Biomarker-Based CardioMEMS Candidates Benefit Less

CLEVELAND — Elevated natriuretic peptides didn’t select for patients that got as much benefit from pulmonary pressure wire-guided heart failure (HF) treatment as did recent hospitalization, an analysis of the GUIDE-HF trial showed.

For the trial’s primary efficacy endpoint of combined HF hospitalizations, urgent HF visits, and death, patients enrolled based on NT-proBNP or BNP without a recent HF hospitalization had lower risk of those outcomes than patients enrolled based on an admission without elevated natriuretic peptides (HR 0.51, 95% CI 0.44-0.60).

That difference — driven by clinical worsening events despite similar New York Heart Association (NYHA) class III symptoms — fell outside the equivalence margin, Mandeep R. Mehra, MD, MSc, of Brigham and Women’s Hospital and Harvard Medical School in Boston, reported at the Heart Failure Society of America (HFSA) meeting.

Both groups, though, had similar benefits of hemodynamic-guided management on reduction in pulmonary artery pressure and improvement in NYHA class and quality-of-life domains.

“We believe based upon these data that this supports the indication for CardioMEMS implantation and hemodynamically-guided management in the presence of elevated natriuretic peptides, but prior to the occurrence of HF hospitalizations,” Mehra concluded.

While not unexpected, the data showed just how different are these “strata” of HF identified by natural peptides versus by a prior HF hospitalization even though not “distinct phenotypes,” noted HFSA late-breaking session discussant Barry H. Greenberg, MD, of the University of California San Diego.

While that has implications for clinical trial design, Greenberg still agreed with the researchers that there was meaningful benefit for both groups: “To me, it says that patients with NYHA class III symptoms across the spectrum of heart failure with classification by ejection fraction who have congestive symptoms will benefit from a CardioMEMS regardless of whether they’re hospitalized or whether or not they’re identified with high levels of natural peptides.”

“The risk for hospitalization is going to be greater in those individuals who had previously been hospitalized, but there still is residual risk in those individuals identified only by N-terminal proBNP,” he continued. “And in that class of patients, you can significantly reduce hospitalizations and improve the symptomatic burden.”

Average change from baseline pulmonary artery diastolic pressure was similar between groups, at -2.44 mm Hg in the elevated biomarker group and -2.05 mm Hg in the prior HF hospitalization group (both P<0.0001 vs baseline, P=0.23 for between-group comparison).

NYHA class improvement at 12 months occurred in 30% and 37%, respectively (P=0.28 between groups). Kansas City Cardiomyopathy Questionnaire overall summary score gain from baseline was 6.26 and 5.42, respectively (both P<0.0001).

GUIDE-HF included 1,000 patients with NYHA class II-IV HF regardless of ejection fraction who were considered high risk based on elevated natriuretic peptides or HF hospitalization in the prior 12 months.

The trial missed its primary endpoint overall, but has largely been seen as a positive trial because a prespecified analysis of only data from before the pandemic did meet statistical significance for the composite primary endpoint.

Mehra’s subanalysis looked only at the 816 patients who qualified for enrollment based on natriuretic peptides or recent HF admission, not both, and had 12 months of follow-up.

Natriuretic peptides, as designed, were higher in the group of patients enrolled based on elevated levels compared with the hospitalization-based enrollment group both for baseline BNP (546.6 vs 424.9 pg/mL, P<0.0001) and NT-proBNP (2,433 vs 1,840 pg/mL, P<0.0001).

Many other characteristics differed as well, with the natriuretic peptide group being older; more often male and white; with more atrial fibrillation, HF with reduced ejection fraction, prior implanted cardiac devices, and ACE inhibitor/angiotensin-receptor blocker/sacubitril-valsartan (Entresto) use; less hydralazine use; lower diabetes rates; and a lower BMI.

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