Hoeper, Marius M., Pausch, Christine, Olsson, Karen M., Huscher, Doerte, Pittrow, David, Gruenig, Ekkehard, Staehler, Gerd, Vizza, Carmine Dario ORCID: 0000-0002-3540-4983, Gall, Henning ORCID: 0000-0001-7016-7373, Distler, Oliver, Opitz, Christian, Gibbs, J. Simon R., Delcroix, Marion, Ghofrani, H. Ardeschir, Ewert, Ralf, Kaemmerer, Harald, Kabitz, Hans-Joachim, Skowasch, Dirk, Behr, Juergen, Milger, Katrin, Halank, Michael, Wilkens, Heinrike, Seyfarth, Hans-Juergen, Held, Matthias, Dumitrescu, Daniel, Tsangaris, Iraklis, Vonk-Noordegraaf, Anton, Ulrich, Silvia ORCID: 0000-0002-5250-5022, Klose, Hans, Claussen, Martin, Eisenmann, Stephan ORCID: 0000-0002-0387-0760, Schmidt, Kai-Helge, Rosenkranz, Stephan and Lange, Tobias J. (2022). Prognostic value of improvement endpoints in pulmonary arterial hypertension trials: A COMPERA analysis. J. Heart Lung Transplant., 41 (7). S. 971 - 982. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1557-3117

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Abstract

BACKGROUND: The prognostic value of improvement endpoints that have been used in clinical trials of treatments for pulmonary arterial hypertension (PAH) needs to be further investigated. METHODS: Using the COMPERA database, we evaluated the prognostic value of improvements in functional class (FC) and absolute or relative improvements in 6-min walking distance (6MWD) and N-terminal fragment of pro-brain natriuretic peptide (NT-proBNP). In addition, we investigated multicomponent endpoints based on prespecified improvements in FC, 6MWD and NT-proBNP that have been used in recent PAH trials. Finally, we assessed the predictive value of improvements determined by risk stratification tools. The effects of changes from baseline to first follow-up (3-12 months after initiation of PAH therapy) on consecutive survival were determined by Kaplan-Meier analysis with Log-Rank testing and Cox proportional hazard analyses. RESULTS: All analyses were based on 596 patients with newly diagnosed PAH for whom complete data were available at baseline and first follow-up. Improvements in FC were associated with improved survival, whereas absolute or relative improvements in 6MWD had no predictive value. For NT-proBNP, absolute declines conferred no prognostic information while relative declines by >= 35% were associated with better survival. Improvements in multicomponent endpoints were associated with improved survival and the same was found for risk stratification tools. CONCLUSION: While sole improvements in 6MWD and NT-proBNP had minor prognostic relevance, improvements in multicomponent endpoints and risk stratification tools based on FC, 6MWD, and NT-proBNP were associated with improved survival. These tools should be further explored as outcome measures in PAH trials. (C) 2022 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pausch, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olsson, Karen M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huscher, DoerteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pittrow, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruenig, EkkehardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staehler, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vizza, Carmine DarioUNSPECIFIEDorcid.org/0000-0002-3540-4983UNSPECIFIED
Gall, HenningUNSPECIFIEDorcid.org/0000-0001-7016-7373UNSPECIFIED
Distler, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Opitz, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gibbs, J. Simon R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delcroix, MarionUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghofrani, H. ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ewert, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaemmerer, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kabitz, Hans-JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Skowasch, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Behr, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Milger, KatrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Halank, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wilkens, HeinrikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seyfarth, Hans-JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Held, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dumitrescu, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tsangaris, IraklisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vonk-Noordegraaf, AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ulrich, SilviaUNSPECIFIEDorcid.org/0000-0002-5250-5022UNSPECIFIED
Klose, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Claussen, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eisenmann, StephanUNSPECIFIEDorcid.org/0000-0002-0387-0760UNSPECIFIED
Schmidt, Kai-HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lange, Tobias J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-698259
DOI: 10.1016/j.healun.2022.03.011
Journal or Publication Title: J. Heart Lung Transplant.
Volume: 41
Number: 7
Page Range: S. 971 - 982
Date: 2022
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1557-3117
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
WALK DISTANCE; RISK SCORE; THERAPY; AMBRISENTAN; MORBIDITY; TADALAFIL; RIOCIGUAT; MORTALITY; SURVIVAL; BOSENTANMultiple languages
Cardiac & Cardiovascular Systems; Respiratory System; Surgery; TransplantationMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69825

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