Two New Studies Explore Role of Sacubitril/Valsartan in HF with Mid-Range, Preserved EF

By Annette M. Boyle
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Recent researcher in Circulation showed that two large heart failure trials indicate that heart failure mainstay sacubitril/valsartan provides a benefit to heart failure patients with mid-range or preserved ejection fraction, not just those with reduced ejection fraction for whom it has long been approved.

Heart failure with preserved ejection fraction is the most common type of heart failure in women. As there is no approved treatment for these type of heart failure, the finding of benefit from sacubitril/valsartan could address a significant therapeutic void for the women who suffer from heart failure.

A prespecified subgroup analysis of the PARAGON-HF trial compared valsartan to sacubitril/valsartan in 2,479 women and 2,317 men with preserved ejection fraction. The women were, on average, older, more likely to be obese, and had lower estimated glomerular filtration rate and NT-proBNP levels. The study determined that sacubitril/valsartan reduced the risk of a composite of first and recurrent hospitalization in women by 27%, but had no significant impact on hospitalization rates for men. 

A second study, a pooled analysis of the PARAGON-HF and PARADIGM-HF trials, evaluated sacubitril/valsartan to a renin-angiotensin-aldosterone-system inhibitor alone in 13,195 randomized patients with left ventricle ejection fraction ranging from less than 22.5% to more than 62.5%. Patients were divided into six groups: ejection fraction of 22.5% or less (1,269 patients), 22.5% to 32.5% (3,987), 32.5% to 42.5% (3,143), 42.5% to 52.5% (2,166), and 62.5% or more (1,202). 

The researchers found that sacubitril/valsartan extended the time to cardiovascular death or first heart failure hospitalization each by 16% and all-cause mortality by 12%. 

The benefits “appear to extend to patients with heart failure and mildly reduced ejection fraction,” the researchers concluded. The benefit for men largely disappeared at an ejection fraction of about 55%, while it persisted for women until about 65%.

 

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