Sacubitril/Valsartan Treatment Cuts Down the 30-Day Readmission Rate vs. Enalapril after Heart Failure Hospitalization

Background

Despite effective medical therapy, heart failure (HF) patients have a high risk of rehospitalisation in the first 30 days.

Aim

To determine if treatment with sacubitril/valsartan as compared to enalapril would reduce the rate of hospital readmission at 30-days following HF hospitalization.

Patient Profile

• Patients (age ≥18 years; n=8399) with New York Heart Association (NYHA) class II to IV symptoms having an ejection fraction of ≤40% (changed to ≤35% by protocol amendment) and plasma B-type natriuretic peptide (BNP) ≥150 pg/mL (or N-terminal pro-BNP [NTproBNP] ≥600 pg/mL)
• Patients with lower levels of natriuretic peptides were eligible only if they had been hospitalized for HF within 12 months.
• Patients on ongoing therapy were required to tolerate angiotensin converting enzyme (ACE)-inhibitor or angiotensin receptor blocker (ARB) equivalent to at least enalapril 10 mg daily for at least 4 weeks before screening along with stable doses of a ?-blocker (unless contraindicated or not tolerated) and a mineralocorticoid antagonist (if indicated).

Methods

Study Design

• Multi-center, randomized, double blind trial with a single blind run-in period

Treatment Strategy

• The primary unit of subsequent analysis was hospitalizations, rather than patients so as to include data on multiple HF hospitalizations per patient.

Primary Outcome

• Incidence of 30-day hospital readmission for any cause following index hospitalizations for HF in the PARADIGM-HF trial during the median 27-month period after randomization

Results

• A total of 2,383 HF hospitalizations were recorded. Of these, 1,076 (45.2%) occurred in the sacubitril/valsartan group and 1,307 (54.8%) occurred in the enalapril group.
• There was a 26% lower rate of readmission due to any cause at 30 days due to sacubitril/valsartan treatment vs. the enalapril treatment (17.8% vs. 21.0%; odds ratio [OR]: 0.74; p=0.031) (Figure 1).
• The rates of readmission for HF at 30-days were also 38% lower in the sacubitril/valsartan group vs. the enalapril group (9.7% vs. 13.4%; OR: 0.62; p=0.006) (Figure 1).
• The reduction in both all-cause and HF readmissions with sacubitril/valsartan persisted even when the time window from discharge was extended to 60 days and in sensitivity analyses that was restricted to adjudicated HF hospitalizations.

Conclusion

As compared to enalapril, sacubitril/valsartan treatment reduced the incidence of hospital readmissions for any cause or for HF at 30 days following discharge from HF hospitalization.

J Am Coll Cardiol 2016; 68: 241–8