WASHINGTON — Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.
One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, cialis refills and colleagues.
Five-year results from the EMPROVE study were presented here in a poster session at the American Thoracic Society annual conference.
The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.
The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.
Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).
Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.
The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV1). At five years, the FEV1 values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV1 at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV1 improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.
Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.
Overall, a total of 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.
The results suggest that the FEV1 improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.
The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine in 2019. Am J Respir Crit Care Med. 2019;200:1354-1362. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
American Thoracic Society 2023 International Conference: Poster 723. Presented May 23, 2023.
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