Is natriuretic peptide–guided therapy superior to usual care in the management of high-risk adults with heart failure and reduced ejection fraction?

Natriuretic peptide–guided therapy was not more effective than a usual care strategy for high-risk adults with heart failure (HF) and reduced ejection fraction. (LOE = 1b)

Felker GM, Anstrom KJ, Adams KF, et al. Effect of natriuretic peptide-guided therapy on hospitalization or cardiovascular mortality in high-risk patients with heart failure and reduced ejection fraction. A randomized clinical trial. JAMA 2017;318(8):713-720.  [PMID:28829876]

Randomized controlled trial (single-blinded)

Industry + govt

Concealed

Outpatient (specialty)

These investigators identified adults (median age: 63 years) with HF (ejection fraction of 40% or less), a history of a prior heart failure–related event (hospitalization, emergency department visit, or outpatient visit requiring intravenous diuretics) within the past 12 months, and an amino-terminal pro-B-type natriuretic peptide (NT-proBNP) level of more than 2000 pg/mL or a BNP level of more than 400 pg/mL. Patients (N = 894) randomly received (concealed allocation assignment) either NT-proBNP–guided therapy or usual care. Clinicians providing care for the NT-proBNP–guided group were instructed to titrate HF therapy to target an NT-proBNP level of less than 1000 pg/mL. Clinicians in the usual care group provided care based on clinical symptoms and physical findings without access to natriuretic peptide levels. Individuals who assessed outcomes remained masked to treatment group assignment. After clinic visits at 2 weeks and 6 weeks, visits occurred every 3 months. Complete follow-up occurred for 94% of participants for a median follow-up time of 15 months. The study was stopped prematurely after meeting prespecified inefficacy criteria. Using intention-to-treat analyses, the primary outcome of a composite end point of hospitalization for HF or death from a cardiovascular cause occurred in 37% of patients in both the biomarker-guided group and the usual care group. Similarly, no significant group differences occurred for all-cause mortality. Changes in the concentrations of NT-proBNP based on masked laboratory data from both groups were also not significantly different between the 2 groups. Adverse event rates were low and similar between groups.