Findings from the PARAGON-HF trial were presented in the first hot-line session at the ESC Congress today in Paris. Investigators from Brigham and Women's Hospital presented the results of the Prospective Comparison of ARNI with ARB Global Outcome in HF With Preserved Ejection Fraction (PARAGON-HF). This is the largest, randomised clinical trial conducted with heart failure patients with preserved ejection fraction.
As per the findings presented today, the combination drug sacubitril-valsartan did not significantly reduce heart failure hospitalisations and cardiovascular death compared to valsartan alone. However, the drug may still benefit patients in the lower ejection fraction range who have no other approved therapies.
While there were fewer hospitalisations among patients treated with sacubitril/valsartan compared with valsartan alone, these results were statically insignificant. And so the gap in treatment for heart failure patients with reduced ejection fraction remains.
4822 patients were included in the PARAGON-HF study. Patients were randomly assigned to receive sacubitril-valsartan or valsartan alone and were followed for up to five years. Overall, there were 894 primary events (690 hospitalisations for heart failure and 204 deaths from cardiovascular causes) in the sacubitril-valsartan group compared to 1,009 primary events (797 hospitalisations for heart failure and 212 cardiovascular deaths) in the valsartan group. As is obvious from the results, the difference between the groups did not meet the predetermined level of statistical significance.
"Heart failure with preserved ejection fraction accounts for about half of all patients with heart failure; there are currently no approved therapies, and so this represents a huge unmet need," said study co-chair John McMurray, MD, of the British Heart Foundation (BHF) Cardiovascular Research Centre, University of Glasgow.
Results of the PARAGON-HF trial were just published in The New England Journal of Medicine.
/ESC Congress 2019
Slide Credit: Dr. Scott Solomon, ESC Congress 2019
Image Credit: ESC