心力衰竭患者分钟通气量目标导向的适应性伺服通气治疗的心血管结局：CAT-HF 试验。
Cardiovascular Outcomes With Minute Ventilation-Targeted Adaptive Servo-Ventilation Therapy in Heart Failure: The CAT-HF Trial.
机构信息
Duke University and Duke Clinical Research Institute, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia.
Thomas Jefferson University, Philadelphia, Pennsylvania.
出版信息
J Am Coll Cardiol. 2017 Mar 28;69(12):1577-1587. doi: 10.1016/j.jacc.2017.01.041.
BACKGROUND
Sleep apnea is common in hospitalized heart failure (HF) patients and is associated with increased morbidity and mortality.
OBJECTIVES
The CAT-HF (Cardiovascular Improvements With MV-ASV Therapy in Heart Failure) trial investigated whether minute ventilation (MV) adaptive servo-ventilation (ASV) improved cardiovascular outcomes in hospitalized HF patients with moderate-to-severe sleep apnea.
METHODS
Eligible patients hospitalized with HF and moderate-to-severe sleep apnea were randomized to ASV plus optimized medical therapy (OMT) or OMT alone (control). The primary endpoint was a composite global rank score (hierarchy of death, cardiovascular hospitalizations, and percent changes in 6-min walk distance) at 6 months.
RESULTS
126 of 215 planned patients were randomized; enrollment was stopped early following release of the SERVE-HF (Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure) trial results. Average device usage was 2.7 h/night. Mean number of events measured by the apnea-hypopnea index decreased from 35.7/h to 2.1/h at 6 months in the ASV group versus 35.1/h to 19.0/h in the control group (p < 0.0001). The primary endpoint did not differ significantly between the ASV and control groups (p = 0.92 Wilcoxon). Changes in composite endpoint components were not significantly different between ASV and control. There was no significant interaction between treatment and ejection fraction (p = 0.10 Cox model); however, pre-specified subgroup analysis suggested a positive effect of ASV in patients with HF with preserved ejection fraction (p = 0.036).
CONCLUSIONS
In hospitalized HF patients with moderate-to-severe sleep apnea, adding ASV to OMT did not improve 6-month cardiovascular outcomes. Study power was limited for detection of safety signals and identifying differential effects of ASV in patients with HF with preserved ejection fraction, but additional studies are warranted in this population. (Cardiovascular Improvements With MV ASV Therapy in Heart Failure [CAT-HF]; NCT01953874).
背景
睡眠呼吸暂停在住院心力衰竭（HF）患者中很常见，与发病率和死亡率的增加有关。
目的
CAT-HF（心力衰竭患者 MV-ASV 治疗的心血管改善）试验研究了分钟通气（MV）适应性伺服通气（ASV）是否改善了患有中重度睡眠呼吸暂停的住院 HF 患者的心血管结局。
方法
符合条件的因 HF 住院且患有中重度睡眠呼吸暂停的患者被随机分配至 ASV 加优化的药物治疗（OMT）或 OMT 单独治疗（对照组）。主要终点是 6 个月时的综合全球等级评分（死亡、心血管住院和 6 分钟步行距离百分比变化的层次结构）。
结果
计划的 215 例患者中有 126 例被随机分组；在 SERVE-HF（心力衰竭中适应性伺服通气治疗中枢性睡眠呼吸暂停）试验结果发布后提前停止入组。平均设备使用率为每晚 2.7 小时。在 ASV 组中，通过睡眠呼吸暂停低通气指数测量的平均事件数从 6 个月时的 35.7/小时减少至 2.1/小时，而对照组从 35.1/小时减少至 19.0/小时（p<0.0001）。ASV 组和对照组之间的主要终点没有显著差异（p=0.92 Wilcoxon）。ASV 和对照组之间的复合终点组成部分的变化没有显著差异。治疗与射血分数之间没有显著的相互作用（p=0.10 Cox 模型）；但是，预先指定的亚组分析表明，ASV 对射血分数保留的心力衰竭患者有积极作用（p=0.036）。
结论
在患有中重度睡眠呼吸暂停的住院 HF 患者中，将 ASV 添加到 OMT 中并未改善 6 个月的心血管结局。检测安全性信号和确定 ASV 在射血分数保留的心力衰竭患者中的差异作用的研究能力有限，但该人群仍需要进一步研究。（心力衰竭患者 MV ASV 治疗的心血管改善 [CAT-HF]；NCT01953874）。
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