Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial
Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial
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DOI：
10.1093/eurjhf/hft010
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发表时间：
2013-05-01
影响因子：
18.2
通讯作者：
Ahmed, Ali
中科院分区：
文献类型：
--
作者：
Gheorghiade, Mihai;Patel, Kanan;Ahmed, Ali
在洋地黄研究组（DIG）试验中，地高辛降低了几个预先规定的高风险HF患者亚组中因心力衰竭（HF）导致的死亡率或住院率，但未提供方案规定的2年结局数据。在本研究中，我们在方案规定的2年随机化后随访期间，检查了地高辛对高风险亚组中HF死亡或HF住院以及全因死亡或全因住院的影响。在DIG试验中，6800例慢性HF、正常窦性心律和LVEF 45的非卧床患者（平均年龄64岁，26名女性，17名非白人）被随机分配接受地高辛或安慰剂。三个高风险组定义为NYHA IIIIV级症状（n 2223）、LVEF 25（n 2256）和心胸比率（CTR）55（n 2345）。在所有三个高风险亚组中，与安慰剂组患者相比，地高辛组患者的2年复合终点HF死亡或HF住院治疗风险显著降低：NYHA IIIIV [风险比（HR）0.65; 95置信区间（CI）0.57 - 0.75; P 0.001]，LVEF 25（HR 0.61; 95 CI 0.530.71; P 0.001）和CTR 55（HR 0.65; 95 CI 0.570.75; P 0.001）。对于NYHA IIIIV、LVEF 25和CTR 55的亚组，地高辛相关的2年全因死亡或全因住院的HR（95 CI）为0.88（0.800.97; P 0.012），0.84（0.760.93; P 0.001）和0.85地高辛可改善NYHA IIIIV级、LVEF 25或CTR 55的慢性HF患者的结局，在这些患者中应考虑使用地高辛。
In the Digitalis Investigation Group (DIG) trial, digoxin reduced mortality or hospitalization due to heart failure (HF) in several pre-specified high-risk subgroups of HF patients, but data on protocol-specified 2-year outcomes were not presented. In the current study, we examined the effect of digoxin on HF death or HF hospitalization and all-cause death or all-cause hospitalization in high-risk subgroups during the protocol-specified 2 years of post-randomization follow-up.In the DIG trial, 6800 ambulatory patients with chronic HF, normal sinus rhythm, and LVEF 45 (mean age 64 years, 26 women, 17 non-whites) were randomized to receive digoxin or placebo. The three high-risk groups were defined as NYHA class IIIIV symptoms (n 2223), LVEF 25 (n 2256), and cardiothoracic ratio (CTR) 55 (n 2345). In all three high-risk subgroups, compared with patients in the placebo group, those in the digoxin group had a significant reduction in the risk of the 2-year composite endpoint of HF mortality or HF hospitalization: NYHA IIIIV [hazard ratio (HR) 0.65; 95 confidence interval (CI) 0.570.75; P 0.001], LVEF 25 (HR 0.61; 95 CI 0.530.71; P 0.001), and CTR 55 (HR 0.65; 95 CI 0.570.75; P 0.001). Digoxin-associated HRs (95 CI) for 2-year all-cause mortality or all-cause hospitalization for subgroups with NYHA IIIIV, LVEF 25, and CTR 55 were 0.88 (0.800.97; P 0.012), 0.84 (0.760.93; P 0.001), and 0.85 (0.770.94; P 0.002), respectively.Digoxin improves outcomes in chronic HF patients with NYHA class IIIIV, LVEF 25, or CTR 55, and should be considered in these patients.