Hot Line - Is haemodynamic-guided management beneficial across a range of patients with HF?
27 Aug 2021
Hot Line presented at ESC Congress
Haemodynamic-guided heart failure (HF) management reduced HF hospitalisations in previously hospitalised HF patients with New York Heart Association (NYHA) class III symptoms in the CHAMPION trial.1 However, it remained uncertain whether this approach also reduces all-cause mortality and if benefits extend to patients with NYHA class II and IV HF or to those symptomatic patients with elevated natriuretic peptides without recent HF hospitalisation. In a Hot Line session today and just published in The Lancet, Professor JoAnn Lindenfeld (Vanderbilt University Medical Center, Nashville, USA) presented results from the GUIDE-HF trial, which sought to answer these important questions.
This single-blind trial enrolled 1,000 patients with NYHA class II–IV HF and either a hospitalisation for HF within the preceding 12 months or elevated natriuretic peptides (B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide) within 30 days. All participants underwent implantation of a CardioMEMS device. Patients were then randomised 1:1 to either a treatment group, managed with provider remote access to the haemodynamic data, or a control group, managed without provider access to these data. The primary endpoint was a composite of cumulative HF hospitalisations, urgent HF visits and mortality.
During a median follow-up of 11.7 months, there were 253 primary endpoint events in the treatment group and 289 in the control group, representing a 12% reduction in the treatment group, which did not meet statistical significance (hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.74 to 1.05; p=0.16). Of note, however, a prespecified pre-COVID-19 analysis, performed on data up to 13 March 2020, showed a significant 19% reduction in primary endpoint events in the treatment group (HR 0.81; CI 0.66 to 1.00; p=0.0489).
Regarding HF hospitalisations, these were reduced by 17% in the treatment group in the overall analysis (p=0.064) and by 28% in the pre-COVID-19 analysis (p=0.0072) – the latter reduction was similar to that achieved in the CHAMPION trial.1 Neither urgent HF visits nor mortality were reduced independently with treatment in the overall or pre-COVID-19 analyses.
Prof. Lindenfeld commented: “The findings indicate that the benefits of haemodynamic guided management in reducing HF hospitalisations extend to patients with less severe HF (NYHA class II) and to those with NYHA II and III symptoms and elevated natriuretic peptides but no previous hospitalisation. The NYHA class IV HF patients did not show consistent results but were small in number.” She also added, “The COVID-19 pandemic clearly affected the outcomes of GUIDE-HF, as it did in the AFFIRM-AHF trial.2 Clinical trials conducted during pandemics will require statistical analysis plans to account for their effects.”
Missed the session? Watch it on demand:
1. Abraham WT, et al. Lancet. 2011;377:658–666
2. Ponikowski P, et al. Lancet. 2020;396:1895–1904.