July 15, 2016
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Sacubitril/valsartan linked to fewer 30-day readmissions after hospitalization for HF

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New data from the PARADIGM-HF trial suggest that sacubitril/valsartan reduces 30-day readmissions after HF hospitalization compared with enalapril.

In the trial’s main results, sacubitril/valsartan (Entresto, Novartis) was found to reduce the primary composite endpoint of CV death or HF hospitalization by 20% compared with enalapril in patients with HF with reduced ejection fraction.

Akshay S. Desai, MD, MPH, from the cardiovascular division at Brigham and Women’s Hospital, and colleagues conducted an analysis of the PARADIGM-HF cohort to determine whether sacubitril/valsartan reduced 30-day readmission rates compared with enalapril.

Of the 8,399 patients in the PARADIGM-HF trial, 1,450 survived a HF hospitalization (675 in the sacubitril/valsartan group and 775 in the enalapril group). Overall, there were 2,383 readmissions, 45.2% in the sacubitril/valsartan group and 54.8% in the enalapril group, according to the researchers.

The rate of 30-day all-cause readmission for the sacubitril/valsartan group was 17.8% compared with 21% in the enalapril group (OR = 0.74; 95% CI, 0.56-0.97), the researchers found. Readmission rates for HF were 9.7% in the sacubitril/valsartan group and 13.4% in the enalapril group (OR = 0.62; 95% CI, 0.45-0.87). Extending the time window to 60 days did not change the results, nor did restricting the analysis to adjudicated hospitalizations for HF.

“These data ... provide additional rationale for use of sacubitril/valsartan in preference to enalapril in patients with chronic, symptomatic HF and reduced [EF],” the researchers wrote.

Robert J. Mentz, MD, and Emily C. O’Brien, PhD, from Duke Clinical Research Institute, wrote in an editorial that although the study provided important data supporting use of sacubitril/valsartan to reduce readmissions, there is one important limitation.

Robert J. Mentz

Robert J. Mentz

“Because the study population is, by design, restricted to those patients who experienced a first event (17.3% of PARADIGM-HF), the population now exists as an observational cohort rather than a randomized sample,” Mentz and O’Brien wrote.

Emily C. O’Brien, PhD

Emily C. O’Brien

“To truly answer the question of whether sacubitril/valsartan reduced HF readmission, future studies could use a SMART (Sequential, Multiple Assignment, Randomized Trial) design, in which patients are re-randomized at key decision points during follow-up, such as readmission,” the authors wrote. by Tracey Romero

Disclosure : PARADIGM-HF was funded by Novartis. Desai reports consulting for Janssen, Merck, Novartis, Relypsa, Sanofi and St. Jude Medical. Please see the full study for all other researchers’ relevant financial disclosures. Mentz reports receiving research funding from Amgen and Novartis. O’Brien reports receiving research funding from Novartis.