Olympus announced today the publication of the results of the EMPROVE clinical trial, entitled “Improving Lung Function in Severe Heterogenous Emphysema with the Spiration® Valve System (EMPROVE): A Multicenter, Open-Label, Randomized, Controlled Trial” in the American Journal of Respiratory and Critical Care Magazine (AJRCCM), appearing the week of July 29, 2019. The AJRCCM, frequently called the “Blue Journal,” is a biweekly peer-reviewed medical journal published in two yearly volumes by the American Thoracic Society.
For patients with the progressive disability of severe emphysema, improved lung function and quality of life have been seen with lung volume reduction surgery. However, eligibility for such invasive surgery is contingent upon the patient’s overall health status and pattern of emphysema, leaving the vast majority of patients ineligible. Less invasive measures are therefore needed.
The Spiration Valve is an umbrella-shaped device that is placed in targeted airways of the lung during a short bronchoscopic procedure. Once in place, the valves redirect air from diseased parts of the lung to healthier parts, allowing the healthier lung tissue to expand and function more effectively. With a potential reduction in lung volume, a patient may be able to breathe more easily and experience improvement in their quality of life.1 FDA approval of the Spiration Valve System (SVS), which was based on results of the EMPROVE trial, was announced in December 2018. The product has been commercially available since January 2019.
In this multicenter, open-label, randomized, controlled trial, 172 subjects aged ≥40 years with severe heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control). The primary efficacy outcome was the difference in mean forced expiratory volume in 1 second (FEV1) from baseline to 6 months. Mean FEV1 improved significantly for the treatment group (0.099 liters) vs the control group (‑0.002 liters). FEV1, which measures the amount of air a person can breathe out quickly and forcibly after a deep breath, is a frequently used measurement for staging COPD and a predictor of morbidity. Further analysis of the EMPROVE trial data showed that the treatment group had significantly greater improvement in secondary endpoints including target lobe volume reduction, hyperinflation, health status and dyspnea. These results were durable through the 12 month follow-up.
The primary safety outcome, incidence of composite thoracic serious adverse events (SAE), was greater in the treatment than control group (31.0% and 11.9%, respectively). However, pneumothorax was the only individual SAE with significantly higher treatment group incidence, a finding also shown in other comparable studies. Early-onset pneumothorax in the treatment group likely resulted due to acute reduction in lung volume by valve therapy and is a recognized indicator of successful target lobe occlusion. Other SAEs observed in the study include COPD exacerbations, pneumonia and death. Overall, investigators concluded that, in patients with severe heterogeneous emphysema, the Spiration Valve System shows significant improvement in multiple efficacy outcomes, with a favorable risk-benefit profile.
Emphysema is a progressive form of Chronic Obstructive Pulmonary Disease (COPD) that has affected 3.4 million people in the U.S., according to the Centers for Disease Control and Prevention.2 The disease causes a loss of elasticity in lung tissue and enlargement of the alveoli. As a result, emphysematous lobes become hyperinflated, causing shortness of breath. The results of the EMPROVE Trial and other randomized trials of valve therapy have led to the inclusion of bronchoscopic lung volume reduction therapy as an important component of the clinical therapy recommendations3,4 for the underserved patient population with severe emphysema.