Application of the REVEAL risk score calculator 2.0 in the PATENT study.

BACKGROUND

Regular risk assessment is recommended in pulmonary arterial hypertension (PAH) management to improve patient outcomes. The REVEAL risk score (RRS) predicts survival in patients with PAH, including those from the PATENT study, which assessed riociguat, a soluble guanylate cyclase stimulator approved for PAH treatment. An updated version, RRS 2.0, has been developed to further refine risk prediction.

METHODS

This post hoc analysis of PATENT-1 and its open-label extension PATENT-2 (n = 396) assessed RRS 2.0 score and risk stratum and their association with survival and clinical worsening-free survival (CWFS).

RESULTS

At PATENT-1 Week 12, riociguat improved RRS 2.0 versus placebo (least-squares mean difference versus placebo: -1.0 [95% confidence interval - 1.4 to -0.6; p < 0.0001]) and more patients improved risk stratum with riociguat (57%) versus placebo (42%). These improvements were maintained at PATENT-2 Week 12. RRS 2.0 score and risk strata at PATENT-1 baseline and Week 12 were significantly associated with survival and CWFS in PATENT-2 (p < 0.0001); change in RRS 2.0 score from PATENT-1 baseline to Week 12 was also significantly associated with outcomes.

CONCLUSIONS

These data suggest that RRS 2.0 has clinical utility in predicting long-term outcomes and monitoring treatment response in patients with PAH.

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest R.L. Benza reports receiving grants from Actelion, Bayer AG, Bellerophon, and Eiger. H.W. Farber reports receiving grants from Actelion, Gilead, and United Therapeutics, and receiving personal fees from Actelion, Acceleron, Altavant, Bayer AG, Bellerophon, Boehringer-Ingelheim, Gilead, and United Therapeutics. A.E. Frost has received honoraria for consultations and/or speaking about a product or about pulmonary hypertension from Actelion, Bayer, Gilead, Novartis, Pfizer, and United Therapeutics/Lung LLC; grant support from Actelion, Bayer, Gilead, Novartis, Pfizer, and United Therapeutics/Lung LLC; and is currently on the Independent Data Monitoring Committee (IDMC) for two studies funded by Actelion (UNISUS and MACITEPH). H.-A. Ghofrani 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 IDMC for two studies funded by Actelion. P.A. Corris reports participation and remuneration in Clinical Trial Committees for Bayer and Johnson and Johnson. M. Lambelet is an external employee of Bayer AG. S. Nikkho is an employee of Bayer AG. C. Meier is an employee of Bayer AG. M.M. Hoeper reports receiving personal fees from Acceleron, Actelion, Bayer AG, GSK, Janssen, MSD, and Pfizer.