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A prospective study of the 6 min walk test as a surrogate marker for haemodynamics in two independent cohorts of treatment-naive systemic sclerosis-associated pulmonary arterial hypertension

Pascal de Groote 1 Vincent Cottin 2, 3 Pascal Magro Gregoire Prevot Fabrice Bauer 4 Emmanuel Bergot 5 Céline Chabanne 6, 7 Martine Reynaud-Gaubert 8, 9 Sylvie Leroy 10 Matthieu Canuet 11 Olivier Sanchez 12 Christophe Gut-Gobert 13 Claire Dauphin 14 Christophe Pison 15, 16, 17 Clement Boissin Gilbert Habib 18, 8 Pierre Clerson 19 Francois Conesa Jean-François Cordier 20 Steven M. Kawut Gérald Simonneau 21, 22, 23 Marc Humbert 21, 22, 23 Sebastien Sanges David Launay 1, 24, 25 Rennie L. Rhee Olivier Sitbon 21, 23, 22 Eric Hachulla 26 Luc Mouthon 27 Loïc Guillevin 27 Laurence Rottat David Montani 21, 22, 23 
Abstract :
Objectives Despite the wide use of the 6 min walk distance (6MWD), no study has ever assessed its validity as a surrogate marker for haemodynamics and predictor of outcome in isolated pulmonary arterial hypertension associated with systemic sclerosis (SSc-PAH). We designed this work to address this issue.
Methods Treatment-naive patients with SSc-PAH were prospectively included from two sources: the French PAH Network (a prospective epidemiological cohort) (n=83) and randomised clinical trials submitted for drug approval (Food and Drug Administration) (n=332). Correlations between absolute values of the 6MWD and haemodynamics at baseline, as well as between variations of 6MWD and haemodynamics during follow-up, were studied in both populations.
Results In the French cohort, baseline cardiac output (CO) (R-2=0.19, p=0.001) and New York Heart Association class (R-2=0.10, p<0.001) were significantly and independently correlated with baseline 6MWD in multivariate analysis. A significant, independent, but weaker, correlation with CO was also found in the Food and Drug Administration sample (R-2=0.04, p<0.001). During follow-up, there was no association between the changes in 6MWD and haemodynamic parameters in patients under PAH-specific treatments.
Conclusions In SSc-PAH, CO independently correlates with 6MWD at baseline, but accounts for a small amount of the variance of 6MWD in both study samples. This suggests that other non-haemodynamic factors could have an impact on the walk distance. Moreover, variations of 6MWD do not reflect changes in haemodynamics among treated patients. Our results suggest that 6MWD is not an accurate surrogate marker for haemodynamic severity, nor an appropriate outcome measure to assess changes in haemodynamics during follow-up in treated SSc-PAH.
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Submitted on : Friday, February 3, 2017 - 4:28:22 PM
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Distributed under a Creative Commons Attribution - NonCommercial 4.0 International License

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Pascal de Groote, Vincent Cottin, Pascal Magro, Gregoire Prevot, Fabrice Bauer, et al.. A prospective study of the 6 min walk test as a surrogate marker for haemodynamics in two independent cohorts of treatment-naive systemic sclerosis-associated pulmonary arterial hypertension. Annals of the Rheumatic Diseases, BMJ Publishing Group, 2016, 75 (8), pp.1457-1465. ⟨10.1136/annrheumdis-2015-207336⟩. ⟨hal-01455600⟩

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