依伐布雷定治疗射血分数保留的心力衰竭患者的效果：EDIFY 随机安慰剂对照试验。
Effect of ivabradine in patients with heart failure with preserved ejection fraction: the EDIFY randomized placebo-controlled trial.
机构信息
Department of Cardiology, University of Pierre and Marie Curie Paris VI, La Pitié-Salpêtrière Hospital, Paris, France.
UMR-S 942, Department of Cardiology, Paris Diderot University, Sorbonne Paris Centre, Lariboisière Hospital, Paris, France.
出版信息
Eur J Heart Fail. 2017 Nov;19(11):1495-1503. doi: 10.1002/ejhf.876. Epub 2017 Apr 30.
AIMS
This randomized, double-blind, placebo-controlled trial assessed whether heart rate (HR) reduction with ivabradine improves cardiac function in heart failure with preserved ejection fraction (HFpEF).
METHODS AND RESULTS
The prEserveD left ventricular ejectIon fraction chronic heart Failure with ivabradine studY (EDIFY) included 179 patients in New York Heart Association (NYHA) classes II and III, in sinus rhythm, with HR of ≥70 b.p.m., NT-proBNP of ≥220 pg/mL (BNP ≥80 pg/mL) and left ventricular ejection fraction of ≥45%. Ivabradine (or placebo) was titrated to 7.5 mg b.i.d. Patients were followed for 8 months on the change and assessed for three co-primary endpoints: echo-Doppler E/e' ratio, distance on the 6-min walking test (6MWT), and plasma NT-proBNP concentration. At baseline, median E/e' was 12.8 [interquartile range (IQR): 9.9-16.3], median distance on the 6MWT was 320 m (IQR: 247-375 m), and median NT-proBNP was 375 pg/mL (IQR: 253-701 pg/mL). Baseline median HR was 75 b.p.m. (IQR: 70-107 b.p.m.). A total of 171 patients (87 in the ivabradine group, 84 in the placebo group) were evaluated for treatment efficacy. After 8 months of treatment, findings showed a median change in HR of -13.0 b.p.m. (IQR: -18.0 to -6.0 b.p.m.) in the ivabradine group and -3.5 b.p.m. (IQR: -11.5 to 3.0 b.p.m.) in the placebo group [estimated between-group difference: 7.7 b.p.m.; 90% confidence interval (CI) -10 to -5.4; P < 0.0001]. No evidence of improvement was found in any of the three co-primary endpoints. There was almost no change in median E/e' in either of the two groups [median change: +1.0 (IQR: -0.8 to 2.9) in the ivabradine group; -0.6 (IQR: -2.2 to 1.4) in the placebo group; estimated between-group difference: 1.4, 90% CI 0.3-2.5; P = 0.135]. There were no meaningful changes in the other co-primary endpoints and no apparent trends. There was no significant safety concern.
CONCLUSIONS
In patients with HFpEF, HR reduction with ivabradine did not improve outcomes. These findings do not support the use of ivabradine in HFpEF.
目的
本随机、双盲、安慰剂对照试验旨在评估伊伐布雷定降低心率是否改善射血分数保留的心力衰竭（HFpEF）患者的心功能。
方法和结果
保留左心室射血分数慢性心力衰竭伊伐布雷定研究（EDIFY）纳入了 179 名纽约心脏协会（NYHA）心功能 II 级和 III 级、窦性心律、心率≥70 次/分、氨基末端脑钠肽前体（NT-proBNP）≥220pg/ml（BNP≥80pg/ml）和左心室射血分数≥45%的患者。伊伐布雷定（或安慰剂）滴定至 7.5mg bid。患者在 8 个月的随访期间接受了三个主要终点的评估：超声心动图多普勒 E/e'比值、6 分钟步行试验（6MWT）距离和血浆 NT-proBNP 浓度。基线时，中位 E/e'为 12.8[四分位距（IQR）：9.9-16.3]，中位 6MWT 距离为 320m（IQR：247-375m），中位 NT-proBNP 为 375pg/ml（IQR：253-701pg/ml）。基线时的中位心率为 75bpm（IQR：70-107bpm）。共有 171 名患者（伊伐布雷定组 87 名，安慰剂组 84 名）接受了治疗效果评估。治疗 8 个月后，伊伐布雷定组的平均心率变化为-13.0bpm（IQR：-18.0 至-6.0bpm），安慰剂组为-3.5bpm（IQR：-11.5 至 3.0bpm）[估计组间差异：7.7bpm；90%置信区间（CI）-10 至-5.4；P<0.0001]。三个主要终点均未见改善。两组的中位 E/e'均无明显变化[伊伐布雷定组中位数变化：+1.0（IQR：-0.8 至 2.9）；安慰剂组-0.6（IQR：-2.2 至 1.4）；估计组间差异：1.4，90%CI 0.3-2.5；P=0.135]。其他主要终点也没有明显变化，也没有明显的趋势。没有明显的安全问题。
结论
在射血分数保留的心力衰竭患者中，伊伐布雷定降低心率并不能改善预后。这些发现不支持伊伐布雷定在 HFpEF 中的应用。
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