A study recently published in Heart identified a potential set of criteria for worsening cardiac disease in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) who are taking tafamidis.
While tafamidis is known to reduce mortality and improve cardiac stability, a subset of patients exhibit cardiac disease progression during treatment. However, a clear definition of worsening cardiac disease has not yet been established.
“Worsening cardiac disease criteria could help guide therapy adjustments, inform clinical decisions and serve as endpoints in clinical trials,” the study’s authors noted.
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Elevated levels of N-terminal pro-B-natriuretic peptide (NT-proBNP, a protein released when the heart is damaged) and increased oral diuretic use are associated with mortality due to ATTR-CM. However, no studies have assessed this association in a cohort of patients receiving tafamidis.
The study included 238 individuals with ATTR-CM who were diagnosed at Columbia University and prescribed tafamidis between January 2018 and December 2023. The authors defined worsening cardiac disease as NT-proBNP levels exceeding 700 pg/mL with an increase greater than 30% from baseline, or a sustained increase in diuretic dose within one year of tafamidis initiation.
The authors found that 100 (42%) participants experienced worsening cardiac disease. Of these individuals, 51 increased their diuretic dose, 27 had elevated NT-proBNP levels and 22 showed both markers.
Additionally, worsening cardiac disease was significantly associated with mortality, genotype and baseline stage according to the National Amyloidosis Centre staging system. The proposed criteria for worsening disease also showed a cumulative relationship with mortality, with each additional criterion met increasing mortality risk.
During the follow-up period, 58 individuals died and 78 had at least one cardiovascular-related hospitalization. After adjusting for age, genotype and National Amyloidosis Centre stage, the risk of cardiovascular-related hospitalizations was higher among patients experiencing worsening heart disease.
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