In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial.

IF 37.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal Pub Date : 2024-11-08 DOI:10.1093/eurheartj/ehae561

Atsushi Tanaka, Keisuke Kida, Yuya Matsue, Takumi Imai, Satoru Suwa, Isao Taguchi, Itaru Hisauchi, Hiroki Teragawa, Yoshiyuki Yazaki, Masao Moroi, Koichi Ohashi, Daisuke Nagatomo, Toru Kubota, Takeshi Ijichi, Yuji Ikari, Keisuke Yonezu, Naohiko Takahashi, Shigeru Toyoda, Tsutomu Toshida, Hiroshi Suzuki, Tohru Minamino, Kazutaka Nogi, Kazuki Shiina, Yu Horiuchi, Kengo Tanabe, Daisuke Hachinohe, Shunsuke Kiuchi, Kenya Kusunose, Michio Shimabukuro, Koichi Node

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Abstract

Background and aims: The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.

Methods: This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.

Results: A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.

Conclusions: In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America.

Clinical trial registration: ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).

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急性心力衰竭患者在院内开始使用血管紧张素受体-肾素抑制剂：PREMIER 试验。

背景和目的：在北美以外地区，急性心力衰竭（AHF）后早期开始使用沙库比妥/缬沙坦（Sac/Val）治疗的有效性和安全性尚未得到证实。本研究旨在评估日本患者在急性心力衰竭发作后开始院内 Sac/Val 治疗对 N 端前 B 型钠尿肽（NT-proBNP）水平的影响：这是一项由研究者发起的多中心、前瞻性、随机、开放标签、盲终点实用性试验。符合条件的住院患者在住院 7 天内血流动力学稳定后，被分配从血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂转为 Sac/Val（Sac/Val 组），或继续使用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂（对照组）。主要疗效终点是 8 周后 NT-proBNP 水平几何平均的比例变化：共有 400 名患者接受了随机治疗，其中 376 人（中位年龄 75 岁，女性占 31.9%，新发心力衰竭率 55.6%，中位左室射血分数 37%）接受了分析。第 4/8 周时，NT-proBNP 水平的几何平均变化百分比分别为-35%/-45%（Sac/Val 组）和-18%/-32%（对照组），第 4 周时的组间比率（Sac/Val vs. 对照组）为 0.80（95% 置信区间 0.68-0.94；P = .008），第 8 周时为 0.81（95% 置信区间 0.68-0.95；P = .012）。在预先指定的亚组分析中，Sac/Val的效果仅限于左室射血分数小于40%的患者，而且在窦性心律和服用矿质皮质激素受体拮抗剂的患者中更为明显。没有明显的不良安全信号：结论：对于因急性心肌梗死住院的日本患者来说，除了采用当前推荐的治疗方法外，在院内启动 Sac/Val 治疗可显著降低 NT-proBNP 水平。这些研究结果可能会在北美以外的地区扩大 Sac/Val 疗法在这种临床情况下的应用范围：临床试验注册：ClinicalTrial.gov (NCT05164653) 和日本临床试验注册 (jRCTs021210046)。

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来源期刊

European Heart Journal 医学-心血管系统

CiteScore

39.30

自引率

6.90%

发文量

3942

审稿时长

1 months

期刊介绍： The European Heart Journal is a renowned international journal that focuses on cardiovascular medicine. It is published weekly and is the official journal of the European Society of Cardiology. This peer-reviewed journal is committed to publishing high-quality clinical and scientific material pertaining to all aspects of cardiovascular medicine. It covers a diverse range of topics including research findings, technical evaluations, and reviews. Moreover, the journal serves as a platform for the exchange of information and discussions on various aspects of cardiovascular medicine, including educational matters. In addition to original papers on cardiovascular medicine and surgery, the European Heart Journal also presents reviews, clinical perspectives, ESC Guidelines, and editorial articles that highlight recent advancements in cardiology. Additionally, the journal actively encourages readers to share their thoughts and opinions through correspondence.