沙库巴曲缬沙坦治疗急性失代偿射血分数降低心力衰竭患者的有效性和安全性

Efficacy and safety of Sacubitril/Valsartan treatment in patients with acute decompensated heart failure and reduced ejection fraction in clinical practice

目的探讨沙库巴曲缬沙坦(S/V)治疗射血分数降低急性失代偿心力衰竭(ADHF)患者的有效性和安全性。方法连续纳入2018年5月~2019年10月重庆4个研究中心心血管内科射血分数降低的ADHF患者,根据临床处方信息患者被分为S/V组和血管紧张素转换酶抑制剂(ACEI)/血管紧张素受体阻滞剂(ARB)组(ACEI/ARB组)。住院期间和出院后医生根据患者的一般情况和血压滴定药物剂量,随访至出院后12个月。主要有效性终点是心源性死亡和心衰(HF)住院发生率,次要有效性终点是全因死亡和全因住院发生率。安全性终点肾功能损伤、高钾血症、咳嗽、血管神经性水肿和症状性低血压发生率。结果筛选期共纳入758例,根据入排标准排除127例,631例纳入倾向性评分,最后502例患者纳入数据分析,S/V组和ACEI/ARB组各251例。S/V组和ACEI/ARB组患者主要疗效性终点心血管死亡和HF住院发生率分别为23.5%和32.3%(HR:0.687;95%CI:0.493~0.958;P=0.027),其中心血管死亡发生率分别为4.8%和10.4%(HR:0.444;95%CI:0.235~0.840;P=0.017),HF再住院发生率分别为18.7%和21.9%(HR:0.845;95%CI:0.573~1.247;P=0.398);次要疗效终点全因死亡和全因住院发生率分别为35.1%和38.2%(HR:0.891;95%CI:0.668~1.191;P=0.4.37),其中全因死亡发生率分别为4.8%和11.6%(HR:0.396;95%CI:0.214~0.731;P=0.0005),全因住院发生率分别为30.3%和26.7%(HR,1.168;95%CI:0.841~1.622;P=0.352)。安全性终点两组无显著差异。结论与ACEI/ARB相比,S/V治疗可降低射血分数降低的ADHF患者1年心源性死亡和心衰住院复合终点,并且其安全性相当。

Objective In clinical practice,efficacy and safety of Sacubitril/Valsartan(S/V)treatment in patients with acute decompensated heart failure(ADHF)and reduced ejection fraction compared with angiotensin converting enzyme inhibitor(ACEI)/Angiotensin receptor blocker(ARB).Methods From May 2018 to October 2019,according to the inclusion and exclusion standards,patients with ADHF and reduced ejection fraction were successively enrolled in 4 research cardiology centres.The patients were divided into the S/V or ACEI/ARB group according to the clinical prescribing information.During hospitalization and after discharge,the doctor titrated the drug dose according to the patient’s condition and blood pressure,followed up to 12 months after discharge.The primary endpoint was the composite of death from cardiovascular causes and rehospitalization for heart failure,and the secondary efficacy endpoint was the composite of death from any causes and rehospitalization for any causes.The safety endpoint was a composite of worsening renal function,hyperkalaemia,cough,angioneurotic oedema,and symptomatic hypotension.Results A total of 758 patients were included during the screening period,of which 127 were excluded according to the inclusion criteria,631 were included for propensity score matching,and 502 patients were included in the data analysis.In total,251 patients who received S/V and 251 patients who received an ACEI/ARB had similar propensity scores and were included and compared.In the S/V group and ACEI/ARB group,the incidences of the primary endpoints(cardiovascular causes and rehospitalization for HF)were 23.5%and 32.3%,respectively(HR:0.687;95%CI:0.493~0.958;P=0.027),the incidences of cardiovascular death were 4.8%and 10.4%,respectively(HR:0.444;95%CI:0.235~0.840;P=0.017),and the incidences of rehospitalization for heart failure were 18.7%and 21.9%(HR:0.845;95%CI:0.573~1.247;P=0.398).The incidences of the secondary endpoints(death from any causes and rehospitalization for any causes)were 35.1%and 38.2%,respectively(HR:0.891;95%CI:0.668~1.191;P=0.437).The incidences of death from any causes were 4.8%and 11.6%,respectively(HR:0.396;95%CI:0.214~0.731;P=0.0005),and the incidences of rehospitalization for any causes were 30.3%and 26.7%(HR:1.168;95%CI:0.841~1.622;P=0.352);The safety end point did not differ significantly between the two groups.Conclusion In clinical practice,among patients hospitalized with ADHF and a reduced left ventricular ejection fraction,S/V therapy led to a reduction in the number of deaths from cardiovascular causes and rehospitalizations for heart failure compared to ACEI/ARB therapy alone,and the safety is similar.