PMID- 11386264 OWN - NLM STAT- MEDLINE DCOM- 20010607 LR - 20220408 IS - 0028-4793 (Print) IS - 0028-4793 (Linking) VI - 344 IP - 22 DP - 2001 May 31 TI - A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure. PG - 1659-67 AB - BACKGROUND: Although beta-adrenergic-receptor antagonists reduce morbidity and mortality in patients with mild-to-moderate chronic heart failure, their effect on survival in patients with more advanced heart failure is unknown. METHODS: A total of 2708 patients with heart failure designated as New York Heart Association (NYHA) functional class III (in 92 percent of the patients) or IV (in 8 percent) and a left ventricular ejection fraction of 35 percent or lower were randomly assigned to double-blind treatment with either bucindolol (1354 patients) or placebo (1354 patients) and followed for the primary end point of death from any cause. RESULTS: The data and safety monitoring board recommended stopping the trial after the seventh interim analysis. At that time, there was no significant difference in mortality between the two groups (unadjusted P=0.16). The results presented here are based on complete follow-up at the time of study termination (average, 2.0 years). There were a total of 449 deaths in the placebo group (33 percent) and 411 deaths in the bucindolol group (30 percent; adjusted P=0.13). The risk of the secondary end point of death from cardiovascular causes was lower in the bucindolol group (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99), as was the risk of heart transplantation or death (hazard ratio, 0.87; 95 percent confidence interval, 0.77 to 0.99). CONCLUSIONS: In a demographically diverse group of patients with NYHA class III and IV heart failure, bucindolol resulted in no significant overall survival benefit. CN - Beta-Blocker Evaluation of Survival Trial Investigators FAU - Eichhorn, Eric J AU - Eichhorn EJ FAU - Domanski, Michael J AU - Domanski MJ FAU - Krause-Steinrauf, Heidi AU - Krause-Steinrauf H FAU - Bristow, Michael R AU - Bristow MR FAU - Lavori, Philip W AU - Lavori PW LA - eng PT - Clinical Trial 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, Non-P.H.S. 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 (Adrenergic beta-Antagonists) RN - 0 (Propanolamines) RN - E9UO06K7CE (bucindolol) SB - IM CIN - ACP J Club. 2001 Nov-Dec;135(3):84 CIN - N Engl J Med. 2001 May 31;344(22):1711-2. PMID: 11386271 CIN - N Engl J Med. 2001 Sep 27;345(13):998; author reply 998-9. PMID: 11575300 MH - Adrenergic beta-Antagonists/adverse effects/*therapeutic use MH - Aged MH - Chronic Disease MH - Double-Blind Method MH - Female MH - Heart Failure/classification/*drug therapy/ethnology/mortality MH - Heart Transplantation/statistics & numerical data MH - Hospitalization/statistics & numerical data MH - Humans MH - Male MH - Middle Aged MH - Propanolamines/adverse effects/*therapeutic use MH - Proportional Hazards Models MH - Severity of Illness Index MH - Survival Analysis EDAT- 2001/06/02 10:00 MHDA- 2001/06/08 10:01 CRDT- 2001/06/02 10:00 PHST- 2001/06/02 10:00 [pubmed] PHST- 2001/06/08 10:01 [medline] PHST- 2001/06/02 10:00 [entrez] AID - 10.1056/NEJM200105313442202 [doi] PST - ppublish SO - N Engl J Med. 2001 May 31;344(22):1659-67. doi: 10.1056/NEJM200105313442202.