Prognostic value of improvement endpoints in pulmonary arterial hypertension trials: A COMPERA analysis.
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Hoeper Marius M, Pausch Christine, Olsson Karen M, Huscher Doerte, Pittrow David, Grünig Ekkehard, Staehler Gerd, Vizza Carmine Dario, Gall Henning, 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-Jürgen, Held Matthias, Dumitrescu Daniel, Tsangaris Iraklis, Vonk-Noordegraaf Anton, Ulrich Silvia, Klose Hans, Claussen Martin, Eisenmann Stephan, Schmidt Kai-Helge, Rosenkranz Stephan, Lange Tobias J
Аннотация
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.