Noiri Jun-Ichi, Fujimoto Wataru, Takemoto Makoto, Kuroda Koji, Yamashita Soichiro, Imanishi Junichi, Iwasaki Masamichi, Todoroki Takafumi, Okuda Masanori, Nagao Manabu, Konishi Akihide, Shinohara Masakazu, Toh Ryuji, Nishimura Kunihiro, Tanaka Hidekazu
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine Kobe Japan.
Department of Cardiology, Hyogo Prefectural Awaji Medical Center Hyogo Japan.
Circ Rep. 2025 Apr 8;7(5):331-340. doi: 10.1253/circrep.CR-25-0002. eCollection 2025 May 9.
Heart failure (HF) management has been improved by guideline-directed medical therapy (GDMT) based on findings of major randomized controlled trials (RCTs). However, the applicability of these findings to real-world HF populations, especially Japan's current super-aged society, remains uncertain.
We analyzed findings for chronic HF patients from the KUNIUMI registry, a prospective observational study conducted on Awaji Island, Japan, representative of a super-aged society (aging rate ≈37%). We determined what percentage of these patients met the inclusion criteria as well as the exclusion criteria of 6 major representative RCTs (PARADIGM-HF, PARAGON-HF, DAPA-HF, DELIVER, EMPEROR-Reduced, EMPEROR-Preserved) and compared the incidence of cardiovascular death and HF hospitalization over 3 years for patients who did and did not meet the exclusion criteria. Of the 1,646 patients from the KUNIUMI registry, 225 were eligible for PARADIGM-HF, DAPA-HF and EMPEROR-Reduced, 554 for PARAGON-HF, and 631 for DELIVER and EMPEROR-Preserved. The exclusion percentages for the overall eligible population were 48.4% (PARADIGM-HF), 36.4% (DAPA-HF), 42.7% (EMPEROR-Reduced), 57.9% (PARAGON-HF), 32.3% (DELIVER), and 31.4% (EMPEROR-Preserved). It should be noted that ineligible patients had a poorer prognosis than eligible patients (P<0.05 for each trial).
The population gap between HF patients in major RCTs and the current super-aged society underscores the need for further evidence of GDMT in real-world settings.
基于大型随机对照试验（RCT）的结果，指南指导的药物治疗（GDMT）改善了心力衰竭（HF）的管理。然而，这些研究结果在现实世界HF人群中的适用性，尤其是在日本当前的超老龄化社会中，仍不确定。
我们分析了来自国见登记处的慢性HF患者的研究结果，这是一项在日本淡路岛进行的前瞻性观察性研究，该岛是超老龄化社会的代表（老龄化率约为37%）。我们确定了这些患者中符合6项主要代表性RCT（PARADIGM-HF、PARAGON-HF、DAPA-HF、DELIVER、EMPEROR-Reduced、EMPEROR-Preserved）纳入标准以及排除标准的百分比，并比较了符合和不符合排除标准的患者在3年内心血管死亡和HF住院的发生率。在国见登记处的1646例患者中，225例符合PARADIGM-HF、DAPA-HF和EMPEROR-Reduced的标准，554例符合PARAGON-HF的标准，631例符合DELIVER和EMPEROR-Preserved的标准。总体符合条件人群的排除百分比分别为48.4%（PARADIGM-HF）、36.4%（DAPA-HF）、42.7%（EMPEROR-Reduced）、57.9%（PARAGON-HF）、32.3%（DELIVER）和31.4%（EMPEROR-Preserved）。需要注意的是，不符合条件的患者预后比符合条件的患者差（每项试验P<0.05）。
主要RCT中的HF患者与当前超老龄化社会之间的人群差距凸显了在现实世界环境中进一步获得GDMT证据的必要性。
