OBJECTIVES: The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH). BACKGROUND: 6MWD is used as an endpoint to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown. METHODS: Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes. RESULTS: Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio [OR]: 0.429; 95% confidence interval [CI]: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected. CONCLUSIONS: In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes.
OBJECTIVES: The objectives of this study were to verify whether improvement in 6-min walk distance (6MWD) is associated with clinical outcome in pulmonary arterial hypertension (PAH). BACKGROUND: 6MWD is used as an endpoint to assess the benefit of therapies in PAH. However, whether changes in 6MWD correlate with clinical outcome is unknown. METHODS: Randomized trials assessing 6MWD in patients with PAH and reporting clinical endpoints were included in a meta-analysis. The meta-analysis was performed to assess the influence of treatment on outcomes. Meta-regression analysis was performed to test the relationship between 6MWD changes and outcomes. RESULTS: Twenty-two trials enrolling 3,112 participants were included. Active treatments led to significant reduction of all-cause death (odds ratio [OR]: 0.429; 95% confidence interval [CI]: 0.277 to 0.664; p < 0.01), hospitalization for PAH, and/or lung or heart-lung transplantation (OR: 0.442; 95% CI: 0.309 to 0.632; p < 0.01), initiation of PAH rescue therapy (OR: 0.555; 95% CI: 0.347 to 0.889; p = 0.01), and composite outcome (OR: 0.400; 95% CI: 0.313 to 0.510; p < 0.01). No relationship between 6MWD changes and outcomes was detected. CONCLUSIONS: In patients with PAH, improvement in 6MWD does not reflect benefit in clinical outcomes.
Authors: John H Newman; Stuart Rich; Steven H Abman; John H Alexander; John Barnard; Gerald J Beck; Raymond L Benza; Todd M Bull; Stephen Y Chan; Hyung J Chun; Declan Doogan; Jocelyn Dupuis; Serpil C Erzurum; Robert P Frantz; Mark Geraci; Hunter Gillies; Mark Gladwin; Michael P Gray; Anna R Hemnes; Roy S Herbst; Adrian F Hernandez; Nicholas S Hill; Evelyn M Horn; Kendall Hunter; Zhi-Cheng Jing; Roger Johns; Sanjay Kaul; Steven M Kawut; Tim Lahm; Jane A Leopold; Greg D Lewis; Stephen C Mathai; Vallerie V McLaughlin; Evangelos D Michelakis; Steven D Nathan; William Nichols; Grier Page; Marlene Rabinovitch; Jonathan Rich; Franz Rischard; Sharon Rounds; Sanjiv J Shah; Victor F Tapson; Naomi Lowy; Norman Stockbridge; Gail Weinmann; Lei Xiao Journal: Am J Respir Crit Care Med Date: 2017-06-15 Impact factor: 21.405