Baseline characteristics of patients in the Coronary Artery Bypass Graft (CABG) Patch Trial

BACKGROUND: Patients with left ventricular dysfunction who undergo coronary artery bypass graft (CABG) surgery frequently have late sudden cardiac death. The CABG Patch Trial is a prospective, randomized, multicenter clinical trial that randomized patients at high risk at the completion of CABG surgery to implantation of an epicardial implantable cardioverter defibrillator (ICD) or to no antiarrhythmic treatment. The trial was designed to determine whether prophylactic implantation of an ICD at the time of CABG surgery would result in a lower total mortality in long-term follow-up. METHODS: Patients undergoing CABG surgery were eligible for the trial if they were younger than 80 years, had a left ventricular ejection fraction less than 0.36, and had an abnormal signal averaged electrocardiogram. Patients with a history of sustained ventricular tachycardia or ventricular fibrillation were excluded from the trial. All patients were scheduled to undergo follow-up at 3-month intervals until 42 months after surgery. RESULTS: Randomization of patients in the trial ended in February 1996. During the recruitment period 71,855 patients were screened, 1,422 were eligible, 1,055 were enrolled (signed consent forms), and 900 patients (76% of eligible patients) were randomized. The mean age of the 446 patients in the ICD group was 64 years versus 63 years for the 454 patients in the control group. A total of 87% of the participants in the ICD group were men versus 82% in the control group (p = NS). Most of the patients had a history of hypertension (55%), smoking (78%), and hypercholesterolemia (54%). Half of the patients had clinical heart failure, and the mean ejection fraction for both patient groups was 0.27 +/- 0.06. No difference was seen in the history of myocardial infarction (83%), congestive heart failure (50%), or atrial (11%) or ventricular (17%) arrhythmias between the two groups. Major clinical characteristics (age, sex, number of previous infarctions, incidence of heart failure, and mean left ventricular ejection fraction) were almost identical to those found in another ICD primary prevention trial, the Multicenter Automatic Defibrillator Implantation Trial (MADIT). CONCLUSIONS: A high risk sample of patients was enrolled in The CABG Patch Trial, as shown by examination of their baseline characteristics.