Patients with severe emphysema experienced significant and durable clinical improvements over 24 months with bronchoscopic lung volume reduction (BLVR) using the Spiration Valve System (SVS), which maintained an acceptable safety profile, according to study findings published in the Annals of the American Thoracic Society.
In the EMPROVE trial of patients with severe heterogeneous emphysema (ClinicalTrials.gov Identifier: NCT01812447), BLVR/SVS demonstrated improvements in lung function, dyspnea, and quality-of-life (QOL) over 24 months of use. For the current report, researchers evaluated follow-up data from patients enrolled in EMPROVE to assess BLVR/SVS efficacy and safety for patients’ second year of device use.
EMPROVE, a prospective, open-label, randomized controlled trial, enrolled 172 patients at 31 sites across Canada and the United States from October 2013 to mid-December 2019. Patients, who were at least 40 years of age, initially were assigned in a 2:1 ratio to the treatment group (n=113) and to a control group (n=59). After the initial 12 months of EMPROVE, 96 patients remained evaluable in the treatment group and 43 patients in the control group. After the 24-month follow-up period, 80 patients in the treatment group and 34 patients in the control group remained evaluable.
At baseline, no between-group differences were discernible in participants’ high-resolution computed tomography, plethysmography, pulmonary function, or QOL.
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The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months.The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months.
The researchers found forced mean (SD) expiratory volume in 1 second (FEV1) improved significantly and continued across 24 months in the treatment group (n=71) compared with the control group (n=30) (-0.082L [0.156] vs 0.005L [0.163], respectively). In the treatment group, 19.7% (14/71) of patients showed FEV1 response at 24 months, although this was not statistically significant compared with the control group (P =.57).
The St. George’s Respiratory Questionnaire and the COPD (chronic obstructive pulmonary disease) Assessment Test showed that significant improvement was maintained.
The researchers noted the modified Medical Research Council dyspnea scale score indicated the treatment group experienced significantly less dyspnea vs the control group. No between-group differences were noted in adverse events at 24 months. Acute COPD exacerbation rates were similar (treatment group, 13.7% [14/102]; control group, 15.6% [7/45]). Pneumothorax rates were low (treatment group, 1.0% [1/102]; control group, 0.0% [0/45]).
The researchers stated there were no occurrences of unexpected serious device-related adverse events (SAEs) between 12 and 24 months; however, 2 device-related deaths occurred from baseline to 12 months. Overall mortality rates at 24 months were 18% in the treatment group and 15% in the control group (P =.81). Patients who died at 24 months vs those who survived were older at baseline and had a significantly lower 6-minute-walk distance and poorer lung function at baseline.
Study limitations include the unblinded design, which lead to potential bias that was reflected in the subjective parameters of the control group.
“The results of the EMPROVE study indicate a marked improvement in lung function, QOL, and dyspnea in patients in the SVS treatment group, which remained durable for at least 24 months,” the researchers concluded. The study authors wrote, “The safety profile remains satisfactory, with minimal device-related issues in this longer follow-up period.”
Disclosure: This research was supported by Olympus Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
