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A Randomized Trial

John D. Puskas, MD, MSc; Willis H. Williams, MD; Elizabeth M. Mahoney, ScD; Philip R. Huber, MD; Peter C. Block, MD; Peggy G. Duke, MD; James R. Staples, MD; Katherine E. Glas, MD; J. Jeffrey Marshall, MD; Mark E. Leimbach, MD; Susan A. McCall, RN; Rebecca J. Petersen, RN; Dianne E. Bailey, RN, PA-C; William S. Weintraub, MD; Robert A. Guyton, MD

JAMA. 2004;291:1841-1849.

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 A total of 200 patients were enrolled; 3 patients were withdrawn after randomization for mitral valve repair or replacement.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 (95% CI, $755-$3732) less for OPCAB (P = .002) and $1955 (95% CI, –$766 to $4727) 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.

Author Affiliations: Divisions of Cardiothoracic Surgery (Drs Puskas, Williams, and Guyton and Mss McCall, Petersen, and Bailey), Cardiology (Drs Huber, Block, Marshall, and Leimbach), and Cardiac Anesthesiology (Drs Duke, Staples, and Glas), Emory University School of Medicine and Emory Center for Outcomes Research (Drs Williams and Weintraub), Atlanta, Ga; and the New England Research Institutes, Watertown, Mass (Dr Mahoney).

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