Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Floridsdorf, Austria.
Respiration. 2021;100(8):804-810. doi: 10.1159/000515744. Epub 2021 May 7.
Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity.
We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection.
Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] >55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score at 6 months.
Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV1 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV1 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by -10.6 [-15.9 to -5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported.
Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.
支气管镜肺减容术使用支气管内线圈是一种治疗严重肺气肿患者的新方法。迄今为止，其疗效有限，并且在严重过度充气和非多合并症患者中效果更大。
我们旨在通过优化患者选择，在一项随机多中心临床试验中评估支气管内线圈治疗的疗效和安全性。
对 HRCT 扫描显示严重肺气肿、严重过度充气（残气量[RV]≥200%预测值且 RV/总肺容量[TLC]＞55%）的患者进行随机分组，接受线圈治疗或对照组治疗。主要终点测量指标为治疗 6 个月时用力呼气量 1 秒率（FEV1）和圣乔治呼吸问卷（SGRQ）总评分的差异。
由于研究提前终止，共有 120 名患者（年龄 63±7 岁，FEV1 预测值 29±7%，RV 预测值 251±41%，RV/TLC 67±6%，和 SGRQ 58±13 分），而不是 210 名患者被随机分组。研究终止时，91 名患者（线圈组 57 名，对照组 34 名）有 6 个月的结果。分析表明，线圈组明显更有利于改善。与对照组相比，线圈组的 FEV1 增加了+10.3[+4.7 至+16.0]%，SGRQ 减少了-10.6[-15.9 至-5.4]分。研究终止时，线圈组有 5 名（6.8%）患者死亡。
尽管研究提前终止，但与对照组相比，线圈治疗在 6 个月内可显著改善肺气肿和严重过度充气患者的肺功能和生活质量，这些改善具有临床意义，但与严重不良事件的发生几率较高相关。
