Key result
Amiodarone shows no difference in total mortality versus an ICD.
Why the study?
Whether an ICD reduces mortality more than amiodarone in patients with nonischemic dilated cardiomyopathy and nonsustained ventricular tachycardia was unknown.
RCT (n=103)
randomized
Yes
Absolute Event Rate: 88% vs 87%
p-value: p=0.8
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Thus far, there had been no single trial with non-ischemic HF in which the ICD showed clear benefit. The first lesson I think is that for an ICD to provide benefits>harms, there has to be a high enough baseline risk of cardiac arrest.”
“The simple message is that the same groups of patients that benefited strongly from the ICD in the original SCD-HeFT – the NYHA class 2 patients and those with ischemic cardiomyopathy – were really the ones who benefited the greatest over the long term.”
“the implications for patients with NICM are less clear. Given evidence for intermediate-term benefit and the limitations inherent to assessing longer-term benefit, we do not believe it is appropriate to walk back guideline recommendations regarding ICD implantation for NICM patients.”
Amiodarone's higher adverse events warrant caution versus ICD despite similar mortality; extends randomized evidence to nonischemic cardiomyopathy.
OBJECTIVES: The purpose of this multicenter randomized trial was to compare total mortality during therapy with amiodarone or an implantable cardioverter-defibrillator (ICD) in patients with nonischemic dilated cardiomyopathy (NIDCM) and nonsustained ventricular tachycardia (NSVT). BACKGROUND: Whether an ICD reduces mortality more than amiodarone in patients with NIDCM and NSVT is unknown. METHODS: One hundred three patients with NIDCM, left ventricular ejection fraction < or =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. RESULTS: 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 US dollars vs. $22,039 US dollars, p = 0.1). CONCLUSIONS: 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.
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Strickberger et al. (2003) conducted an RCT in Nonischemic dilated cardiomyopathy and nonsustained ventricular tachycardia (n=103). Amiodarone vs. Implantable cardioverter-defibrillator (ICD) was evaluated on Total mortality (p=0.8). Amiodarone did not significantly differ from an implantable cardioverter-defibrillator for total mortality, with 3-year survival rates of 88% versus 87% (p=0.8).
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