Abstract

Introduction: Recent large-scale clinical trials of novel heart failure (HF) agents (angiotensin receptor-neprilysin inhibitor, sodium-glucose cotransporter 2 inhibitor, and ivabradine) emphasize the use of baseline conventional guideline-directed medical therapy (GDMT; angiotensin-converting enzyme inhibitor, beta-blocker and mineral corticosteroid receptor antagonist); however, its use among real-world trial-eligible patients remains unclear. Objectives: To evaluate the prescription rate of GDMT and its association with long-term outcomes in patients that met enrollment criteria of recent large-scale clinical trials within hospitalized HF patients. Methods: We examined 1631 consecutive patients with HF with reduced ejection fraction (HFrEF) discharged after an episode of acute heart failure in the multicenter registry in Japan. We assessed the use of GDMT among patients that met PARADIGM-HF/ DAPA-HF enrollment criteria and SHIFT enrollment criteria. We then examined the association between the use of GDMT and long-term outcomes within each enrollment criteria. Results: Overall, 63.2% (n=1030) and 34.9% (n=569) of the patients met the enrollments criteria of PARADIGM/DAPA-HF and SHIFT trials. Within each patient subset, 32.5% (n=335) and 29.2% (n=166) had full GDMT, respectively. Although 82.6% (n=470) of patients that met SHIFT enrollment criteria received beta-blockers, only 21.3% (n=121) and 4.4% (n=25) patients were on >50% or higher dose (recommended dose). The use of GDMT was associated with lower rates of 2-year mortality and HF readmission in both of these populations (HR 0.85, 95% CI 0.81-0.89; HR 0.90, 95% CI 0.85-0.95, respectively). Conclusions: The underutilization of GDMT was observed among patients meeting the enrollment criteria of novel trials within Japanese multicenter registry of HF patients. Further effort to optimize the conventional GDMT before initiating novel therapeutics needs to be implemented.

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