Journal
JOURNAL OF HEART AND LUNG TRANSPLANTATION
Volume 34, Issue 3, Pages 362-368Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.healun.2014.08.020
Keywords
6-minute walk distance; pulmonary arterial hypertension; survival outcomes; prognostic value; surrogate end points
Funding
- Actelion Pharmaceuticals US Inc
- Gilead
- United Therapeutics
- Gilead Sciences Inc
- Medtronic Inc
- Ventripoint
- GlaxoSmithKline
- Actelion
- Pfizer
- United Therapeutics/Lung Rx
- Intermune
- Stomedix
- Bayer
- Novartis
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BACKGROUND: Clinical studies of pulmonary arterial hypertension have used the change in the 6-minute walk distance (6MWD) as a clinical end point; however, its association with survival outcomes has not been well established. In this analysis, we examined the prognostic value of the baseline 6MWD, absolute thresholds of the 6MWD, and change in the 6MWD. METHODS: Patients in the Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL) with 6MVVD at enrollment, with or without a follow-up assessment within the first year of observation, were included. Kaplan-Meier survival estimates were computed for sub-sets with baseline 6MWD results that were above or below all possible thresholds and for sub-sets with a change in the 61VIWD that was 10 percentage points above or below all possible thresholds, including improvement thresholds and worsening thresholds. Multivariable Cox regression models assessed the effect of improvement and worsening in the 6MWD on 1-year survival, adjusted for baseline factors. RESULTS: One-year survival estimates were higher for patients with a baseline 6MV TD above vs below a threshold, although no specific threshold was more prognostic than another. In a model adjusted for the baseline 6MWD and risk score, worsening of the 6MWD over time significantly predicted decreased survival, but improvement in the 6MWD did not affect survival. CONCLUSIONS: No 6MWD improvement threshold carries particular prognostic value. Improvement in the 6MWD was not associated with survival, but worsening of the 6MWD was strongly and significantly associated with poor prognosis. (C) 2015 International Society for Heart and Lung Transplantation. All rights reserved.
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