Background: The STICH (Surgical Treatment for Ischemic Heart Failure) trial compared a strategy of routine coronary artery bypass grafting (CABG) with guideline-based medical therapy for patients with ischemic left ventricular dysfunction.
Objective: To describe treatment-related quality-of-life (QOL) outcomes, a major prespecified secondary end point in the STICH trial.
Design: Randomized trial. (ClinicalTrials.gov: NCT00023595).
Setting: 99 clinical sites in 22 countries.
Patients: 1212 patients with a left ventricular ejection fraction of 0.35 or less and coronary artery disease.
Intervention: Random assignment to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients).
Measurements: A battery of QOL instruments at baseline (98.9% complete) and 4, 12, 24, and 36 months after randomization (collection rates were 80% to 89% of those eligible). The principal prespecified QOL measure was the Kansas City Cardiomyopathy Questionnaire, which assesses the effect of heart failure on patients' symptoms, physical function, social limitations, and QOL.
Results: The Kansas City Cardiomyopathy Questionnaire overall summary score was consistently higher (more favorable) in the CABG group than in the medical therapy group by 4.4 points (95% CI, 1.8 to 7.0 points) at 4 months, 5.8 points (CI, 3.1 to 8.6 points) at 12 months, 4.1 points (CI, 1.2 to 7.1 points) at 24 months, and 3.2 points (CI, 0.2 to 6.3 points) at 36 months. Sensitivity analyses to account for the effect of mortality on follow-up QOL measurement were consistent with the primary findings.
Limitation: Therapy was not masked.
Conclusion: In this cohort of symptomatic high-risk patients with ischemic left ventricular dysfunction and multivessel coronary artery disease, CABG plus medical therapy produced clinically important improvements in quality of life compared with medical therapy alone over 36 months.
Primary funding source: National Heart, Lung, and Blood Institute.