Background Patients with coronary heart disease, left ventriculardysfunction, and abnormalities on signal-averaged electrocardiogramshave an increased risk of sudden death. We evaluated the effecton survival of the prophylactic implantation of cardioverterdefibrillatorsin such patients at the time of coronary-artery bypass surgery.
Methods Over the course of five years, 37 clinical centers screenedall patients who were scheduled for elective coronary bypasssurgery. Patients were eligible for the trial if they were lessthan 80 years old, had a left ventricular ejection fractionof less than 0.36, and had abnormalities on signal-averagedelectrocardiograms. We identified 1422 eligible patients, enrolled1055, and randomly assigned 900 to therapy with an implantablecardioverterdefibrillator (446 patients) or to the controlgroup (454 patients). The primary end point of the study wasoverall mortality, and the two groups were compared in an intention-to-treatanalysis.
Results The base-line characteristics of the two groups weresimilar. During an average (±SD) follow-up of 32±16months, there were 101 deaths in the defibrillator group (71from cardiac causes) and 95 in the control group (72 from cardiaccauses). The hazard ratio for death from any cause was 1.07(95 percent confidence interval, 0.81 to 1.42; P = 0.64). Therewas no statistically significant interaction between defibrillatortherapy and any of 10 preselected base-line covariates.
Conclusions We found no evidence of improved survival amongpatients with coronary heart disease, a depressed left ventricularejection fraction, and an abnormal signal-averaged electrocardiogramin whom a defibrillator was implanted prophylactically at thetime of elective coronary bypass surgery.
Source Information
Address reprint requests to Dr. Bigger at the Data Coordinating Center, the CABG Patch Trial, PH 103-D, Columbia University, 630 W. 168th St., New York, NY 10032.
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