Document Type
Article
Publication Date
10-2024
Abstract
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 (n = 28) or placebo (n = 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; p = .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR 40.0% receiving placebo (p = .0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903.
Recommended Citation
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; and Rame, J. Eduardo, "SOPRANO: Macitentan in Patients With Pulmonary Hypertension Following Left Ventricular Assist Device Implantation" (2024). Jefferson Hospital Staff Papers and Presentations. Paper 45.
https://jdc.jefferson.edu/tjuhpapers/45
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License
Language
English
Comments
This article is the author's final published version in Pulmonary Circulation, Volume 14, Issue 4, October 2024, Article number e12446.
The published version is available at https://doi.org/10.1002/pul2.12446. Copyright © 2024 Actelion Pharmaceuticals US, Inc. Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.