Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials

Gianluigi Savarese, Stefania Paolillo, Pierluigi Costanzo, Carmen D'Amore, Milena Cecere, Teresa Losco, Francesca Musella, Paola Gargiulo, Caterina Marciano, Pasquale Perrone-Filardi

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1192-1201
Number of pages10
JournalJournal of the American College of Cardiology
Volume60
Issue number13
DOIs
Publication statusPublished - Sep 25 2012

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Pulmonary Hypertension
Meta-Analysis
Odds Ratio
Confidence Intervals
Heart-Lung Transplantation
Cause of Death
Hospitalization
Therapeutics
Regression Analysis
Lung

Keywords

  • 6-minute walk distance (6MWD)
  • 6-minute walk test (6MWT)
  • pulmonary arterial hypertension

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials. / Savarese, Gianluigi; Paolillo, Stefania; Costanzo, Pierluigi; D'Amore, Carmen; Cecere, Milena; Losco, Teresa; Musella, Francesca; Gargiulo, Paola; Marciano, Caterina; Perrone-Filardi, Pasquale.

In: Journal of the American College of Cardiology, Vol. 60, No. 13, 25.09.2012, p. 1192-1201.

Research output: Contribution to journalArticle

Savarese, Gianluigi ; Paolillo, Stefania ; Costanzo, Pierluigi ; D'Amore, Carmen ; Cecere, Milena ; Losco, Teresa ; Musella, Francesca ; Gargiulo, Paola ; Marciano, Caterina ; Perrone-Filardi, Pasquale. / Do changes of 6-minute walk distance predict clinical events in patients with pulmonary arterial hypertension? A meta-analysis of 22 randomized trials. In: Journal of the American College of Cardiology. 2012 ; Vol. 60, No. 13. pp. 1192-1201.
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AU - Paolillo, Stefania

AU - Costanzo, Pierluigi

AU - D'Amore, Carmen

AU - Cecere, Milena

AU - Losco, Teresa

AU - Musella, Francesca

AU - Gargiulo, Paola

AU - Marciano, Caterina

AU - Perrone-Filardi, Pasquale

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AB - 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.

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