In:
Respiration, S. Karger AG, Vol. 100, No. 8 ( 2021), p. 804-810
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Objective: 〈 /i 〉 〈 /b 〉 We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. 〈 b 〉 〈 i 〉 Method: 〈 /i 〉 〈 /b 〉 Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] & #x3e;55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV 〈 sub 〉 1 〈 /sub 〉 ) and St George’s Respiratory Questionnaire (SGRQ) total score at 6 months. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV 〈 sub 〉 1 〈 /sub 〉 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 FEV 〈 sub 〉 1 〈 /sub 〉 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. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 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.
Type of Medium:
Online Resource
ISSN:
0025-7931
,
1423-0356
Language:
English
Publisher:
S. Karger AG
Publication Date:
2021
detail.hit.zdb_id:
1464419-8
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