Baroreflex activation: a novel option to improve heart failure symptoms

A new patient-level meta-analysis of phase 2 and 3 data on Barostim therapy for heart failure (HF) patients with reduced ejection fraction confirmed significant improvements in 6-minute walking distance and quality of life across different classes of patients.

The Barostim^TM system successfully reduced muscle sympathetic nerve activity while demonstrating safety in a proof-of-concept phase 1 study on baroreflex stimulation in HF patients [1,2]. In the phase 2 HOPE4HF trial (NCT01720160), the Barostim^TM system also appeared to be safe and effective. Recently, the baroreflex activation with Barostim^TM resulted in significant improvements in exercise capacity and quality of life in the pivotal BEAT-HF study (NCT02627196) [3]. “We decided to do a meta-analysis of individual patient data of these 2 randomised trials,” stated Prof. Andrew Coats (University of Warwick, UK) [2].

Most of the inclusion criteria in the 2 studies were similar: ejection fraction ≤35%, mainly NYHA III, 6-minute hall walking distance (6MWD) between 150–400 metres, and a stable and guideline-conform therapy for 4 weeks. In BEAT-HF, participants also had a prior hospitalisation for HF, and an N-terminal pro B-type natriuretic peptide (NT-proBNP) of ≥400 pg/mL. Excluded were those with a class 1 indication for cardiac resynchronisation therapy (CRT). The demographic data of both trials were fairly similar, as were the comorbidities. For example, overall drug use was 80-84% renin-angiotensin system inhibitors and 86-95% of β-blockers.

The results of this new meta-analysis revealed significant improvements in the 6MWD by 48.5 metres as well as health status in terms of a reduction in the Minnesota Livingwith Heart Failure Questionnaire (MLWHFQ) score by 13.4 points. Furthermore, the odds ratio for an NYHA class amelioration was 3.4. As for the relative change in NT-proBNP, a trend was observed but no significance was reached. The investigation also looked at results in 4 different cohorts: A) all patients; B) only patients without CRT indication (no CRT); C) no CRT and an NT-proBNP <1,600 pg/mL; and D) NT-proBNP <1,600 pg/mL.

In general, the differences in effectiveness were not very extensive. Though in, for example, the 6MWD test, cohorts C and D had a higher improvement (63.0 and 61.2 metres, respectively) than cohorts A and B (48.5 and 50.2 metres, respectively). Looking also at subgroups by gender, Prof. Coats pointed out that the effect on 6MWD and health status was slightly better in women. “We believe Barostim^TM may be a new option to improve HF symptoms and we look forward to longer term follow-up in terms of looking at more significant major clinical outcomes,” said Prof. Coats in his conclusion.

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   1. Gronda E, et al. Eur J Heart Fail. 2014;16(9):977-83.
   2. Coats A. BAROSTIM therapy in patients with HFrEF: A patient level meta-analysis of randomized trials. LBT 3, Heart Failure and World Congress on Acute Heart Failure 2021, 29 June–1 July.
   3. Zile MR, et al. J Am Coll Cardiol. 2020;76(1):1-13.

 

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Posted on 19 August, 202120 August, 2021