The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) trial was published in NEJM in 2005 . SCD-HeFT randomized 2521 patients into three groups. They were in New York Association (NYHA) class II or III congestive heart failure (CHF) and had left ventricular ejection fraction (LVEF) ≤35%. It was a comparison between amiodarone or an implantable cardioverter-defibrillator (ICD) for congestive heart failure, with placebo control. The patients were divided into three groups:
- Conventional therapy for CHF plus placebo (847 patients)
- Conventional therapy plus amiodarone (845 patients)
- Conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients)
Amiodarone and placebo were given in a double blind pattern. Primary endpoint of the study was all cause mortality. Median follow of period of SCD-HeFT was forty five and a half months. Mortality rate was twenty nine percent in the placebo group and twenty eight percent in the amiodarone group. Those on ICD had a mortality rate of twenty two percent.
Compared with placebo, amiodarone had a similar death rate with hazard ratio on 1.06 (P=0.53) which was not statistically significant. Death rate was 23 percent lower in the ICD group with a hazard ratio of 0.77 (P=0.007). Absolute reduction in mortality was 7.2% in the ICD group after five years of follow up.
Though amiodarone was not found to be superior to placebo in the SCD-HeFT, this was better than the results of the Cardiac Arrhythmia Suppression Trial (CAST) which was published in NEJM in 1991 , which showed excess deaths with encainide or flecainide, two class Ic antiarrhythmic agents.
- Gust H Bardy, Kerry L Lee, Daniel B Mark, Jeanne E Poole, Douglas L Packer, Robin Boineau, Michael Domanski, Charles Troutman, Jill Anderson, George Johnson, Steven E McNulty, Nancy Clapp-Channing, Linda D Davidson-Ray, Elizabeth S Fraulo, Daniel P Fishbein, Richard M Luceri, John H Ip, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37.
- D S Echt, P R Liebson, L B Mitchell, R W Peters, D Obias-Manno, A H Barker, D Arensberg, A Baker, L Friedman, H L Greene, Huther ML, Richardson DW, and the CAST Investigators. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med.1991 Mar 21;324(12):781-8.