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

Autor: Benza RL; Department of Medicine, Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address: Raymond.Benza@osumc.edu., Farber HW; Pulmonary Hypertension Center, Boston University/Boston Medical Center, Boston, MA, USA., Frost AE; Department of Medicine, Research Institute and Institute of Academic Medicine, Houston Methodist, Houston, TX, USA., Ghofrani HA; University of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Giessen, Germany; Department of Medicine, Imperial College London, London, UK; Department of Pneumology, Kerckhoff-Klinik, Bad Nauheim, Germany., Corris PA; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK., Lambelet M; CHRESTOS Concept GmbH & Co. KG, Essen, Germany., Nikkho S; Global Clinical Development, Bayer AG, Berlin, Germany., Meier C; Global Medical Affairs, Bayer AG, Berlin, Germany., Hoeper MM; Clinic for Respiratory Medicine, Hannover Medical School, Member of the German Center for Lung Research (DZL), Hannover, Germany.
Jazyk: angličtina
Zdroj: International journal of cardiology [Int J Cardiol] 2021 Jun 01; Vol. 332, pp. 189-192. Date of Electronic Publication: 2021 Mar 17.
DOI: 10.1016/j.ijcard.2021.03.034
Abstrakt: 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.
Competing Interests: 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.
(Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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