The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema

Background: 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. Objectives: The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration (R) Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema. Methods: 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). Results: 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, p = 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. Conclusion: The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile. (c) 2018 The Author(s) Published by S. Karger AG, Basel