LATE-BREAKING ABSTRACT: The REACH study, a randomized controlled trial assessing the safety and effectiveness of the spiration valve system intra-bronchial therapy for severe emphysema

The REACH study is the first multicenter randomized controlled trial conducted in China assessing the safety and effectiveness of bronchial valve treatment for severe emphysema patients with complete fissures. The study objectives were target lobe volume reduction (TLVR) and significant improvement in lung function. 101 subjects, 66 treatment and 35 control, were enrolled at 12 study sites. Target lobe selection, based on visual HRCT identified an upper lobe in 55% and a lower lobe in 45% of patients. Treatment consisted of target lobe occlusion utilizing the Spiration Valve System (Olympus, USA). The control group received optimal medical management. 67% of patients at 6 months showed evidence of significant (TLVR). Mean TLVR in treatment patients was 779 ml at 6 months. Compared to control, the treatment group achieved a significant and clinically meaningful improvement in FEV1 at the 1, 3, and 6 month visits (16.8%, 14.2%, 20.7%, respectively) with a responder rate of approximately 60% at these time periods. Significant improvements were also observed for quality of life measures and 6MWT. There were 24 serious adverse events in the treatment group consisting primarily of acute COPD exacerbations (12) and pneumothorax (5). There was one control and no treatment group deaths. In conclusion, this is the first multicenter study comparing bronchial valve therapy to medical arm control that has met its primary effectiveness end point and demonstrated sustained clinically meaningful benefit with acceptable adverse events for severe emphysema patients selected only by HRCT.