Gerard J. Criner, Antoine Delage , Kirk Voelker et al
Summary: In this multicenter, open-label, randomized, controlled trial, subjects aged 40years or older with severe, heterogeneous emphysema were randomized 2:1 to Spiration Valve System (SVS) (n=113) with medical management (treatment) or medical management alone (control) (n=59).
Results: the primary endpoint of Mean FEV1 showed statistically significant improvements with between-group difference at 6 and 12 months, respectively, of 0.101 L (95% BCI, 0.060–0.141) and 0.099 L (95% BCI, 0.048–0.151). At 6 months, the treatment group had statistically significant improvements in all secondary endpoints including health status and dyspnea, except 6-minute-walk distance. Adverse event incidence through 6 months was greater in the treatment group (31.0% vs. 11.9%), primarily due to a 12.4% incidence of serious pneumothorax.