The Effectiveness And Safety Of Zephyr Endobronchial Valve For The Treatment Of Heterogeneous Emphysema In China : A Multi-center Randomized Controlled Clinical Trial

X. Xie*^a (Prof), X. Li^a (Prof), X. Li^a (Prof), Y. Huang^b (Prof), Q. Feng^c (Prof), X. Wang^a (Prof), J. Luo^a (Prof), C. Wei^a (Mrs), J. Liu^a (Mrs)

^a The First People's Hospital of Neijiang, Neijiang, CHINA ; ^b Chongqing People's Hospital, Chongqing, CHINA ; ^c Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University, Guangzhou, CHINA

* xiufangxie84@163.com

Objective: To assess the efficacy and safety of Zephyr valve Endobronchial Valve (EBV) for treating Chinese patients with severe heterogeneous emphysema without collateral ventilation.

Methods: This prospective, multi-center, randomized controlled clinical trial enrolled patients from 3 sites from April 2017 to April 2020. Subjects were randomized into an EBV group and Standard-of-Care (SoC) group. The subjects from the SoC group received Standard-of-Care and were discharged after post-bronchoscopy; those with EBV underwent placement of Zephyr EBV valves during the same session. The primary outcome was the percentage of subjects who showed improvement in the post-bronchodilator (post-BD) FEV1 of ≥15% at 1-year follow-up. Secondary endpoints were: the difference between an absolute change in FEV1, Six-Minute Walk Distance (6MWD), St.George’s Respiratory Questionnaire (SGRQ), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Modified Medical Research Council Dyspnea Scale (mMRC) at 12-months.

Results: A total of 60 subjects (20 EBV, and 40 SoC) were included. At 12-months, 55% EBV and 25% SoC subjects had a ∆FEV1 ≥15% (p＜0.001).with a between-group absolute difference of 30.0, RR:2.2 [95% CI: 22.84% to 57.16%; p<0.001; Intention-to-Treat], from baseline to 12-months follow-up difference in FEV1 (0.249L, [95% CI: 0.200 to 0.298]), 6MWD (+154.640meters, [95% CI: 120.463 to 188.817]), mMRC (-0.75 points, [95% CI: -0.287 to -1.213]), SGRQ (-14.125 points, [95% CI: -13.076 to -15.174]), CAT (-9.10 points, [95% CI: -8.24 to -11.35](all p＜0.05)

Conclusions: Compared to Standard-of-Care (SoC), Zephyr valve EBV can improve lung function, dyspnea, quality of life, and exercise capacity for at least 1-year in COPD patients without collateral ventilation.

References:

1. Low SW, Lee JZ, Desai H, Hsu CH, Sam AR, Knepler JL. Endobronchial Valves Therapy for Advanced Emphysema: A Meta-Analysis of Randomized Trials. J Bronchology Interv Pulmonol. 2019;26(2):81-89.

Disclosure of funding source(s):

This work was supported by the Key Support Project of Sichuan Provincial Health Commission[17ZD003].