PURPOSE:Given the mutifactorial nature of COPD, accurately assessing global changes in patient clinical status is complex. New composite end points such as the BODE Index have been developed in an effort to address this issue. The goal of this study was to assess changes in BODE Index following endobronchial valve therapy in patients with advanced emphysema.
METHODS:A large, multicenter, randomized, trial comparing endobronchial valve therapy to medical management in patients with severe emphysema was conducted between December 2004 and April 2006. The study enrolled 321 patients (220 treatment, 101 control). Each component of the BODE Index (body mass index, FEV1, dyspnea and 6 minute walk test distance) was measured at baseline and during follow-up. BODE index was calculated for each patient and analyzed. The index uses a 0–10 point scale where a lower score indicates better health status. A multivariate analysis was performed to assess whether BODE index was correlated with mortality.
RESULTS:The BODE Index at 180 day follow-up worsened in the controlgroup (index increased) and improved in the valve treatment group (index decreased). The difference in the mean changes from baseline were highly statistically significant. (Control: +0.32; Treatment: -0.21; p=0.002). The proportion of patients whose index decreased by 1 or more points was also statistically significantly higher in the valve treatment group (40.0%) compared to controls (18.6%), p=0.002. Results of a multivariate Cox regression model analysis showed baseline BODE to be significantly associated with mortality with a higher value beingassociated with higher risk (hazard ratio 1.637; p=0.022).
CONCLUSION:Endobronchial valve therapy is associated with statistically significant increases in BODE Index. The correlation of baseline BODE index to mortality in this study parallels findings of other trials and reinforces its potential value as a clinical endpoint.
CLINICAL IMPLICATIONS:BODE Index may be use useful marker for measuring outcomes of new therapies. Further study of the impact of endobronchial valve therapy on BODE Index is warranted.
DISCLOSURE:Felix Herth, None.