Introduction of sacubitril/valsartan in primary care follow‐up of heart failure: a prospective observational study (THESEUS)

Abstract

Aims

Switch from angiotensin converting enzyme inhibitor treatment to sacubitril/valsartan (sac/val) is associated with benefit in heart failure with reduced ejection fraction (HFrEF). Reports on management of this switch are largely based on randomized controlled trials, retrospective analyses, and hospital‐based care, while patients with chronic heart failure (CHF) are frequently followed‐up in primary care. The THESEUS study aimed to characterize the transition to sac/val and early maintenance period of HFrEF in primary care.

Method and results

THESEUS was a prospective, observational, non‐interventional study, performed at primary care sites throughout Switzerland. Patient characteristics, sac/val transition, and maintenance were reported at study enrolment and approximately 3 and 6 months after sac/val initiation. The primary endpoint was achievement of 200 mg BID sac/val with maintenance for ≥12 weeks. Secondary outcomes included dosing regimens, healthcare utilization in the 6 months prior to sac/val initiation and during the study, patient well‐being, safety, and tolerability. Fifty‐eight patients with CHF were enrolled from 45 primary care centres. Six patients were excluded, and 19 achieved the primary endpoint (36.5%, Achievers). Non‐Achievers underwent fewer titration steps than Achievers (1.9 ± 0.9 vs. 3.1 ± 1.4). In both groups, patient well‐being improved and the percentage of New York Heart Association III patients decreased. Healthcare utilization decreased (19% vs. 30.8% in the 6 months pre‐enrolment period). The most frequent reasons for target dose non‐achievement were asymptomatic and symptomatic hypotension (15.3% and 12.1%, respectively).

Conclusions

Results from THESEUS suggest that transition to sac/val is manageable in primary care, with a safety profile corresponding to reports from specialized heart failure care.