Long-term comparison of the implantable cardioverter defibrillator versus amiodarone - Eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS)

Background-The implantable cardioverter defibrillator (ICD) is superior to amiodarone for secondary prophylaxis of sudden cardiac death. However, the magnitude of this benefit over long-term follow-up is not known. Thus, our objective was to evaluate the long-term consequences of using amiodarone versus an ICD as first-line monotherapy in patients with a prior history of sustained ventricular tachycardia/ventricular fibrillation or cardiac arrest. Methods and Results-A total of 120 patients were enrolled at St Michael's Hospital in the Canadian Implantable Defibrillator Study (CIDS) and were randomly assigned to receive either amiodarone (n = 60) or an ICD (n = 60). The treatment strategy was not altered after the end of CIDS unless the initial assigned therapy was not effective or was associated with serious side effects. After a mean follow-up of 5.6 +/- 2.6 years, there were 28 deaths (47%) in the amiodarone group, compared with 16 deaths (27%) in the ICD group (P = 0.0213). Total mortality was 5.5% per year in the amiodarone group versus 2.8% per year in the ICD group ( hazard ratio of amiodarone: ICD, 2.011; 95% confidence interval, 1.087 to 3.721; P = 0.0261). In the amiodarone group, 49 patients (82% of all patients) had side effects related to amiodarone, of which 30 patients (50% of all patients) required discontinuation or dose reduction; 19 patients crossed over to ICD because of amiodarone failure (n = 7) or side effects (n = 12). Conclusions-In a subset of CIDS, the benefit of the ICD over amiodarone increases with time; most amiodarone-treated patients eventually develop side effects, have arrhythmia recurrences, or die.