Medtronic
 
 

Heart Failure

Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Bardy GH, Lee KL, Mark DB, et al, for the Sudden Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-237.

SCD-HeFT investigated the use of ICDs or amiodarone to reduce the risk of death from any cause in patients with mild to moderate HF due to either ischemic and nonischemic disease. The multicenter study enrolled 2,521 patients with NYHA class II or III heart failure and a LVEF < 35%. Patients were followed for a median of 3.8 years. The etiology of the underlying heart disease was 52% ischemic cardiomyopathy and 48% dilated, nonischemic cardiomyopathy The majority of the patients were in NYHA class II (70%), and the remainder were class III. Mean LVEF was 25%. Patients were randomized to receive conventional therapy for HF plus placebo, conventional therapy plus amiodarone, or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD. Placebo and amiodarone were administered in a double-blind fashion. The primary endpoint was death from any cause.

The results showed that compared to placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5% confidence interval, 0.86-1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23% (0.77; 97.5 percent confidence interval, 0.62-0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after 5 years in the overall population. Results did not vary according to either ischemic or nonischemic causes of HF, but they did vary according to NYHA class. ICD therapy had a significant benefit in patients with NYHA class II HF, but not in those in NYHA class III HF. In contrast, amiodarone therapy had no benefit in patients in NYHA class II and decreased survival among patients in NYHA class III HF, as compared with those who received placebo.

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