Population Gap for Chronic Heart Failure Patients Between Randomized Controlled Trials and Japan’s Super-Aged Society

Abstract

Background: 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.

Methods and Results: 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).

Conclusions: 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.