Blinded withdrawal of randomized treatment with low-dose digoxin or placebo in heart failure: the DECISION trial.

This pre-specified analysis of the DECISION trial evaluated outcomes following blinded withdrawal of digoxin or placebo.

这项预先设定的DECISION试验分析评估了在双盲条件下撤回地高辛或安慰剂后的结果。

Methods

In DECISION, 1001 patients were randomized to low-dose digoxin or placebo and treated for a median of 36.5 months.

在DECISION研究中，1001名患者被随机分配到低剂量地高辛或安慰剂组，并接受了中位数为36.5个月的治疗。

At the end of the study, 587 patients on active treatment (digoxin 288 and placebo 299) underwent blinded withdrawal with an in-person follow-up visit at 6 weeks.

在研究结束时，587名接受活性治疗的患者（地高辛288例，安慰剂299例）进行了双盲撤药，并在6周后进行了面对面的随访。

All events were adjudicated.

所有事件都经过了裁定。

Results

During the pre-withdrawal phase (100 days), incidencerates of cardiovascular (CV) death or worsening HF events were 5.7 vs 6.5 events per 100 patient-years in the digoxin vs placebo group; rate ratio (RR) 0.88; 95% confidence interval(CI) [0.24-3.10].

在撤药前阶段（100天），心血管（CV）死亡或心力衰竭恶化事件的发生率在地高辛组为每100患者年5.7例，安慰剂组为6.5例；比率比（RR）为0.88；95%置信区间（CI）[0.24-3.10]。

Following withdrawal, the incidencerate increased markedly in patients withdrawn from digoxin but not placebo (42.8 vs 5.9 events per 100 patient-years; time period-by-treatment interaction, P = .036).

撤药后，从地高辛撤出的患者的发病率显著增加，而安慰剂组则没有（每100患者年42.8例 vs 5.9例；时间段与治疗的交互作用，P = .036）。

Fourteen events (12 hospitalizations and 2 urgent HF visits) occurred in the digoxin withdrawal arm vs two (one HF hospitalization and one CV death) in the placebo withdrawal arm (RR 7.37, 95% CI 1.56-34.88; P = .012).

在地高辛撤药组发生了14起事件（12次住院和2次紧急心力衰竭就诊），而在安慰剂撤药组发生了2起事件（1次心力衰竭住院和1次心血管死亡）（RR 7.37，95% CI 1.56-34.88；P = .012）。

Withdrawal of digoxin was accompanied by an increase in heart rate (P = .003), reduction in systolic blood pressure (P = .014), and rise in NT-proBNP (P = .002).

停用地高辛后，心率增加（P = .003），收缩压降低（P = .014），NT-proBNP水平上升（P = .002）。

Conclusions

Discontinuation of digoxin after long-term treatment is associated with clinical deterioration in patients with HF and a reduced or mildly reduced ejection fraction.

长期治疗后停用地高辛与射血分数减少或轻度减少的心力衰竭患者临床恶化相关。

These findings warrant caution when stopping digoxin.

这些发现提示在停用地高辛时应保持警惕。