Borer Jeffrey S, Swedberg Karl, Komajda Michel, Ford Ian, Tavazzi Luigi, Böhm Michael, Depre Christophe, Wu Yuna, Maya Juan, Dominjon Fabienne
The Howard Gilman Institute for Heart Valve Diseases and Schiavone Institute for Cardiovascular Translational Research, SUNY Downstate Medical Center, Brooklyn and New York, N.Y., USA.
Cardiology. 2017;136(2):138-144. doi: 10.1159/000449243. Epub 2016 Sep 10.
In the Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT), slowing of the heart rate with ivabradine reduced cardiovascular death or heart failure hospitalizations among patients with systolic chronic heart failure (CHF). Subsequently, in the Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients with Coronary Artery Disease (SIGNIFY) slowing of the heart rate in patients without CHF provided no benefit for cardiovascular death or nonfatal myocardial infarction (primary composite end point), with secondary analyses suggesting possible harm in the angina subgroup. Therefore, we examined the impact of ivabradine in the patients with CHF plus angina in SHIFT.
SHIFT enrolled adults with stable, symptomatic CHF, a left ventricular ejection fraction ≤35% and a sinus rhythm with a resting heart rate ≥70 bpm. Outcomes were the SHIFT and SIGNIFY primary composite end points and their components.
Of 6,505 patients in SHIFT, 2,220 (34%) reported angina at randomization. Ivabradine numerically, but not significantly, reduced the SIGNIFY primary composite end point by 8, 11 and 11% in the SHIFT angina subgroup, nonangina subgroup and overall population, respectively. Ivabradine also reduced the SHIFT primary composite end point in all 3 subgroups.
In SHIFT, ivabradine showed consistent reduction of cardiovascular outcomes in patients with CHF; similar results were seen in the subgroup of SHIFT patients with angina.
在伊伐布雷定治疗收缩期心力衰竭试验(SHIFT)中,伊伐布雷定使心率减慢可降低收缩期慢性心力衰竭(CHF)患者的心血管死亡或心力衰竭住院率。随后,在评估伊伐布雷定对冠心病患者发病率和死亡率益处的研究(SIGNIFY)中,无CHF患者心率减慢对心血管死亡或非致死性心肌梗死(主要复合终点)无益处,二次分析提示在心绞痛亚组可能有害。因此,我们在SHIFT研究中考察了伊伐布雷定对CHF合并心绞痛患者的影响。
SHIFT纳入了有症状的稳定CHF成年患者,左心室射血分数≤35%,静息心率≥70次/分且为窦性心律。观察指标为SHIFT和SIGNIFY的主要复合终点及其组成部分。
在SHIFT研究的6505例患者中,2220例(34%)在随机分组时报告有心绞痛。在SHIFT心绞痛亚组、无心绞痛亚组和总体人群中,伊伐布雷定分别使SIGNIFY主要复合终点数值上降低了8%、11%和11%,但差异无统计学意义。伊伐布雷定也使所有3个亚组的SHIFT主要复合终点降低。
在SHIFT研究中,伊伐布雷定可使CHF患者的心血管结局持续降低;在SHIFT合并心绞痛的患者亚组中也观察到了类似结果。