Outcomes vary among patients eligible for hemodynamic-guided HF management
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Key takeaways:
- Among patients with NYHA class III HF, those with elevated peptides face differing outcome trajectories vs. those with prior HF hospitalization.
- Both groups derived benefit from hemodynamic-guided HF management.
Moderately symptomatic patients with HF with elevated peptides or prior HF hospitalization, while experiencing differing outcome trajectories, derived similar benefit from hemodynamic-guided management, a speaker reported.
The results of a single-arm analysis of the GUIDE-HF trial of pulmonary artery pressure-guided management via implanted sensor (CardioMEMS, Abbott) for patients with NYHA class III HF were presented at the Heart Failure Society of America Annual Scientific Meeting.
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“During the conduct of the GUIDE-HF trial, in parallel, the single-arm study was also underway. This study included only NYHA class III patients, and the primary objective of this particular study was to assess the equivalence and the benefits between these two strata of those patients who were enrolled with moderately symptomatic heart failure and a prior heart failure hospitalization compared to those with only an elevated [B-type natriuretic peptide] but no prior heart failure hospitalization,” Mandeep R. Mehra, MD, MSc, the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and medical director of Brigham and Women’s Hospital Heart and Vascular Center and professor of medicine at Harvard Medical School, said during a presentation. “The primary endpoint was a test ... not for noninferiority, but for equivalence, which is a more stringent test using a two one-sided test.”
GUIDE-HF was a randomized, single-blind trial that tested pulmonary artery pressure-guided management using a device implanted via a right heart catheterization in patients with NYHA class II, III and IV HF and either an HF hospitalization within the prior year or elevated natriuretic peptide levels within the prior month.
As Healio previously reported, hemodynamic-guided management was associated with reduction of HF hospitalizations in an analysis of events before the COVID-19 pandemic, but not in the overall results.
In February 2022, the implantable received an expanded indication from the FDA for patients with NYHA class II HF and those with blood tests confirming elevated natriuretic peptides.
For the present study, the single-arm GUIDE-HF cohort was divided into one of three subgroups: patients with elevated N-terminal pro-B-type natriuretic peptide; those with prior HF hospitalization only; and patients with both elevated NT-proBNP and prior HF hospitalization.
The primary composite endpoint of HF hospitalization, urgent HF visit and death were compared between patients with elevated peptides only and those with prior hospitalization only.
Overall, 1,076 GUIDE-HF participants completed 12-month follow-up, of whom 376 were in the elevated peptide group and 440 were in the prior HF hospitalization group.
Compared with the elevated peptide arm, patients with a prior HF hospitalization were more likely to be younger, to be women, to be Black and to have a higher BMI.
In addition, patients with prior HF hospitalization had a higher prevalence of diabetes and left ventricular ejection fraction greater than 40% compared with those with elevated NT-proBNP, but lower prevalence of atrial fibrillation/atrial flutter.
Observed similarities between the two groups included NYHA class III, HF etiology, hemodynamics, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, kidney function and medications (SGLT2 inhibitors, beta-blockers and diuretics).
Mehra reported that risk for the primary composite endpoint did not fall within the equivalence margin (HR = 0.51; 95% CI, 0.44-0.6; P = 1), suggesting that patients with elevated NT-proBNP only and those with prior HF hospitalization only may have different distinctive outcome trajectories.
Patients with elevated peptides only experienced nearly half as many events in the year after implant compared with the HF hospitalization-only group.; however, those in the prior HF hospitalization-only group experienced an approximately 54% reduction in HF hospitalizations in the year after sensor implant.
Significant and similar reductions in diastolic pulmonary artery-pressure were observed between the two groups (P between groups = .23):
- elevated NT-proBNP only (mean change, 2.44 mm Hg; P < .0001); and
- prior HF hospitalization only (mean change, 2.05 mm Hg; P < .0001).
Most participants had improved or sustained NYHA class at 6 and 12 months, with researchers reporting a similar directional change toward improvement in both groups (P < .0001; P between groups = .28).
KCCQ responses indicated significant improvement with pulmonary artery pressure-guided management in overall summary score, symptom frequency and social limitation score for both groups, according to the presentation.
“Moderately symptomatic heart failure patients with elevated natriuretic peptide levels or those with a heart failure hospitalization alone, these patients are not equivalent when it comes to the risk of heart failure hospitalizations. They actually represent distinctive outcome trajectories,” Mehra said during the presentation. “But despite these distinctive outcome trajectories, these patients demonstrate similar benefits of hemodynamic-guided management on reduction of pulmonary arterial pressure, improvement in NYHA class and all quality of life domains. We believe, based on this data, that this supports the indication for the use of CardioMEMS implantation and hemodynamic-guided management in the presence of elevated natriuretic peptides, but prior to occurrence of heart failure hospitalizations.”
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Mehra MR, et al. Late breaking clinical trials. Presented at: The Heart Failure Society of America Annual Scientific Meeting; Oct. 6-9, 2023; Cleveland.
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