Anderson Jeffrey L, Krause-Steinrauf Heidi, Goldman Steven, Clemson Barry S, Domanski Michael J, Hager W David, Murray David R, Mann Douglas L, Massie Barry M, McNamara Dennis M, Oren Ron, Rogers William J
Division of Cardiology, LDS Hospital, University of Utah, Salt Lake City 84143, USA.
J Card Fail. 2003 Aug;9(4):266-77. doi: 10.1054/jcaf.2003.42.
The risks and benefits of beta-blockade with bucindolol were assessed in heart failure (HF) patients with Class IV symptoms within the Beta-blocker Evaluation of Survival Trial (BEST).
beta-blockade is accepted therapy for mild to moderate HF, but its safety and efficacy in advanced HF have not been established.
BEST recruited 2708 HF patients; of these, 226 with Class IV symptoms (n=114 randomized to bucindolol, n=112 to placebo) formed the basis of this study. All-cause death, HF hospitalization, and drug discontinuations occurring early during therapy (< or =6 months) and overall during follow-up were assessed. Compared with Class III, Class IV patients were older and had higher plasma norepinephrine levels, prevalence of coronary disease, S3 gallops, and lower ejection fractions, but characteristics of the 2 Class IV treatment groups were similar.
During a mean of 1.6 years, 49% Class IV patients died, and 54% were hospitalized for HF. Bucindolol increased the combined endpoint of death or HF hospitalization within the first 6 months (hazard ratio [HR]=1.7, 95% confidence interval [CI]=1.1-2.7) and did not result in benefit overall (HR=1.2, 95% CI=0.9-1.6). HF hospitalization alone within 6 months was increased by bucindolol (HR=1.7), and an early adverse trend for death was seen (HR=1.6) with no benefit overall (HR=1.1). Bucindolol was discontinued more frequently than placebo for worsening HF (11% versus 4%) and hypotension (3% versus 0%).
Class IV HF patients in BEST were at high risk. Bucindolol did not reduce death or HF hospitalization and was associated with early hazard.
在β受体阻滞剂生存评估试验（BEST）中，对布新洛尔进行β受体阻滞治疗的风险和益处，在纽约心功能分级IV级症状的心力衰竭（HF）患者中进行了评估。
β受体阻滞是轻至中度HF的公认治疗方法，但其在晚期HF中的安全性和有效性尚未确立。
BEST招募了2708例HF患者；其中，226例有IV级症状的患者（n = 114随机分配至布新洛尔组，n = 112至安慰剂组）构成了本研究的基础。评估了全因死亡、HF住院以及治疗早期（≤6个月）和随访期间总体发生的药物停用情况。与III级患者相比，IV级患者年龄更大，血浆去甲肾上腺素水平更高，冠心病患病率、S3奔马律更高，射血分数更低，但两个IV级治疗组的特征相似。
在平均1.6年的时间里，49%的IV级患者死亡，54%因HF住院。布新洛尔在前6个月内增加了死亡或HF住院的复合终点（风险比[HR]=1.7，95%置信区间[CI]=1.1 - 2.7），总体上未带来益处（HR = 1.2，95% CI = 0.9 - 1.6）。布新洛尔使6个月内单独的HF住院增加（HR = 1.7），并且观察到早期死亡有不良趋势（HR = 1.6），总体无益处（HR = 1.1）。因HF恶化（11%对4%）和低血压（3%对0%），布新洛尔比安慰剂更频繁地停药。
BEST中的IV级HF患者风险很高。布新洛尔未降低死亡或HF住院率，且与早期风险相关。
