Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-05-12 DOI:10.1016/j.ahj.2024.04.019

Mattia Arrigo MD , Beth Davison PhD , Christopher Edwards BS , Marianna Adamo MD , Andrew P. Ambrosy MD , Marianela Barros MD , Jan Biegus MD , Jelena Celutkiene MD , Kamilė Čerlinskaitė-Bajorė MD , Ovidiu Chioncel MD , Alain Cohen-Solal MD PhD , Albertino Damasceno MD PhD , Rafael Diaz MD , Gerasimos Filippatos MD , Etienne Gayat MD PhD , Antoine Kimmoun MD PhD , Carolyn S.P. Lam MD PhD , Marco Metra MD , Maria Novosadova MD , Matteo Pagnesi MD , Alexandre Mebazaa MD PhD

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引用次数: 0

Abstract

Background

The STRONG-HF trial showed that high-intensity care (HIC) consisting of rapid up-titration of guideline-directed medical therapy (GDMT) and close follow-up reduced all-cause death or heart failure (HF) readmission at 180 days compared to usual care (UC). We hypothesized that significant differences in patient characteristics, management, and outcomes over the enrolment period may exist.

Methods

Two groups of the 1,078 patients enrolled in STRONG-HF were created according to the order of enrolment within center. The early group consisted of the first 10 patients enrolled at each center (N = 342) and the late group consisted of the following patients (N = 736).

Results

Late enrollees were younger, had more frequently reduced ejection fraction, slightly lower NT-proBNP and creatinine levels compared with early enrollees. The primary outcome occurred less frequently in early compared to late enrollees (15% vs. 21%, aHR 0.65, 95% CI 0.42-0.99, P = .044). No treatment-by-enrolment interaction was seen in respect to the average percentage of optimal dose of GDMT after randomization, which was consistently higher in early and late patients randomized to HIC compared to UC. The higher use of renin-angiotensin-inhibitors in the HIC arm was more pronounced in the late enrollees both after randomization (interaction-P = .013) and at 90 days (interaction-P < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, P = .10), but the efficacy of HIC showed no interaction with the enrolment group (aHR 0.77, 95% CI 0.35-1.67 in early and 0.58, 95% CI 0.40-0.83 in late enrollees, adjusted interaction-P = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, P = .73).

Conclusions

Late enrollees have different clinical characteristics and higher event rates compared to early enrollees. GDMT implementation in the HIC arm robustly achieved similar doses with consistent efficacy in early and late enrollees, mitigating the higher risk of adverse outcome in late enrollees.

Trial registration

ClinicalTrials.gov Identifier: NCT03412201.

查看原文本刊更多论文

STRONG-HF 试验早期与晚期参加者的特征、治疗和结果。

背景STRONG-HF 试验表明，与常规护理（UC）相比，高强度护理（HIC）包括快速上调指导性医疗疗法（GDMT）和密切随访，可减少全因死亡或心衰（HF）180 天后的再入院。我们假设，在入组期间，患者的特征、管理和结果可能存在显著差异：在加入 STRONG-HF 的 1,078 名患者中，根据中心内的入组顺序分为两组。早期组包括每个中心最先注册的 10 名患者（N = 342），晚期组包括随后注册的患者（N = 736）：结果：与早期入组的患者相比，晚期入组的患者更年轻，射血分数降低的频率更高，NT-proBNP 和肌酐水平略低。与晚期入选者相比，早期入选者出现主要结局的频率较低（15% 对 21%，aHR 0.65，95% CI 0.42-0.99，P = 0.044）。随机分组后，GDMT 最佳剂量的平均百分比在早期和晚期随机接受 HIC 治疗的患者中一直高于接受 UC 治疗的患者。在随机分组后（交互作用-P = .013）和90天时（交互作用-P < .001），HIC组中肾素-血管紧张素抑制剂的使用率较高，这在晚期患者中更为明显。在安全事件方面未观察到交互作用。晚期随机接受 UC 治疗的患者显示出更严重后果的趋势（26% 对 16%，P = .10），但 HIC 的疗效与注册组没有交互作用（早期注册者的 aHR 为 0.77，95% CI 为 0.35-1.67，晚期注册者的 aHR 为 0.58，95% CI 为 0.40-0.83，调整后的交互作用-P = .51），HIC 治疗组对晚期和早期注册者的疗效相似（16% 对 13%，P = .73）：结论：与早期加入者相比，晚期加入者具有不同的临床特征和更高的事件发生率。GDMT在HIC治疗组中的实施效果显著，早期和晚期参试者的剂量相似，疗效一致，降低了晚期参试者出现不良结果的较高风险：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT03412201。

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

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.