SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation

Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was...

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Published in:Pulmonary circulation 2024-10, Vol.14 (4), p.e12446-n/a
Main Authors: Frantz, Robert P, Desai, Shashank S, Ewald, Gregory, Franco, Veronica, Hage, Antoine, Horn, Evelyn M, LaRue, Shane J, Mathier, Michael A, Mandras, Stacy, Park, Myung H, Ravichandran, Ashwin K, Schilling, Joel D, Wang, I-Wen, Zolty, Ronald, Rendon, Gabriela Gomez, Rocco, Mark A, Selej, Mona, Zhao, Carol, Rame, J Eduardo
Format: Article
Language:English
Subjects:
left ventricular assist device
macitentan
Pulmonary arteries
Pulmonary hypertension
pulmonary vascular resistance
SOPRANO
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Summary:Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (  = 28) or placebo (  = 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94;  = .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR 
ISSN:2045-8932
2045-8940
2045-8940
DOI:10.1002/pul2.12446