Srivastava PK, et al. - In this multicenter, international study, researchers determine 5-year projected number needed to treat (NNT) values overall and for different subpopulations for the PARADIGM-HF cohort. According to results, the estimated 5-year NNT with angiotensin receptor neprilysin inhibitor (ARNI) therapy incremental to angiotensin-converting enzyme inhibitor (ACEI) therapy in general and for clinically relevant subpopulations of heart failure with reduced ejection fraction (HFrEF) patients are comparable to the well-established HF therapeutics. Among eligible patients with HFrEF, these data further support guideline recommendations for use of ARNI therapy.

Methods

• Using data from PARADIGM-HF, a double-blind, randomized trial of sacubitril-valsartan vs enalapril, overall and subpopulation 5-year NNT values were estimated for different end points.
• Study participants included 8,399 men and women with HFrEF (ejection fraction, ≤ 40%).
• The study started in December 2009 and was completed in March 2014; analyses were initiated in March 2018.
• Interventions included random assignment to sacubitril-valsartan or enalapril.
• Cardiovascular death or HF hospitalization, cardiovascular death, and all-cause mortality were the main outcomes and measures.

Results

• The final cohort consisted of 1,832 women (21.8%) and 5,544 white individuals (66.0%), with a mean (SD) age of 63.8 (11.4) years.
• Researchers found that the 5-year estimated NNT in the overall cohort for the primary outcome of cardiovascular death or HF hospitalization with ARNI therapy incremental to ACEI therapy was 14.
• The 5-year estimated NNT values for various clinically relevant subpopulations were calculated and ranged from 12-19.
• The 5-year estimated NNT for all-cause mortality in the overall ARNI increment to ACEI cohort was 21 with values ranging from 16-31 in various subgroups.
• It was noted that the 5-year estimated NNT for all-cause mortality with ARNI was 11 vs imputed placebo.
• The 5-year estimated NNT values for other HFrEF therapies were also calculated in comparison with all-cause mortality controls from landmark trials and were found to be 18 for ACEI, 24 for angiotensin receptor blockers, 8 for β-blockers, 15 for mineralocorticoid antagonists, 14 for implantable cardioverter defibrillator, and 14 for cardiac resynchronization therapy.