Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure.
BACKGROUND
Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to improve the prognosis in such patients.


METHODS
We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause.


RESULTS
The median LVEF in patients was 25 percent; 70 percent were in NYHA class II, and 30 percent were in class III CHF. The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent. The median follow-up was 45.5 months. There were 244 deaths (29 percent) in the placebo group, 240 (28 percent) in the amiodarone group, and 182 (22 percent) in the ICD group. As compared with placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5 percent confidence interval, 0.86 to 1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23 percent (0.77; 97.5 percent confidence interval, 0.62 to 0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population. Results did not vary according to either ischemic or nonischemic causes of CHF, but they did vary according to the NYHA class.


CONCLUSIONS
In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent.
Bardy
Gust H
GH
Seattle Institute for Cardiac Research, Seattle, WA 98103, USA. gbardy@sicr.org
Lee
Kerry L
KL
Mark
Daniel B
DB
Poole
Jeanne E
JE
Packer
Douglas L
DL
Boineau
Robin
R
Domanski
Michael
M
Troutman
Charles
C
Anderson
Jill
J
Johnson
George
G
McNulty
Steven E
SE
Clapp-Channing
Nancy
N
Davidson-Ray
Linda D
LD
Fraulo
Elizabeth S
ES
Fishbein
Daniel P
DP
Luceri
Richard M
RM
Ip
John H
JH
D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D002423:Cause of Death; D018592:Cross-Over Studies; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012306:Risk; D013318:Stroke Volume; D016019:Survival Analysis
D000889:Anti-Arrhythmia Agents; D000638:Amiodarone