Geographic region variation in patient characteristics, clinical outcomes and treatment of HFrEF in the VICTORIA trial.

IF 3.7 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Cynthia M Westerhout, Wendimagegn Alemayehu, Alain Cohen-Solal, Carolyn S P Lam, Justin A Ezekowitz, Stefano Corda, Ciaran J McMullan, Christopher M O'Connor, Paul W Armstrong
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Abstract

Aims: Heterogeneity in demographics, aetiology, healthcare access and guideline-directed medical therapy (GDMT), and survival bias of patients with heart failure with reduced ejection fraction (HFrEF) is evident from international trials and registries. The current study examines conventional geographic variation in participants' phenotypes, standard of care, clinical outcomes and treatment effects of vericiguat versus placebo within the VICTORIA trial. We then evaluate an alternative approach to assessing the relationship between geographic variation in the efficacy of new therapeutics.

Methods and results: Characteristics, standard of care and outcomes (time to first HF hospitalization (HFH) or cardiovascular death (CVD), time to first HFH and to CVD) of the 5050 participants from 42 countries and the effect of vericiguat versus placebo were analysed according to five prespecified geographic regions. Further examination of the study treatment effect according to country-level human development index (HDI) was undertaken to evaluate intra-regional variation. Notable inter-region differences existed in participant characteristics, standard of care at randomization and clinical outcomes. There was no modification of vericiguat's treatment benefit across geographic regions for the primary composite endpoint or its components. When examined by HDI, vericiguat's benefit on HFH and the primary composite was retained overall but attenuated as HDI rose (Pinteraction = 0.009, 0.088, respectively). There was no apparent treatment effect modification due to HDI on cardiovascular death (Pinteraction = 0.623).

Conclusions: Geographic variation in the phenotype of patients with HFrEF, standard of care, and clinical outcomes was observed, while there was no intra-regional heterogeneity in vericiguat's treatment effect. However, when considering contextual/systemic measures via country-level HDI, further insights into treatment effect were revealed. Country-level measures may be helpful in the planning of future trials and in the translation of evidence into practice.

VICTORIA试验中HFrEF患者特征、临床结果和治疗的地理区域差异。
目的:从国际试验和登记中可以明显看出,心力衰竭伴射血分数降低(HFrEF)患者在人口统计学、病因学、医疗保健可及性和指南导向药物治疗(GDMT)以及生存偏倚方面存在异质性。目前的研究在VICTORIA试验中检查了参与者表型的传统地理差异、护理标准、临床结果和vericiguat与安慰剂的治疗效果。然后,我们评估了另一种方法来评估新疗法疗效中地理差异之间的关系。方法和结果:根据五个预先指定的地理区域,分析了来自42个国家的5050名参与者的特征、护理标准和结局(到首次HF住院(HFH)或心血管死亡(CVD)的时间,到首次HFH和CVD的时间)以及vericiguat与安慰剂的效果。根据国家级人类发展指数(HDI)进一步检查研究的治疗效果,以评估区域内的差异。受试者特征、随机化时的护理标准和临床结果存在显著的地区间差异。对于主要复合终点或其组成部分,vericiguat在不同地理区域的治疗效果没有变化。通过HDI检测,vericiguat对HFH和主要复合材料的益处总体上保持不变,但随着HDI的升高而减弱(p互作分别= 0.009,0.088)。HDI对心血管死亡的治疗效果无明显影响(p交互作用= 0.623)。结论:观察到HFrEF患者的表型、标准治疗和临床结局存在地理差异,而vericiguat的治疗效果没有区域内异质性。然而,当通过国家层面的人类发展指数考虑情境/系统措施时,揭示了对治疗效果的进一步见解。国家一级的措施可能有助于规划未来的试验和将证据转化为实践。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
ESC Heart Failure
ESC Heart Failure Medicine-Cardiology and Cardiovascular Medicine
CiteScore
7.00
自引率
7.90%
发文量
461
审稿时长
12 weeks
期刊介绍: ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.
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