Key result
Among Korean hospitalized patients with HFrEF, 94.9% met the FDA/EC label criteria for vericiguat, whereas only 58% met the inclusion criteria of the VICTORIA trial.
Why the study?
Following the approval of vericiguat based on the VICTORIA trial, there had been no report characterizing the generalizability of vericiguat to real-world clinical practice.
What proportion of real-world hospitalized HFrEF patients are eligible for vericiguat based on FDA/EC labels versus VICTORIA trial criteria?
Cohort (n=3,014)
Yes
What proportion of real-world hospitalized HFrEF patients are eligible for vericiguat based on FDA/EC labels versus VICTORIA trial criteria?
A significant gap exists between regulatory label eligibility (94.9%) and clinical trial eligibility (58%) for vericiguat in real-world decompensated HFrEF patients, largely driven by low blood pressure and natriuretic peptide levels.
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High real-world eligibility supports label applicability in hospitalized HFrEF; leaves open whether VICTORIA benefits extend to this cohort.
Oh et al. (2022) conducted a cohort in Decompensated Heart Failure with Reduced Ejection Fraction (n=3,014). Vericiguat eligibility criteria was evaluated on Proportion of patients meeting FDA/EC label criteria and VICTORIA trial inclusion criteria. Among Korean hospitalized patients with HFrEF, 94.9% met the FDA/EC label criteria for vericiguat, whereas only 58% met the inclusion criteria of the VICTORIA trial.
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