The representativeness of VICTORIA and GALACTIC-HF trials in a contemporary cohort of patients with heart failure with reduced ejection fraction

Abstract

Abstract Introduction New therapies for heart failure with reduced ejection fraction (HFrEF) have been recently developed. It is still unclear the proportion of patients of clinical practice that will benefit from them. We aimed to examine the representativeness of the VICTORIA and GALACTIC-HF trials among a contemporary cohort of HFrEF patients followed at an HF outpatient clinic. Methods We performed a retrospective, cross-sectional, single-center study of 100 consecutive HFrEF patients from our HF outpatient clinic (January-June 2020). VICTORIA eligibility criteria were an LVEF <45%; NT-proBNP ≥1000 pg/mL if sinus rhythm (SR) or ≥1600 pg/mL if atrial fibrillation (Afib); and prior hospitalization in the last 6 months or IV diuretic therapy in the last 3 months. GALACTIC-HF eligibility criteria were an LVEF <35%, hospitalization or emergency room visit in the last 12 months; NT-proBNP >400 ng/mL if SR or ≥1200 pg/mL if Afib or atrial flutter. Results The mean age of our patients was 62±12 years and only 24% were female. The etiology of HF was ischemic in 42% of the patients, 86% of patients were in NYHA II class and 5% in NYHA III-IV. The mean LVEF was 34±5% and the median NT-proBNP was 482 pg/mL [172–1120]. Regarding treatment, 92% of patients were on betablockers (BB), 67% on ACEI/ARBs, 25% on ARNI, 81% on MRA and 30% on iSGLT2. The use of implantable cardioverter-defibrillators was 38% and 20% of patients were resynchronized. The proportion of patients meeting VICTORIA and GALACTIC-HF eligibility criteria was 11% and 21%, respectively. But excluding the criteria of recent hospitalization the representativeness of the VICTORIA trial increased to 28% and the GALACTIC-HF to 44%. The patients that met VICTORIA eligibility criteria were older (60±11 y vs 10±12 y; p=0.006), had worse functional class (NYHA III-IV: 18% vs 3%; p=0.03), were less likely to be treated with an MRA (55% vs 85%; p=0.013) and an iSGLT2 (0% vs 34%; p=0.02). Those that met GALACTIC-HF eligibility criteria had a lower LVEF (31±3% vs 35±6%; p=0.01), were less likely to be treated with an iSGLT2 (35% vs 10%; p=0.02) and more likely to be treated with a loop diuretic (86% vs 65%; p=0.06). Conclusions In a contemporary optimally treated HFrEF cohort only a small proportion of patients met the eligibility criteria used in VICTORIA and GALACTIC-HF trials, which identified older patients with more advanced disease. Funding Acknowledgement Type of funding sources: None.