Whether an ICD reduces mortality more than amiodarone in patients with NIDCM and NSVT is unknown.
One hundred three patients with NIDCM, left ventricular ejection fraction ≤0.35, and asymptomatic NSVT were randomized to receive either amiodarone or an ICD. The primary end point was total mortality. Secondary end points included arrhythmia-free survival, quality of life, and costs.
The study was stopped when the prospective stopping rule for futility was reached. The percent of patients surviving at one year (90 % vs. 96 % ) and three years (88 % vs. 87 % ) in the amiodarone and ICD groups, respectively, were not statistically different (p = 0.8). Quality of life was also similar with each therapy (p = NS). There was a trend with amiodarone, as compared to the ICD, towards improved arrhythmia-free survival (p = 0.1) and lower costs during the first year of therapy ($8,879 vs. $22,039, P = 0.1).
Mortality and quality of life in patients with NIDCM and NSVT treated with amiodarone or an ICD are not statistically different. There is a trend towards a more beneficial cost profile and improved arrhythmia-free survival with amiodarone therapy.