The REACH study, a randomized controlled trial assessing the safety and effectiveness of the Spiration Valve System endobronchial therapy for severe emphysema: 12 month follow-up results

The REACH study is the first multicenter randomized controlled trial conducted in China assessing the safety and effectiveness of endobronchial 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. 64.6% of patients at 12 months showed evidence of significant (TLVR at 350 ml MCID). Mean TLVR in treatment patients was 781 ml at 12 months. Compared to control, the treatment group achieved a significant and clinically meaningful improvement in FEV1 at the 1, 3, 6 and 12 month visits (16.8%, 14.2%, 20.7%, 22.8%) with a responder rate of approximately 39.8% at 12 months. Significant improvements were also observed for quality of life measures and 6MWT. Between the 6 and 12 month follow-up visits, there were 8 serious adverse events in the treatment group consisting primarily of acute COPD exacerbations (6), lung abscess (1) and pneumothorax (1). There was one control and no treatment group deaths. In conclusion, this is the first multicenter study comparing endobronchial valve therapy to medical arm control that has demonstrated 12 month sustained clinically meaningful benefit with acceptable adverse events for severe emphysema patients selected only by HRCT.