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Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure.
N Engl J Med. 2005 Jan 20; 352(3):225-37.NEJM

Abstract

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.

Authors+Show Affiliations

Seattle Institute for Cardiac Research, Seattle, WA 98103, USA. gbardy@sicr.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15659722

Citation

Bardy, Gust H., et al. "Amiodarone or an Implantable Cardioverter-defibrillator for Congestive Heart Failure." The New England Journal of Medicine, vol. 352, no. 3, 2005, pp. 225-37.
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225-37.
Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., Domanski, M., Troutman, C., Anderson, J., Johnson, G., McNulty, S. E., Clapp-Channing, N., Davidson-Ray, L. D., Fraulo, E. S., Fishbein, D. P., Luceri, R. M., & Ip, J. H. (2005). Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. The New England Journal of Medicine, 352(3), 225-37.
Bardy GH, et al. Amiodarone or an Implantable Cardioverter-defibrillator for Congestive Heart Failure. N Engl J Med. 2005 Jan 20;352(3):225-37. PubMed PMID: 15659722.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. AU - Bardy,Gust H, AU - Lee,Kerry L, AU - Mark,Daniel B, AU - Poole,Jeanne E, AU - Packer,Douglas L, AU - Boineau,Robin, AU - Domanski,Michael, AU - Troutman,Charles, AU - Anderson,Jill, AU - Johnson,George, AU - McNulty,Steven E, AU - Clapp-Channing,Nancy, AU - Davidson-Ray,Linda D, AU - Fraulo,Elizabeth S, AU - Fishbein,Daniel P, AU - Luceri,Richard M, AU - Ip,John H, AU - ,, PY - 2005/1/22/pubmed PY - 2005/1/28/medline PY - 2005/1/22/entrez SP - 225 EP - 37 JF - The New England journal of medicine JO - N Engl J Med VL - 352 IS - 3 N2 - 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15659722/Amiodarone_or_an_implantable_cardioverter_defibrillator_for_congestive_heart_failure_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa043399?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -