The REACH trial: a randomized controlled trial assessing the safety and effectiveness of the Spiration® Valve System in the treatment of severe emphysema

<b><i>Background:</i></b> Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. <b><i>Objectives:</i></b>...

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Main Authors:	Li, Shiyue (Author) , Wang, Guangfa (Author) , Wang, Changhui (Author) , Gao, Xinglin (Author) , Jin, Faguang (Author) , Yang, Huaping (Author) , Han, Baohui (Author) , Zhou, Rui (Author) , Chen, Chengshui (Author) , Chen, Liangan (Author) , Bai, Chunxue (Author) , Shen, Huahao (Author) , Herth, Felix (Author) , Zhong, Nanshan (Author)
Format:	Article (Journal)
Language:	English
Published:	2019
In:	Respiration Year: 2018, Volume: 97, Issue: 5, Pages: 416-427
ISSN:	1423-0356
DOI:	10.1159/000494327
Online Access:	Verlag, Volltext: https://doi.org/10.1159/000494327 Verlag, Volltext: https://www.karger.com/Article/FullText/494327
Author Notes:	Shiyue Li, Guangfa Wang, Changhui Wang, Xinglin Gao, Faguang Jin, Huaping Yang, Baohui Han, Rui Zhou, Chengshui Chen, Liangan Chen, Chunxue Bai, Huahao Shen, Felix J. F. Herth, Nanshan Zhong

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Summary:	<b><i>Background:</i></b> Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors. <b><i>Objectives:</i></b> The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. <b><i>Methods:</i></b> Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone). <b><i>Results:</i></b> The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, <i>p</i> = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group. <b><i>Conclusion:</i></b> The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.
Item Description:	Published online: December 14, 2018 Gesehen am 13.11.2019
Physical Description:	Online Resource
ISSN:	1423-0356
DOI:	10.1159/000494327