documented graft patency prior to hospital discharge and at 1 year; health-related quality of life; and cost of the index and subsequent hospitalization(s). RESULTS: Graft patency was similar for OPCAB and conventional CABG with cardiopulmonary bypass at 30 days (absolute difference, 1.3%; 95% confidence interval [CI], -0.66% to 3.31%; P =.19) and at 1 year (absolute difference, -2.2%; 95% CI, -6.1% to 1.7%; P =.27). Rates of death, stroke, myocardial infarction, angina, and reintervention were similar at 30 days and 1 year. There were no significant differences in health-related quality of life. Mean total hospitalization cost per patient at hospital discharge was 2272 dollars (95% CI, 755 dollars-3732 dollars) less for OPCAB (P =.002) and 1955 dollars (95% CI, -766 dollars to 4727 dollars) less at 1 year (P =.08). CONCLUSIONS: In this randomized single-surgeon trial among unselected patients with angiographic follow-up, OPCAB achieved similar graft patency in the hospital and at 1 year. Cardiac outcomes and health-related quality of life at 30 days and 1 year were similar and patients incurred a lower cost. OPCAB may provide complete revascularization that is durable and cost-effective.
Authors: Veena Guru; Kevin W Glasgow; Stephen E Fremes; Peter C Austin; Kevin Teoh; Jack V Tu Journal: Can J Cardiol Date: 2007-03-15 Impact factor: 5.223