Application of REVEAL Lite 2 and COMPERA 2.0 risk scores to patients with pulmonary arterial hypertension switching to riociguat in the REPLACE study.

In REPLACE (NCT02891850), improvements in risk status were observed in patients with pulmonary arterial hypertension (PAH) at intermediate risk switching to riociguat vs continuing phosphodiesterase-5 inhibitors (PDE5i). This post hoc study applied the REVEAL Lite 2 and COMPERA 2.0 risk-assessment tools to REPLACE to investigate the impact of baseline risk status on clinical improvement. The proportions of riociguat- and PDE5i-treated patients achieving the primary endpoint at REVEAL Lite 2 low, intermediate, and high baseline risk reflected the overall population. Proportions of riociguat-treated patients achieving the primary endpoint were comparable between the COMPERA 2.0 intermediate-low risk (39%) and intermediate-high risk (43%) groups. Our findings show that patients in REPLACE achieved clinical improvement by switching from PDE5i to riociguat across all COMPERA 2.0 and most REVEAL Lite 2 baseline risk strata.

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Copyright © 2024. Published by Elsevier Inc.

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Disclosure statement R.L.B. is the founder and Chief Medical Officer of PHope and reports receiving grants from Actelion, Bayer AG, Bellerophon, and Eiger. G.S. reports personal fees and non-financial support from Actelion, Bayer AG, and MSD. H.A.G. reports receiving grants from Actelion, Bayer AG, Ergonex, and Pfizer; personal fees from Actelion, Bayer AG, Ergonex, Gilead, GSK, Merck, Novartis, and Pfizer; and is currently on the independent data monitoring committee for two studies funded by Actelion. P.A.C. has no conflicts of interest to report. D.L. reports honoraria, consultation fees, research support, and travel expenses from Actelion, Arena, Bayer AG, Northern Therapeutics, PhaseBio, and United Therapeutics. S.R. reports remunerations for lectures and consultancy from Abbott, Acceleron, Actelion, Arena, Bayer AG, Bristol-Myers Squibb, Ferrer, GSK, Janssen, MSD, Novartis, Pfizer, and United Therapeutics, and research support to his institution from Actelion, Bayer AG, Novartis, Pfizer, and United Therapeutics. R.J.W. reports grants and personal fees from Bayer AG and personal fees from MSD. C-C.C. has no conflicts of interest to report. F.F.C. has no conflicts of interest to report. H.K.K. reports research grants from Boryung Pharm, ChongKunDang Pharm, Dae-Woong Pharm, GSK, Handok Pharm, Hanmi, HK inno.N, Johnson & Johnson, JW Pharm, Samjin Pharm, and Yuhan. R.S. reports remunerations for lectures and consultancy from Acceleron, Actelion, Bayer AG, Janssen, and MSD. M.C. is an employee of Bayer AG. C.R. is an external employee of Bayer AG. C.M. is an employee of Bayer AG. M.M.H. reports receiving personal fees from Acceleron, Actelion, AOP, Bayer AG, Ferrer, Janssen, and MSD.