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

Abstract

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® 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.

<p>An Integrative Approach of the Fissure Completeness Score and Chartis Assessment in Endobronchial Valve Treatment for Emphysema</p>

“…Various studies used a cut-off value of 90% to define a fissure as complete. 3,14,16,18,20 However, as our study shows, even with a fissure integrity of over 90%, a significant number of patients still have collateral ventilation and will not benefit from endobronchial valve treatment.…”

“…12,13 Although Chartis measurement is clinical practice in many clinics, there are recent studies that advocate the use of the fissure cut-off score of 90% only. 19,20 However, more accurate selection of responder patients prevents unnecessary procedures, non-beneficial treatments and extra costs in patients with collateral ventilation. Therefore, we performed a study to correlate the FCS to the Chartis assessment.…”

Endobronchial valves for severe emphysema

“…Currently, there are two RCTs that investigated the Spiration valve system. In the REACH study [21] (EBV: n=66; standard of care: n=33), the patients treated with valve significantly improved after 6 months in FEV1 (+91 mL), SGRQ (−8.4 points) and 6MWD (+21 m) and after 12 months the improvements were +40 mL, −3.8 points and +4.5 m, respectively [22]. The pneumothorax rate was 7.5% in the REACH trial up to 6 months follow-up.…”

Lung Volume Reduction in Pulmonary Emphysema

“…REACH in 2019 was a Chinese multicenter RCT of 99 patients with severe heterogeneous emphysema (!15% difference between target and ipsilateral lobes), intact interlobar fissures (!90%) and hyperinflation comparing the SVS (n ¼ 66) to SoC (n ¼ 33). 46 The primary endpoint, the difference between groups' absolute FEV1 changes at 3 months, was statistically significant favoring the treatment arm (0.104 AE 0.178 L vs. 0.003 AE 0.147 L; p ¼ 0.001) durable to 6 months with a responder rate for FEV1 !15 of 41% (21% SoC). This was accompanied by mean TLVR of 757 mL (MCID of À350 mL was The SAE rate was 33% in the treatment group and 24.2% in the control group: the majority were COPD exacerbations (19.7% SVS vs. 12.1% SoC).…”