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Baseline characteristics of patients in the coronary artery bypass graft (CABG) Patch Trial
A B Curtis1, D S Cannom, J T Bigger
1University of Florida, Gainesville, USA.
Insights
The CABG Patch Trial investigated implantable cardioverter defibrillators (ICDs) in high-risk patients after bypass surgery. Results showed this high-risk group was well-characterized by baseline data.
Area of Science:
- Cardiology
- Cardiac Surgery
- Electrophysiology
Background:
- Patients with left ventricular dysfunction undergoing coronary artery bypass graft (CABG) surgery face a high risk of sudden cardiac death.
- The CABG Patch Trial aimed to assess the efficacy of prophylactic implantable cardioverter defibrillators (ICDs) in this population.
Purpose of the Study:
- To determine if prophylactic ICD implantation at the time of CABG surgery reduces long-term total mortality.
- To evaluate the effectiveness of ICDs in preventing sudden cardiac death in high-risk patients post-CABG.
Main Methods:
- A prospective, randomized, multicenter clinical trial involving patients with left ventricular dysfunction post-CABG.
- Eligible patients (younger than 80, LVEF < 0.36, abnormal ECG) were randomized to receive an ICD or no antiarrhythmic treatment.
- Follow-up occurred at 3-month intervals for up to 42 months.
Main Results:
- 900 high-risk patients were randomized (446 ICD, 454 control).
- Mean age was 63-64 years, with most participants being male and having a history of hypertension, smoking, and hypercholesterolemia.
- Baseline characteristics, including ejection fraction (0.27 ± 0.06), were similar between groups and comparable to other ICD trials like MADIT.
Conclusions:
- The CABG Patch Trial successfully enrolled a high-risk patient sample.
- Baseline characteristics confirmed the high-risk profile of the enrolled participants.
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.