Effect of Macitentan in Pulmonary Arterial Hypertension and the Relationship Between Echocardiography and cMRI Variables: REPAIR Echocardiography Sub-study Results.

Agreement Cardiac magnetic resonance imaging Correlation Echocardiography Macitentan Pulmonary arterial hypertension

Journal

Cardiology and therapy
ISSN: 2193-8261
Titre abrégé: Cardiol Ther
Pays: England
ID NLM: 101634495

Informations de publication

Date de publication:
28 Jan 2024
Historique:
received: 26 10 2023
accepted: 04 12 2023
medline: 28 1 2024
pubmed: 28 1 2024
entrez: 28 1 2024
Statut: aheadofprint

Résumé

The aim of this sub-study was to evaluate the relationship between echocardiography (echo) and cardiac magnetic resonance imaging (cMRI) variables and to utilize echo to assess the effect of macitentan on right ventricle (RV) structure and function. REPAIR (NCT02310672) was a prospective, multicenter, single-arm, open-label, 52-week, phase 4 study in pulmonary arterial hypertension (PAH) patients, which investigated the effect of macitentan 10 mg as monotherapy, or in combination with a phosphodiesterase 5 inhibitor, on RV structure, function, and hemodynamics using cMRI and right heart catheterization. In this sub-study, patients were also assessed by echo at screening and at weeks 26 and/or 52. Post hoc correlation analyses between echo and cMRI variables were performed using Pearson's correlation coefficient, Spearman's correlation coefficient, and Bland-Altman analyses. The Echo sub-study included 45 patients. Improvements in echo-assessed RV stroke volume (RVSV), left ventricular SV (LVSV), LV end-diastolic volume (LVEDV), RV fractional area change (RVFAC), tricuspid annular plane systolic excursion (TAPSE), and in 2D global longitudinal RV strain (2D GLRVS) were observed at weeks 26 and 52 compared to baseline. There was a strong correlation between echo (LVSV, 2D GLRVS, and LVEDV) and cMRI variables, with a moderate correlation for RVSV. Bland-Altman analyses showed a good agreement for LVSV measured by echo versus cMRI, whereas an overestimation in echo-assessed RVSV was observed compared to cMRI (bias of - 15 mL). Hemodynamic and functional variables, as well as safety, were comparable between the Echo sub-study and REPAIR. A good relationship between relevant echo and cMRI parameters was shown. Improvements in RV structure and function with macitentan treatment was observed by echo, consistent with results observed by cMRI in the primary analysis of the REPAIR study. Echo is a valuable complementary method to cMRI, with the potential to non-invasively monitor treatment response at follow-up. REPAIR NCT02310672.

Identifiants

DOI: 10.1007/s40119-023-00345-2 PMID: 38281309
pubmed: 38281309
doi: 10.1007/s40119-023-00345-2
pii: 10.1007/s40119-023-00345-2
doi:

Banques de données

ClinicalTrials.gov
['NCT02310672']

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2024. The Author(s).

Références

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Auteurs

Adam Torbicki (A)

Department of Pulmonary Circulation, Thromboembolic Disease and Cardiology, Centre for Postgraduate Medical Education ECZ-Otwock, ERN-LUNG Member, F. Chopin Hospital European Health Centre, ul. Borowa 14/18, 05-400, Otwock, Poland. atorbicki@gmail.com.
ORCID: 0000-0003-3475-8832

Richard Channick (R)

David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Nazzareno Galiè (N)

Cardiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna and Dipartimento DIMES, Università di Bologna, Bologna, Italy.

David G Kiely (DG)

Sheffield Pulmonary Vascular Disease Unit, NIHR Biomedical Research Centre Sheffield and University of Sheffield, Sheffield, UK.

Pamela Moceri (P)

Cardiology Department, UR2CA, Pasteur University Hospital, Côte-d'Azur University, Nice, France.

Andrew Peacock (A)

Scottish Pulmonary Vascular Unit, Glasgow, UK.

Andrew J Swift (AJ)

Department of Infection, Immunity & Cardiovascular Disease, National Institute for Health and Care Research Sheffield Biomedical Research Centre, University of Sheffield, Sheffield, UK.

Ahmed Tawakol (A)

Massachusetts General Hospital and Harvard Medical School, Boston, USA.

Anton Vonk Noordegraaf (A)

Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Dayana Flores (D)

Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Global Medical Affairs, Allschwil, Switzerland.

Nicolas Martin (N)

Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, Statistical Decision Science, Allschwil, Switzerland.

Stephan Rosenkranz (S)

Department of Cardiology, Heart Center, University Hospital Cologne, and Cologne Cardiovascular Research Center (CCRC), University of Cologne, Cologne, Germany.

Classifications MeSH