Pirfenidone in Heart Failure With Preserved Ejection Fraction - PIROUTTE

May 17, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Manchester University NHS Foundation Trust
Date Presented:
05/17/2021
Date Updated:
05/17/2021
Original Posted Date:
05/17/2021
References

Contribution To Literature:

The PIROUETTE trial showed that pirfenidone was beneficial at reducing myocardial fibrosis among patients with HFpEF.

Description:

The goal of the trial was to evaluate pirfenidone, an antifibrotic agent, compared with placebo among patients with heart failure with preserved ejection fraction (HFpEF).

Study Design

  • Randomized
  • Parallel

Patients with HFpEF were randomized to pirfenidone (n = 47) versus placebo (n = 47).

  • Total number of enrollees: 94
  • Duration of follow-up: 12 months
  • Mean patient age: 78 years
  • Percentage female: 47%
  • Percentage with diabetes: 34%

Inclusion criteria:

  • HFpEF (left ventricular EF [LVEF] ≥45%)
  • N-terminal pro–B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml
  • Extracellular volume ≥27%, as assessed by cardiac magnetic resonance imaging (MRI)

Principal Findings:

The primary outcome, change in myocardial extracelluar volume (%) from baseline to 52 weeks, was -0.7 in the pirfenidone group compared with 0.5 in the placebo group (p = 0.009).

Secondary outcomes:

  • No difference in diastolic function
  • No difference in 6-minute walk distance
  • No difference in Kansas City Cardiomyopathy Questionnaire summary score

Interpretation:

Among patients with HFpEF, pirfenidone appeared to be beneficial. This medication was associated with a modest reduction in myocardial fibrosis, as assessed by cardiac MRI, compared with placebo. The clinical significance of this finding is unknown.

References:

Presented by Dr. Christopher Miller at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 17, 2021.

Clinical Topics: Anticoagulation Management, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Acute Heart Failure, Heart Failure and Cardiac Biomarkers, Magnetic Resonance Imaging

Keywords: ACC21, ACC Annual Scientific Session, Cardiomyopathies, Diastole, Fibrosis, Geriatrics, Heart Failure, Magnetic Resonance Imaging, Natriuretic Peptide, Brain, Peptide Fragments, Stroke Volume


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