Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease

Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.

Abstract

Background: In a randomized trial, baroreflex activation therapy (BAT) improved exercise capacity, quality of life and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF). In view of different mechanisms underlying HFrEF, we performed a post-hoc subgroup analysis of efficacy and safety of BAT in patients with and without coronary artery disease (CAD).

Methods and results: Patients with left ventricular ejection fraction <35% and NYHA Class III were randomized 1:1 to guideline-directed medical and device therapy alone or plus BAT. Patients with a history of CAD, prior myocardial infarction or coronary artery bypass graft were assigned to the CAD group with all others assigned to the no-CAD group. Of 71 BAT treated patients, 52 had CAD and 19 had no CAD. In the control group, 49 of 69 patients had CAD and 20 had no CAD. The system- or procedure-related major adverse neurological or cardiovascular event rate was 3.8% in the CAD group vs. 0% in the no-CAD group (p = 1.0). In the whole cohort, NYHA Class, Minnesota Living with Heart Failure score, 6-minute hall walk distance and NTproBNP were improved in BAT treated patients compared with controls. Statistical analyses revealed no interaction between the presence of CAD and effect of BAT (all p > 0.05).

Conclusion: No major differences were found in BAT efficacy or safety between patients with and without CAD, indicating that BAT improves exercise capacity, quality of life and NTproBNP in patients with ischemic and non-ischemic cardiomyopathy. CLINICALTRIALS.

Gov identifier: NCT01471860 and NCT01720160.

Keywords: Baroreflex activation therapy; Coronary artery disease; Device; Heart failure.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Baroreflex / physiology*
  • Biomarkers / blood
  • Coronary Artery Disease / blood
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Electric Stimulation Therapy / instrumentation
  • Electric Stimulation Therapy / methods*
  • Female
  • Heart Failure / blood
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Humans
  • Male
  • Natriuretic Peptide, Brain / blood
  • Peptide Fragments / blood
  • Retrospective Studies
  • Stroke Volume / physiology*
  • Treatment Outcome

Substances

  • Biomarkers
  • Peptide Fragments
  • pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain

Associated data

  • ClinicalTrials.gov/NCT01471860
  • ClinicalTrials.gov/NCT01720160