Spiration valve system for emphysema yields sustained quality of life benefit at 2 years

Patients with severe heterogeneous emphysema treated with a support expiration valve system had a sustained clinically significant benefit in health-related quality of life at 24 months in the EMPROVE trial.

“Our current treatments for patients with COPD are effective for patients with predominant airways disease to alleviate the hyperinflation that patients face. However, for those with a predominant emphysematous phenotype, it’s challenging for those drugs to give effective relief,” Gerard J. Criner, MD, FACP, FACCP, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center, Philadelphia, said during a presentation at the European Respiratory Society International Congress.

The prospective, multicenter, randomized controlled EMPROVE trial included 174 patients from 31 sites in North America with advanced emphysema who were older than 40 years with an FEV₁ less than 45%, a total lung capacity of 100% or more and a residual volume of 150% or more. Patients were randomly assigned to treatment with the Spiration Valve System (Olympus; n = 113) or the control group (n = 59).

For the current analysis, researchers assessed health-related quality of life at 24-month follow-up. Health-related quality of life was determined using the St. George’s Respiratory Questionnaire, the modified Medical Research Council dyspnea scale and the COPD Assessment Test. At 24 months, researchers had data on 80 patients in the treatment group and 34 in the control group.

At 24 months, results showed sustained health-related quality of life in patients in the treatment group, Criner said. Mean change from baseline to 24 months in the modified Medical Research Council dyspnea scale was –0.6 points compared with the control group (P < .01). The researchers reported a similar improvement of –6.5 points in the St. George’s Respiratory Questionnaire and –2.6 points on the COPD Assessment Test (P < .05 for both).

Change in the global assessment of quality of life was not significant at 24 months.

When evaluating FEV₁, researchers reported a 90 mL difference at 24 months favoring the treatment group compared with an intergroup difference of 100 mL at 12 months. Both declines in FEV₁ were similar, suggesting disease progression and not change in the trajectory of change with treatment vs. the control group, according to Criner.

Researchers reported no difference in safety outcomes between the two groups for all serious adverse events plus the components of death, COPD exacerbation, pneumonia or pneumothorax at follow-up.

“We concluded from this study, at 24 months, following up the improved data and randomized controlled trial that Spiration Valve System treatment provided a sustained clinically significant benefit and disease-specific health-related quality of life in patients with severe heterogeneous emphysema,” Criner said. “It also produced statistically significant and clinically meaningful outcomes in lung function dyspnea along with a good safety profile, which indicates durability of its treatment benefits.”