PMID- 15659722
OWN - NLM
STAT- MEDLINE
DCOM- 20050127
LR  - 20231024
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 352
IP  - 3
DP  - 2005 Jan 20
TI  - Amiodarone or an implantable cardioverter-defibrillator for congestive heart 
      failure.
PG  - 225-37
AB  - 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.
CI  - Copyright 2005 Massachusetts Medical Society.
FAU - Bardy, Gust H
AU  - Bardy GH
AD  - Seattle Institute for Cardiac Research, Seattle, WA 98103, USA. gbardy@sicr.org
FAU - Lee, Kerry L
AU  - Lee KL
FAU - Mark, Daniel B
AU  - Mark DB
FAU - Poole, Jeanne E
AU  - Poole JE
FAU - Packer, Douglas L
AU  - Packer DL
FAU - Boineau, Robin
AU  - Boineau R
FAU - Domanski, Michael
AU  - Domanski M
FAU - Troutman, Charles
AU  - Troutman C
FAU - Anderson, Jill
AU  - Anderson J
FAU - Johnson, George
AU  - Johnson G
FAU - McNulty, Steven E
AU  - McNulty SE
FAU - Clapp-Channing, Nancy
AU  - Clapp-Channing N
FAU - Davidson-Ray, Linda D
AU  - Davidson-Ray LD
FAU - Fraulo, Elizabeth S
AU  - Fraulo ES
FAU - Fishbein, Daniel P
AU  - Fishbein DP
FAU - Luceri, Richard M
AU  - Luceri RM
FAU - Ip, John H
AU  - Ip JH
CN  - Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators
LA  - eng
GR  - UO1 HL55297/HL/NHLBI NIH HHS/United States
GR  - UO1 HL55496/HL/NHLBI NIH HHS/United States
GR  - UO1 HL55766/HL/NHLBI NIH HHS/United States
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Anti-Arrhythmia Agents)
RN  - N3RQ532IUT (Amiodarone)
SB  - IM
EIN - N Engl J Med. 2005 May 19;352(20):2146
CIN - N Engl J Med. 2005 Jan 20;352(3):222-4. PMID: 15659721
CIN - N Engl J Med. 2005 Jan 20;352(3):285-7. PMID: 15659729
CIN - N Engl J Med. 2005 May 12;352(19):2022-5; author reply 2022-5. PMID: 15888706
CIN - N Engl J Med. 2005 May 12;352(19):2022-5; author reply 2022-5. PMID: 15892193
CIN - N Engl J Med. 2005 May 12;352(19):2022-5; author reply 2022-5. PMID: 15892194
CIN - N Engl J Med. 2005 May 12;352(19):2022-5; author reply 2022-5. PMID: 15892195
CIN - ACP J Club. 2005 Jul-Aug;143(1):6. PMID: 15989294
CIN - Evid Based Cardiovasc Med. 2005 Jun;9(2):112-4. PMID: 16380004
MH  - Aged
MH  - Amiodarone/*therapeutic use
MH  - Anti-Arrhythmia Agents/*therapeutic use
MH  - Cause of Death
MH  - Cross-Over Studies
MH  - Death, Sudden, Cardiac/*prevention & control
MH  - *Defibrillators, Implantable
MH  - Female
MH  - Heart Failure/drug therapy/mortality/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Risk
MH  - Stroke Volume
MH  - Survival Analysis
EDAT- 2005/01/22 09:00
MHDA- 2005/01/28 09:00
CRDT- 2005/01/22 09:00
PHST- 2005/01/22 09:00 [pubmed]
PHST- 2005/01/28 09:00 [medline]
PHST- 2005/01/22 09:00 [entrez]
AID - 352/3/225 [pii]
AID - 10.1056/NEJMoa043399 [doi]
PST - ppublish
SO  - N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.