肾脏专区丨急性心力衰竭后安全、耐受、有效的药物滴定

文摘   2024-12-07 20:38   广东  
结论:与UC相比,无论潜在的HF风险如何,HIC都能更好地使用GDMT,降低HF相关的发病率和死亡率。
*详细数据可点击左下角“阅读原文
发表在JACC: Heart Failure(2023 IF 10.3,JCR Q1)
Titration of Medications After Acute Heart Failure Is Safe, Tolerated, and Effective Regardless of Risk
背景:指南导向的药物治疗(GDMT)决策可能受血压或肾功能等单一患者变量的影响较小,受整体风险状况的影响较大。在STRON-HF(指南指导的急性心力衰竭药物治疗上调的安全性、耐受性和有效性)中,以心力衰竭(HF)快速上调GDMT形式的高强度护理(HIC)总体上是有效的,但HIC在HF严重程度范围内的安全性,耐受性和疗效尚不清楚。使用简单的基于风险的框架进行评估,提供了一种比传统亚组分析更具临床可翻译性的替代方法。
目的:根据简单、强大且可临床翻译的MAGGIC(Meta Analysis Global Group in Chronic)HF风险评分来评估HIC的安全性、耐受性和疗效。
方法:在STRON-HF中,1078名急性HF患者被随机分为HIC组(出院后2周内将治疗剂量增加到推荐剂量的100%,出院后2个月内安排4次门诊)和常规护理组(UC)。
主要终点:第180天全因死亡或首次HF再住院的复合指标。基线HF风险状况由之前验证的MAGGIC风险评分确定。根据MAGGIC风险评分作为分类变量和连续变量对治疗效果进行分层。

结果
(表1)最终的分析队列包括1062名数据完整的患者,他们的MAGGIC评分可以在基线时计算出来。患者根据MAGGIrisk评分分为以下三个等级:等级1(5-18)、等级2(19-23)和等级3(24-39)。
基线时MAGGIC风险评分较高的患者往往是年龄较大、男性和自我报告的白人。MAGGIC风险评分为第3组的患者也更有可能患有HF的心脏病化学检查,LVEF较低,某些心脏和非心脏疾病的负担较高,NT-proBNP的血清水平较高。尽管根据NYHA功能分级和利尿剂要求评估,MAGGIC风险评分在第3级的患者症状更严重。
最常见的不良事件是心力衰竭、低血压、高钾血症和肾功能损害。HICvsUC组的不良事件发生率较高,但根据MAGGIC风险评分表,这一观察结果没有差异。

(表2)整体和单个药物类别的GDMT使用率在HICvsUC组中更高,这种影响在MAGGIC风险评分三分位数之间没有显著差异。

(图1)在参与两种治疗方案的研究期间,NT-proBNP水平均有所下降,但MAGGIC风险评分表3中HIC组与UC组相比,NT-proBNP从基线到第90天的相对下降幅度更大。尽管HIC组MAGGIC风险评分第1位的NT-proBNP水平下降幅度最大,但这些下降幅度在统计学上没有显著差异。

(图2)HIC组在第14天达到HFGDMT最佳剂量的平均百分比,与MAGGIC风险评分三分位数相比。对于个体药物类别,这一发现是相似的。

(图3)在第180天,HIC组与UC组在所有原因导致的HFreadmission的主要复合终点的风险较低,无论是作为分类还是连续变量,这一结果在跨MAGGIC风险评分上都没有显著差异。

(图4)基线90开始,HICvsU组的健康相关生活质量有了更大的改善。

在MAGGIC风险评分范围广泛的随访期间,HIC与更好地遵守GDMT有关。尽管HIC中观察到的不良事件总体发生率较高,但这一发现在基线MAGGIC风险评分上没有差异,HIC和UC组报告的严重不良事件发生率相似。最重要的是,MAGGIC风险评分较高的三分位数经历了未经调整的HF相关发病率和死亡率的增加,但当使用基于风险的方法进行检查时,HICvsUC的益处得以保留。因此,STRON-HF验证了这一概念框架,用于在未来评估新护理策略的试验中评估治疗效果的异质性,重要的是,它表明HIC对高基线风险和低基线风险的患者都是安全、可耐受和有效的,因此高风险或低需求不应阻止临床医生快速启动和加强GDMT。

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原文搜索:Ambrosy AP, Chang AJ, Davison B, Voors A, Cohen-Solal A, Damasceno A, Kimmoun A, Lam CSP, Edwards C, Tomasoni D, Gayat E, Filippatos G, Saidu H, Biegus J, Celutkiene J, Ter Maaten JM, Čerlinskaitė-Bajorė K, Sliwa K, Takagi K, Metra M, Novosadova M, Barros M, Adamo M, Pagnesi M, Arrigo M, Chioncel O, Diaz R, Pang PS, Ponikowski P, Cotter G, Mebazaa A. Titration of Medications After Acute Heart Failure Is Safe, Tolerated, and Effective Regardless of Risk. JACC Heart Fail. 2024 Sep;12(9):1566-1582. doi: 10.1016/j.jchf.2024.04.017. Epub 2024 May 12. PMID: 38739123.
英文摘要Abstract

Background:Guideline-directed medical therapy (GDMT) decisions may be less affected by single patient variables such as blood pressure or kidney function and more by overall risk profile.In STRONG-HF (Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure), high-intensity care (HIC) in the form of rapid uptitration of heart failure (HF) GDMT was effective overall, but the safety, tolerability and efficacy of HIC across the spectrum of HF severity is unknown.Evaluating this with a simple risk-based framework offers an alternative and more clinically translatable approach than traditional subgroup analyses.

Objectives:The authors sought to assess safety, tolerability, and efficacy of HIC according to the simple, powerful, and clinically translatable MAGGIC (Meta-Analysis Global Group in Chronic) HF risk score.

Methods:In STRONG-HF, 1,078 patients with acute HF were randomized to HIC (uptitration of treatments to 100% of recommended doses within 2 weeks of discharge and 4 scheduled outpatient visits over the 2 months after discharge) vs usual care (UC).The primary endpoint was the composite of all-cause death or first HF rehospitalization at day 180.Baseline HF risk profile was determined by the previously validated MAGGIC risk score.Treatment effect was stratified according to MAGGIC risk score both as a categorical and continuous variable.

Results:Among 1,062 patients (98.5%) with complete data for whom a MAGGIC score could be calculated at baseline, GDMT use at baseline was similar across MAGGIC tertiles.Overall GDMT prescriptions achieved for individual medication classes were higher in the HIC vs UC group and did not differ by MAGGIC risk score tertiles (interaction nonsignificant).The incidence of all-cause death or HF readmission at day 180 was, respectively, 16.3%, 18.9%, and 23.2% for MAGGIC risk score tertiles 1, 2, and 3.The HIC arm was at lower risk of all-cause death or HF readmission at day 180 (HR: 0.66; 95% CI: 0.50-0.86) and this finding was robust across MAGGIC risk score modeled as a categorical (HR: 0.51; 95% CI: 0.62-0.68 in tertiles 1, 2, and 3; interaction nonsignificant) for all comparisons and continuous (interaction nonsignificant) variable.The rate of adverse events was higher in the HIC group, but this observation did not differ based on MAGGIC risk score tertile (interaction nonsignificant).

Conclusions:HIC led to better use of GDMT and lower HF-related morbidity and mortality compared with UC, regardless of the underlying HF risk profile.(Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies [STRONG-HF]; NCT03412201).


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