Hoeper, Marius M. and Pausch, Christine and Olsson, Karen M. and Huscher, Doerte and Pittrow, David and Gruenig, Ekkehard and Staehler, Gerd and Vizza, Carmine Dario and Gall, Henning and Distler, Oliver and Opitz, Christian and Gibbs, J. Simon R. and Delcroix, Marion and Ghofrani, H. Ardeschir and Ewert, Ralf and Kaemmerer, Harald and Kabitz, Hans-Joachim and Skowasch, Dirk and Behr, Juergen and Milger, Katrin and Halank, Michael and Wilkens, Heinrike and Seyfarth, Hans-Juergen and Held, Matthias and Dumitrescu, Daniel and Tsangaris, Iraklis and Vonk-Noordegraaf, Anton and Ulrich, Silvia and Klose, Hans and Claussen, Martin and Eisenmann, Stephan and Schmidt, Kai-Helge and Rosenkranz, Stephan and Lange, Tobias J. (2022) Prognostic value of improvement endpoints in pulmonary arterial hypertension trials: A COMPERA analysis. JOURNAL OF HEART AND LUNG TRANSPLANTATION, 41 (7). pp. 971-981. ISSN 1053-2498, 1557-3117
Full text not available from this repository. (Request a copy)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: | Article |
|---|---|
| Uncontrolled Keywords: | WALK DISTANCE; RISK SCORE; THERAPY; AMBRISENTAN; MORBIDITY; TADALAFIL; RIOCIGUAT; MORTALITY; SURVIVAL; BOSENTAN; pulmonary arterial hypertension; treatment; clinical trials; endpoints; risk; mortality |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 19 Sep 2023 13:33 |
| Last Modified: | 19 Sep 2023 13:33 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58806 |
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